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Sections
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Order 1. Short title and commencement.
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Order 2. Definitions.
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Order 3. Directions to manufacturers of active pharmaceutical ingredients or bulk drugs or formulations.
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Order 4. Calculation of ceiling price of a scheduled formulation.
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Order 5. Calculation of retail price of a new drug for existing manufacturers of scheduled formulations.
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Order 6. Ceiling price of a scheduled formulation in case of no reduction in price due to absence of competition.
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Order 7. Margin to retailer.
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Order 8. Maximum retail price.
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Order 9. Reference data and source of market based data.
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Order 10. Pricing of the formulations covered under Drugs (Prices Control) Order, 1995.
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Order 11. Ceiling price or retail price of a pack.
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Order 12. Price of formulations (branded or generic version) listed in the National List of Essential Medicines, launched by a manufacturer.
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Order 13. Price of scheduled formulations for the existing manufacturers.
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Order 14. Fixation of ceiling price of scheduled formulations.
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Order 15. Fixation of retail price of a new drug for existing manufacturers of scheduled formulations.
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Order 16. Revision of ceiling price of scheduled formulations.
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Order 17. Amendment of the list of scheduled formulation.
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Order 18. Revision of ceiling price on the basis of moving annual turnover (MAT).
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Order 19. Fixation of ceiling price of a drug under certain circumstances.
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Order 20. Monitoring the prices of non-scheduled formulations.
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Order 21. Monitoring the availability of scheduled formulations.
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Order 22. Recovery of dues accrued under the Drugs (Prices Control) Order, 1979 and to deposit the same into the Drugs Prices Equalisation Account.
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Order 23. Recovery of overcharged amount under Drugs Prices Control Orders 1987 and 1995.
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Order 24. Carrying into effect the price fixed or revised by the Government, its display and proof thereof.
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Order 25. Display of prices of non-scheduled formulations and price list thereof.
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Order 26. Control of sale prices of formulations.
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Order 27. Sale of split quantities of formulations.
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Order 28. Manufacturer, distributor or dealer not to refuse sale of drug.
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Order 29. Maintenance of records and production thereof for inspection.
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Order 30. Power of entry, search and seizure.
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Order 31. Power to review.
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Order 32. Non-application of the provisions of this order in certain cases.
Drugs
(Prices Control) Order, 2013
PREAMBLE
In exercise of the powers
conferred by section 3 of the Essential Commodities Act, 1955, (10 of 1955),
and supersession of the Drug (Prices Control) Order, 1995, except as respect to
things done or omitted to be done before such supersession, the Central Government
hereby makes the following Order, namely:-
Order 1. Short title and commencement.
(1)
This Order may be called the Drugs (Prices Control) Order, 2013.
(2)
It shall come into force on the date of its publication in the
Official Gazette.
Order 2. Definitions.
(1)
In this Order, unless the context otherwise requires,-
(a)
"Act" means the Essential Commodity Act, 1955 (10 of
1955);
(b)
"active pharmaceutical ingredients or bulk drug" means
any pharmaceutical, chemical, biological or plant product including its salts,
esters, isomers, analogues and derivatives, conforming to standards specified
in the Drugs and Cosmetics Act, 1940 (23 of 1940) and which is used as such or
as an ingredient in any formulation;
(c)
"brand" means a name, term, design, symbol, trademark or
any other feature that identifies one seller's drug as distinct from those of
other sellers;
(d)
"ceiling price" means a price fixed by the Government
for Scheduled formulations in accordance with the provisions of this Order;
(e)
"dealer" means a person carrying on the business of
purchase or sale of drugs, whether as a wholesaler or retailer and includes his
agent;
(f)
"distributor" means a person engaged in the work of
distribution of drugs and includes an agent or a stockist for stocking drugs
for sale to a dealer;
(g)
"existing manufacturer" means manufacturer existing on
the date of publication of this order in the Official Gazette.
(h)
"Form" means a form specified in the Second Schedule;
(i)
"formulation" means a medicine processed out of or
containing one or more drugs with or without use of any pharmaceutical aids,
for internal or external use for or in the diagnosis, treatment, mitigation or
prevention of disease and, but shall not include-
(i)
any medicine included in any bonafide Ayurvedic (including Sidha)
or Unani (Tibb) systems of medicines;
(ii)
any medicine included in the Homeopathic system of medicine; and
(iii)
any substance to which the provisions of the Drugs and Cosmetics
Act, 1940 (23 of 1940) do not apply;
(j)
"generic version of a medicine" means a formulation sold
in pharmacopeial name or the name of the active pharmaceutical ingredient
contained in the formulation, without any brand name;
(k)
"Government" means the Central Government;
(l)
"import" with its grammatical variations and cognate
expressions means bringing a drug into India from a place outside India for its
sale;
(m)
"local taxes" means any tax or levy (except excise or
import duty included in retail price) paid or payable to the Government or the
State Government or any local body under any law for the time being in force by
the manufacturer or his agent or dealer;
[1][(n)
"manufacturer" for the purpose of this Order means any person who
manufactures or imports or markets drugs for distribution or sale in the
country;]
(o) "market share" means the ratio of
domestic sales value (on the basis of moving annual turnover) of a brand or a
generic version of a medicine and the sum of total domestic sales value of the
all brands and generic versions of that medicine sold in the domestic market
having same strength and dosage form;
(p) "margin to retailer" for the
purposes of this Order shall mean a percentage of price to retailer;
(q) "market based data" means the data
of sales related to a drug collected or obtained by the Government as deemed
fit, from time to time;
(r) "maximum retail price" means the
ceiling price or the retail price plus local taxes and duties as applicable, at
which the drug shall be sold to the ultimate consumer and where such price is
mentioned on the pack;
(s) "moving annual turnover" in a
particular month means cumulative sales value for twelve months in domestic
market, where the sales value of that month is added and the corresponding
sales of the same month in the previous year are subtracted;
(t) "National List of Essential
Medicines" means National List of Essential Medicines, 2011 published by
the Ministry of Health and Family Welfare as updated or revised from time to
time and included in the first schedule of this order by the Government through
a notification in the Official Gazette;
(u) "new drug" for the purposes of this
Order shall mean a formulation launched by an existing manufacturer of a drug
of specified dosages and strengths as listed in the National List of Essential
Medicines by combining the drug with another drug either listed or not listed
in the National List of Essential Medicines or a formulation launched by
changing the strength or dosages or both of the same drug of specified dosages
and strengths as listed in the National List of Essential Medicines.
[2][(v)
"non-scheduled formulation" means a formulation which is not included
in Schedule-I;]
(w) "pharmacoeconomics" means a
scientific discipline that compares the therapeutic value of one pharmaceutical
drug or drug therapy to another;
(x) "price list" means a price list
referred to in paragraphs 24 and 25 and includes a supplementary price list;
(y) "price to retailer" means the price
of a drug at which it is sold to a retailer which includes duties and does not
include local taxes;
(z) "retail price" means the price fixed
by the Government for a new drug under paragraph 5;
(za)
"retailer" means a dealer carrying on the retail business of sale of
drugs to customers;
(zb)
"scheduled formulation" means any formulation, included in the First
Schedule whether referred to by generic versions or brand name;
(zc)
"schedule" means a Schedule appended to this Order;
(zd)
"wholesaler" means a dealer or his agent or a stockist engaged in the
sale of drugs to a retailer, hospital, dispensary, medical, educational or
research institution or any other agency;
(ze)
"wholesale price index" means annual wholesale price index of all
commodities as announced by the Department of Industrial Policy and Promotion,
Government of India, from time to time.
(2)
All other words and expressions used herein and not defined but
defined in the Act or the Drugs and Cosmetics Act, 1940 (23 of 1940) shall have
the meanings respectively assigned to them in the said Acts.
Order 3. Directions to manufacturers of active pharmaceutical ingredients or bulk drugs or formulations.
The Government may,-
(i)
with a view to achieve adequate availability and to regulate the
distribution of drugs, in case of emergency or in circumstances of urgency or
in case of non-commercial use in public interest, direct any manufacturer of
any active pharmaceutical ingredient or bulk drug or formulation to increase
the production and to sell such active pharmaceutical ingredient or bulk drug
to such other manufacturer(s) of formulations and to direct formulators to sell
the formulations to institutions, hospitals or any agency as the case may be;
(ii)
for the purpose of giving any direction under sub-paragraph (i),
call for such information from manufacturers of active pharmaceutical
ingredients or bulk drugs or formulations, as it may consider necessary and
such manufacturer shall furnish the required information within such time the
Government may fix.
Order 4. Calculation of ceiling price of a scheduled formulation.
(1)
The ceiling price of a scheduled formulation of specified
strengths and dosages as specified under the first schedule shall be calculated
as under:
Step1. First the Average Price to
Retailer of the scheduled formulation i.e. P(s) shall be calculated as below:
Average Price to Retailer, P(s) =
(Sum of prices to retailer of all the brands and generic versions of the
medicine having market share more than or equal to one percent of the total
market turnover on the basis of moving annual turnover of that medicine)/(Total
number of such brands and generic versions of the medicine having market share
more than or equal to one percent of total market turnover on the basis of
moving annual turnover for that medicine.)
Step2. Thereafter, the ceiling
price of the scheduled formulation i.e. P(c) shall be calculated as below:
P(c) = P(s).(1+M/100), where
P(s) = Average Price to Retailer
for the same strength and dosage of the medicine as calculated in step1 above.
M = % Margin to retailer and its
value =16
(2)
The ceiling price calculated as per sub-paragraph (1) and notified
by the Government shall be applicable to scheduled imported formulations also.
Order 5. Calculation of retail price of a new drug for existing manufacturers of scheduled formulations.
(1)
The retail price of the new drug available in domestic market
shall be calculated as provided in sub-paragraph (1) of paragraph 4.
(2)
(i) the price to retailer of a new drug, not available in domestic
market, shall be fixed by the Government on the principles of
"Pharmacoeconomics" of the new drug, on the recommendation of a
Standing Committee of Experts formed under paragraph 15.
(ii) the retail price of such new
drug shall be fixed by adding sixteen percent margin to retailer on the price
to retailer as fixed in item (i):
Order 6. Ceiling price of a scheduled formulation in case of no reduction in price due to absence of competition.
(1)
where the average price to retailer of a scheduled formulation,
arrived at as per the formula specified in sub-paragraph (1) of paragraph 4,
has the effect of,-
(a)
no reduction in average price to retailer with respect to the
prices to retailer of the schedule formulation; and
(b)
there are less than five manufacturers for that formulation having
one percent or more market share, the ceiling price shall be calculated as
under:-
(i)
in the event of other strengths or dosage forms of the same scheduled
formulation is available in the list of scheduled formulation, the average
price to retailer shall be calculated as under:
Step1: First the Average Price to
Retailer of such scheduled formulation i.e. P(s) shall be calculated as under:
P(s) = Pm{1-(Pi1+Pi2+...)/(N*100)}
Where,
Pm = Price to Retailer of highest
priced scheduled formulation under consideration.
Pi = % reduction in Average Price
to Retailer of other strengths and dosage forms (calculated as in step1 of
sub-paragraph (1) of paragraph 4) in the list of schedule formulations w.r.t.
the highest priced formulation taken for calculating the average price to
retailer of such strengths and dosage forms.
N = Number of such other
strengths or dosage forms or both in the list of schedule formulations
Step2. Thereafter, the ceiling
price of the scheduled formulation i.e. P(c) shall be calculated as under:
P(c) = P(s).(1+M/100), where
P(s) = Average Price to Retailer
of the scheduled formulation as calculated in step1 hereinabove and
M = % Margin to retailer and its
value=16
(ii)
in the event of other strengths or dosage forms of the scheduled
formulation is not available in the schedule but there are other scheduled
formulations in same sub-therapeutic category as that of the scheduled
formulation, then the Ceiling Price shall be calculated as under:
Step1: First the Average Price to
Retailer of such scheduled formulation i.e. P(s) shall be calculated as under:
P(s) = Pm{1-(Pi1+Pi2+...)/(N*100)},
Where,
Pm = Price of highest priced
formulation taken for calculating the average price to retailer of the
formulation under consideration.
Pi = % reduction in Average Price
to Retailer of other schedule formulations (calculated as in step1 of
sub-paragraph (1) of paragraph 4) in same sub-therapeutic category as that of
the scheduled formulation under consideration w.r.t. the highest priced
formulation taken for calculating the average price to retailer.
N = Number of such other schedule
formulations in same sub-therapeutic category as that of the scheduled formulation
under consideration.
Step2. Thereafter, the ceiling
price of the scheduled formulation i.e. P(c) shall be calculated as under:
P(c) = P(s)*(1+M/100), where
P(s) = Average Price to Retailer
of the scheduled formulation as calculated in step1 above and
M = % Margin to retailer and its
value=16 Explanation. - where the scheduled formulation under consideration is
coming under more than one sub-therapeutic category, the Average Price to
Retailer of the scheduled formulation shall be calculated after taking into
consideration the percentage reduction in Average Price to Retailer of other
schedule formulations under all such sub-therapeutic categories and the lowest
average price to retailer shall be taken for calculating the ceiling price of
the scheduled formulation under consideration;
(iii)
in case the other strengths or dosage forms of the scheduled
formulation are not available in the schedule and there is no sub therapeutic
category of the scheduled under consideration, the ceiling price shall be
calculated as under:
Step1: First the Average Price to
Retailer of such scheduled formulation i.e. P(s) shall be calculated as under:
P(s) =
Pm{1-(Pi1+Pi2+...)/(N*100)} Where,
Pm = Price of highest priced
formulation taken for calculating the average price to retailer of the
formulation under consideration.
Pi = % reduction in Average Price
to Retailer of other schedule formulations (calculated as in step1
sub-paragraph (1) of paragraph 4) in same therapeutic category as that of the
scheduled formulation under consideration w.r.t. the highest priced formulation
taken for calculating the average price to retailer.
N = Number of such other schedule
formulations in same therapeutic category as that of the scheduled formulation
under consideration.
Step2. Thereafter, the ceiling
price of the scheduled formulation i.e. P(c) shall be calculated as under:
P(c) = P(s).(1+M/100), where
P(s) = Average Price to Retailer
of the scheduled formulation as calculated in step1 above and
M = % Margin to retailer and its
value=16
Explanation. - where the
scheduled formulation under consideration is coming under more than one
therapeutic category, the Average Price to Retailer of the scheduled
formulation shall be calculated after taking into consideration the percentage
reduction in Average Price to Retailer of other schedule formulations under all
such therapeutic categories and the lowest average price to retailer shall be
taken for calculating the ceiling price of the scheduled formulation under
consideration.
(2)
Notwithstanding anything contained in this paragraph, where the
price has been fixed and notified by the Government under the Drugs (Prices
Control) Order, 1995 the provisions of sub-paragraph (1) shall not apply.
Order 7. Margin to retailer.
While fixing a ceiling price of scheduled
formulations and retail prices of new drugs, sixteen percent of price to
retailer as a margin to retailer shall be allowed.
Order 8. Maximum retail price.
(1)
The maximum retail price of scheduled formulations shall be fixed
by the manufacturers on the basis of ceiling price notified by the Government
plus local taxes wherever applicable, as under:
Maximum Retail Price = Ceiling
price + Local Taxes as applicable
(2)
The maximum retail price of a new drug shall be fixed by the
manufacturers on the basis of retail price determined by the Government plus
local taxes wherever applicable, as under:
Maximum Retail Price = Retail
Price + Local Taxes as applicable.
Order 9. Reference data and source of market based data.
[3][(1) The
source of market based data shall be the data available with the pharmaceutical
market data specializing company as decided by the Government and if the
Government deems it necessary, it may validate such data by appropriate survey
or evaluation.]
(2) The Government may in the due course of time
come out with other appropriate mechanism of collecting or obtaining the market
based data related to drugs and the decision of Government with respect to
collection or obtaining of data shall be final.
(3) The market based data, for fixing the ceiling
price of scheduled formulations for the first time after the notification of
this order, shall be the data of May, 2012.
(4) The market based data for fixing the retail
price of new drugs available in the market, shall be the data available for the
month ending immediately before six months of receipt of application for fixing
the price of the new drug.
(5) The market based data for fixing the ceiling
price of a scheduled formulation due to a revision in the first schedule shall
be the data available for the month ending immediately before six month of
notification of revision in the first schedule.
(6) Notwithstanding anything contained in this
order, the reference date for the formulations which are part of the Drugs
(Prices Control) Order, 1995 shall be as per the provisions of paragraph 10 of
this Order.
[4][(7)
Notwithstanding anything contained in this paragraph, for fixing or revising
the ceiling price for formulations, the Government may, if it is necessary so
to do, consider market based data available for any month, as deemed fit.]
Order 10. Pricing of the formulations covered under Drugs (Prices Control) Order, 1995.
(1)
The prices of scheduled formulations, which are also specified in
the First Schedule to the Drugs (Prices Control) Order, 1995, fixed and
notified under the provisions of the said order, up to 31st May, 2012, shall
remain effective for further one year i.e. up to 30th May' 2013 and the
manufacturers may revise the prices of such scheduled formulations as per the
annual wholesale price index for the previous calendar year announced by
Department of Industrial Promotion and Policy and thereafter the formula as in
sub-paragraph (1) of paragraph 4 of this Order shall be applied for fixing the
ceiling prices of such formulations.
(2)
The prices of scheduled formulations, which are also specified in
the First Schedule to the Drugs (Prices Control) Order, 1995, fixed and
notified under the provisions of Drugs (Prices Control) Order, 1995 after 31st
May, 2012, shall remain effective for one year from the date of notification of
such prices under Drugs (Prices Control) Order, 1995 and immediately thereafter
the manufacturers may revise the prices as per the annual wholesale price index
for the previous calendar year announced by Department of Industrial Promotion
and Policy and on the 1st April of succeeding financial year, the formula as in
sub-paragraph (1) of paragraph 4 of this Order shall be applied for fixing the
ceiling prices of such schedule formulations.
(3)
The prices of scheduled formulations, which are specified in the
Drugs (Prices Control) Order, 1995 but not specified in the First Schedule of
this order, fixed and notified under the provisions of the said order, up to
31st May, 2012, shall remain effective for further one year i.e. up to the 30th
May' 2013 and thereafter prices of such formulations shall be regulated as in
case of other non-scheduled formulations as stated in paragraph 20 of this
Order.
(4)
The prices of scheduled formulations, which are specified in the
Drugs (Prices Control) Order, 1995 but not specified in the First Schedule of
this order, fixed and notified under the provisions of the said order, after
31st May, 2012, shall remain effective for one year from the date of
notification of such prices and thereafter prices of such formulations shall be
regulated as in case of other non-scheduled formulations as stated in paragraph
20 of this Order.
Order 11. Ceiling price or retail price of a pack.
(1)
The average price to retailer calculated as per the provisions in paragraphs
4, 5 and 6 shall be on the dosage basis, (per tablet, per capsule or injection
in volume as listed in first schedule) and the ceiling price or retail price of
a pack shall be reached by multiplying the same with the number or quantity in
the pack as the case may be.
(2)
In the event of the unit of the dosage for a scheduled formulation
not available in the first schedule, the lowest pack size for that category of
medicine, as specified in the Drugs and Cosmetics Act, 1940 (23 of 1940) and
the rules thereunder, shall be taken as unit dosage for calculating the ceiling
price or retail price as the case may be, for that scheduled formulation and
this shall be applicable while calculating the per unit price of even
non-scheduled medicines for arriving at the retail price in case of paragraph
5.
[5][(3)
Notwithstanding anything contained in sub-paragraphs (1) and (2), in the case
of injections or inhalation or any other medicine for which dosage form or
strength or both are not specified in the Schedule-I of the Drugs (Prices
Control) Order, 2013, the Government may fix and notify separate ceiling price
or retail price for such formulations with specific therapeutic rationale,
considering the type of packaging or pack size or dosage compliance or content
in the pack namely liquid, gaseous or any other form, in the unit dosage as the
case may be, conforming to Indian Pharmacopeia or other standards as specified
in the Drugs and Cosmetics Act, 1940 (23 of 1940) and the rules made thereunder
for the same formulation.
(4) The Government shall form a Committee of
Experts, as it may deem fit, within a period of fifteen days from the date of
issue of this order, to recommend fixing of separate ceiling price of scheduled
formulations or retail price of a new drug as per the above parameters.]
Order 12. Price of formulations (branded or generic version) listed in the National List of Essential Medicines, launched by a manufacturer.
(1)
A manufacturer, launching a scheduled formulation, shall be free
to fix the price of the scheduled formulation equal to or below the ceiling
price fixed for that schedule formulation by the Government.
(2)
Where an existing brand is re-launched by another manufacturer the
provisions of paragraph 13 shall be applicable.
Order 13. Price of scheduled formulations for the existing manufacturers.
(1)
All the existing manufactures of scheduled formulations, selling
the branded or generic or both the versions of scheduled formulations at a
price higher than the ceiling price (plus local taxes as applicable) so fixed
and notified by the Government, shall revise the prices of all such
formulations downward not exceeding the ceiling price (plus local taxes as
applicable):
Provided, that in case of
scheduled formulations produced or available in the market before the date of
notification of ceiling price, the manufacturers shall ensure within a period
of forty-five days of the date of such notification that the maximum retail
price of such scheduled formulation does not exceed the ceiling price (plus
local taxes as applicable).
(2)
All the existing manufactures of scheduled formulations, selling
the branded or generic or both the versions of scheduled formulations at a
price lower than the ceiling price (plus local taxes as applicable) so fixed
and notified by the Government shall maintain their existing maximum retail
price.
(3)
Annual increase in maximum retail price may be carried out as per
the increase in the wholesale price index with respect to previous year as per
the provision of sub-paragraphs (2) and (3) of paragraph 16.
Provided that in case of decline
in wholesale price index, a corresponding reduction in the prices shall be made
as per the provision of sub-paragraph (4) of paragraph 16.
Order 14. Fixation of ceiling price of scheduled formulations.
(1)
The Government shall fix and notify the ceiling prices of the
scheduled formulations in accordance with the provisions of the paragraphs 4
and 6, as the case may be, and no manufacturer shall sell the scheduled
formulations at a price higher than the ceiling price (plus local taxes as
applicable) so fixed and notified by the Government.
(2)
Where any manufacturer sells a scheduled formulation at a price
higher than the ceiling price (plus local taxes as applicable) fixed and
notified by the Government, such manufacturers shall be liable to deposit the
overcharged amount along with interest thereon from the date of such
overcharging.
Order 15. Fixation of retail price of a new drug for existing manufacturers of scheduled formulations.
(1)
The Government shall form a Standing Committee of such Experts, as
it may deem fit, within sixty days of notification of this order with a view to
recommend the retail prices of new drugs on the principles of
"Pharmacoeconomics".
(2)
Where an existing manufacturer of a drug with dosages and strengths
as specified in National List of Essential Medicines launches a new drug, such
existing manufacturers shall apply for prior price approval of such new drug
from the Government in Form-I specified under Schedule-II of this Order.
(3)
On receipt of the application under sub-paragraph (2), in the
event of the new drug available in domestic market, the Government shall fix
the retail price of the new drug in accordance with the provision of
sub-paragraph(1) of paragraph 5 and in the event of the new drug not available
in domestic market, the Government shall forward the same to the Standing
Committee of Experts who shall examine the application on the principles of
"Pharmacoeconomics" and make recommendations of retail price of the
new drug to the Government within thirty days of the receipt of application.
(4)
The Government shall, on receipt of recommendation under
sub-paragraph (3), within thirty days, fix the retail price of such new drug
and such price shall be applicable to such applicant of such new drug.
(5)
Where existing manufacturer of scheduled formulation fails to
apply for prior approval of the price of the new drug in Form-I, such
manufacturer shall be liable to deposit the overcharged amount over and above
such price fixed and notified by the Government, if any, along with interest
thereon from the date of launch of the new drug, in addition to the penalty.
(6)
No existing manufacturer of a scheduled formulation shall sell
such a new drug at a price higher than the retail price (plus local taxes as applicable)
fixed by the Government for such new drug and in case such a manufacturer is
found to sell such a new drug at a price higher than the retail price (plus
local taxes as applicable) fixed by the Government, such manufacturer of the
new drug shall be liable to deposit the overcharged amount along with interest
from the date of overcharge, in addition to the penalty.
Order 16. Revision of ceiling price of scheduled formulations.
(1)
The Government shall revise the ceiling prices of scheduled
formulations as per the annual wholesale price index (WPI) for preceding
calendar year on or before 1st April of every year and notify the same on the
1st day of April every year.
(2)
The manufacturers may increase the maximum retail price (MRP) of
scheduled formulations once in a year, in the month of April, on the basis of
the wholesale price index with respect to previous calendar year and no prior
approval of the Government in this regard shall be required.
(3)
Information about the revision, if carried out, shall be forwarded
to the Government in either electronic or physical form in Form-II within a
period of fifteen days of such revision and non-submission of information under
this sub-paragraph shall be construed as non revision of maximum retail price
(MRP) and the concerned manufacturer shall be liable to deposit the amount
charged over and above the pre-revised maximum retail price (MRP), alongwith
interest thereon from the date of overcharging.
(4)
In case of decline in wholesale price index, there shall be a
corresponding reduction in the maximum retail price and in case of scheduled
formulations produced or available in the market before the date of
notification of revised ceiling price, the manufacturers shall ensure within a
period of forty-five days of the date of such notification that the maximum
retail price (MRP) of such scheduled formulation does not exceed the revised
ceiling price (plus local taxes as applicable) and information about the
revision shall be sent to the Government in either electronic or physical form
in Form-II within a period of fifteen days of such revision.
(5)
Non-submission of information under the sub-paragraph (4) shall be
construed as non reduction in maximum retail price (MRP) and the concerned
manufacturer shall be liable to deposit the amount charged over and above the
maximum retail price revised based on decline in wholesale price index,
alongwith interest thereon as overcharged amount from the date of overcharging.
Order 17. Amendment of the list of scheduled formulation.
(1)
A decision to amend the first schedule, clearly stating the
reasons thereof, shall be taken by the Government within sixty days of receipt
of communication from the Ministry of Health and Family Welfare and the
amendment(s) or revision, if required, in the first schedule shall be notified
and thereafter, the ceiling price(s) for the medicine(s) added in the first
schedule shall be fixed as per the provisions of this order within a period of
sixty days from the date of the notification.
(2)
The medicines omitted from the first schedule shall fall under the
category of non-scheduled formulations.
Order 18. Revision of ceiling price on the basis of moving annual turnover (MAT).
The revision of ceiling prices on
the basis of moving annual turnover value shall be carried out,-
[6][(i)
every five years from the date of fixing the ceiling price under this Order for
formulations as specified under the SCHEDULE - I.]
(ii) when the number of manufacturers of a
scheduled formulation, having price of a scheduled formulation more than or
equal to seventy five percent of the ceiling price fixed and notified by the
Government, has decreased by twenty five percent or more than the number of
manufacturers as existing on the reference date;
(iii) when the number of manufacturers of a
scheduled formulation, having prices of their scheduled formulation equal to or
lower than twenty five percent of the ceiling price fixed by the Government,
has increased by twenty five percent or more than the number of manufacturers
as existing on the reference date.
Explanation. - For the purpose of
items (ii) and (iii) the "reference date" shall be for first revision
of ceiling price May, 2012 and for second or subsequent revision the date of
previous revision of the ceiling price.
Order 19. Fixation of ceiling price of a drug under certain circumstances.
Notwithstanding anything
contained in this order, the Government may, in case of extra-ordinary
circumstances, if it considers necessary so to do in public interest, fix the
ceiling price or retail price of any Drug for such period, as it may deem fit
and where the ceiling price or retail price of the drug is already fixed and
notified, the Government may allow an increase or decrease in the ceiling price
or the retail price, as the case may be, irrespective of annual wholesale price
index for that year.
Order 20. Monitoring the prices of non-scheduled formulations.
(1)
The Government shall monitor the maximum retail prices (MRP) of
all the drugs, including the non-scheduled formulations and ensure that no
manufacturer increases the maximum retail price of a drug more than ten percent
of maximum retail price during preceding twelve months and where the increase
is beyond ten percent of maximum retail price, it shall reduce the same to the
level of ten percent of maximum retail price for next twelve months.
(2)
The manufacturer shall be liable to deposit the overcharged amount
along with interest thereon from the date of increase in price in addition to
the penalty.
Order 21. Monitoring the availability of scheduled formulations.
(1)
The Government shall monitor the production and availability of
scheduled formulations and the active pharmaceutical ingredients contained in
the scheduled formulation and the manufacturer of scheduled formulations and
the active pharmaceutical ingredients contained in the scheduled formulation
shall furnish the information as stated in Form-III of schedule-II of this
Order quarterly.
(2)
Any manufacturer of scheduled formulation, intending to
discontinue any scheduled formulation from the market shall issue a public
notice and also intimate the Government in Form-IV of schedule-II of this order
in this regard at least six month prior to the intended date of discontinuation
and the Government may, in public interest, direct the manufacturer of the scheduled
formulation to continue with required level of production or import for a
period not exceeding one year, from the intended date of such discontinuation
within a period of sixty days of receipt of such intimation.
Order 22. Recovery of dues accrued under the Drugs (Prices Control) Order, 1979 and to deposit the same into the Drugs Prices Equalisation Account.
(1)
Notwithstanding anything contained in this order, the Government
may by notice, require a manufacturer, importer or distributor as the case may be,
to deposit the amount which has accrued under the provisions of the Drugs
(Prices Control) Order, 1979 on or before the commencement of this order, into
the Drugs Prices Equalisation Account and the manufacturer, importer or
distributor, as the case may be, shall deposit the said amount into the said
account within such time as the Government may specify in the said notice.
(2)
The existing amount, if any, in the Drugs Prices Equalisation
Account on or before the date of commencement of this Order, and the amount
deposited under sub-paragraph (1) shall be utilised for;-
(a)
paying to the manufacturer, importer or distributor, as the case
may be, the shortfall between his retention price and the common selling price
or, as the case may be, the pooled price for the purpose of increasing the
production, or securing the equitable distribution and availability at fair
prices, of drugs;
(b)
meeting the expenses incurred by the Government in discharging the
functions under this paragraph; and
(c)
promoting higher education and research in Pharmaceutical Sciences
and Technology and for the purposes incidental thereto.
Order 23. Recovery of overcharged amount under Drugs Prices Control Orders 1987 and 1995.
Notwithstanding anything
contained in this order, the Government shall by notice, require the
manufacturers, importer or distributor or as the case may be, to deposit the
amount accrued due to charging of prices higher than those fixed or notified by
the Government under the provisions of Drugs (Prices Control) Order, 1987 and Drugs
(Prices Control) Order, 1995 under the provisions of this Order.
Order 24. Carrying into effect the price fixed or revised by the Government, its display and proof thereof.
(1)
For all the scheduled formulations having maximum retail price
(MRP) higher than ceiling price (plus local taxes as applicable), the
manufactures shall revise the maximum retail price (MRP) not exceeding the
ceiling price (plus local taxes as applicable):
Provided that in case of
scheduled formulations produced or available in the market before the date of
notification of ceiling price, the manufacturers shall ensure within a period
of forty-five days of the date of the notification that the maximum retail
price of such scheduled formulation does not exceed the ceiling price (plus local
taxes as applicable).
(2)
Every manufacturer of a schedule formulation intended for sale
shall display in indelible print mark, on the label of container of the
formulation and the minimum pack thereof offered for retail sale, the maximum
retail price of that formulation based on the ceiling price notified in the
Official Gazette or ordered by the Government in this behalf with the words
"Maximum Retail Price" preceding it and the words 'inclusive of all
taxes' succeeding it.
(3)
Every manufacturer shall issue a price list and supplementary
price list, if required, in Form-V 7[or
Form-VI] to the dealers, State Drugs Controllers and the Government indicating
reference to such price fixation or revision as covered by the order or Gazette
notification issued by the Government, from time to time.
(4)
Every retailer and dealer shall display the price list and the
supplementary price list, if any, as furnished by the manufacturer, on a
conspicuous part of the premises where he carries on business in a manner so as
to be easily accessible to any person wishing to consult the same.
Order 25. Display of prices of non-scheduled formulations and price list thereof.
(1)
Every manufacturer of a non-Scheduled formulation intended for
sale shall display in indelible print mark, on the label of container of the
formulation and the minimum pack thereof offered for retail sale, the maximum
retail price of that formulation with the words "Maximum Retail
Price" preceding it and the words 'inclusive of all taxes' succeeding it.
(2)
Every manufacturer shall issue a price list and supplementary
price list, if required, of the non-Scheduled formulations in Form-V 7[or
Form-VI] to the dealers, State Drugs Controllers and the Government indicating
changes, from time to time.
(3)
Every retailer and dealer shall display the price list and the supplementary
price list, if any, as furnished by the manufacturer or importer, on a
conspicuous part of the premises where he carries on business in a manner so as
to be easily accessible to any person wishing to consult the same.
Order 26. Control of sale prices of formulations.
No person shall sell any
formulation to any consumer at a price exceeding the price specified in the
current price list or price indicated on the label of the container or pack
thereof, whichever is less.
Order 27. Sale of split quantities of formulations.
No dealer shall sell loose
quantity of any formulation at a price which exceeds the pro-rata price of the
formulation.
Order 28. Manufacturer, distributor or dealer not to refuse sale of drug.
Subject to the provisions of the Drug
and Cosmetics Act, 1940 (23 of 1940) and the rules made thereunder, -
(a)
no manufacturer or distributor shall withhold from sale or refuse
to sell to a dealer any drug without good and sufficient reasons;
(b)
no dealer shall withhold from sale or refuse to sell any drug
available with him to a customer intending to purchase such drug.
Order 29. Maintenance of records and production thereof for inspection.
Every manufacturer shall maintain
records relating to the sales of individual active pharmaceutical ingredients
or bulk drugs manufactured or imported and marketed by him, as the case may be,
and the sales of formulations units and packs and also such other records as
may be directed from time to time by the Government and the Government shall
have the power to call for any record and to inspect such records at the
premises of the manufacturer.
Order 30. Power of entry, search and seizure.
(1)
Any Gazetted Officer of the Central Government or of a State
Government, as the case may be, authorised by a general or special order by the
Central Government or by the State Government, as the case may be, in this
behalf may, with a view to securing compliance with this Order or to satisfy
himself that the provision of this Order have been complied with-
(a)
enter and search any place;
(b)
seize any drug, alongwith the containers, packages or coverings in
which the drug is found, in respect of which he suspects that any provision of
this Order has been, is being, or is about to be contravened, and thereafter
take all measures necessary for securing production of the drug, containers,
packages or coverings, so seized, in a court of law and for their safe custody
pending such production;
(c)
seize any document, such as, cash memo or credit memo books, books
of account and records of purchase and sale of the drugs in respect of which he
suspects that any provision of this Order has been, is being, or is about to be
contravened.
(2)
The provisions of Code of Criminal Procedure, 1973 (2 of 1974),
relating to search and seizure shall, so far as may be, apply to searches and
seizures under this Order.
Order 31. Power to review.
Any person aggrieved by any
notification issued or order made under paragraphs 4, 5 and 6 of this Order,
may apply to the Government for a review of the notification or order within a
period of thirty days of the date of publication of the notification in the
Official Gazette or the receipt of the order by him, as the case may be, and
the Government may make such order on the application as it may deem proper:
Provided that pending a decision
by the Government on the application submitted under the above paragraph, no
manufacturer shall sell a scheduled formulation or a new drug, as the case may
be, at a price exceeding the ceiling price or retail price, as the case may be,
fixed by the Government of which a review has been applied for.
Order 32. Non-application of the provisions of this order in certain cases.
The provisions of this order
shall not apply to, -
[7][(i) a
manufacturer producing a new drug patented under the Indian Patent Act, 1970
(39 of 1970), for a period of five years from the date of commencement of its
commercial marketing by the manufacturer in the country.]
(ii) a manufacturer producing a new drug in the
country by a new process developed through indigenous Research and Development
and patented under the Indian Patent Act, 1970 (39 of 1970) (process patent)
for a period of five years from the date of the commencement of its commercial
production in the country.
(iii) a manufacturer producing a new drug involving
a new delivery system developed through indigenous Research and Development for
a period of five years from the date of its market approval in India:
Provided that the provision of
this paragraph shall apply only when a document showing approval of such new
drugs from Drugs Controller General (India) is produced before the Government.
Explanation. - Notwithstanding
anything contained in this Order, for the purpose of this paragraph "new
drug" shall have the same meaning as is assigned to under rule 122E of the
Drugs and Cosmetics Rules, 1945;
[8][(iv)
Drugs for treating orphan diseases as decided by the Ministry of Health and
Family Welfare, Government of India.]
[9][SCHEDULE-I
National List of Essential Medicines (NLEM) 2022
[See paragraphs-2(t) and 2(zb)]
|
(Symbols P,S and T
appearing in this Schedule denote essentiality at Primary, Secondary and
Tertiary levels respectively) |
||||||||||||||||
|
Section 1 Medicines used in
Anaesthesia |
||||||||||||||||
|
1.1-General Anaesthetics
and Oxygen |
||||||||||||||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|||||||||||||
|
1.1.1 |
Halothane |
S,T |
Liquid for inhalation |
|||||||||||||
|
1.1.2 |
Isoflurane |
S,T |
Liquid for inhalation |
|||||||||||||
|
1.1.3 |
Ketamine |
P,S,T |
Injection 10 mg/mL Injection 50 mg/mL |
|||||||||||||
|
1.1.4 |
Nitrous oxide |
P,S,T |
As licensed for medical
purpose |
|||||||||||||
|
1.1.5 |
Oxygen* |
P,S,T |
As licensed for medical
purpose |
|||||||||||||
|
1.1.6 |
Propofol |
P,S,T |
Injection 10 mg/mL |
|||||||||||||
|
1.1.7 |
Sevoflurane |
S,T |
Liquid for inhalation |
|||||||||||||
|
1.1.8 |
Thiopentone |
P,S,T |
Powder for injection 0.5
g Powder for injection 1 g |
|||||||||||||
|
*Oxygen is also listed in
Section 27.5-Medicines for COVID-19 management |
||||||||||||||||
|
1.2-Local Anaesthetics |
||||||||||||||||
|
|
Medicine |
Level of Dosage form(s)
and strength(s) Healthcare |
||||||||||||||
|
1.2.1 |
Bupivacaine |
S,T |
Injection 0.25% Injection 0.5% Injection 0.5% with 7.5%
glucose |
|||||||||||||
|
1.2.2 |
Lignocaine* |
P,S,T |
Topical forms 2-5% Injection 1% Injection 2% Injection 5% with 7.5%
glucose |
|||||||||||||
|
1.2.3 |
Lignocaine (A) +
Adrenaline (B) |
P,S,T |
Injection 1% (A) +
1:200000 (5 mcg/mL) (B) Injection 2% (A) +
1:200000 (5 mcg/mL) (B) |
|||||||||||||
|
1.3-Preoperative
Medication and Sedation for Short Term Procedures |
||||||||||||||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|||||||||||||
|
1.3.1 |
Atropine** |
P,S,T |
Injection 0.6 mg/mL |
|||||||||||||
|
*Lignocaine formulations
are also listed in Section 10.2.5 cardiovascular medicines-Antiarrhythmic
medicines **Atropine formulations
are also listed in - A. Section 4.2.1-Antidotes
and Other Substances used in Management of Poisonings/Envenomation-Specific B. Section
21.5.1-Ophthalmological Medicines-Mydriatics |
||||||||||||||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|||||||||||||
|
1.3.2 |
Glycopyrrolate |
S,T |
Injection 0.2 mg/mL |
|||||||||||||
|
1.3.3 |
Midazolam* |
P,S,T |
Tablet 7.5 mg Nasal Spray 0.5mg Nasal Spray 1.25 mg Injection 1 mg/mL Injection 5 mg/mL |
|||||||||||||
|
1.3.4 |
Morphine** |
P,S,T |
Injection 10 mg/mL Injection 15 mg/mL |
|||||||||||||
|
Section 1.4-Muscle
Relaxants and Cholinesterase Inhibitors |
||||||||||||||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|||||||||||||
|
1.4.1 |
Atracurium |
S,T |
Injection 10 mg/mL |
|||||||||||||
|
1.4.2 |
Baclofen |
S,T |
Tablet 5 mg Tablet 10 mg Tablet 20 mg |
|||||||||||||
|
*Midazolam formulations
are also listed in- A. Section
5.1.7-Medicines used in Neurological Disorders Anticonvulsants/Antiepileptics B. Section
7.4.12-Anti-cancer agents including Immunosuppressives, and Medicines used in
Palliative Care **Morphine formulations
are also listed in- A. Section
2.2.2-Analgesics, Antipyretics, Non-steroidal Anti-inflammatory Drugs
(NSAIDs), Medicines used to treat Gout and Disease Modifying Agents used in
Rheumatoid Disorders-Opioid Analgesics B. Section
7.4.13-Anti-cancer agents including immunosuppressives, and medicines used in
Palliative Care |
||||||||||||||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|||||||||||||
|
1.4.3 |
Neostigmine* |
S,T |
Tablet 15 mg Injection 0.5 mg/mL |
|||||||||||||
|
1.4.4 |
Succinylcholine |
S,T |
Injection 50 mg/mL |
|||||||||||||
|
1.4.5 |
Vecuronium |
S,T |
Powder for injection 4 mg
Powder for injection 10 mg |
|||||||||||||
|
Section 2 Analgesics, Antipyretics,
Non-steroidal Anti-inflammatory Drugs (NSAIDs), Medicines used to treat Gout
and Disease Modifying Agents used in Rheumatoid Disorders |
||||||||||||||||
|
2.1-Non-opioid
Analgesics, Antipyretics and Non-steroidal Anti-inflammatory Drugs |
||||||||||||||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|||||||||||||
|
2.1.1 |
Acetylsalicylic acid** |
P,S,T |
Tablet 300 mg to 500 mg Effervescent/Dispersible/Enteric
coated Tablet 300 mg to 500 mg |
|||||||||||||
|
*Neostigmine formulations
are also listed in Section 4.2.8-Antidotes and Other substances used in Management
of poisoning/Envenomation-Specific **Acetylsalicylic acid
formulations are also listed in- A. Section
5.2.1-Medicines used in Neurological Disorders Antimigraine medicines B. Section
10.5.1-Cardiovascular medicines-Antithrombotic Medicines (Cardiovascular/Cerebrovascular)-Antiplatelet
and Antithrombotic Medicines |
||||||||||||||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|||||||||||||
|
2.1.2 |
Diclofenac |
P,S,T |
Tablet 50 mg Injection 25 mg/mL |
|||||||||||||
|
2.1.3 |
Ibuprofen* |
P,S,T |
Tablet 200 mg Tablet 400 mg Oral liquid 100 mg/5 mL
(p) |
|||||||||||||
|
2.1.4 |
Mefenamic acid |
P,S,T |
Tablet 250 mg Oral liquid 100 mg/5 mL
(p) |
|||||||||||||
|
2.1.5 |
Paracetamol** |
P,S,T |
Tablet 500 mg Tablet 650
mg Oral liquid 120 mg/5 mL
(p) Oral Liquid 125 mg/5 mL
(p) Oral Liquid 250 mg/5 mL
(p) Injection 150 mg/mL Suppository 80 mg Suppository 170 mg |
|||||||||||||
|
2.2-Opioid Analgesics |
||||||||||||||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|||||||||||||
|
2.2.1 |
Fentanyl |
S,T |
Injection 50 mcg/mL |
|||||||||||||
|
*Ibuprofen formulations
are also listed in Section 5.2.2-Medicines used in Neurological Disorders-Antimigraine
Medicines ** Paracetamol
formulations are also listed in- A. Section
5.2.3-Medicines used in Neurological Disorders-Antimigraine Medicines B. Section 27.4-Medicines
for COVID-19 Management |
||||||||||||||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|||||||||||||
|
2.2.2 |
Morphine* |
P,S,T |
Tablet 10 mg Injection 10 mg/mL Injection 15 mg/mL |
|||||||||||||
|
2.2.3 |
Tramadol** |
S,T |
Capsule 50 mg Capsule 100 mg Injection 50 mg/mL |
|||||||||||||
|
2.3-Medicines used to
treat Gout |
||||||||||||||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and strength(s) |
|||||||||||||
|
2.3.1 |
Allopurinol*** |
P,S,T |
Tablet 100 mg Tablet 300 mg |
|||||||||||||
|
2.3.2 |
Colchicine |
P,S,T |
Tablet 0.5 mg |
|||||||||||||
|
*Morphine formulations
are also listed in - A. Section
1.3.4-Medicines used in Anaesthesia-Preoperative medication and sedation for
short term procedures B. Section
7.4.13-Anti-cancer agents including Immunosuppressives, and Medicines used in
Palliative Care |
||||||||||||||||
|
** Tramadol formulations
are also listed in- Section 7.4.15-Tramadol
formulations are also listed in Anti-cancer agents including Immunosuppressives,
and Medicines used in Palliative Care *** Allopurinol
formulations are also listed in- Section 7.4.1-Allopurinol
formulations are also listed in Anti-cancer agents including
Immunosuppressives, and Medicines used in Palliative Care |
||||||||||||||||
|
2.4-Disease Modifying
Agents used in Rheumatoid Disorders |
||||||||||||||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|||||||||||||
|
2.4.1 |
Azathioprine* |
S,T |
Tablet 25 mg (p) Tablet 50 mg |
|||||||||||||
|
2.4.2 |
Hydroxychloroquine |
P,S,T |
Tablet 200 mg Tablet 400 mg |
|||||||||||||
|
2.4.3 |
Methotrexate** |
P,S,T |
Tablet 2.5 mg Tablet 5 mg Tablet 10 mg |
|||||||||||||
|
2.4.4 |
Sulfasalazine |
S,T |
Tablet 500 mg |
|||||||||||||
|
Section 3 Antiallergics and
Medicines used in Anaphylaxis |
||||||||||||||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|||||||||||||
|
3.1 |
Adrenaline |
P,S,T |
Injection 1 mg/mL |
|||||||||||||
|
3.2 |
Cetirizine |
P,S,T |
Tablet 10 mg Oral liquid 5 mg/5 mL (p) |
|||||||||||||
|
* Azathioprine
formulations are also listed in Section 7.3.1-Anti-cancer agents including
Immunosuppressives, and Medicines used in Palliative Care ** Methotrexate
formulations are also listed in Section 7.1.30-Anti-cancer agents including
Immunosuppressives, and Medicines used in Palliative Care |
||||||||||||||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|||||||||||||
|
3.3 |
Dexamethasone* |
P,S,T |
Tablet 0.5 mg Tablet 2 mg Tablet 4 mg Oral liquid 0.5 mg/5 mL
(p) Injection 4 mg/mL |
|||||||||||||
|
3.4 |
Hydrocortisone** |
P,S,T |
Tablet 5 mg Tablet 10 mg Powder for Injection 100
mg Powder for Injection 200
mg |
|||||||||||||
|
3.5 |
Pheniramine |
P,S,T |
Injection 22.75 mg/mL |
|||||||||||||
|
3.6 |
Prednisolone*** |
P,S,T |
Tablet 5 mg Tablet 10 mg Tablet 20 mg Oral liquid 5 mg/5 mL (p) Oral liquid 15 mg/5 mL
(p) |
|||||||||||||
|
*Dexamethasone
formulations are also listed in- A. Section
7.4.3-Anti-cancer agents including Immunosuppressives, and Medicines used in
Palliative Care B. Section
18.1.1-Hormones, other Endocrine Medicines and Contraceptives-Adrenal
Hormones and Synthetic Substitutes C. Section 27.1-Medicines
for COVID-19 Management ** Hydrocortisone
formulations are also listed in Section 18.1.3-Hormones, other Endocrine
Medicines and Contraceptives-Adrenal Hormones and Synthetic Substitutes ***Prednisolone
formulations are also listed in- A. Section
7.2.4-Anti-cancer agents including Immunosuppressives, and Medicines used in
Palliative Care-Hormones and Anti-Hormones used in cancer therapy B. Section
18.1.5-Hormones, other Endocrine Medicines and Contraceptives -Adrenal
Hormones and Synthetic Substitutes C. Section
21.2.1-Ophthalmological Medicines-Anti-inflammatory Medicine |
||||||||||||||||
|
Section 4 Antidotes and Other
Substances used in Management of Poisonings/Envenomation |
||||||||||||||||
|
4.1-Nonspecific |
||||||||||||||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|||||||||||||
|
4.1.1 |
Activated Charcoal |
P,S,T |
Powder (as licensed) |
|||||||||||||
|
4.2 Specific |
||||||||||||||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|||||||||||||
|
4.2.1 |
Atropine* |
P,S,T |
Injection 0.6 mg/mL |
|||||||||||||
|
4.2.2 |
Calcium gluconate** |
P,S,T |
Injection 100 mg/mL |
|||||||||||||
|
4.2.3 |
D-Penicillamine |
P,S,T |
Capsule 150 mg (p) Capsule 250 mg |
|||||||||||||
|
4.2.4 |
Desferoxamine |
S,T |
Powder for injection 500
mg |
|||||||||||||
|
4.2.5 |
Methylthioninium chloride
(Methylene blue) |
S,T |
Injection 10 mg/mL |
|||||||||||||
|
*Atropine formulations
are also listed in- A. Section
1.3.1-Medicines used in Anaesthesia-Preoperative Medication and Sedation for
short term procedures B. Section
21.5.1-Ophthalmological Medicines-Mydriatics |
||||||||||||||||
|
** Calcium gluconate
formulations are also listed in Section 26.3-Vitamins and minerals |
||||||||||||||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|||||||||||||
|
4.2.6 |
N-acetylcysteine |
P,S,T |
Sachet 200 mg Injection 200 mg/mL |
|||||||||||||
|
4.2.7 |
Naloxone |
P,S,T |
Injection 0.4 mg/mL |
|||||||||||||
|
4.2.8 |
Neostigmine* |
P,S,T |
Injection 0.5 mg/mL |
|||||||||||||
|
4.2.9 |
Pralidoxime chloride
(2-PAM) |
P,S,T |
Injection 25 mg/mL |
|||||||||||||
|
4.2.10 |
Snake venom antiserum** |
P,S,T |
Soluble/liquid
polyvalent-As licensed Lyophilized polyvalent-As
licensed |
|||||||||||||
|
4.2.11 |
Sodium nitrite |
S,T |
Injection 30 mg/mL |
|||||||||||||
|
4.2.12 |
Sodium thiosulphate |
S,T |
Injection 250 mg/mL |
|||||||||||||
|
* Neostigmine
formulations are also listed in Section 1.4.3-Medicines used in
Anaesthesia-Muscle relaxants and cholinesterase inhibitors ** Snake Venom antiserum
is also listed in Section 19.2.7.-Immunologicals-Sera and immunoglobulins
(Liquid/Lyophilized) |
||||||||||||||||
|
Section 5 Medicines used in
Neurological Disorders |
||||||||||||||||
|
Section
5.1-Anticonvulsants/Antiepileptics |
||||||||||||||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|||||||||||||
|
5.1.1 |
Carbamazepine* |
P,S,T |
Tablet 100 mg Tablet 200 mg Tablet 400 mg Modified Release - Tablet 200 mg Tablet 400 mg Oral liquid 100 mg/5 mL
(p) |
|||||||||||||
|
5.1.2 |
Clobazam |
S,T |
Tablet 5 mg Tablet 10 mg |
|||||||||||||
|
5.1.3 |
Diazepam** |
P,S,T |
Oral liquid 2 mg/5 mL (p) Injection 5 mg/mL Suppository 5 mg |
|||||||||||||
|
5.1.4 |
Levetiracetam |
S,T |
Tablet 250 mg Tablet 500 mg Tablet 750 mg Modified Release Tablet
750 mg Oral liquid 100 mg/mL (p) Injection 100 mg/mL |
|||||||||||||
|
5.1.5 |
Lorazepam |
P,S,T |
Tablet 1 mg Tablet 2 mg Injection 2 mg/mL Injection 4 mg/mL |
|||||||||||||
|
*Carbamazepine
formulations are also listed in Section 23.2.2.3 Medicines used in treatment
of Psychiatric disorder-Medicines used in Bipolar disorders ** Diazepam formulations
are also listed in Section 7.4.4-Anti-cancer agents including
Immunosuppressives, and Medicines used in Palliative Care-Medicines used in
Palliative Care |
||||||||||||||||
|
|
Medicine |
Level of Dosage form(s)
and strength(s) Healthcare |
||||||||||||||
|
5.1.6 |
Magnesium sulphate |
S,T |
Injection 500 mg/mL |
|||||||||||||
|
5.1.7 |
Midazolam* |
P,S,T |
Tablet 7.5 mg Tablet 15 mg Nasal Spray 0.5 mg/actuation Nasal Spray 1.25
mg/actuation Injection 1 mg/mL Injection 5 mg/mL |
|||||||||||||
|
5.1.8 |
Phenobarbitone |
P,S,T |
Tablet 30 mg Tablet 60 mg Oral liquid 20 mg/5 mL
(p) |
|||||||||||||
|
S,T |
Injection 200 mg/mL |
|||||||||||||||
|
5.1.9 |
Phenytoin |
P,S,T |
Tablet 50 mg Tablet 100 mg Tablet 300 mg Modified Release Tablet
300 mg Oral liquid 30 mg/5 mL
(p) Oral liquid 125 mg/5 mL
(p) Injection 25 mg/mL Injection 50 mg/mL |
|||||||||||||
|
*Midazolam formulations
are also listed in- A. Section
1.3.3-Medicines used in Anaesthesia-Preoperative Medication and Sedation for
short term procedures B. Section
7.4.12-Anti-cancer agents including Immunosuppressives, and Medicines used in
Palliative Care-Medicines used in Palliative Care |
||||||||||||||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|||||||||||||
|
|
|
|
Tablet 200 mg Tablet 300 mg |
|||||||||||||
|
5.1.10 |
Sodium Valproate* |
P,S,T |
Tablet 500 mg Modified Release - Tablet 300 mg Tablet 500 mg Oral liquid 200 mg/5 mL
(p) |
|||||||||||||
|
S,T |
Injection 100 mg/mL |
|||||||||||||||
|
Section 5.2-Antimigraine
Medicines |
||||||||||||||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|||||||||||||
|
5.2.1 |
Acetylsalicylic acid** |
P,S,T |
Tablet 300 mg to 500 mg Effervescent/Dispersible/Enteric
coated Tablet 300 mg to 500 mg |
|||||||||||||
|
*Sodium Valproate
formulations are also listed in- Section
23.2.2.2-Medicines used in treatment of Psychiatric Disorders-Medicines used
in Bipolar disorders-Medicines used in mood disorders **Acetylsalicyclic acid
formulations are also listed in- A. Section
2.1.1-Analgesics, Antipyretics, Non-steroidal Anti-inflammatory Drugs (NSAIDs), Medicines
used to treat Gout and Disease Modifying Agents used in Rheumatoid
Disorders-Non-Opioid Analgesics, Antipyretics and Non-Steroidal
Anti-Inflammatory Drugs B. Section
10.5.1-Cardiovascular medicines-Antiplatelet and Antithrombotic Medicines |
||||||||||||||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and strength(s) |
|||||||||||||
|
5.2.2 |
Ibuprofen* |
P,S,T |
Tablet 200 mg Tablet 400 mg Oral liquid 100 mg/5 mL
(p) |
|||||||||||||
|
5.2.3 |
Paracetamol** |
P,S,T |
Tablet 500 mg Tablet 650 mg Oral liquid 120 mg/5mL
(p) Oral Liquid 125 mg/5mL
(p) Oral Liquid 250 mg/5mL
(p) |
|||||||||||||
|
5.2.4 |
Sumatriptan |
P,S,T |
Tablet 25 mg Tablet 50 mg |
|||||||||||||
|
Section 5.2.1-For
Prophylaxis |
||||||||||||||||
|
5.2.1.1 |
Amitriptyline*** |
P,S,T |
Tablet 10 mg Tablet 25 mg Tablet 75 mg |
|||||||||||||
|
*Ibuprofen formulations
are also listed in Section 2.1.3-Analgesics, Antipyretics, Non-steroidal
Anti-inflammatory Drugs (NSAIDs), Medicines used to treat Gout and Disease
Modifying Agents used in Rheumatoid Disorders Non-opioid Analgesics,
Antipyretics and Non-steroidal Anti-inflammatory Drugs **Paracetamol
formulations are also listed in- A. Section
2.1.5-Analgesics, Antipyretics, Non-steroidal Anti-inflammatory Drugs
(NSAIDs), Medicines used to treat Gout and Disease Modifying Agents used in
Rheumatoid Disorders-Non-opioid analgesics, antipyretics and nonsteroidal
anti-inflammatory medicines B. Section 27.4-Medicines
for COVID-19 management *** Amitriptyline
formulations are also listed in- A. Section
7.4.2-Anti-cancer agents including Immunosuppressives, and Medicines used in
Palliative Care-Medicines used in Palliative Care- B. Section
23.2.1.1-Medicines used in treatment of Psychiatric Disorders-Medicines used
in mood disorders-Medicines used in depressive disorders
|
||||||||||||||||
|
Section
5.3-Antiparkinsonism Medicines |
||||||||||||||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|||||||||||||
Section 5.4-Medicines
used in Dementia |
||||||||||||||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|||||||||||||
|
5.4.1 |
Donepezil |
S,T |
Tablet 5 mg Tablet 10 mg |
|||||||||||||
|
Section 6 Anti-infective Medicines |
|||
|
6.1-Anthelminthics |
|||
|
6.1.1-Intestinal
Anthelminthics |
|||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
6.1.1.1 |
Albendazole* |
P,S,T |
Tablet 400 mg Chewable Tablet 400 mg Oral liquid 200 mg/5 mL
(p) |
|
6.1.1.2 |
Mebendazole |
P,S,T |
Tablet 100 mg Oral liquid 100 mg/5 mL
(p) |
|
6.1.2 Antifilarial |
|||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
6.1.2.1 |
Albendazole* |
P,S,T |
Tablet 400 mg Chewable Tablet 400 mg Oral liquid 200 mg/5 mL
(p) |
|
6.1.2.2 |
Diethylcarbamazine(DEC) |
P,S,T |
Tablet 50 mg Tablet 100 mg Oral liquid 120 mg/5 mL
(p) |
|
* Albendazole
formulations are also listed Section 6.1.1.1-in Anti-infective
Medicines-Antifilarial |
|||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and strength(s) |
|
6.1.2.3 |
Ivermectin |
P,S,T |
Tablet 6 mg Tablet 12 mg |
|
6.1.3-Anti-schistosomal
and Anti-trematodal Medicine |
|||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
6.1.3.1 |
Praziquantel |
S,T |
Tablet 600 mg |
|
6.2-Antibacterials |
|||
|
6.2.1 Beta-lactam
Medicines |
|||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
6.2.1.1 |
Amoxicillin |
P,S,T |
Capsule 250 mg Capsule 500 mg Oral liquid 125 mg/5 mL
(p) Oral liquid 250 mg/5 mL
(p) Powder for Injection 250
mg Powder for Injection 500
mg Powder for injection 1000
mg |
|
6.2.1.2 |
Amoxicillin (A) +
Clavulanic acid (B) |
P,S,T |
Tablet 500 mg (A) + 125
mg (B) Oral liquid 200 mg (A) +
28.5 mg (B)/5 mL (P) Dry Syrup 125 mg (A) +
31.25 (B)/5 mL (p) |
|
|
|
S,T |
Powder for Injection 500
mg (A) +-100 mg (B) Powder for Injection 1 g
(A) +200 mg (B) |
|
6.2.1.3 |
Ampicillin |
P,S,T |
Powder for Injection 500
mg Powder for Injection 1000 mg |
|
6.2.1.4 |
Benzathine
benzylpenicillin |
P,S,T |
Powder for Injection 6
lac units Powder for Injection 12 lac units Powder for injection 24 lac units |
|
6.2.1.5 |
Benzylpenicillin |
P,S,T |
Powder for injection 5
lac units Powder for injection 10 lac units |
|
6.2.1.6 |
Cefadroxil |
P,S,T |
Tablet 500 mg Tablet 100 mg Oral liquid 125 mg/5 mL
(p) |
|
6.2.1.7 |
Cefazolin |
P,S,T |
Powder for Injection 500
mg Powder for Injection 1000
mg |
|
6.2.1.8 |
Cefixime |
S,T |
Tablet 200 mg Tablet 400 mg Oral liquid 50 mg/5 mL
(p) Oral liquid 100 mg/5 mL
(p) |
|
6.2.1.9 |
Cefotaxime* |
S,T |
Powder for Injection 250
mg Powder for Injection 500
mg Powder for Injection 1000
mg |
|
*Cefotaxime formulations
are also listed in Section 6.7.5.2-Anti-infective Medicines-Antiviral
Medicines-Medicines for treating Opportunistic Infections in People living
with HIV |
|||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
6.2.1.10 |
Ceftazidime |
S,T |
Powder for Injection 250
mg Powder for Injection 1000
mg |
|
6.2.1.11 |
Ceftriaxone |
S,T |
Powder for Injection 250
mg Powder for Injection 500
mg Powder for Injection 1000
mg Powder for Injection 2000
mg |
|
6.2.1.12 |
Cloxacillin |
P,S,T |
Capsule 250 mg Capsule 500 mg Oral Liquid 125 mg/5 mL
(p) Powder for Injection 250
mg |
|
|
Piperacillin (A)
+Tazobactam (B) |
|
Powder for Injection 1000
mg (A) + 125 mg (B) Powder for Injection 2000
mg |
|
6.2.1.13 |
|
T |
(A) + 250 mg (B) Powder for Injection 4000
mg (A) + 500 mg (B) |
|
|
|
|
Powder for Injection 500
mg (astrihydrate) |
|
6.2.1.14 |
Meropenem |
T |
Powder for Injection 1000
mg (as trihydrate) |
|
6.2.2-Other
Antibacterials |
|||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
|
|
|
Tablet 250 mg |
|
6.2.2.1 |
Azithromycin* |
P,S,T |
Tablet 500 mg Oral liquid 200 mg/5 mL
(p) Powder for Injection 500
mg |
|
6.2.2.2 |
Cefuroxime |
P,S,T |
Tablet 500 mg Oral liquid 125 mg/5 mL
(p) Injection 1500 mg |
|
*Azithromycin
formulations are also listed in Section 6.7.6.1 Anti-infective
Medicines-Medicines used in the management of HIV-Additional Medicines for
Syndromic Management of Sexually Transmitted Infections |
|||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
6.2.2.3 |
Ciprofloxacin* |
P,S,T |
Tablet 250 mg Tablet 500 mg Oral liquid 250 mg/5 mL (p) Injection 200 mg/100 mL |
|
6.2.2.4 |
Clarithromycin* * |
S,T |
Tablet 250 mg Tablet 500 mg Oral liquid 125 mg/5 mL
(p) |
|
6.2.2.5 |
Clindamycin* * * |
P,S,T |
Capsule 150 mg Capsule 300 mg Injection 150 mg/mL |
|
6.2.2.6 |
Co-trimoxazole
[Sulphamethoxazole (A) + Trimethoprim(B)]**** |
P,S,T |
Tablet 400 mg (A) + 80 mg
(B) Tablet 800 mg (A) + 160
mg (B) Oral liquid 200 mg (A) +
40 mg (B)/5 mL (P) |
|
* Ciprofloxacin
formulations are also listed in- A. Section 16.2-Ear, Nose
and Throat Medicines, B. Section 21.1.2-Ophthalmological
Medicines-Anti-infective Medicines, ** Clarithromycin
formulations are also listed in Section 6.4.3-Anti-infective
medicines-Anti-tuberculosis Medicines ***Clindamycm
formulations are also listed in- |
|||
|
A. Section 6.7.5.3-Anti-infective
Medicines-Antiviral Medicines-Medicines for treating Opportunistic Infections
in People living with HIV B. Section
6.9.3.1-Anti-infective Medicines-Drugs for amoebiasis and other parasitic
infections-Antipneumocystosis and antitoxoplasmosis medicines C. Section
6.10.1.5-Anti-infective Medicines-Antimalarial medicines-For curative
treatment **** Co-trimoxazole
formulations are also listed in Section 6.9.3.2-Anti-infective
Medicines-Medicines for amoebiasis and other parasitic infections-Antipneumocystosis
andantitoxoplasmosis medicines |
|||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
6.2.2.7 |
Doxycycline* |
P,S,T |
Capsule 100 mg Dry Syrup 50 mg/5 mL (p) Power for Injection 100
mg |
|
6.2.2.8 |
Gentamicin |
P,S,T |
Injection 10 mg/mL Injection 40 mg/mL |
|
6.2.2.9 |
Metronidazole** |
P,S,T |
Tablet 200 mg Tablet 400 mg Oral liquid 200 mg/5 mL
(p) Injection 500 mg/100 mL |
|
6.2.2.10 |
Nitrofurantoin |
P,S,T |
Tablet 100 mg Oral liquid 25 mg/5 mL
(p) |
|
6.2.2.11 |
Phenoxymethyl penicillin |
P,S,T |
Tablet 250 mg |
|
6.2.2.12 |
Procaine Benzylpenicillin |
P,S,T |
Powder for injection 1000
mg (=1 million IU) |
|
6.2.2.13 |
Vancomycin |
S,T |
Capsule 125 mg Capsule 250 mg Powder for Injection 250
mg Powder for Injection 500
mg Powder for Injection 1000
mg |
|
*Doxycycline formulations
are also listed in Section 6.10.2.1-Anti-infective Medicines-Antimalarial
medicines-For prophylaxis **Metronidazole
formulations are also listed in Section 6.9.1.1-Anti-infective
Medicines-Antiprotozoal Medicines-Medicines for amoebiasis and other parasitic
infections |
|||
|
6.3-Antileprosy Medicines |
|||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
6.3.1 |
Clofazimine* |
P,S,T |
Capsule 50 mg Capsule 100 mg |
|
6.3.2 |
Dapsone |
P,S,T |
Tablet 50 mg Tablet 100 mg |
|
6.3.3 |
Rifampicin* * |
P,S,T |
Capsule 150 mg Capsule 300 mg |
|
6.4-Antituberculosis
Medicines |
|||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
6.4.1 |
Amikacin |
S,T |
Injection 100 mg/mL Injection 250 mg/mL Injection 500 mg/mL |
|
6.4.2 |
Bedaquiline |
T |
Tablet 100 mg |
|
6.4.3 |
Clarithromycin*** |
S,T |
Tablet 250 mg Tablet 500 mg Tablet 750 mg |
|
*Clofazimine formulations
are also listed Section 6.4.5-Anti-infective Medicines-Anti-tuberculosis
medicines **Rifampicin formulations
are also listed in Section 6.4.15-Anti-infective Medicines-Anti-tubercular
medicine ***Clarithromycin
formulations are also listed in Section 6.2.2.4-Anti-infective
Medicines-Antibacterials-Other Antibacterials |
|||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
6.4.4 |
Clofazimine* |
S,T |
Capsule 50 mg Capsule 100 mg |
|
6.4.5 |
Cycloserine |
S,T |
Capsule 125 mg Capsule 250 mg |
|
6.4.6 |
Delamanid |
T |
Tablet 50 mg |
|
6.4.7 |
Ethambutol |
P,S,T |
Tablet 200 mg Tablet 400 mg Tablet 600 mg Tablet 800 mg |
|
6.4.8 |
Ethionamide |
S,T |
Tablet 125 mg Tablet 250 mg |
|
6.4.9 |
Isoniazid |
P,S,T |
Tablet 100 mg Tablet 300 mg Oral Liquid 50 mg/5 mL
(p) |
|
6.4.10 |
Levofloxacin |
P,S,T |
Tablet 250 mg Tablet 500 mg Tablet 750 mg |
|
|
|
|
Tablet 300 mg |
|
6.4.11 |
Linezolid |
P,S,T |
Tablet 600 mg |
|
6.4.12 |
Moxifloxacin |
P,S,T |
Tablet 400 mg |
|
*Clofazimine formulations
are also listed in Section 6.3.1-Anti-infective Medicines-Antileprosy
medicines |
|||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
6.4.13 |
Para-aminosalicylic acid |
S,T |
Granules (As licensed) |
|
6.4.14 |
Pyrazinamide |
P,S,T |
Tablet 500 mg Tablet 750 mg Tablet 1000 mg Tablet 1500 mg Oral liquid 250 mg/5 mL
(p) |
|
6.4.15 |
Rifampicin* |
P,S,T |
Capsule 150 mg Capsule 300 mg Capsule 450 mg Capsule 600 mg Oral liquid 100 mg/5 mL
(p) |
|
6.4.16 |
Streptomycin |
P,S,T |
Powder for Injection 750
mg Powder for Injection 1000
mg |
|
6.5-Antifungal Medicines |
|||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
6.5.1 |
Amphotericin B** |
S,T |
a) Amphotericin B
(conventional) Injection 50mg/vial b) Lipid Amphotericin
B-Injection 50 mg/vial c) Liposomal Amphotericin
B-Injection 50 mg/vial |
|
*Rifampicin formulations
are also listed in Section 6.3.3-Anti-infective Medicines-Antileprosy
medicines **Amphotericin B
formulations are also listed Section 6.9.2.1-Anti-infective Medicines
Antileishmaniasis medicines |
|||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
6.5.2 |
Clotrimazole* |
P,S,T |
Pessary 100 mg |
|
6.5.3 |
Fluconazole |
P,S,T |
Tablet 50 mg Tablet 100 mg Tablet 150 mg Tablet 200 mg Tablet 400 mg Oral liquid 50 mg/5 mL
(p) |
|
|
|
S,T |
Injection 200 mg/100 mL |
|
6.5.4 |
Griseofulvin |
P,S,T |
Tablet 125 mg Tablet 250 mg Tablet 375 mg |
|
|
|
|
Capsule 100 mg |
|
6.5.5 |
Itraconazole |
S,T |
Capsule 200 mg Oral liquid 10 mg/mL |
|
6.5.6 |
Mupirocin |
P,S,T |
Ointment 2% |
|
6.5.7 |
Nystatin |
S,T |
Pessary 1 Lac IU Oral Liquid 1 Lac IU/mL
(p) |
|
6.5.8 |
Terbinafine |
P,S,T |
Cream 1% |
|
*Clotrimazole
formulations are also listed in - |
|
||
|
A. Section
6.7.5.4-Anti-infective Medicines-Antiviral medicines-Medicines for treating
Opportunistic Infections in People living with HIV |
|||
|
B. Section
11.1.1-Dermatological Medicines (Topical)-Antifungal medicines |
|||
|
C. Section 16.3-Ear, Nose
and Throat Medicines |
|||
|
6.6-Antiviral Medicines |
|||
|
6.6.1-Antiherpes
Medicines |
|||
|
|
|
Level of |
|
|
|
Medicine |
Healthcare |
Dosage form(s) and
strength(s) |
|
|
|
|
Tablet 200 mg |
|
|
|
|
Tablet 400 mg |
|
|
|
|
Tablet 800 mg |
|
6.6.1.1 |
Acyclovir* |
P,S,T |
Powder for Injection 250
mg Powder for Injection 500 mg |
|
|
|
|
Oral liquid 400 mg/5 mL
(p) |
|
6.6.2-Anti-cytomegalovirus
(CMV) medicines |
|||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
|
|
|
Tablet 450 mg |
|
6.6.2.1 |
Valganciclovir** |
S, T |
Powder for oral solution
50 mg/mL |
|
6.7-Medicines used in the
Management of HIV |
|||
|
6.7.1 Nucleoside Reverse
Transcriptase Inhibitors |
|||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
6.7.1.1 |
Abacavir |
S,T |
Tablet 60 mg (p) Tablet 300 mg |
|
*Acyclovir formulations
are also listed in- |
|||
|
A. Section
6.7.5.1-Anti-infective Medicines-Medicines used in the management of
HIV-Medicines for treating Opportunistic Infections in People living with HIV B. Section 21.1.1-Ophthalmological
Medicines-Anti-infective medicine **Valganciclovir
formulations are also listed in Section 6.7.5.5-Anti-infective
Medicines-Antiviral medicines-Medicines for treating Opportunistic Infections
in People living with HIV |
|||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
6.7.1.2 |
Abacavir (A) + Lamivudine
(B) |
S,T |
Tablet 60 mg (A) + 30 mg
(B)(p) Tablet 600 mg (A) + 300
mg (B) |
|
6.7.1.3 |
Lamivudine |
S,T |
Tablet 100 mg Tablet 150 mg |
|
6.7.1.4 |
Tenofovir Disproxil
Fumarate (TDF)* |
S,T |
Tablet 300 mg |
|
6.7.1.5 |
Tenofovir Disproxil
Fumarate (A) + Lamivudine (B) |
S,T |
Tablet 300 mg (A) + 300
mg (B) |
|
6.7.1.6 |
Tenofovir Disproxil
Fumarate (A) + Lamivudine (B) + Dolutegravir (C) |
P,S,T |
Tablet 300 mg (A) + 300
mg (B) + 50 mg (C) |
|
6.7.1.7 |
Tenofovir Disproxil
Fumarate (A) + Lamivudine (B) + Efavirenz (C) |
S,T |
Tablet 300 mg (A) + 300
mg (B) + 600 mg (C) |
|
6.7.1.8 |
Zidovudine |
S,T |
Tablet 300 mg Oral liquid 50 mg/5 mL
(p) |
|
6.7.1.9 |
Zidovudine (A) +
Lamivudine (B) |
S,T |
Tablet 60 mg (A) + 30 mg
(B)(p) Tablet 300 mg (A) + 150
mg (B) |
|
* Tenofovir Disproxil
Fumarate formulations are also listed in Section 6.8.6- Anti-infective
Medicines-Medicines used in Hepatitis B and Hepatitis C |
|||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
6.7.1.10 |
Zidovudine (A) +
Lamivudine (B) +Nevirapine (C) |
S,T |
Tablet 60 mg (A) + 30 mg
(B) +50 mg (C) (P) Tablet 300 mg (A) + 150
mg (B) +-200 mg (C) |
|
6.7.2 Non-nucleoside
Reverse Transcriptase Inhibitors |
|||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
6.7.2.1 |
Efavirenz |
S,T |
Tablet 200 mg (p) Tablet 600 mg |
|
6.7.2.2 |
Nevirapine |
P,S,T |
Tablet 200 mg Dispersible Tablet 50 mg
(p) Oral liquid 50 mg/5 mL
(p) |
|
6.7.3 Integrase
Inhibitors |
|||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
6.7.3.1 |
Dolutegravir |
S,T |
Tablet 50 mg |
|
6.7.3.2 |
Raltegravir |
S,T |
Tablet 400 mg |
|
6.7.4 Protease Inhibitors |
|||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
6.7.4.1 |
Atazanavir (A) +
Ritonavir (B) |
S,T |
Tablet 300 mg (A) +Tablet
100 mg (B) |
|
6.7.4.2 |
Darunavir |
S,T |
Tablet 600 mg |
|
6.7.4.3 |
Darunavir (A) +Ritonavir
(B) |
S,T |
Tablet 600 mg (A) +Tablet
100 mg (B) |
|
6.7.4.4 |
Lopinavir (A) +Ritonavir
(B) |
S,T |
Tablet 100 mg (A) + 25 mg
(B) Tablet 200 mg (A) + 50 mg
(B) Oral Liquid 80 mg (A) +20
mg (B)/mL (p) Capsule/Sachet
(containing pellets/granules) 40 mg (A) + 10 mg (B) (p) |
|
6.7.4.5 |
Ritonavir |
S,T |
Tablet 100 mg |
|
6.7.5 Medicines for
treating Opportunistic Infections in People living with HIV |
|||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
6.7.5.1 |
Acyclovir* |
P,S,T |
Injection 250 mg |
|
6.7.5.2 |
Cefotaxime** |
P,S,T |
Injection 1000 mg |
|
6.7.5.3 |
Clindamycin* * * |
P,S,T |
Tablet 300 mg |
|
* Acyclovir formulations
are also listed in- A. Section
6.6.1.1-Anti-infective Medicines-Antiviral medicines-Anti-herpes medicines B. Section 21.1.1-Ophthalmological
Medicines-Anti-infective Medicine ** Cefotaxime
formulations are also listed in Section 6.2.1.9-Anti-infective
Medicines-Antibacterials-Beta-Lactam medicines ***Clindamycm
formulations are also listed in- A. Section
6.2.2.5-Anti-infective Medicines-Antibacterials-Other antibacterials B. Section
6.9.3.1-Anti-infective Medicines-Medicines for amoebiasis and other
parasiticinfections-Antipneumocystosis and antitoxoplasmosis medicines C. Section
6.10.1.5-Anti-infective Medicines-Antimalarial medicines-For curative
treatment |
|||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
6.7.5.4 |
Clotrimazole* |
P,S,T |
Ointment 1% |
|
6.7.5.5 |
Valganciclovir* * |
S,T |
Tablet/Capsule 450 mg |
|
6.7.6 Additional
Medicines for Syndromic Management of Sexually Transmitted Infections |
|||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
6.7.6.1 |
Azithromycin* * * |
P,S,T |
Tablet 1000 mg |
|
Section 6.8-Medicines
used in Hepatitis B and Hepatitis C |
|||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and strength(s) |
|
6.8.1 |
Daclatasvir |
S,T |
Tablet 30 mg Tablet 60 mg |
|
6.8.2 |
Entecavir |
S,T |
Tablet 0.5 mg Tablet 1 mg Oral liquid 0.05 mg/mL
(p) |
|
*Clotrimazole
formulations are also listed in- A. Section
6.5.2-Anti-infective Medicines-Antifungal medicines B. Section
11.1.1-Dermatological Medicines (Topical)-Antifungal medicines C. Section 16.3-Ear, Nose
and Throat Medicines **Valganciclovir
formulations are also listed in Section 6.6.2.1-Anti-infective
Medicines-Antiviral medicines-Anti Cytomegalovirus (CMV) medicines ***Azithromycin
formulations are also listed in Section 6.2.2.1-Anti-infective
Medicines-Other antibacterials |
|||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
6.8.3 |
Ribavirin |
S,T |
Capsule 200 mg |
|
6.8.4 |
Sofosbuvir |
S,T |
Tablet 400 mg |
|
6.8.5 |
Tenofovir Alafenamide
Fumarate (TAF) |
S,T |
Tablet 25 mg |
|
6.8.6 |
Tenofovir Disproxil
Fumarate (TDF)* |
S,T |
Tablet 300 mg |
|
Section 6.9-Antiprotozoal
Medicines |
|||
|
6.9.1-Medicines for
Amoebiasis and other Parasitic Infections |
|||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
6.9.1.1 |
Metronidazole** |
P,S,T |
Tablet 200 mg Tablet 400
mg Injection 500 mg/100 mL Oral liquid 200 mg/5 mL
(p) |
|
* Tenofovir Disproxil
Fumarate formulations are also listed in Section 6.7.1.4- Anti-infective Medicines
Medicines used in the management of HIV-Nucleoside reverse transcriptase
inhibitors ** Metronidazole
formulations are also listed in Section 6.2.2.9-Anti-infective
Medicines-Antibacterials Beta-lactam medicines-Other antibacterials |
|||
|
6.9.2-Antileishmaniasis Medicines |
|||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
6.9.2.1 |
Amphotericin B* |
S,T |
a) Amphotericin B
(conventional)-Injection 50 mg b) Lipid Amphotericin
B-Injection 50 mg c) Liposomal Amphotericin
B-Injection 50 mg |
|
6.9.2.2 |
Miltefosine |
P,S,T |
Capsule 50 mg |
|
6.9.2.3 |
Paromomycin |
P,S,T |
Injection 375 mg/mL |
|
6.9.3-Antipneumocystosis
and Antitoxoplasmosis Medicines |
|||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
6.9.3.1 |
Clindamycin** |
P,S,T |
Capsule 150 mg Capsule 300 mg |
|
*Amphotericin B
formulations are also listed in Section 6.5.1-Anti-infective
Medicines-Antifungal medicines **Clindamycin
formulations are also listed in- A. Section
6.2.2.5-Anti-infective Medicines-Antibacterials-Other antibacterials B. Section 6.7.5.3-Anti-infective
Medicines-Antiviral medicines-Medicines for treating Opportunistic Infections
in People living with HIV C. Section
6.10.1.5-Anti-infective Medicines-Antimalarial Medicines-For curative
treatment |
|||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
6.9.3.2 |
Co-trimoxazole*
[Sulphamethoxazole (A) + Trimethoprim (B)] |
P,S,T |
Tablet 400 mg (A) + 80 mg
(B) Tablet 800 mg (A) + 160 mg (B) Oral liquid 200 mg (A) + 40 mg (B)/5 mL (p) |
|
6.10-Antimalarial
Medicines |
|||
|
6.10.1-For curative
treatment |
|||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
6.10.1.1 |
Artemether (A) +
Lumefantrine (B) |
P,S,T |
Tablet 20 mg (A) + 120 mg
(B) Tablet 40 mg (A) + 240 mg
(B) Tablet 80 mg (A) + 480 mg
(B) |
|
6.10.1.2 |
Artesunate |
P,S,T |
Powder for Injection 60
mg Powder for Injection 120
mg |
|
6.10.1.3 |
Artesunate (A) +
Sulphadoxine Pyrimethamine (B) |
P,S,T |
Combi pack (A+B) 1 Tablet 25 mg (A) + 1
Tablet (250 mg + 12.5 mg) (B) 1 Tablet 50 mg (A) + 1
Tablet (500 mg + 25 mg) (B) 1 Tablet 100 mg (A) + 1
Tablet (750 mg + 37.5 mg) (B) 1 Tablet 150 mg (A) + 2
Tablet (500 mg + 25 mg) (B) 1 Tablet 200 mg (A) + 2
Tablet (750 mg + 37.5 mg) (B) |
|
*Co-trimoxazole
formulations are also listed in Section 6.2.2.6-Anti-infective
Medicines-Antibacterials-Other antibacterials |
|||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
6.10.1.4 |
Chloroquine |
P,S,T |
Tablet 150 mg Oral liquid 50 mg/5 mL |
|
6.10.1.5 |
Clindamycin* |
P,S,T |
Capsule 150 mg Capsule
300 mg |
|
6.10.1.6 |
Primaquine |
P,S,T |
Tablet 2.5 mg Tablet 7.5 mg Tablet 15 mg |
|
6.10.1.7 |
Quinine |
P,S,T |
Tablet 300 mg Injection 300 mg/mL |
|
6.10.2-For prophylaxis |
|||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
6.10.2.1 |
Doxycycline**# |
P,S,T |
Capsule 100 mg Oral liquid 50 mg/5mL #for prophylaxis of P.
vivax |
|
6.10.2.2 |
Mefloquine# |
T |
Tablet 250 mg #Only for use as
chemoprophylaxis for long term travellers like military and travel troops,
travelling from low endemic to high endemic area. |
|
* Clindamycin
formulations are also listed in- A. Section
6.2.2.5-Anti-infective Medicines-Antibacterials-Other antibacterials B. Section
6.7.5.3-Anti-infective Medicines-Antiviral medicines-Medicines for treating
Opportunistic Infections in People living with HIV C. Section
6.9.3.1-Anti-infective Medicines-Antipneumocystosis and antitoxoplasmosismedicines ** Doxycycline
formulations are also listed in Section 6.2.2.7-Anti-infective
Medicines-Antibacterials-Other antibacterials |
|||
|
Section 7 Anti-cancer agents
including Immunosuppressives and Medicines used in Palliative Care |
|||
|
7.1-Antineoplastic medicines |
|||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
7.1.1 |
5-Fluorouracil |
T |
Injection 250 mg/5 mL |
|
7.1.2 |
6-Mercaptopurine |
T |
Tablet 50 mg |
|
7.1.3 |
Actinomycin D |
T |
Powder for Injection 0.5
mg |
|
7.1.4 |
All-trans retinoic acid |
T |
Capsule 10 mg |
|
7.1.5 |
Arsenic trioxide |
T |
Injection 1mg/mL |
|
7.1.6 |
Bendamustine
hydrochloride |
T |
Injection 25 mg/vial Injection 100 mg/vial |
|
7.1.7 |
Bleomycin |
T |
Powder for Injection 15
units |
|
7.1.8 |
Bortezomib |
T |
Powder for Injection 2 mg |
|
7.1.9 |
Calcium folinate |
T |
Tablet 15 mg Injection 3 mg/mL |
|
7.1.10 |
Capecitabine |
T |
Tablet 500 mg |
|
7.1.11 |
Carboplatin |
T |
Injection 10 mg/mL |
|
7.1.12 |
Chlorambucil |
T |
Tablet 2 mg Tablet 5 mg |
|
7.1.13 |
Cisplatin |
T |
Injection 1mg/mL |
|
7.1.14 |
Cyclophosphamide |
T |
Tablet 50 mg Powder for Injection 500
mg |
|
7.1.15 |
Cytosine arabinoside |
T |
Injection 100 mg/vial Injection 500 mg/vial Injection 1000 mg/vial |
|
7.1.16 |
Dacarbazine |
T |
Powder for Injection 200
mg Powder for Injection 500
mg |
|
7.1.17 |
Daunorubicin |
T |
Injection 5 mg/mL |
|
7.1.18 |
Docetaxel |
T |
Powder for Injection 20
mg Powder for Injection 80
mg |
|
7.1.19 |
Doxorubicin |
T |
Injection 2 mg/mL |
|
7.1.20 |
Etoposide |
T |
Capsule 50 mg |
|
|
|
|
Injection 20 mg/mL |
|
7.1.21 |
Gefitinib |
T |
Tablet 250 mg |
|
7.1.22 |
Gemcitabine |
T |
Powder for Injection 200
mg Powder for Injection 1000 mg |
|
7.1.23 |
Hydroxyurea* |
T |
Capsule 500 mg |
|
7.1.24 |
Ifosfamide |
T |
Powder for Injection 1000
mg Powder for Injection 2000 mg |
|
7.1.25 |
Imatinib |
T |
Tablet 100 mg Tablet 400 mg |
|
7.1.26 |
Irinotecan HCl trihydrate |
T |
Solution for injection 20
mg/mL |
|
7.1.27 |
L-Asparaginase |
T |
Powder for Injection 5000
KU Powder for Injection 10000 KU |
|
7.1.28 |
Lenalidomide |
T |
Capsule 5 mg Capsule 25 mg |
|
7.1.29 |
Melphalan |
T |
Tablet 2 mg Tablet 5 mg |
|
7.1.30 |
Methotrexate** |
S,T |
Tablet 2.5 mg Tablet 5 mg Tablet 10 mg Injection 50 mg/mL |
|
*Hydroxyurea formulations
are also listed in Section 8.1.6-Medicines affecting Blood-Antianaemia
Medicines **Methotrexate
formulations are also listed in Section 2.4.3-Analgesics, Antipyretics,
Non-steroidal Anti-inflammatory Drugs (NSAIDs), Medicines used to treat Gout
and Disease Modifying Agents used in Rheumatoid Disorders-Disease Modifying
Agents used in Rheumatoid Disorders |
|||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
7.1.31 |
Oxaliplatin |
T |
Injection 5 mg/mL in 10
mL vial Injection 5 mg/mL in 20 mL vial |
|
7.1.32 |
Paclitaxel |
T |
Injection 30 mg/5 mL Injection 100 mg/16.7 mL |
|
7.1.33 |
Rituximab |
T |
Injection 10 mg/mL |
|
7.1.34 |
Temozolomide |
T |
Capsule 20 mg Capsule 100 mg Capsule 250 mg |
|
7.1.35 |
Thalidomide |
T |
Capsule 50 mg Capsule 100 mg |
|
7.1.36 |
Trastuzumab |
T |
Injection 440 mg/50 mL |
|
7.1.37 |
Vinblastine |
T |
Injection 1 mg/mL |
|
7.1.38 |
Vincristine |
T |
Injection 1 mg/mL |
|
7.2-Hormones and
Anti-hormones used in Cancer Therapy |
|||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
7.2.1 |
Bicalutamide |
T |
Tablet 50 mg |
|
7.2.2 |
Letrozole |
T |
Tablet 2.5 mg |
|
7.2.3 |
Leuprolide acetate |
T |
Powder for injection 3.75
mg Powder for injection
11.25 mg Powder for injection 22.5
mg |
|
7.2.4 |
Prednisolone* |
S,T |
Tablet 10 mg Tablet 20 mg Tablet 40 mg Oral liquid 5 mg/5 mL (p) Oral liquid 15 mg/5 mL
(p) Injection 20 mg/2 mL |
|
7.2.5 |
Tamoxifen |
T |
Tablet 10 mg Tablet 20 mg |
|
7.3-Immunosuppressive
Medicines |
|||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
7.3.1 |
Azathioprine** |
T |
Tablet 50 mg |
|
7.3.2 |
Cyclosporine |
T |
Capsule 25 mg Capsule 50 mg Capsule 100 mg Oral liquid 100 mg/mL (p) Injection 50 mg/mL |
|
*Prednisolone
formulations are also listed in- A. Section
3.6-Antiallergics and Medicines used in Anaphylaxis B. Section
18.1.5-Hormones, other Endocrine Medicines and Contraceptives-Adrenal
Hormones and synthetic substitutes C. Section
21.2.1-Ophthalmological Medicines-Antiinflammatory Medicine **Azathioprine
formulations are also listed in Section 2.4.1-Analgesics, Antipyretics,
Non-steroidal Anti-inflammatory Drugs (NSAIDs), Medicines used to treat Gout
and Disease Modifying Agents used in Rheumatoid Disorders-Disease Modifying
Agents used in Rheumatoid Disorders |
|||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
7.3.3 |
Mycophenolate mofetil |
T |
Tablet 250 mg Tablet 500 mg |
|
7.3.4 |
Tacrolimus |
T |
Capsule 0.5 mg Capsule 1 mg |
|
|
|
|
Capsule 2 mg |
|
7.4-Medicines used in
Palliative Care |
|||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
7.4.1 |
Allopurinol* |
S,T |
Tablet 100 mg |
|
7.4.2 |
Amitriptyline** |
S,T |
Tablet 10 mg Tablet 25 mg |
|
7.4.3 |
Dexamethasone*** |
S,T |
Tablet 0.5 mg Tablet 4 mg Injection 4 mg/mL |
|
*Allopurinol formulations
are also listed in Section 2.3.1-Analgesics, Antipyretics, Non-steroidal
Anti-inflammatory Drugs (NSAIDs), Medicines used to treat Gout and Disease
Modifying Agents used in Rheumatoid Disorders-Medicines used to treat Gout **Amitriptyline
formulations are also listed in A. Section 5.2.5-Medicines used in
Neurological Disorders-Anti-migraine medicines- For prophylaxis B. Section 23.2.1.1-Medicines
in treatment of Psychiatric Disorders-Medicines used in mood
disorders-Medicines used in depressive disorders ***Dexamethasone
formulations are also listed in A. Section
3.4-Antiallergics and medicines used in anaphylaxis B. Section
18.1.1-Hormones, other Endocrine Medicines and Contraceptives-Adrenal
hormones and synthetic substitutes C. Section 27.1-Medicines
for COVID-19 management |
|||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
7.4.4 |
Diazepam* |
S,T |
Tablet 2 mg Tablet 5 mg Injection 5 mg/mL |
|
7.4.5 |
Filgrastim |
T |
Injection 300 mcg |
|
7.4.6 |
Fluoxetine** |
S,T |
Capsule 20 mg |
|
7.4.7 |
Haloperidol*** |
S,T |
Tablet 1.5 mg Tablet 5 mg Injection 5 mg/mL |
|
7.4.8 |
Lactulose**** |
S,T |
Oral liquid 10 g/15 mL |
|
7.4.9 |
Loperamide |
S,T |
Tablet 2 mg |
|
*Diazepam formulations
are also listed Section 5.1.3-Medicines used in Neurological
Disorders-Anticonvulsants/Antiepileptics **Fluoxetine formulations
are also listed in A. Section
23.2.1.3-Medicines in used in treatment of Psychiatric Disorders-Medicines
used in mood disorders-Medicines used in depressive disorders |
|||
|
B. Section
23.4.2-Medicines used in treatment of Psychiatric Disorders-Medicines used in
obsessive compulsive disorders and panic attacks ***Haloperidol
formulations are also listed in Section 23.1.3- Medicines used in
treatment of psychiatric Disorders-Medicines used in psychotic disorders ****Lactulose
formulations are also listed in Section 17.5.3- Gastrointestinal
Medicines-Laxatives |
|||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
7.4.10 |
Metoclopramide* |
S,T |
Tablet 10 mg Oral liquid 5 mg/5 mL (p) Injection 5 mg/mL |
|
7.4.11 |
Mesna |
T |
Injection 100 mg/mL |
|
7.4.12 |
Midazolam** |
S,T |
Injection 1 mg/mL |
|
7.4.13 |
Morphine*** |
S,T |
Tablet 10 mg Modified Release Tablet
30 mg |
|
7.4.14 |
Ondansetron**** |
S,T |
Tablet 4 mg Tablet 8 mg Oral liquid 2 mg/5 mL (p) Injection 2 mg/mL |
|
*Metoclopramide
formulations are also listed in Section 17.2.2- Gastrointestinal
Medicines Antiemetics **Midazolam formulations
are also listed in- A. Section
1.3.3-Medicines used in Anaesthesia-Preoperative medication and sedation for
short term procedures B. Section
5.1.7-Medicines used in Neurological Disorders-Anticonvulsants/Antiepileptics
***Morphine formulations are also listed in- A. Section
1.3.4-Medicines used in Anaesthesia-Preoperative medication and sedation for
short term procedures B. Section
2.2.2-Analgesics, Antipyretics, Non-steroidal Anti-inflammatory Drugs
(NSAIDs), Medicines used to treat Gout and Disease Modifying Agents used in
Rheumatoid Disorders-Opioid Analgesics ****Ondansetron
formulations are also listed Section 17.2.3-Gastrointestinal
Medicines-anti-ulcer medicines |
|||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
7.4.15 |
Tramadol* |
S,T |
Capsule 50 mg Capsule 100 mg Injection 50 mg/mL |
|
7.4.16 |
Zoledronic acid |
T |
Powder for Injection 4 mg |
|
Section 8 Medicines affecting Blood |
||||
|
8.1-Antianaemia Medicines |
||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
|
8.1.1 |
Erythropoietin |
S,T |
Injection 2000 IU/mL Injection 10000 IU/mL |
|
|
8.1.2 |
Ferrous salts (a) Iron Dextran (b) Iron sorbitol citrate
complex |
P,S,T |
Tablet equivalent to 60
mg of elemental iron Injection 50 mg/mL Injection 50 mg/mL |
|
|
8.1.3 |
Ferrous Salt (A)+ Folic
acid (B) |
P,S,T |
Tablet 45 mg elemental
iron (A) + 400 mcg (B) Tablet 100 mg elemental
iron (A) + 500 mcg (B) Oral liquid 20 mg
elemental iron (A) + 100 mcg/mL (B) (p) |
|
|
*Tramadol formulations
are also listed in Section 2.2.3-Analgesics, Antipyretics, Non-steroidal
Anti-inflammatory Drugs (NSAIDs), Medicines used to treat Gout and disease
Modifying agents used in Rheumatoid Disorders-Opioid Analgesics |
||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
|
8.1.4 |
Folic Acid |
P,S,T |
Tablet 1 mg Tablet 5 mg |
|
|
8.1.5 |
Hydroxocobalamin |
P,S,T |
Injection 1 mg/mL |
|
|
8.1.6 |
Hydroxyurea* |
S,T |
Capsule 500 mg |
|
|
8.1.7 |
Iron sucrose |
S,T |
Injection 20 mg/mL |
|
|
8.2-Medicines affecting
Coagulation |
||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
|
8.2.1 |
Enoxaparin** |
S,T |
Injection 40 mg/0.4 mL Injection 60 mg/0.6 mL |
|
|
8.2.2 |
Heparin*** |
S,T |
Injection 1000 IU/mL Injection 5000 IU/mL |
|
|
8.2.3 |
Phytomenadione (Vitamin K1) |
P,S,T |
Tablet 10 mg Injection 10 mg/mL |
|
|
8.2.4 |
Protamine Sulphate |
S,T |
Injection 10 mg/mL |
|
|
8.2.5 |
Tranexamic acid |
P,S,T |
Tablet 500 mg Injection 100 mg/mL |
|
|
* Hydroxyurea
formulations are also listed in Section 7.1.26-Anti-cancer agents including
Immunosuppressives, and Medicines used in Palliative Care-Antineoplastic
medicines ** Enoxaparin
formulations are also listed in A. Section
10.5.4-Cardiovascular Medicines-Antiplatelet and Antithrombotic Medicines B. Section 27.2-Medicines
for COVID-19 management *** Heparin formulations
are also listed in Section 10.5.5-Cardiovascular Medicines-Antiplatelet and
Antithrombotic Medicines |
||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and strength(s) |
|
|
8.2.6 |
Warfarin |
S,T |
Tablet 1 mg Tablet 2 mg Tablet 3 mg Tablet 5 mg |
|
|
Section 9 Blood products and Plasma
substitutes |
||||
|
9.1-Blood and Blood
components |
||||
|
All forms of the
following as approved by licensing authority are considered as included in NLEM.
However, considering the process, technology and other relevant aspects, they
should be considered differently for purposes such as procurement policy,
pricing etc. |
||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
|
9.1.1 |
Fresh frozen plasma |
S,T |
As licensed |
|
|
9.1.2 |
Platelet rich
plasma/Platelet concentrates |
S,T |
As licensed |
|
|
9.1.3 |
Red blood cells/Packed
RBCs |
S,T |
As licensed |
|
|
9.1.4 |
Whole blood |
S,T |
As licensed |
|
|
9.2-Plasma substitutes |
||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and strength(s) |
|
|
9.2.1 |
Dextran-40 |
S,T |
Injection 10% |
|
|
9.3-Plasma fractions for
specific use |
||||
|
In case of coagulation
factors and other blood products, irrespective of variation in source, all
forms of these products as approved by licensing authority are considered as
included in NLEM. However, considering the source, process, technology and
other relevant aspects, they should be considered differently for purposes
such as procurement policy, pricing etc. |
||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
|
9.3.1 |
Coagulation factor IX |
S,T |
Powder for Injection 600
IU |
|
|
9.3.2 |
Coagulation factor VIII |
S,T |
Powder for Injection 250
IU Powder for Injection 500
IU |
|
|
9.3.3 |
Cryoprecipitate |
S,T |
As licensed |
|
|
Section 10 Cardiovascular Medicines |
||||
|
10.1-Medicines used in
Angina |
||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
|
10.1.1 |
Diltiazem |
P,S,T |
Tablet 30 mg Tablet 60 mg Modified Release Tablet
180 mg |
|
|
S, T |
Injection 5 mg/mL |
|||
|
|
|
P,S,T |
Sublingual Tablet 0.5 mg |
|
|
10.1.2 |
Glyceryl trinitrate |
S,T |
Injection 5 mg/mL |
|
|
10.1.3 |
Isosorbide dinitrate |
P,S,T |
Tablet 5 mg Tablet 10 mg |
|
|
10.1.4 |
Metoprolol |
P,S,T |
Tablet 25 mg Tablet 50 mg Tablet 100 mg Modified Release Tablet
100 mg |
|
|
S,T |
Injection 1 mg/mL |
|||
|
10.2-Antiarrhythmic
medicines |
||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
|
10.2.1 |
Adenosine |
S,T |
Injection 3 mg/mL |
|
|
10.2.2 |
Amiodarone |
S,T |
Tablet 100 mg Tablet 200 mg Injection 50 mg/mL |
|
|
10.2.3 |
Digoxin* |
S,T |
Tablet 0.25 mg Oral liquid 0.05 mg/mL Injection 0.25 mg/mL |
|
|
10.2.4 |
Esmolol |
S,T |
Injection 10 mg/mL |
|
|
10.2.5 |
Lignocaine** |
S,T |
Injection 2% |
|
|
10.2.6 |
Verapamil |
S,T |
Tablet 40 mg Tablet 80 mg Injection 2.5 mg/mL |
|
|
10.3-Antihypertensive
Medicines |
||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
|
10.3.1 |
Amlodipine |
P,S,T |
Tablet 2.5 mg Tablet 5 mg Tablet 10 mg |
|
|
*Digoxin formulations are
also listed in Section 10.4.1-Cardiovascular Medicines- Medicines used in Shock
and Heart Failure **Lignocaine formulations
are also listed in Section 1.2.2-Medicines used in Anaesthesia-Local
Anaesthetics |
||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
|
10.3.2 |
Enalapril |
P,S,T |
Tablet 2.5 mg Tablet 5 mg |
|
|
10.3.3 |
Hydrochlorothiazide* |
P,S,T |
Tablet 12.5 mg Tablet 25 mg |
|
|
|
Labetalol |
P,S,T |
Tablet 50 mg Tablet 100 mg |
|
|
10.3.4 |
P,S,T |
Injection 5 mg/mL |
||
|
10.3.5 |
Ramipril |
P,S,T |
Tablet 2.5 mg Tablet 5 mg |
|
|
10.3.6 |
Sodium nitroprusside |
S,T |
Injection 10 mg/mL |
|
|
10.3.7 |
Telmisartan |
P,S,T |
Tablet 20 mg Tablet 40 mg Tablet 80 mg |
|
|
10.4-Medicines used in
Shock and Heart failure |
||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
|
10.4.1 |
Digoxin* * |
S,T |
Tablet 0.25 mg Oral liquid 0.05 mg/mL Injection 0.25 mg/mL |
|
|
*Hydrochlorothiazide
formulations are also listed in Section 15.2-Diuretics **Digoxin formulations
are also listed in Section 10.2.3-Cardiovascular Medicines-Antiarrhythmic
medicines |
||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
|
10.4.2 |
Dobutamine |
S,T |
Injection 50 mg/mL |
|
|
10.4.3 |
Dopamine |
S,T |
Injection 40 mg/mL |
|
|
10.4.4 |
Noradrenaline |
S,T |
Injection 2 mg/mL |
|
|
10.4.5 |
Spironolactone* |
P,S,T |
Tablet 25 mg Tablet 50 mg |
|
|
10.5-Antiplatelet and
Antithrombotic Medicines |
||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
|
10.5.1 |
Acetylsalicylic acid* * |
P,S,T |
Conventional/Effervescent/Dispersible/Enteric
coated Tablets 150 mg Conventional/Effervescent/Dispersible/Enteric
coated Tablets 325 mg Enteric coated Tablet 75
mg Enteric coated Tablet 100 mg |
|
|
*Spironolactone
formulations are also listed in Section 15.4-Diuretics **Acetylsalicyclic acid
formulations are also listed in- A. Section
2.1.1-Analgesics, Antipyretics, Non-steroidal Anti-inflammatory Drugs (NSAIDs), Medicines
used to treat Gout and Disease Modifying Agents used in Rheumatoid
Disorders-Non-opioid Analgesics, Antipyretics and Non-steroidal
Anti-inflammatory Drugs B. Section
5.2.1-Medicines used in Neurological Disorders-Antimigraine medicines |
||||
|
10.5.2 |
Clopidogrel |
P,S,T |
Tablet 75 mg Tablet 150 mg |
|
|
10.5.3 |
Dabigatran |
S, T |
Tablet 110 mg Tablet 150 mg |
|
|
10.5.4 |
Enoxaparin* |
S,T |
Injection 40 mg/0.4 mL Injection 60 mg/0.6 mL |
|
|
10.5.5 |
Heparin** |
S,T |
Injection 1000 IU/mL Injection 5000 IU/mL |
|
|
10.5.6 |
Streptokinase |
S,T |
Injection 750,000 IU Injection 15,00,000 IU |
|
|
10.5.7 |
Tenecteplase |
S,T |
Injection 30 mg/vial Injection 40 mg/vial |
|
|
10.6-Hypolipidemic
Medicines |
||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
|
10.6.1 |
Atorvastatin |
P,S,T |
Tablet 10 mg Tablet 20 mg Tablet 40 mg Tablet 80 mg |
|
|
*Enoxaparin formulations
are also listed in- A. Section
8.2.1-Medicines affecting Blood-Medicines affecting coagulation B. Section 27.2-Medicines
for COVID-19 management **Heparin formulations
are also listed in Section 8.2.2-Medicines affecting Blood-Medicines
affecting coagulation |
||||
|
Section 11 Dermatological Medicines
(Topical) |
||||
|
11.1-Antifungal Medicines |
||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
|
|
|
|
Cream 1% Lotion 1% |
|
|
11.1.1 |
Clotrimazole* |
P,S,T |
||
|
11.2-Antibacterial
Medicines |
||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
|
11.2.1 |
Framycetin |
P,S,T |
Cream 1% |
|
|
11.2.2 |
Fusidic acid |
P,S,T |
Cream 2% |
|
|
11.2.3 |
Silver sulphadiazine |
P,S,T |
Cream 1% |
|
|
11.3-Antiinflammatory and
Antipruritic Medicines |
||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
|
11.3.1 |
Betamethasone valerate |
P,S,T |
Cream 0.05% Cream 0.1% |
|
|
*Clotnmazole formulations
are also listed in- A. Section
6.5.2-Anti-infective Medicines-Antifungal medicines B. Section
6.7.5.4-Anti-infective Medicines-Antiviral medicines-Medicines used in the
management of HIV C. Section 16.3-Ear, Nose
and Throat Medicines |
||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
|
11.3.2 |
Calamine |
P,S,T |
Lotion (As per IP) |
|
|
11.4-Keratolytic agents |
||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
|
11.4.1 |
Benzoyl peroxide |
P,S,T |
Gel 2.5%-5% |
|
|
11.4.2 |
Coal tar (A) + Salicylic
Acid (B) |
P,S,T |
Solution 1% (A) + 3% (B) |
|
|
11.4.3 |
Podophyllin resin |
S,T |
Solution 20% |
|
|
11.4.4 |
Salicylic acid |
P,S,T |
Ointment 3-6% |
|
|
11.5-Scabicides and
Pediculicides |
||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
|
11.5.1 |
Permethrin |
P,S,T |
Lotion 1% Cream 5% |
|
|
11.6 Miscellaneous |
||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and strength(s) |
|
|
11.6.1 |
Glycerin/glycerol (as
mentioned in IP) |
P,S,T |
Topical |
|
|
Section 12 Diagnostic agents |
||||
|
12.1-Ophthalmic Medicines |
||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
|
12.1.1 |
Fluorescein |
S,T |
Ophthalmic Strips |
|
|
12.1.2 |
Proparacaine* |
S,T |
Eye Drops 0.5% |
|
|
12.1.3 |
Tropicamide** |
S,T |
Eye drop 1% |
|
|
12.2-Radiocontrast Media |
||||
|
12.2.1 |
Barium sulphate |
S,T |
Oral Liquid 95% w/v |
|
|
12.2.2 |
Gadobenate dimeglumine |
T |
Injection 529 mg/mL |
|
|
12.2.3 |
Iohexol |
S,T |
Injection 140 to 350 mg
iodine/mL |
|
|
12.2.4 |
Meglumine diatrizoate |
S,T |
Injection 60% w/v Injection 76% w/v |
|
|
* Proparacame
formulations are also listed in Section 21.3.1-Ophthalmological
Medicines-Local Anaesthetics ** Tropicamide
formulations are also listed in Section 21.5.4-Ophthalmological Medicines-Mydriatics |
||||
|
Section 13 Dialysis components
(Haemodialysis and Peritoneal Dialysis) |
||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
|
13.1 |
Haemodialysis fluid |
S,T |
As licensed |
|
|
13.2 |
Peritoneal dialysis
solution |
S,T |
As licensed |
|
|
Section 14 Antiseptics and
Disinfectants |
||||
|
14.1 Antiseptics |
||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
|
14.1.1 |
Chlorhexidine |
P,S,T |
Solution 5% (Concentrate) |
|
|
14.1.2 |
Ethyl alcohol(Denatured) |
P,S,T |
Solution 70% |
|
|
14.1.3 |
Hydrogen peroxide |
P,S,T |
Solution 6% |
|
|
14.1.4 |
Methylrosaniliniumchloride
(Gentian Violet) |
P,S,T |
Topical preparation 0.25%
to 2% |
|
|
14.1.5 |
Povidone iodine* |
P,S,T |
Solution 4% to 10% |
|
|
*Povidone Iodine
formulations are also listed in Section 21.1.5-Ophthalmological Medicines-Anti-infective
medicine |
||||
|
14.2 Disinfectants |
||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
|
14.2.1 |
Glutaraldehyde |
S,T |
As Licensed |
|
|
14.2.2 |
Potassium permanganate |
P,S,T |
Crystals for
topicalsolution |
|
|
Section 15 Diuretics |
||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
|
15.1 |
Furosemide |
P,S,T |
Tablet 40 mg Oral liquid 10 mg/mL Injection 10 mg/mL |
|
|
15.2 |
Hydrochlorothiazide* |
P,S,T |
Tablet 25 mg Tablet 50 mg |
|
|
15.3 |
Mannitol |
P,S,T |
Injection 10% Injection 20% |
|
|
15.4 |
Spironolactone** |
P,S,T |
Tablet 25 mg Tablet 50 mg |
|
|
* Hydrochlorothiazide
formulations are also listed in Section 10.3.3-Antihypertensive Medicines **Spironolactone
formulations are also listed in Section 10.4.5-Cardiovascular
Medicines-Medicines used in shock and heart failure |
||||
|
Section 16 Ear, Nose and Throat
Medicines |
||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
|
16.1 |
Budesonide* |
P,S,T |
Nasal Spray 50 mcg/dose Nasal Spray 100 mcg/dose |
|
|
16.2 |
Ciprofloxacin* * |
P,S,T |
Drops 0.3% |
|
|
16.3 |
Clotrimazole*** |
P,S,T |
Drops 1% |
|
|
16.4 |
Xylometazoline |
P,S,T |
Nasal drops 0.05% Nasal drops 0.1% |
|
|
*Budesonide formulations
are also listed in Section 24.1-Medicines acting on the respiratory
tract-Antiasthmatic Medicines **Ciprofloxacin
formulations are also listed in A. Section
6.2.2.3-Anti-infective Medicines-Antibacterials-Other Antibacterials B. Section
21.1.2-Ophthalmological Medicines-Anti-infective Medicines ***Clotnmazole
formulations are also listed in- A. Section
6.5.2-Anti-infective Medicines-Antifungal medicines B. Section
6.7.5.4-Anti-infective Medicines-Antiviral medicines-Medicines used in the
management of HIV C. Section
11.1.1-Dermatological Medicines (Topical)-Antifungal medicines |
||||
|
Section 17 Gastrointestinal
Medicines |
||||
|
17.1 - Antiulcer
Medicines |
||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
|
17.1.1 |
Omeprazole |
P,S,T |
Capsule 10 mg Capsule 20 mg Capsule 40 mg Powder for oral liquid 20
mg |
|
|
17.1.2 |
Pantoprazole |
S,T |
Injection 40 mg |
|
|
17.2 Antiemetics |
||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
|
17.2.1 |
Domperidone |
P,S,T |
Tablet 10 mg Oral Liquid 1 mg/mL |
|
|
17.2.2 |
Metoclopramide * |
P,S,T |
Tablet 10 mg Injection 5 mg/mL |
|
|
17.2.3 |
Ondansetron* |
S,T |
Tablet 4 mg Oral Liquid 2 mg/5 mL (p) Injection 2 mg/mL |
|
|
*Metoclopramide
formulations are also listed in Section 7.4.10-Anti-cancer agents including
Immunosuppressives, and Medicines used in Palliative Care-Medicines used in
Palliative Care *Ondansetron formulations
are also listed in Section 7.4.14-Anti-cancer agents including
Immunosuppressives, and Medicines used in Palliative Care-Medicines used in
Palliative Care |
||||
|
17.3 Anti-inflammatory
medicines |
||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
|
17.3.1 |
5-aminosalicylic acid
(Mesalazine/Mesalaine) |
S,T |
Tablet 400 mg Suppository 500 mg Retention Enema |
|
|
17.4 Antispasmodic
medicines |
||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
|
17.4.1 |
Dicyclomine |
P,S,T |
Tablet 10 mg Oral Solution 10 mg/5mL Injection 10 mg/mL |
|
|
17.4.2 |
Hyoscine butyl bromide |
P,S,T |
Tablet 100 mg Injection 20 mg/mL |
|
|
17.5 Laxatives |
||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
|
17.5.1 |
Bisacodyl |
P,S,T |
Tablet 5 mg Suppository 5 mg |
|
|
17.5.2 |
Ispaghula |
P,S,T |
Granules/Husk/Powder |
|
|
17.5.3 |
Lactulose* |
S,T |
Oral Liquid 10 g/15 mL |
|
|
17.6 Medicines used in
diarrhea |
||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
|
17.6.1 |
Oral rehydrationsalts** |
P,S,T |
As licensed |
|
|
17.6.2 |
Zinc Sulphate |
P,S,T |
Dispersible Tablet 20 mg |
|
|
17.7 Other medicines |
||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
|
17.7.1 |
Somatostatin |
T |
Powder for Injection 3 mg |
|
|
*Lactulose formulations
are also listed in Section 7.4.8-Anti-cancer agents including
Immunosuppressives, and Medicines used in Palliative Care-Medicines used in
Palhative Care **Oral rehydration salts
formulations are also listed in Section 25.3-Solutions correcting water,
electrolyte disturbances and acid-base disturbances |
||||
|
Section 18 Hormones, other Endocrine
Medicines and Contraceptives |
||||
|
18.1-Adrenal Hormones and
Synthetic substitutes |
||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
|
18.1.1 |
Dexamethasone* |
S,T |
Tablet 0.5 mg Injection 4 mg/mL |
|
|
18.1.2 |
Fludrocortisone |
S,T |
Tablet 0.1 mg |
|
|
18.1.3 |
Hydrocortisone* * |
P,S,T |
Tablet 5 mg Tablet 10 mg Tablet 20 mg Powder for Injection 100
mg |
|
|
18.1.4 |
Methylprednisolone*** |
S,T |
Injection 40mg/mL |
|
|
*Dexamethasone
formulations are also listed in- A. Section
3.4-Antiallergics and Medicines used in Anaphylaxis B. Section
7.4.3-Anti-cancer agents including Immunosuppressives, and Medicines used in
Palhative Care-Medicines used in Palliative Care C. Section 27.1-Medicines
for COVID-19 Management ** Hydrocortisone
formulations are also listed in Section 3.5-Antiallergics and Medicines used
in Anaphylaxis ***Methylprednisolone
formulations are also listed in section 27.3-Medicines for COVID-19 management |
||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
|
|
|
|
Tablet 5 mg Tablet 10 mg |
|
|
18.1.5 |
Prednisolone* |
P,S,T |
Tablet 20 mg Oral liquid 5 mg/5 mL (p) Oral liquid 15 mg/5 mL
(p) |
|
|
18.2 Contraceptives |
||||
|
18.2.1-Hormonal
Contraceptives |
||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
|
18.2.1.1 |
Ethinylestradiol (A)+
Levonorgestrel (B) |
P,S,T |
Tablet 0.03 mg (A)+Tablet
0.15 mg (B) |
|
|
18.2.1.2 |
Levonorgestrel |
P,S,T |
Tablet 0.75 mg Tablet 1.5 mg |
|
|
18.2.1.3 |
Ormeloxifene
(Centchroman) |
P,S,T |
Tablet 30 mg |
|
|
*Prednisolone
formulations are also listed in- A. Section
3.7-Antiallergics and Medicines used in Anaphylaxis B. Section
7.2.4-Anti-cancer agents including Immunosuppressives, and Medicines used in
Palhative Care Hormones and anti-hormones used in cancer therapy C. Section
21.2.1-Ophthalmological Medicines-Anti-inflammatory medicine |
||||
|
18.2.2-Intrauterine
Devices |
||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
|
18.2.2.1 |
Hormone releasing IUD |
T |
Contains 52 mg of
Levonorgestrel |
|
|
18.2.2.2 |
IUD containing Copper |
P,S,T |
As licensed |
|
|
18.2.3-Barrier methods |
||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
|
18.2.3.1 |
Condom |
P,S,T |
As Licensed-as per the
standards of Drugs Rules, 1945 |
|
|
18.3-Medicines used in
Diabetes Mellitus |
||||
|
18.3.1-Insulins and other
Antidiabetic agents |
||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
|
18.3.1.1 |
Glimepiride |
P,S,T |
Tablet 1 mg Tablet 2 mg |
|
|
18.3.1.2 |
Insulin (Soluble) |
P,S,T |
Injection 40 IU/mL |
|
|
18.3.1.3 |
Insulin Intermediate
Acting (NPH) |
P,S,T |
Injection 40 IU/mL |
|
|
18.3.1.4 |
Insulin Glargine |
P,S,T |
Injection 100 IU/mL |
|
|
18.3.1.5 |
Insulin Premix Injection
30:70 (Regular: NPH) |
P,S,T |
Injection 40 IU/mL |
|
|
18.3.1.6 |
Metformin |
P,S,T |
Tablet 500 mg Tablet 1000 mg Modified release Tablet
1000 mg |
|
|
18.3.1.7 |
Teneligliptin |
P,S,T |
Tablet 20 mg |
|
|
18.3.2-Medicines used to
treat Hypoglycemia |
||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
|
18.3.2.1 |
Glucose* |
P,S,T |
Injection 25% |
|
|
18.4-Ovulation Inducers |
||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
|
18.4.1 |
Clomiphene citrate |
T |
Tablet 50 mg Tablet 100 mg |
|
|
18.4.2 |
Human chorionic
gonadotropin |
S,T |
Injection 2000 IU Injection 5000 IU Injection 10000 IU |
|
|
*Glucose formulations are
also listed in Section 25.1-Solutions correcting water,
electrolytedisturbances and acid-base disturbances |
||||
|
18.5-Progestogens |
||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
|
18.5.1 |
Medroxyprogesteroneacetate |
P,S,T |
Tablet 5 mg Tablet 10 mg Injection 150 mg/mL |
|
|
18.5.2 |
Norethisterone |
P,S,T |
Tablet 5 mg |
|
|
18.6-Thyroid and
Antithyroid Medicines |
||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
|
18.6.1 |
Carbimazole |
P,S,T |
Tablet 5 mg Tablet 10 mg Tablet 20 mg |
|
|
18.6.2 |
Levothyroxine |
P,S,T |
Tablet 12.5 mcg to 150
mcg* (*Several strengths are
available in market such as 12.5, 25, 50, 62.5, 75, 88, 100, 112mcg.
Therefore, it was considered to give a range of available strengths) |
|
|
Section 19 Immunologicals |
||||
|
In case of these
biologicals, irrespective of variation in source, composition and strengths,
all the products of the same vaccine/sera/immunoglobulin, as approved by
licensing authority are considered as included in NLEM. However, considering
the source, process, technology and other relevant aspects, different
products of the same biological should be considered differently for purposes
such as procurement policy, pricing etc. |
||||
|
19.1-Diagnostic agents |
||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
|
19.1.1 |
Tuberculin, Purified
Protein derivative |
P,S,T |
As Licensed |
|
|
19.2-Sera and
Immunoglobulins (Liquid/Lyophilized) |
||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
|
19.2.1 |
Anti-rabies
immunoglobulin |
P,S,T |
As Licensed |
|
|
19.2.2 |
Anti-tetanus immunoglobulin |
P,S,T |
As Licensed |
|
|
19.2.3 |
Anti-D immunoglobulin |
S,T |
As Licensed |
|
|
19.2.4 |
Diphtheria antitoxin |
P,S,T |
As Licensed |
|
|
19.2.5 |
Hepatitis B
immunoglobulin |
S,T |
As Licensed |
|
|
19.2.6 |
Human normal
immunoglobulin |
T |
As Licensed |
|
|
19.2.7 |
Snake Venom Antiserum* |
P,S,T |
a) Soluble/liquid
polyvalent-As Licensed b) Lyophilized
polyvalent-As Licensed |
|
|
*Snake Venom antiserum
also listed in Section 4.2.12-Antidotes and Other Substances used in
Management of Poisonings/Envenomation-Specific |
||||
|
19.3-Vaccines |
||||
|
a) All the vaccines which
are under Universal Immunization Program of India (UIP) will be deemed
included in NLEM. Presently, the UIP has BCG, DPT, OPV, measles, Hepatitis B,
Japanese encephalitis, Pentavalent Vaccines and Rota virus vaccine. |
||||
|
b) The vaccines, which
have been approved by National Technical Advisory Group on Immunization
(NTAGI) and planned to be given under UIP, will be deemed to be included as
and when listed in UIP. These vaccines are inactivatedpolio vaccine (IPV) and
Measles Rubella (MR). |
||||
|
c) In future, the
vaccines which are under consideration, if and when included in UIP, will
also be deemed included from the date of inclusion in UIP. These are
pneumococcal and HPV vaccines. |
||||
|
For Universal
Immunization |
||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
|
19.3.1 |
BCG vaccine |
P,S,T |
As licensed |
|
|
19.3.2 |
DPT + Hib + Hep B vaccine |
P,S,T |
As licensed |
|
|
19.3.3 |
DPT vaccine |
P,S,T |
As licensed |
|
|
19.3.4 |
Hepatitis B vaccine |
P,S,T |
As licensed |
|
|
19.3.5 |
Japanese encephalitis
vaccine |
P,S,T |
As licensed |
|
|
19.3.6 |
Measles vaccine |
P,S,T |
As licensed |
|
|
19.3.7 |
Oral poliomyelitisvaccine |
P,S,T |
As licensed |
|
|
19.3.8 |
Rotavirus vaccine |
P,S,T |
As licensed |
|
|
19.3.9 |
Tetanus toxoid |
P,S,T |
As licensed |
|
|
19.4-For Specific Group
of Individuals |
||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
|
19.4.1 |
Rabies vaccine |
P,S,T |
As licensed |
|
|
Section 20 Medicines for Neonatal
Care |
||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
|
20.1 |
Alprostadil |
S,T |
Injection 0.5 mg/mL |
|
|
20.2 |
Caffeine |
S,T |
Oral liquid 20 mg/mL
Injection 20 mg/mL |
|
|
20.3 |
Surfactant |
S,T |
Suspension for
intratracheal instillation (As licensed) |
|
|
Section 21 Ophthalmological
Medicines |
||||
|
21.1-Anti-infective
Medicines |
||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
|
21.1.1 |
Acyclovir* |
P,S,T |
Ointment 3% |
|
|
21.1.2 |
Ciprofloxacin* * |
P,S,T |
Drops 0.3% Ointment 0.3% |
|
|
21.1.3 |
Natamycin |
P,S,T |
Drops 5% |
|
|
21.1.4 |
Povidone iodine*** |
P,S,T |
Drops 5% |
|
|
21.2-Antiinflammatory
Medicine |
||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
|
21.2.1 |
Prednisolone**** |
P,S,T |
Drops 1% |
|
|
*Acyclovir formulations
are also listed in- A. Anti-infective
Medicines-Antiviral medicines-Anti-herpes medicines Section 6.6.1.1 B. Anti-infective
Medicines-Medicines used in the management of HIV-Medicines for treating |
||||
|
Opportunistic Infections
in People living with HIV Section 6.7.5.1 **Ciprofloxacin
formulations are also listed in- A. Section
6.2.2.3-Anti-infective Medicines-Antibacterials-Other Antibacterials B. Section 16.2 Ear, Nose
and Throat Medicines * * *Povidone Iodine Also
listed in Section 14.1.5-Antiseptics and Disinfectants-Antiseptics ****Prednisolone
formulations are also listed in- A. Section
3.7-Antiallergics and Medicines used in Anaphylaxis B. Section
7.2.4-Anti-cancer agents including Immunosuppressives, and Medicines used in
Palliative Care-Hormones and anti-hormones used in cancer therapy C. Section
18.1.5-Hormones, other Endocrine Medicines and Contraceptives-Adrenal
Hormones and synthetic substitutes |
||||
|
21.3-Local Anaesthetic |
||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
|
21.3.1 |
Proparacaine* |
P,S,T |
Drops 0.5% |
|
|
21.4-Miotics and
Antiglaucoma Medicines |
||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
|
21.4.1 |
Acetazolamide |
P,S,T |
Tablet 250 mg |
|
|
21.4.2 |
Latanoprost |
P,S,T |
Drops 0.005% |
|
|
21.4.3 |
Pilocarpine |
P,S,T |
Drops 2% Drops 4% |
|
|
21.4.4 |
Timolol |
P,S,T |
Drops 0.25% Drops 0.5% |
|
|
21.5-Mydriatics |
||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
|
21.5.1 |
Atropine** |
P,S,T |
Drops 1% Ointment 1% |
|
|
*Proparacaine
formulations are also listed in listed in Section 12.1.2-Diagnostic
agents-Ophthalmic Medicines **Atropine formulations
are also listed in- A. Section
1.3.1-Medicines used in Anaesthesia-Preoperative medication and sedation for
short term procedures B. Section
4.2.1-Antidotes and Other substances used in Management of
poisoning/Envenomation-specific |
||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
|
21.5.2 |
Homatropine |
P,S,T |
Drops 2% |
|
|
21.5.3 |
Phenylephrine |
P,S,T |
Drops 5% Drops 10% |
|
|
21.5.4 |
Tropicamide* |
P,S,T |
Drops 1% |
|
|
21.6-Miscellaneous |
||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
|
21.6.1 |
Carboxymethylcellulose |
P,S,T |
Drops 0.5% Drops 1% |
|
|
21.6.2 |
Hydroxypropyl
methylcellulose |
T |
Injection 2% |
|
|
Section 22 Oxytocics and Antioxytocics |
||||
|
22.1-Oxytocics and
Abortifacient |
||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
|
22.1.1 |
Dinoprostone |
S,T |
Tablet 0.5 mg Gel 0.5 mg |
|
|
22.1.2 |
Methylergometrine |
P,S,T |
Tablet 0.125 mg Injection 0.2 mg/mL |
|
|
*Tropicamide formulations
are also listed in Section 12.1.3-Diagnostic agents-Ophthalmic Medicines |
||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
|
22.1.3 |
Mifepristone |
P,S,T |
Tablet 200 mg |
|
|
22.1.4 |
Misoprostol |
P,S,T |
Tablet 100 mcg Tablet 200 mcg |
|
|
22.1.5 |
Oxytocin |
P,S,T |
Injection 5 IU/mL Injection 10 IU/mL |
|
|
22.2-Medicines used in
Preterm Labour |
||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
|
22.2.1 |
Betamethasone |
P,S,T |
Injection 4 mg/mL |
|
|
22.2.2 |
Nifedipine |
S,T |
Tablet 10 mg |
|
|
Section 23 Medicines used in
treatment of Psychiatric Disorders |
||||
|
23.1-Medicines used in
Psychotic Disorders |
||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
|
23.1.1 |
Clozapine |
T |
Tablet 25 mg Tablet 50 mg Tablet 100 mg |
|
|
23.1.2 |
Fluphenazine |
P,S,T |
Injection 25 mg/mL |
|
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
|
23.1.3 |
Haloperidol* |
S,T |
Tablet 2 mg Tablet 5 mg Tablet 10 mg Tablet 20 mg Oral liquid 2 mg/5 mL Injection 5 mg/mL |
|
|
23.1.4 |
Risperidone |
P,S,T |
Tablet 1 mg Tablet 2 mg Tablet 4 mg Oral liquid 1 mg/mL Injection (Long acting)
25 mg Injection (Long acting)
37.5 mg |
|
|
23.2-Medicines used in
Mood Disorders |
||||
|
23.2.1-Medicines used in
Depressive Disorders |
||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
|
23.2.1.1 |
Amitriptyline** |
P,S,T |
Tablet 10 mg Tablet 25 mg Tablet 50 mg Tablet 75 mg |
|
|
*Haloperidol formulations
are also listed in Section 7.4.7-Anti-cancer agents including
Immunosuppressives, and Medicines used in Palliative are-Medicines used in
Palliative Care **Amitriptylme
formulations are also listed in- A. Section
5.2.5-Medicines used in Neurological Disorders-Anti-migraine medicines-For
prophylaxis B. Section
7.4.2-Anti-cancer agents including Immunosuppressives, and Medicines used in
Palliative are-Medicines used in Palliative Care |
||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
|
23.2.1.2 |
Escitalopram |
P,S,T |
Tablet 5 mg Tablet 10 mg Tablet 20 mg |
|
|
|
|
|
Capsule 10 mg |
|
|
23.2.1.3 |
Fluoxetine* |
P,S,T |
Capsule 20 mg Capsule 40 mg Capsule 60 mg |
|
|
23.2.2-Medicines used in
Bipolar Disorders |
||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
|
23.2.2.1 |
Lithium |
S,T |
Tablet 300 mg |
|
|
23.2.2.2 |
Sodium valproate** |
P,S,T |
Tablet 200 mg Tablet 300 mg Tablet 500 mg Modified Release- Tablet 300 mg Tablet 500 mg |
|
|
23.2.2.3 |
Carbamazepine*** |
P,S,T |
Tablet 100 mg Tablet 200 mg Tablet 400 mg Modified Release- Tablet 200 mg Tablet 400 mg Oral liquid 100 mg/5 mL
(p) |
|
|
*Fluoxetine formulations
are also listed in- A. Section
7.4.6-Anti-cancer agents including Immunosuppressives, and Medicines used in
Palhative are-Medicines used in Palliative Care B. Section
7.4.6-Medicines used in treatment of psychiatric Disorders-Medicines used
inobsessive compulsive disorders and panic attacks ** Sodium Valproate
formulations are also listed in Section 5.1.10-Medicines used in Neurological
Disorders-Anticonvulsants/antiepileptics ***Carbamazepine
formulations are also listed in Section 5.1.1-Medicines used in Neurological Disorders-Anticonvulsants/antiepileptics |
||||
|
23.3-Medicines used in
Generalized Anxiety and Sleep Disorders |
||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
|
23.3.1 |
Clonazepam |
P,S,T |
Tablet 0.25 mg Tablet 0.5 mg Tablet 1 mg |
|
|
23.3.2 |
Zolpidem |
P,S,T |
Tablet 5 mg Tablet 10 mg |
|
|
23.4-Medicines used in
Obsessive Compulsive Disorders and Panic attacks |
||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
|
23.4.1 |
Clomipramine |
P,S,T |
Capsule 10 mg Capsule 25 mg Capsule 75 mg |
|
|
23.4.2 |
Fluoxetine* |
S,T |
Capsule 10 mg Capsule 20 mg Capsule 40 mg Capsule 60 mg |
|
|
*Fluoxetine formulations
are also listed in- A. Section
7.4.6-Anti-cancer agents including Immunosuppressives, and Medicines used in
Palliative are-Medicines used in Palliative Care B. Section 23.2.1.3 Medicines
used in treatment of Psychiatric Disorders-Medicines used in mood
disorders-Medicines used in depressive disorders |
||||
|
23.5 Medicines used in
Disorders due to Psychoactive substance abuse |
||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
|
23.5.1 |
Buprenorphine |
P,S,T |
Tablet (Sub-lingual) 0.4
mg |
|
|
23.5.2 |
Buprenorphine (A) +
Naloxone (B) |
P,S,T |
Tablet (Sub-lingual) 0.4
mg (A) + 0.1 mg(B) Tablet (Sub-lingual) 2 mg
(A) + 0.5 mg (B) |
|
|
23.5.3 |
Nicotine (for nicotine
replacement therapy) |
P,S,T |
Oral Dosage forms 2 mg Oral Dosage forms 4 mg |
|
|
Section 24 Medicines acting on the
Respiratory tract |
||||
|
24.1-Antiasthmatic
Medicines |
||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
|
24.1.1 |
Budesonide* |
P,S,T |
Inhalation (MDI/DPI)
100mcg/dose Inhalation (MDI/DPI)
200mcg/dose Respirator solution for
use in nebulizer 0.5 mg/mL Respirator solution for
use in nebulizer 1 mg/mL |
|
|
*Budesonide formulations
are also listed in Section 16.1-Ear, Nose and Throat Medicines |
||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
|
24.1.2 |
|
|
Inhalation (MDI/DPI) 100
mcg(A) + 6 mcg (B) Inhalation (MDI/DPI) 200
mcg(A) |
|
|
|
Budesonide (A)
+Formoterol (B) |
P,S,T |
+ 6 mcg (B) Inhalation (MDI/DPI) 400
mcg(A) + 6 mcg (B) |
|
|
24.1.3 |
Hydrocortisone* |
P,S,T |
Powder for Injection 100
mg Powder for Injection 200
mg |
|
|
24.1.4 |
Ipratropium |
P,S,T |
Inhalation (MDI/DPI)
20mcg/dose Respirator solution for
use in nebulizer 250 mcg/mL |
|
|
24.1.5 |
Montelukast |
S,T |
Tablet 4 mg Tablet 5 mg (including chewable
tablets) Tablet 10 mg |
|
|
24.1.6 |
Salbutamol |
P,S,T |
Tablet 2 mg Tablet 4 mg Oral liquid 2 mg/5 mL Inhalation (MDI/DPI*)
100mcg/dose Respirator Solution (Solution for Nebulizer 5
mg/mL) |
|
|
*Hydrocortisone
formulations are also listed in- A. Section
3.5-Antiallergics and Medicines used in Anaphylaxis B. Section
18.1.3-Hormones, other Endocrine Medicines and Contraceptives-Adrenal
hormones and synthetic substitutes |
||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
|
24.1.7 |
Tiotropium |
P,S,T |
Inhalation (MDI) 9
mcg/dose Inhalation (DPI) 18
mcg/dose |
|
|
MDI-Metered Dose Inhaler DPI-Dry Powder Inhaler |
||||
|
Section 25 Solutions correcting
Water, Electrolyte disturbances and Acid-base disturbances |
||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
|
25.1.1 |
Glucose* |
P,S,T |
Injection 5% Injection 10% Injection 25% Injection 50% |
|
|
25.1.2 |
Glucose(A) + Sodium
chloride (B) |
P,S,T |
Injection 5% (A) + 0.9%
(B) |
|
|
25.1.3 |
Oral rehydrationsalts** |
P,S,T |
As licensed |
|
|
25.1.4 |
Potassium chloride |
P,S,T |
Oral liquid 500 mg/5 mL |
|
|
|
|
S,T |
Injection 150mg/mL |
|
|
*Glucose formulations are
also listed in Section 18.4.2.1-Hormones, other Endocrine Medicines and
Contraceptives-Medicines used in diabetes mellitus-Medicines used to
treathypoglycemia **Oral rehydration salts
are also listed in Section 17.6.1-Gastrointestinal Medicines-Medicines used
in diarrhea |
||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
|
25.1.5 |
Ringer lactate |
P,S,T |
Injection (as per IP) |
|
|
25.1.6 |
Sodium bicarbonate |
P,S,T |
Injection (as per IP) |
|
|
25.1.7 |
Sodium chloride |
P,S,T |
Injection 0.9% |
|
|
|
S,T |
Injection 3% |
||
|
25.2-Miscellaneous |
||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
|
25.2.1 |
Water for Injection |
P,S,T |
Injection |
|
|
Section 26 Vitamins and Minerals |
||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
|
26.1 |
Ascorbic acid (Vitamin C) |
P,S,T |
Tablet 100 mg Tablet 500
mg |
|
|
26.2 |
Calcium carbonate |
P,S,T |
Tablet 625 mg (equivalent
to elemental calcium 250 mg) Tablet 1250 mg
(equivalent to elemental calcium 500 mg) |
|
|
26.3 |
Calcium gluconate* |
P,S,T |
Injection 100 mg/mL |
|
|
26.4 |
Cholecalciferol |
P,S,T |
Solid oral dosage form
1000 IU Solid oral dosage form 60000 IU Oral liquid 400 [U/mL |
|
|
*Calcium Gluconate
formulations are also poisoning/Envenomation-Specific |
listed in Section
4.2.2-Antidotes and Other substances used in |
|||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
|
26.5 |
Pyridoxine |
P,S,T |
Tablet 10 mg Tablet 50 mg Tablet 100 mg |
|
|
26.6 |
Riboflavin |
P,S,T |
Tablet 10 mg |
|
|
26.7 |
Thiamine |
P,S,T |
Tablet 100 mg Injection 100 mg/mL |
|
|
|
|
|
Capsule/Tablet 50000 IU
(including Chewable Tablet) Oral liquid 100000 IU/mL
Injection 50000 |
|
|
26.8 |
Vitamin A |
P,S,T |
IU/mL |
|
|
Section 27 Medicines for COVID-19
management |
||||
|
27.1 |
Dexamethasone* |
P,S,T |
Tablet 0.5 mg Tablet 2 mg Tablet 4 mg Oral liquid 0.5 mg/5 mL
(p) Injection 4 mg/mL |
|
|
27.2 |
Enoxaparin** |
S,T |
Injection 40 mg/0.4 mL Injection 60 mg/0.6 mL |
|
|
*Dexamethasone is also
listed in- A. Section
3.4-Antiallergics and Medicines used in Anaphylaxis B. Section
7.4.3-Anti-cancer agents including Immunosuppressives, and Medicines used in
Palhative are-Medicines used in Palliative Care C. Section
18.1.1-Hormones, other Endocrine Medicines and Contraceptives-Adrenal
hormones and synthetic substitutes **Enoxapann is also
listed in- A. Section
8.2.1-Medicines affecting Blood-Medicines affecting coagulation B. Section
10.5.4-Cardiovascular medicines-Antiplatelet and Antithrombotic Medicines |
||||
|
|
Medicine |
Level of Healthcare |
Dosage form(s) and
strength(s) |
|
|
27.3 |
Methylprednisolone* |
S,T |
Injection 40 mg/mL |
|
|
27.4 |
Paracetamol* * |
P,S,T |
Tablet 500 mg Tablet 650 mg Oral liquid 120 mg/5 mL
(p) Oral Liquid 125 mg/5 mL
(p) Oral Liquid 250 mg/5 mL
(p) |
|
|
27.5 |
Oxygen*** |
P,S,T |
As licensed for medical
purpose |
|
|
*Methylprednisolone is
also listed in Section 18.1.4-Hormones, other Endocrine medicines and Contraceptives-Adrenal
Hormones and synthetic substitutes **Paracetamol is also
listed in A. Section
2.1.5-Analgesics, antipyretics, non-steroidal anti-inflammatory medicines,
medicines used to treat Gout and disease Modifying agents used in Rheumatoid
Disorders-Non-opioid analgesics, antipyretics and nonsteroidal
anti-inflammatory medicines B. Section
5.2.3-Medicines used in Neurological Disorders-Antimigraine medicines *** Oxygen is also listed
in Medicines used in Section 1.1.5-Anaesthesia-General Anaesthetics and
Oxygen |
||||
|
Section 28 Coronary Stents |
||||
|
28.1 |
Bare Metal Stents (BMS) |
|||
|
28.2 |
Drug Eluting Stents (DES)
which include metallic DES and Bioresorbable Vascular Scaffold
(BVS)/Biodegradable stents |
|||
|
Section 29 Medicines for animal use |
||||
|
29.1 |
Foot and Mouth Disease
(Trivalent) Oil adjuvant vaccine |
|||
|
29.2 |
Brucella Abortus (S19
strain) Vaccine, Live Freeze Dried |
|||
All
modified release formulations of same strength such as sustained release,
controlled release, extended release, prolonged release etc. are included.
Explanation.
2.
Any dosage form of a medicine other than that included in this
schedule, but in same strength and route of administration, which does not
demonstrate significant difference in terms of pharmacokinetics/pharmacodynamics/efficacy/safety
over the dosage form mentioned in the list, should be considered as included.
To elaborate, if tablet is included, other oral solid dosage form such as
capsule is considered as included. However, such different dosage forms should
be considered differently for purposes of procurement policy, pricing etc. This
principle also applies to all other dosage forms e.g. oral liquid dosage forms,
injectables, topical dosage forms etc.
3.
In general, medicines have been mentioned in this schedule M in
terms of their active moieties, without mentioning the salts. In case, a
medicine is available in more than one salt without any significant difference
in potency/pharmacokinetics/pharmacodynamics/efficacy-safety profile aspects,
it indicates that these salts are therapeutically similar. Therefore, all salts
of such medicines with specified dosage form and strength are considered
included in this schedule. In case, where the different salts of a medicine
have significant difference in
potency/pharmacokinetics/pharmacodynamics/efficacy-safety profile, the medicine
has been mentioned in this schedule with respect to its specific salt.
4.
Different isomers of a molecule may differ with respect to potency/pharmacodynamics/safety-efficacy
profile. Such different isomers have been considered as separate entities.
Therefore, inclusion of one isomer of a molecule in this schedule does not
imply inclusion of all other isomers of a molecule.
5.
Prodrugs/analogues/derivatives of one active moiety are available
as different medicines. They may differ with respect to
potency/pharmacokinetics/pharmacodynamics/safety-efficacy profile. Inclusion of
one form of such medicines in the schedule will not imply inclusion of other
forms.
6.
Vaccines, sera and immunoglobulins are complex biological
products, which may be manufactured from various sources, by using different
processes and technologies. In such cases, irrespective of variation in source,
composition, or strengths, all the products of the same
vaccine/sera/immunoglobulin, as approved by licensing authority are considered
as included in this schedule.
7.
Innovation in medicine must be encouraged. The formulations
developed through incremental innovation or novel drug delivery systems like
lipid/liposomal formulations etc. should be considered as included only if
specified in the list against any medicine. Such different formulations should
be considered differently for purposes such as procurement policy, pricing, etc.
8.
For injectable preparations, the pack size (single and multi-dose
packs) has not been mentioned. It is suggested that the single and multi-dose
pack sizes be considered as separate entities for purposes such as
procurement/pricing etc.]
SCHEDULE-II
FORM - I
PROFORMA FOR APPLICATION FOR PRICE FIXATION/REVISION OF A NEW DRUG
FORMULATION RELATED TO NLEM FORMULATION
(See paragraphs 2(u), 5, 7, 8, 9, 15)
1.
Name of the formulation:
2.
Name and address of the manufacturer/importer:
3.
Name of the Marketing Company, if any:
4.
Composition as per label claimed and approved by Drug Control
Authorities:
5.
Drugs Control Authority Permission Number and Date (copy to be
enclosed):
6.
Date of commencement of production/import:
7.
Type of formulation (Tablets/Capsules/Syrup/Injection/Ointment/Powder
etc.):
8.
Size of packs (10's/100's/1 ml/2 ml/10 ml/5 gms/10 gms etc.)
9.
Therapeutic category/use of the formulation.
10. The
Retail Price claimed for approval
11. Reason
for submission of application for price fixation/revision.
12. Any other
information relevant to product and its process of
manufacturing/packaging/distribution.
The
information furnished above is correct and true to the best of my knowledge and
belief.
|
Place: |
Authorized Signatory: |
|
|
Name: |
|
Date: |
Designation: |
FORM - II
PROFORMA FOR SUBMISSION OF REVISED-PRICES FOR SCHEDULED
FORMULATIONS
(See paragraph 16)
1.
Name and address of the manufacturer/importer/distributor.
2.
Name and address of the marketing company, if any.
|
Sl. No. |
Name of the Product
(Formulation and its dosage forms) |
Composition of scheduled
formulation/ new drug |
Pack Size |
WPI change w.r.t.
preceeding Year |
Price to retailer (incl.
of E.D.) (Rs.) |
Maximum Retail Price
(incl. of E.D. & Taxes) (Rs.) |
Ceiling Price (Notified) (Rs.) |
Effective Batch No. and
date |
||
|
Pre- Revised |
Revised |
Pre- Revised |
Revised |
|||||||
|
(1) |
(2) |
(3) |
(4) |
(5) |
(6) |
(7) |
(8) |
(9) |
(10) |
(11) |
|
|
Scheduled Formulations |
|
|
|
|
|
|
|
|
|
|
|
Own Manufactured
Formulations |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchased/Imported
Formulations |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Notes:-
In case of purchased formulation, name of the manufacturer shall be indicated.
The
information furnished above is correct and true to the best of my knowledge and
belief.
|
Place: |
Authorized Signatory: |
|
|
Name: |
|
Date: |
Designation: |
FORM - III
PROFORMA FOR QUARTERLY RETURN IN RESPECT OF PRODUCTION/IMPORT AND
SALE OF NLEM DRUGS
(See paragraphs 21(1))
1.
Name and address of the manufacturer/importer:
2.
Name and address of marketing company, if any:
3.
Details of production/import and sale for the Quarter of a Year:
TABLE-A
|
Name of the Scheduled Formulation |
Composition/ Strength |
Dosage Form |
Unit(No/ kg /Ltr.) |
Production/Import Level |
Domestic Sale |
||||||||
|
Previous Year |
Current Year |
Previous Year |
Current Year |
||||||||||
|
1st Quarter |
2nd Quarter |
3rd Quarter |
4th Quarter |
1st Quarter |
2nd Quarter |
3rd Quarter |
4th Quarter |
||||||
|
(1) |
(2) |
(3) |
(4) |
(5) |
(6) |
(7) |
(8) |
(9) |
(10) |
(11) |
(12) |
(13) |
(14) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TABLE-B
|
Name of the Bulk Drug/API
used in Scheduled Formulation |
Unit (Kg/Ltr.) |
Installed Capacity |
Production/Import Level |
Domestic Sale |
||||||||
|
Previous Year |
Current Year |
Previous Year |
Current Year |
|||||||||
|
1st Quarter |
2nd Quarter |
3rd Quarter |
4th Quarter |
1st Quarter |
2nd Quarter |
3rd Quarter |
4th Quarter |
|||||
|
(1) |
(2) |
(3) |
(4) |
(5) |
(6) |
(7) |
(8) |
(9) |
(10) |
(11) |
(12) |
(13) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Constraints,
if any:
Note: (1)
Production outsourced/carried out on job work basis should also be included
The
information furnished above is correct and true to the best of my knowledge and
belief.
|
Place : |
Authorized Signatory: |
|
|
Name: |
|
Date : |
Designation: |
FORM - IV
PROFORMA FOR SUBMISSION OF THE DETAILS IN RESPECT OF
DISCONTINUATION OF THE PRODUCTION AND/OR IMPORT OF SCHEDULED FORMULATION
(See paragraphs 21(2))
1.
Name of the formulation:
2.
Name and address of the manufacturer/importer:
3.
Name of the Marketing Company, if any:
4.
Composition as per label claimed and approved by Drug Control
Authorities:
5.
Drugs Control Authority Permission Number and Date (copy to be enclosed):
6.
Celling Price and date of notification:
7.
Existing maximum retail price (MRP) and its effective date:
8.
Therapeutic category as per NLEM:
9.
Date of commencement of production/import
10. Proposed
date of discontinuation:
11. Reasons
for discontinuation of production/import:
12. Year-wise
Production/Import during the last 5 years including current year
13. Year-wise
sale during the last 5 years including current year
14. Whether
any new drug as defined under Proviso of Definition of "New Drug"
under DPCO, 2013 has been launched or intended to be launched. If so, the
details thereof:
15. Any other
information relevant to discontinuation of scheduled formulation:
|
Place : |
Authorized Signatory: |
|
|
Name: |
|
Date : |
Designation: |
FORM - V
PROFORMA FOR PRICE LIST
(See paragraphs 2(x), 24, 25, 26)
1.
Name and address of the manufacturer/importer/distributor.
2.
Name and address of the marketing company, if any.
TABLE-A
|
Sl. No. |
Name of the Product
(Formulation and its dosage forms) |
Composition approved by
Drug Control Authorities |
Pack Size |
Price to retailer (incl.
of E.D.) (Rs.) |
Maximum Retail Price
(incl. of E.D. & Taxes) (Rs.) |
|
(1) |
(2) |
(3) |
(4) |
(5) |
(6) |
|
|
Scheduled Formulations |
|
|
|
|
|
|
Own Manufactured
Formulations |
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchased/Imported Formulations |
|
|
|
|
|
|
|
|
|
|
|
TABLE-B
|
Sl. No. |
Name of the Product
(Formulation and its dosage forms) |
Composition approved by
Drug Control Authorities |
Pack Size |
Price to retailer (incl.
of E.D.) (Rs.) |
Maximum Retail Price
(incl. of E.D. & Taxes) (Rs.) |
|
(1) |
(2) |
(3) |
(4) |
(5) |
(6) |
|
|
Non-Scheduled
Formulations |
|
|
|
|
|
|
Own Manufactured
Formulations |
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchased/Imported
Formulations |
|
|
|
|
|
|
|
|
|
|
|
Notes:-
In case of purchased formulation, name of the manufacturer shall be indicated.
The
information furnished above is correct and true to the best of my knowledge and
belief.
|
Place: |
Authorized Signatory: |
|
|
Name: |
|
Date: |
Designation: |
[10][Form VI
Proforma for Price List for Medical Devices
[See paragraphs 24(3) & 25(2)]
Name of
the Company:
Name of
the Authorized Signatory:
Address
of the Company:
Contact
Details:
E-mail
Id:
Category-Manufacturer/Importer
|
(Amount in Rupee) |
|||||||||||||
|
Sl. No. |
Medical Device Registration
No. issued by CDSCO |
Medical Device Category
as per the list issued by CDSCO |
Product
Name/Specification as per DCGI approval/Generic Name |
Product Code (if any) |
Brand Name |
Minimal Unit of
Sale/Retail Pack Size |
Price to
Distributor/Stockist Hospital (excluding applicable taxes) |
Price to Retailers
(excluding applicable taxes) |
Applicable GST % |
Revised Maximum Retail
Prices |
Effective Batch No. and
Date |
Previous Maximum Retail
Prices |
Remarks |
|
(1) |
(2) |
(3) |
(4) |
(5) |
(6) |
(7) |
(8) |
(9) |
(10) |
(11) |
(12) |
(13) |
(14) |
|
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|
Date:
Place:
Signature:
Name:
Designation with office seal:
Mobile No.:
Email id:]
[1] Substituted
by the Notification No. SO1233(E) dated 08.05.2015 for the following : -
"(n) "manufacturer" for the
purpose of this Order means any person who manufactures, imports and markets
drugs for distribution or sale in the country;"
[2] Substituted
vide Notification No. SO686(E) dated 09.03.2015 for the following : -
"(v) "non-scheduled formulation" means a formulation, the dosage
and strengths of which are not specified in the First Schedule;"
[3] Substituted
by the Drugs (Prices Control) Amendment Order, 2019 vide Order No. SO39(E)
dated 03.01.2019 for the following:-
"(1) Initially, the source of market
based data shall be the data available with the pharmaceuticals market data
specializing company - IMS Health (IMS) and if the Government deems necessary,
it may validate such data by appropriate survey or evaluation."
[4] Inserted
by the Drugs (Prices Control) Amendment Order, 2019 vide Order No. SO39(E)
dated 03.01.2019.
[5] Inserted
vide Notification No. SO1192(E) dated 22.03.2016.
[6] Substituted
by Drugs (Prices Control) Third Amendment Order, 2021 vide Notifications
No. SO3249(E), dated 12.08.2021, for the following:-
"(i) as and when the National List of
Essential Medicines is revised by the Ministry of Health and Family Welfare or
five years from the date of fixing the ceiling price under this Order whichever
is earlier;"
[7] Substituted
by the Drugs (Prices Control) Amendment Order, 2019 vide Order No. SO39(E)
dated 03.01.2019 for the following:-
"(i) a manufacturer producing a new drug
patented under the Indian Patent Act, 1970 (39 of 1970) (product patent) and
not produced elsewhere, if developed through indigenous Research and
Development, for a period of five years from the date of commencement of its
commercial production in the country."
[8] Inserted
by the Drugs (Prices Control) Amendment Order, 2019 vide Order No. SO39(E)
dated 03.01.2019.
[9] Substituted
by Drugs (Prices Control) Amendment Order, 2022 vide Notification No.
SO5249(E) dated 11.11.2022, for the following:-
" [SCHEDULE-I
National List of
Essential Medicines 2015
[See paragraphs-2(t),
2(zb)]
|
(Symbols P, S and T appearing in this
Schedule denote essentiality at Primary, Secondary and Tertiary levels
respectively) |
|||
|
Section 1-Anesthetic agents |
|||
|
1.1-General Anesthetics and oxygen |
|||
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
1.1.1 |
Halothane |
S,T |
Inhalation |
|
1.1.2 |
Isoflurane |
S,T |
Inhalation |
|
1.1.3 |
Ketamine |
P,S,T |
Injection 10 mg/ml Injection 50 mg/ml |
|
1.1.4 |
Nitrous oxide |
P,S,T |
Inhalation |
|
1.1.5 |
Oxygen |
P,S,T |
Inhalation (Medicinal gas) |
|
1.1.6 |
Propofol |
P,S,T |
Injection 10 mg/ml |
|
1.1.7 |
Sevoflurane |
T |
Inhalation |
|
1.1.8 |
Thiopentone |
P,S,T |
Powder for Injection 0.5g Powder for
Injection 1 g |
|
1.2-Local anesthetics |
|||
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
1.2.1 |
Bupivacaine |
S,T |
Injection 0.25% Injection 0.5% Injection 0.5% with 7.5% glucose |
|
1.2.2 |
Lignocaine |
P,S,T |
Topical forms 2-5% Injection 1% Injection 2% Injection 5% with 7.5% Glucose |
|
1.2.3 |
Lignocaine (A) + Adrenaline (B) |
P,S,T |
Injection 1% (A) + 1: 200000 (5 mcg/ml) (B) Injection 2% (A) + 1: 200000 (5 |
|
1.2.4 |
Prilocaine (A) + Lignocaine (B) |
T |
Cream 2.5% (A) + 2.5% (B) |
|
1.3-Preoperative medication and
sedation for short term procedures |
|||
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
1.3.1 |
Atropine |
P,S,T |
Injection 0.6 mg/ml |
|
1.3.2 |
Glycopyrrolate |
S,T |
Injection 0.2 mg/ml |
|
1.3.3 |
Midazolam |
P,S,T |
Tablet 7.5 mg Tablet 15 mg Oral
liquid 2 mg/ml Injection 1 mg/ml Injection 5 mg/ml |
|
1.3.4 |
Morphine |
P,S,T |
Injection 10 mg/ml Injection 15 mg/ml |
|
Section 2-Analgesics, antipyretics,
non steroidal anti inflammatory medicines, medicines used to treat gout and
disease modifying agents used in rheumatoid disorders |
|||
|
2.1-Non-opioid analgesics,
antipyretics and no steroidal anti-inflammatory medicines |
|||
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
2.1.1 |
Acetylsalicylic acid |
P,S,T |
Tablet 300 mg to 500 mg Effervescent/Dispersible/Enteric
coated Tablet 300 mg to 500 mg |
|
2.1.2 |
Diclofenac |
P,S,T |
Tablet 50 mg Injection 25 mg/ml |
|
2.1.3 |
Ibuprofen |
P,S,T |
Tablet 200 mg Tablet 400 mg Oral liquid 100 mg/5 ml |
|
2.1.4 |
Mefenamic acid |
P,S,T |
Capsule 250 mg Capsule 500 mg Oral liquid 100 mg/5 ml |
|
2.1.5 |
Paracetamol |
P,S,T |
Tablet 500 mg Tablet 650 mg All licenced oral liquid dosage forms and strengths Injection 150 mg/ml Suppository 80 mg Suppository 170 mg |
|
2.2-Opioid analgesics |
|||
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
2.2.1 |
Fentanyl |
S,T |
Injection 50 mcg/ml |
|
2.2.2 |
Morphine |
P,S,T |
Tablet 10 mg Injection 10 mg/ml Injection 15 mg/ml |
|
2.2.3 |
Tramadol |
S,T |
Capsule 50 mg Capsule 100 mg Injection 50 mg/ml |
|
2.3-Medicines used to treat gout |
|||
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
2.3.1 |
Allopurinol |
P,S,T |
Tablet 100 mg Tablet 300 mg |
|
2.3.2 |
Colchicine |
P,S,T |
Tablet 0.5 mg |
|
2.4-Disease modifying agents used in
rheumatoid disorders |
|||
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
2.4.1 |
Azathioprine |
S, T |
Tablet 50 mg |
|
2.4.2 |
Hydroxychloroquine |
S,T |
Tablet 200 mg Tablet 400 mg |
|
2.4.3 |
Leflunomide |
S,T |
Tablet 10 mg Tablet 20 mg |
|
2.4.4 |
Methotrexate |
S,T |
Tablet 5 mg Tablet 7.5 mg Tablet 10 mg Injection 25 mg/ml |
|
2.4.5 |
Sulfasalazine |
S, T |
Tablet 500 mg |
|
Section 3-Antiallergics and medicines
used in anaphylaxis |
|||
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
3.1 |
Adrenaline |
P,S,T |
Injection 1 mg/ml |
|
3.2 |
Cetirizine |
P,S,T |
Tablet 10 mg Oral liquid 5 mg/5ml |
|
3.3 |
Chlorpheniramine |
P,S,T |
Tablet 4 mg Oral liquid 2 mg/5 ml |
|
3.4 |
Dexamethasone |
P,S,T |
Tablet 0.5 mg |
|
3.5 |
Hydrocortisone |
P,S,T |
Powder for Injection 100 mg |
|
3.6 |
Pheniramine |
P,S,T |
Injection 22.75 mg/ml |
|
3.7 |
Prednisolone |
P,S,T |
Tablet 5 mg Tablet 10 mg Tablet 20 mg Oral liquid 5 mg/5 ml Oral liquid 15 mg/5 ml |
|
Section 4-Antidotes and other
substances used in poisoning |
|||
|
4.1-Nonspecific |
|||
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
4.1.1 |
Activated charcoal |
P,S,T |
Powder (as licensed) |
|
4.2-Specific |
|||
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
4.2.1 |
Atropine |
P,S,T |
Injection 1 mg/ml |
|
4.2.2 |
Calcium gluconate |
P,S,T |
Injection 100 mg/ml |
|
4.2.3 |
Desferoxamine |
S,T |
Powder for Injection 500 mg |
|
4.2.4 |
Dimercaprol |
S,T |
Injection 50 mg/ml |
|
4.2.5 |
Methylthioninium chloride (Methylene
blue) |
S,T |
Injection 10 mg/ml |
|
4.2.6 |
N-acetylcysteine |
P,S,T |
Sachet 200 mg Injection 200 mg/ml |
|
4.2.7 |
Naloxone |
P,S,T m |
Injection 0.4 mg/ml |
|
4.2.8 |
Neostigmine |
P,S,T |
Injection 0.5 mg/ml |
|
4.2.9 |
Penicillamine |
S,T |
Capsule 250 mg |
|
4.2.10 |
Pralidoxime chloride (2-PAM) |
P,S,T |
Injection 25 mg/ml |
|
4.2.11 |
Snake venom antiserum a) Soluble/liquid polyvalent |
P,S,T |
a) Injection b) Powder for Injection |
|
4.2.12 |
Sodium nitrite |
S,T |
Injection 30 mg/ml |
|
4.2.13 |
Sodium |
S,T |
Injection 100 mg/ml |
|
Section
5-Anticonvulsants/Antiepileptics |
|||
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
5.1 |
Carbamazepine |
P,S,T |
Tablet 100 mg Tablet 200 mg CR Tablet 200 mg Tablet 400 mg CR Tablet 400 mg Oral liquid 100 mg/5 ml Oral liquid 200 mg/5 ml |
|
5.2 |
Clobazam |
S,T |
Tablet 5 mg Tablet 10 mg |
|
5.3 |
Diazepam |
P,S,T |
Oral liquid 2 mg/5 ml Injection 5 mg/ml Suppository 5 mg |
|
5.4 |
Levetiracetam |
S,T |
Tablet 250 mg Tablet 500 mg Tablet 750 mg ER Tablet 750 mg Oral liquid 100 mg/ml Injection 100 mg/ml |
|
5.5 |
Lorazepam |
P,S,T |
Tablet 1 mg Tablet 2 mg Injection 2 mg/ml |
|
5.6 |
Magnesium sulphate |
S,T |
Injection 500 mg/ml |
|
5.7 |
Phenobarbitone |
P,S,T |
Tablet 30 mg Tablet 60 mg Oral liquid
20 mg/5 ml |
|
S,T |
Injection 200 mg/ml |
||
|
5.8 |
Phenytoin |
P,S,T |
Tablet 50 mg Tablet 100 mg Tablet 300 mg ER Tablet 300 mg Oral liquid 30 mg/5 ml Oral liquid 125 mg/5 ml Injection 25 mg/ml Injection 50 mg/ml |
|
5.9 |
Sodium valproate |
P,S,T |
Tablet 200 mg Tablet 300 mg CR Tablet 300 mg Tablet 500 mg CR Tablet 500 mg Oral liquid 200 mg/5ml |
|
T |
Injection 100 mg/ml |
||
|
Section 6-Anti infective medicines |
|||
|
6.1-Anthelminthics |
|||
|
6.1.1-Intestinal anthelminthics |
|||
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
6.1.1.1 |
Albendazole |
P,S,T |
Tablet 400 mg Oral liquid 200 mg/5 ml |
|
6.1.1.2 |
Mebendazole |
P,S,T |
Tablet 100 mg Oral liquid 100 mg/5 ml |
|
6.1.2-Antifilarial |
|||
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
6.1.2.1 |
Diethy lcarbamazine |
P,S,T |
Tablet 50 mg Tablet 100 mg Oral liquid 120 mg/5 ml |
|
6.1.3-Anti-schistosomal &
anti-trematodal medicine |
|||
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
6.1.3.1 |
Praziquantel |
S,T |
Tablet 600 mg |
|
6.2-Antibacterials |
|||
|
6.2.1-Beta lactam medicines |
|||
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
6.2.1.1 |
Amoxicillin |
P,S,T |
Capsule 250 mg Capsule 500 mg Oral liquid 250 mg/5 ml |
|
6.2.1.2 |
Amoxicillin (A) + Clavulanic acid (B) |
P,S,T |
Tablet 500 mg (A) + 125 mg (B) Oral
liquid 200 mg (A) + 28.5 mg (B)/5 ml Dry Syrup 125 mg (A) + 31.25 (B)/5 ml |
|
|
|
S,T |
Powder for Injection 500 mg (A) + 100
mg (B) Powder for Injection 1g (A) + 200 mg
(B) |
|
6.2.1.3 |
Ampicillin |
P,S,T |
Powder for Injection 500 mg Powder for Injection 1 g |
|
6.2.1.4 |
Benzathine benzylpenicillin |
P,S,T |
Powder for Injection 6 lac units Powder for Injection 12 lac units |
|
6.2.1.5 |
Benzyl penicillin |
P,S,T |
Powder for Injection 10 lac units |
|
6.2.1.6 |
Cefadroxil |
P,S,T |
Tablet 500 mg Tablet 1 g Oral liquid 125 mg/5 ml |
|
6.2.1.7 |
Cefazolin |
P,S,T |
Powder for Injection 500 mg Powder for Injection 1 g |
|
6.2.1.8 |
Cefixime |
S,T |
Tablet 200 mg Tablet 400 mg Oral liquid 50 mg/5 ml Oral liquid 100 mg/5 ml |
|
6.2.1.9 |
Cefotaxime |
S,T |
Powder for Injection 250 mg Powder for Injection 500 mg Powder for Injection 1 g |
|
6.2.1.10 |
Ceftazidime |
S,T |
Powder for Injection 250 mg Powder for Injection 1 g |
|
6.2.1.11 |
Ceftriaxone |
S,T |
Powder for Injection 250 mg Powder for Injection 500 mg Powder for Injection 1 g Powder for Injection 2 g |
|
6.2.1.12 |
Cloxacillin |
P,S,T |
Capsule 250 mg Capsule 500 mg Oral Liquid 125 mg/5 ml Powder for Injection 250 mg |
|
6.2.1.13 |
Piperacillin (A) + Tazobactam (B) |
T |
Powder for Injection 1g (A) + 125 mg (B) Powder for Injection 2g (A) + 250 mg (B) Powder for Injection 4g (A) + 500 mg (B) |
|
6.2.2-Other antibacterials |
|
|
|
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
6.2.2.1 |
Azithromycin |
P,S,T |
Tablet 250 mg Tablet 500 mg Oral liquid 200 mg/5 ml Powder for Injection 500 mg |
|
6.2.2.2 |
Ciprofioxacin |
P,S,T |
Tablet 250 mg Tablet 500 mg Oral liquid 250 mg/5ml Injection 200 mg/100ml |
|
6.2.2.3 |
Clarithromycin |
S,T |
Tablet 250 mg Tablet 500 mg Oral liquid 125mg/5ml |
|
6.2.2.4 |
Co-trimoxazole [Sulphamethoxazole (A)
+ Trimethoprim (B)] |
P,S,T |
Tablet 400 mg (A) + 80 mg (B) Tablet 800 mg (A) + 160 mg (B) Oral liquid 200 mg (A) + 40 mg (B)/5
ml |
|
6.2.2.5 |
Doxycycline |
P,S,T |
Capsule 100 mg Dry Syrup 50 mg/5 ml |
|
6.2.2.6 |
Gentamicin |
P,S,T |
Injection 10 mg/ml Injection 40 mg/ml |
|
6.2.2.7 |
Metronidazole |
P,S,T |
Tablet 200 mg Tablet 400 mg Oral liquid 200 mg/5 ml Injection 500 mg/100 ml |
|
6.2.2.8 |
Nitrofurantoin |
P,S,T |
Tablet 100 mg Oral liquid 25 mg/5 ml |
|
6.2.2.9 |
Vancomycin |
T |
Powder for Injection 250 mg Powder for Injection 500 mg Powder for Injection 1 g |
|
6.2.3-Antileprosy medicines |
|
|
|
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
6.2.3.1 |
Clofazimine |
P,S,T |
Capsule 50 mg Capsule 100 mg |
|
6.2.3.2 |
Dapsone |
P,S,T |
Tablet 25 mg Tablet 50 mg Tablet 100 mg |
|
6.2.3.3 |
Rifampicin |
P,S,T |
Capsule 150 mg Capsule 300 mg |
|
6.2.4-Antituberculosis medicines |
|
|
|
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
6.2.4.1 |
Capreomycin |
P,S,T |
Powder for Injection 1 g |
|
6.2.4.2 |
Cycloserine |
P,S,T |
Capsule 125 mg Capsule 250 mg |
|
6.2.4.3 |
Ethambutol |
P,S,T |
Tablet 200 mg Tablet 400 mg Tablet 600 mg Tablet 800 mg |
|
6.2.4.4 |
Ethionamide |
P,S,T |
Tablet 125 mg Tablet 250 mg |
|
6.2.4.5 |
Isoniazid |
P,S,T |
Tablet 50 mg Tablet 100 mg Tablet 300 mg Oral liquid 100 mg/5 ml |
|
6.2.4.6 |
Kanamycin |
P,S,T |
Powder for Injection 500 mg Powder for Injection 750 mg Powder for Injection 1 g |
|
6.2.4.7 |
Levofloxacin |
P,S,T |
Tablet 250 mg Tablet 500 mg Tablet 750 mg |
|
6.2.4.8 |
Linezolid |
P,S,T |
Tablet 600 mg |
|
6.2.4.9 |
Moxifloxacin |
P,S,T |
Tablet 200 mg Tablet 400 mg |
|
6.2.4.10 |
Para-amino salicylic acid |
P,S,T |
Tablet 500 mg Granules (As licensed) |
|
6.2.4.11 |
Pyrazinamide |
P,S,T |
Tablet 500 mg Tablet 750 mg Tablet 1000 mg Tablet 1500 mg Oral liquid 250 mg/5 ml |
|
6.2.4.12 |
Rifabutin |
S,T |
Capsule 150 mg |
|
6.2.4.13 |
Rifampicin |
P,S,T |
Capsule 150 mg Capsule 300 mg Capsule 450 mg Capsule 600 mg Oral liquid 100 mg/5 ml |
|
6.2.4.14 |
Streptomycin |
P,S,T |
Powder for Injection 750 mg Powder for Injection 1 g |
|
6.3-Antifungal medicines |
|
|
|
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
6.3.1 |
Amphotericin B a) Amphotericin B (conventional) b) Lipid Liposomal Amphotericin B |
S,T |
Powder for Injection 50 mg |
|
6.3.2 |
Clotrimazole |
P,S,T |
Pessary 100 mg |
|
6.3.3 |
Fluconazole |
P,S,T |
Tablet 100 mg Tablet 150 mg Tablet
200 mg Tablet 400 mg Oral liquid 50 mg/5 ml |
|
|
|
S,T |
Injection 200 mg/100 ml |
|
6.3.4 |
Griseofulvin |
P,S,T |
Tablet 125 mg Tablet 250 mg Tablet 375 mg |
|
6.3.5 |
Nystatin |
P,S,T |
Tablet 500,000 IU Pessary 100,000 IU Oral Liquid 100, 000 IU/ml |
|
6.4-Antiviral medicines |
|
|
|
|
6.4.1-Antiherpes medicines |
|
|
|
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
6.4.1.1 |
Acyclovir |
P,S,T |
Tablet 200 mg Tablet 400 mg Powder for Injection 250 mg Powder for Injection 500 mg Oral liquid 400 mg/5 ml |
|
6.4.2-Anti Cytomegalovirus (CMV)
medicines |
|
||
|
6.4.2.1 |
Ganciclovir |
S,T |
Capsule 250 mg Powder for Injection 500 mg |
|
6.4.3-Antiretroviral medicines |
|||
|
6.4.3.1-Nucleoside reverse
transcriptase inhibitors |
|||
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
6.4.3.1.1 |
Abacavir |
S,T |
Tablet 60 mg Tablet 300 mg |
|
6.4.3.1.2 |
Abacavir (A) + Lamivudine (B) |
S,T |
Tablet 60 mg (A) +30 mg (B) Tablet 600 mg (A)+ 300 mg (B) |
|
6.4.3.1.3 |
Lamivudine (A) + Nevirapine (B) +
Stavudine (C) |
S,T |
Dispersible Tablet 30 mg (A) + 50 mg
(B) + 6 mg (C) Tablet 150 mg (A) + 200 mg (B) + 30
mg (C) |
|
6.4.3.1.4 |
Lamivudine (A) + Zidovudine (B) |
S,T |
Tablet 30 mg (A) + 60 mg (B) Tablet 150 mg (A) + 300 mg (B) |
|
6.4.3.1.5 |
Stavudine (A) + Lamivudine (B) |
S,T |
Dispersible Tablet 6 mg (A) + 30 mg (B) Tablet 30 mg (A) + 150 mg (B) |
|
6.4.3.1.6 |
Tenofovir (A) + Lamivudine (B) |
S,T |
Tablet 300 mg (A) +300 mg (B) |
|
6.4.3.1.7 |
Tenofovir (A) + Lamivudine (B) +
Efavirenz (C) |
S,T |
Tablet 300 mg (A) + 300 mg (B) + 600
mg (C) |
|
6.4.3.1.8 |
Zidovudine |
S,T |
Tablet 300 mg Oral liquid 50 mg/5 ml |
|
6.4.3.1.9 |
Zidovudine (A) + Lamivudine (B) + Nevirapine (C) |
S,T |
Tablet 60 mg (A) + 30 mg (B) + 50 mg
(C) Tablet 300 mg (A) + 150 mg (B) + 200
mg (C) |
|
6.4.3.2-Non-nucleoside reverse
transcriptase inhibitors |
|
||
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
6.4.3.2.1 |
Efavirenz |
S,T |
Tablet 50 mg Tablet 200 mg Tablet 600 mg |
|
6.4.3.2.2 |
Nevirapine |
S,T |
Dispersible Tablet 50 mg Tablet 200 mg Oral liquid 50 mg/5 ml |
|
6.4.3.3-Integrase inhibitors |
|
||
|
6.4.3.3.1 |
Raltegravir |
S,T |
Tablet 400 mg |
|
6.4.3.4-Protease Inhibitors |
Medicine |
Level of Healthcare |
Dosage form and strength |
|
6.4.3.4.1 |
Atazanavir (A) + Ritonavir (B) |
S,T |
Tablet 300 mg (A) + 100 mg (B) |
|
6.4.3.4.2 |
Darunavir |
S,T |
Tablet 600 mg |
|
6.4.3.4.3 |
Lopinavir (A) + Ritonavi (B) |
S,T |
Tablet 100mg (A) + 25 mg (B) Tablet 200mg (A) + 50 mg (B) Oral liquid 400mg (A)mg (B)/5ml |
|
6.4.3.4.4 |
Ritonavir |
S,T |
Tablet 100 mg |
|
6.4.4-Medicines for hepatitis B and
hepatitis C |
|
||
|
6.4.4.1 |
Entecavir |
S,T |
Tablet 0.5 mg Tablet 1 mg |
|
6.4.4.2 |
Pegylated interferon alfa 2a |
S,T |
Injection 180 meg |
|
|
|
S,T |
Injection 80 mcg Injection 100 mcg Injection 120 mcg |
|
6.4.4.3 |
Ribavirin |
S,T |
Capsule 200 mg |
|
6.4.4.4 |
Sofosbuvir |
S,T |
Tablet 400 mg |
|
6.4.4.5 |
Tenofovir |
S,T |
Tablet 300 mg |
|
Section 6.5-Antiprotozoal Medicines |
|
|
|
|
6.5.1-Antiamoebic and antigiardiasis
medicines |
|
|
|
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
6.5.1.1 |
Diloxanide furoate |
P,S,T |
Tablet 500 mg |
|
6.5.1.2 |
Metronidazole |
P,S,T |
Tablet 200 mg Tablet 400 mg Injection 500 mg/100 ml Oral liquid 200 mg/5 ml |
|
6.5.2-Antileishmaniasis medicines |
|
||
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
6.5.2.1 |
Amphotericin B a) Amphotericin B (conventional) b) Lipid Liposomal Amphotericin B |
S,T |
Powder for Injection 50 mg |
|
6.5.2.2 |
Miltefosine |
P,S,T |
Capsule 10 mg Capsule 50 mg |
|
6.5.2.3 |
Paromomycin |
P,S,T |
Injection 375 mg/ml |
|
6.S.3-Antimalarial medicines |
|
|
|
|
6.S.3.1-For curative treatment |
|
||
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
6.5.3.1.1 |
Artemether (A) + Lumefantrine (B) |
P,S,T |
Tablet 20 mg (A) + 120 mg (B) Tablet 40 mg (A) + 240 mg (B) Tablet 80 mg (A) + 480 mg (B) Oral liquid 80 mg (A) + 480 mg (B)/5
ml |
|
6.5.3.1.2 |
Artesunate |
P,S,T |
Powder for Injection 60 mg Powder for Injection 120 mg |
|
6.5.3.1.3 |
Artesunate (A) + Sulphadoxine-Pyrimethamine
(B) |
P,S,T |
Combi pack (A+B) 1 Tablet 25 mg (A) + 1 Tablet (250 mg + 12.5 mg) (B) 1 Tablet 50 mg (A) + 1 Tablet (500 mg + 25 mg) (B) 1 Tablet 100 mg (A) + 1 Tablet (750 mg + 37.5 mg) (B) 1 Tablet 150 mg (A) + 2 Tablet (500 mg + 25 mg) (B) 1 Tablet 200 mg (A) + 2 Tablet (750 mg + 37.5 mg) (B) |
|
6.5.3.1.4 |
Chloroquine |
P,S,T |
Tablet 150 mg Oral liquid 50 mg/5 ml |
|
6.5.3.1.5 |
Clindamycin |
P,S,T |
Capsule 150 mg Capsule 300 mg |
|
6.5.3.1.6 |
Primaquine |
P,S,T |
Tablet 2.5 mg Tablet 7.5 mg Tablet 15 mg |
|
6.5.3.1.7 |
Quinine |
P,S,T |
Tablet 300 mg Injection 300 mg/ml |
|
6.5.3.2-For prophylaxis |
|
|
|
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
6.5.3.2.1 |
Mefloquine |
T |
Tablet 250 mg *Only for use as chemoprophylaxis for
long term travellers like military and travel troops, travelling from low
endemic to high endemic area. |
|
6.5.4-Antipneumocystosis and anti
toxoplasmosis medicines |
|
||
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
6.5.4.1 |
Co-trimoxazole [Sulphamethoxazole (A)
+ Trimethoprim (B)] |
P,S,T |
Tablet 400 mg (A) + 80 mg (B) Tablet 800 mg (A) + 160 mg (B) Oral liquid 200 mg (A) + 40 mg (B)/5
ml |
|
6.5.4.2 |
Pentamidine |
S,T |
Powder for Injection 200 mg |
|
|
Section 7-Antimigraine medicines |
||
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
7.1.1 |
Acetylsalicylic acid |
P,S,T |
Tablet 300 mg to 500 mg
Effervescent/Dispersible/Enteric coated Tablet 300 mg to 500 mg |
|
7.1.2 |
Paracetamol |
P,S,T |
Tablet 500 mg Tablet 650 mg |
|
7.1.3 |
Sumatriptan |
P,S,T |
Tablet 25 mg Tablet 50 mg Injection 6 mg/0.5 ml |
|
7.2-For prophylaxis |
|||
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
7.2.1 |
Flunarizine |
P,S,T |
Tablet 5 mg Tablet 10 mg |
|
7.2.2 |
Propranolol |
P,S,T |
Tablet 10 mg Tablet 40 mg Tablet 80 mg |
|
Section 8-Antineoplastic/immunosuppressives
and medicines used in palliative care |
|||
|
8.1-Antineoplastic medicines |
|||
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
8.1.1 |
5-Fluorouracil |
T |
Injection 250 mg/5 ml |
|
8.1.2 |
6-Mercaptopurine |
T |
Tablet 50 mg |
|
8.1.3 |
Actinomycin D |
T |
Powder for Injection 0.5 mg |
|
8.1.4 |
All-trans retinoic acid |
T |
Capsule 10 mg |
|
8.1.5 |
Arsenic trioxide |
T |
Injection 1mg/ml |
|
8.1.6 |
Bleomycin |
T |
Powder for Injection 15 units |
|
8.1.7 |
Bortezomib |
T |
Powder for Injection 2mg |
|
8.1.8 |
Calcium folinate |
T |
Tablet 15 mg Injection 3 mg/ml |
|
8.1.9 |
Capecitabine |
T |
Tablet 500 mg |
|
8.1.10 |
Carboplatin |
T |
Injection 10 mg/ml |
|
8.1.11 |
Chlorambucil |
T |
Tablet 2 mg Tablet 5 mg |
|
8.1.12 |
Cisplatin |
T |
Injection 1 mg/ml |
|
8.1.13 |
Cyclophosphamide |
T |
Tablet 50 mg Tablet 200 mg Powder for Injection 500 mg |
|
8.1.14 |
Cytosine arabinoside |
T |
Injection 100 mg/ml Powder for Injection 500 mg Powder for Injection 1000 mg |
|
8.1.15 |
Dacarbazine |
T |
Powder for Injection 500 mg Powder for Injection 200 mg |
|
8.1.16 |
Daunorubicin |
T |
Injection 5 mg/ml |
|
8.1.17 |
Docetaxel |
T |
Powder for Injection 20 mg Powder for Injection 80 mg |
|
8.1.18 |
Doxorubicin |
T |
Injection 2 mg/ml |
|
8.1.19 |
Etoposide |
T |
Capsule 50 mg Capsule 100 mg Injection 20 mg/ml |
|
8.1.20 |
Gefitinib |
T |
Tablet 250 mg |
|
8.1.21 |
Gemcitabine |
T |
Powder for Injection 200 mg Powder for Injection 1 g |
|
8.1.22 |
Ifosfamide |
T |
Powder for Injection 1 g Powder for Injection 2 g |
|
8.1.23 |
Imatinib |
T |
Tablet 100 mg Tablet 400 mg |
|
8.1.24 |
L-Asparaginase |
T |
Powder for Injection 5000 KU. Powder for Injection 10000 KU |
|
8.1.25 |
Melphalan |
T |
Tablet 2 mg Tablet 5 mg |
|
8.1.26 |
Mesna |
T |
Injection 100 mg/ml |
|
8.1.27 |
Methotrexate |
T |
Tablet 2.5 mg Tablet 5 mg Tablet 10mg Injection 50 mg/ml |
|
8.1.28 |
Oxaliplatin |
T |
Injection 5 mg/ml |
|
8.1.29 |
Paclitaxel |
T |
Injection 30 mg/5 ml Injection 100 mg/16.7 ml |
|
8.1.30 |
Procarbazine |
T |
Capsule 50 mg |
|
8.1.31 |
Rituximab |
T |
Injection 10 mg/ml |
|
8.1.32 |
Temozolomide |
T |
Capsule 20 mg Capsule 100 mg Capsule 250 mg |
|
8.1.33 |
Thalidomide |
T |
Capsule 50 mg Capsule 100 mg |
|
8.1.34 |
Trastuzumab |
T |
Injection 440 mg/50 ml |
|
8.1.35 |
Vinblastine |
T |
Injection 1 mg/ml |
|
8.1.36 |
Vincristine |
T |
Injection 1 mg/ml |
|
8.2-Hormones and antihormones used in
cancer therapy |
|||
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
8.2.1 |
Bicalutamide |
T |
Tablet 50 mg |
|
8.2.2 |
Letrozole |
T |
Tablet 2.5 mg |
|
8.2.3 |
Prednisolone |
S, T |
Tablet 10 mg Tablet 20 mg Tablet 40 mg Oral liquid 5 mg/5 ml Oral liquid 15 mg/5 ml Injection 20 mg/2 ml |
|
8.2.4 |
Tamoxifen |
T |
Tablet 10 mg Tablet 20 mg |
|
8.3-Immunosuppressive medicines |
|||
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
8.3.1 |
Azathioprine |
T |
Tablet 50 mg |
|
8.3.2 |
Cyclosporine |
T |
Capsule 10 mg Capsule 25 mg Capsule 50 mg Capsule 100 mg Oral liquid 100 mg/ml Injection 50 mg/ml |
|
8.3.3 |
Mycophenolate mofetil |
T |
Tablet 250 mg Tablet 500 mg |
|
8.3.4 |
Tacrolimus |
T |
Capsule 0.5 mg Capsule 1 mg Capsule 2 mg |
|
8.4-Medicines used in palliative care |
|
||
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
8.4.1 |
Allopurinol |
T |
Tablet 100 mg |
|
8.4.2 |
Amitriptyline |
T |
Tablet 10 mg Tablet 25 mg |
|
8.4.3 |
Dexamethasone |
T |
Tablet 0.5 mg Injection 4 mg/ml |
|
8.4.4 |
Diazepam |
T |
Tablet 2 mg Tablet 5 mg Injection 5 mg/ml |
|
8.4.5 |
Filgrastim |
T |
Injection 300 mcg |
|
8.4.6 |
Fluoxetine |
T |
Capsule 20 mg |
|
8.4.7 |
Haloperidol |
T |
Tablet 1.5 mg Tablet 5 mg Injection 5 mg/ml |
|
8.4.8 |
Lactulose |
T |
Oral liquid 10 g/15 ml |
|
8.4.9 |
Loperamide |
T |
Tablet 2 mg |
|
8.4.10 |
Metoclopramide |
T |
Tablet 10 mg Oral liquid 5 mg/5 ml Injection 5 mg/ml |
|
8.4.11 |
Midazolam |
T |
Injection 1 mg/ml |
|
8.4.12 |
Morphine |
T |
Tablet 10 mg Tablet 20 mg SR Tablet 30 mg |
|
8.4.13 |
Ondansetron |
S,T |
Tablet 4 mg Tablet 8 mg Oral liquid 2 mg/5 ml Injection 2 mg/ml |
|
8.4.14 |
Tramadol |
T |
Capsule 50 mg Capsule 100 mg Injection 50 mg/ml |
|
8.4.15 |
Zoledronic acid |
T |
Powder for Injection 4 mg |
|
Section 9-Antiparkinsonism medicines |
|||
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
9.1 |
Levodopa (A) + Carbidopa (B) |
P,S,T |
Tablet 100 mg (A) + 10 mg (B) Tablet 100 mg (A) + 25 mg (B) CR Tablet 100 mg (A) + 25 mg (B) CR Tablet 200 mg (A) + 50 (B) mg Tablet 250 mg (A) + 25 mg (B) |
|
9.2 |
Trihexyphenidyl |
P,S,T |
Tablet 2 mg |
|
Section 10-Medicines affecting blood |
|||
|
10.1-Antianaemia medicines |
|||
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
10.1.1 |
Erythropoietin |
S,T |
Injection 2000 IU/ml Injection 10000 IU/ml |
|
10.1.2 |
Ferrous salts |
P,S,T |
Tablet equivalent to 60 mg of
elemental iron Oral liquid equivalent to 25 mg of
elemental iron/ml |
|
10.1.3 |
Ferrous salt (A) + Folic acid (B) |
P,S,T |
Tablet 45mg elemental iron (A) + 400
mcg (B) Tablet 100 mg elemental iron (A) +
500 mcg (B) Oralliqiud 20 mg elemental iron (A) +
100 mcg (B)/ml |
|
10.1.4 |
Folic acid |
P,S,T |
Tablet 5 mg |
|
10.1.5 |
Hydroxocobalamin |
P,S,T |
Injection 1 mg/ml |
|
10.1.6 |
Hydroxyurea |
P,S,T |
Capsule 500 mg |
|
10.1.7 |
Iron sucrose |
S,T |
Injection 20 mg/ml |
|
10.2-Medicines affecting coagulation |
|
|
|
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
10.2.1 |
Enoxaparin |
T |
Injection 40 mg/0.4 ml Injection 60 mg/0.6 ml |
|
10.2.2 |
Heparin |
S,T |
Injection 1000 IU/ml Injection 5000 IU/ml |
|
10.2.3 |
Phytomenadione (Vitamin K1) |
P,S,T |
Tablet 10mg Injection 10 mg/ml |
|
10.2.4 |
Protamine |
S,T |
Injection 10 mg/ml |
|
10.2.5 |
Tranexamic acid |
P,S,T |
Tablet 500 mg Injection 100 mg/ml |
|
10.2.6 |
Warfarin |
S,T |
Tablet 1 mg Tablet 2 mg Tablet 3 mg Tablet 5 mg |
|
Section 11-Blood products and Plasma
substitutes |
|||
|
11.1-Blood and Blood components |
|||
|
All forms of the following as
approved by licensing authority are considered as included in this schedule.
However, considering the process, technology and other relevant aspects, they
should be considered differently for purposes such as procurement policy,
pricing etc. |
|||
|
11.1.1 |
Fresh frozen plasma |
S,T |
As licensed |
|
11.1.2 |
Platelet rich plasma |
S,T |
As licensed |
|
11.1.3 |
Red blood cells |
S,T |
As licensed |
|
11.1.4 |
Whole blood |
S,T |
As licensed |
|
11.2-Plasma substitutes |
|||
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
11.2.1 |
Dextran-40 |
S,T |
Injection 10% |
|
11.3-Plasma fractions for specific
use |
|||
|
In case of coagulation factors and
other blood products, irrespective of variation in source, all forms of these
products as approved by licensing authority are considered as included in as
included in this schedule. However, considering the source, process,
technology and other relevant aspects, and other relevant aspects, they
should be considered differently for purposes such as procurement policy,
Procurement policy, pricing etc |
Medicine |
Level of Healthcare |
Dosage form and strength |
|
11.3.1 |
Coagulation factor IX |
S,T |
Powder for Injection 600 IU |
|
11.3.2 |
Coagulation factor VIII |
S,T |
Powder for Injection 250 IU Powder for Injection 500 IU |
|
11.3.3 |
Cryoprecipitate |
S,T |
As licensed |
|
Section 12-Cardiovascular medicines |
|||
|
12.1-Medicines used in angina |
|||
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
12.1.1 |
Acetylsalicylic acid |
P,S,T |
Tablet 75 mg Effervescent/Dispersible/Enteric coated Tablet 75 mg Tablet 100 mg Effervescent/Dispersible/Enteric coated Tablet 100 mg Tablet 150 mg Effervescent/Dispersible/Enteric coated Tablet 150 mg |
|
12.1.2 |
Clopidogrel |
P,S,T |
Tablet 75 mg |
|
12.1.3 |
Diltiazem |
P,S,T |
Tablet 30 mg Tablet 60 mg SR Tablet 90 mg |
|
|
|
T |
Injection 5 mg/ml |
|
12.1.4 |
Glyceryl trinitrate |
P,S,T |
Sublingual tablet 0.5 mg |
|
S,T |
Injection 5 mg/ml |
||
|
12.1.5 |
Isosorbide-5-mononitrate |
P,S,T |
Tablet 10 mg Tablet 20 mg SR Tablet 30 mg SR Tablet 60 mg |
|
12.1.6 |
Isosorbide dinitrate |
P,S,T |
Tablet 5 mg Tablet 10 mg |
|
12.1.7 |
Metoprolol |
P,S,T |
Tablet 25 mg Tablet 50 mg SR Tablet 25 mg SR Tablet 50 mg |
|
12.2-Antiarrhythmic medicines |
|
|
|
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
12.2.1 |
Adenosine |
S,T |
Injection 3 mg/ml |
|
12.2.2 |
Amiodarone |
S,T |
Tablet 100 mg Tablet 200 mg Injection 50 mg/ml |
|
12.2.3 |
Esmolol |
T |
Injection 10 mg/ml |
|
12.2.4 |
Lignocaine |
S,T |
Injection 2% (Preservative free for
IV use) |
|
12.2.5 |
Verapamil |
S,T |
Tablet 40 mg Tablet 80 mg Injection 2.5 mg/ml |
|
12.3-Antihypertensive medicines |
|
|
|
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
12.3.1 |
Amlodipine |
P,S,T |
Tablet 2.5 mg Tablet 5 mg Tablet 10 mg |
|
12.3.2 |
Atenolol |
P,S,T |
Tablet 50 mg Tablet 100 mg |
|
12.3.3 |
Enalapril |
P,S,T |
Tablet 2.5 mg Tablet 5 mg |
|
12.3.4 |
Hydrochlorothiazide |
P,S,T |
Tablet 12.5 mg Tablet 25 mg |
|
12.3.5 |
Labetalol |
P,S,T |
Injection 5 mg/ml |
|
12.3.6 |
Methyldopa |
P,S,T |
Tablet 250 mg Tablet 500 mg |
|
12.3.7 |
Ramipril |
P,S,T |
Tablet 2.5 mg Tablet 5 mg |
|
12.3.8 |
Sodium nitroprusside |
T |
Injection 10 mg/ml |
|
12.3.9 |
Telmisartan |
P,S,T |
Tablet 20 mg Tablet 40 mg Tablet 80 mg |
|
12.4-Medicines used in shock and
heart failure |
|
||
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
12.4.1 |
Digoxin |
S,T |
Tablet 0.25 mg Oral liquid 0.05 mg/ml Injection 0.25 mg/ml |
|
12.4.2 |
Dobutamine |
S,T |
Injection 50 mg/ml |
|
12.4.3 |
Dopamine |
S,T |
Injection 40 mg/ml |
|
12.4.4 |
Noradrenaline |
S,T |
Injection 2 mg/ml |
|
12.5-Antithrombotic medicine
(Cardiovascular/Cerebrovascular) |
|||
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
12.5.1 |
Acetylsalicylic acid |
P,S,T |
Tablet 75 mg Effervescent/Dispersible/Enteric
coated Tablet 75 mg Tablet 100 mg Effervescent/Dispersible/Enteric
coated Tablet 100 mg Tablet 150 mg Effervescent/Dispersible/Enteric
coated Tablet 150 mg |
|
12.5.2 |
Alteplase |
T |
Powder for Injection 20 mg Powder for Injection 50 mg |
|
12.5.3 |
Heparin |
S,T |
Injection 1000 IU/ml Injection 5000 IU/ml |
|
12.5.4 |
Streptokinase |
S,T |
Injection 750,000 IU Injection
15,00,000 IU |
|
12.6-Hypolipidemic medicines |
|
|
|
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
12.6.1 |
Atorvastatin |
P,S,T |
Tablet 10 mg Tablet 20 mg Tablet 40 mg |
|
Section 13-Medicines used in dementia |
|
||
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
13.1 |
Donepezil |
S,T |
Tablet 5 mg Tablet 10 mg |
|
Section 14-Dermatological medicines
(Topical) |
|||
|
14.1-Antifungal medicines |
|||
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
14.1.1 |
Clotrimazole |
P,S,T |
Cream 1% |
|
14.2-Antiinfective medicines |
|
|
|
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
14.2.1 |
Framycetin |
P,S,T |
Cream 0.5% |
|
14.2.2 |
Fusidic acid |
P,S,T |
Cream 2% |
|
14.2.3 |
Methylrosanilinium chloride (Gentian
Violet) |
P,S,T |
Topial preparation 0.25% to 2% |
|
14.2.4 |
Povidone iodine |
P,S,T |
Solution 4% to 10% |
|
14.2.5 |
Silver sulphadiazine |
P,S,T |
Cream 1% |
|
14.3-Antiinflammatory and
antipruritic medicines |
|||
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
14.3.1 |
Betamethasone |
P,S,T |
Cream 0.05% Cream 0.1% |
|
14.3.2 |
Calamine |
P,S,T |
Lotion (As per IP) |
|
14.4-Medicines affecting skin
differentiation and proliferation |
|||
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
14.4.1 |
Benzoyl peroxide |
P,S,T |
Gel 2.5% |
|
14.4.2 |
Coal tar |
P,S,T |
Solution 5% |
|
14.4.3 |
Podophyllin resin |
S,T |
Solution 10% to 25% |
|
14.4.4 |
Salicylic acid |
P,S,T |
Ointment 6% |
|
14.5-Scabicides and pediculicides |
|
||
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
14.5.1 |
Permethrin |
P,S,T |
Lotion 1% Cream 5% |
|
14.6-Miscellaneous |
|
|
|
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
14.6.1 |
Glycerin |
P,S,T |
Oral Liquid |
|
14.6.2 |
White Petrolatum |
P,S,T |
Jelly 100% |
|
Section 15-Diagnostic agents |
|||
|
15.1-Ophthalmic medicines |
|||
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
15.1.1 |
Fluorescein |
S,T |
Eye drop 1% |
|
15.1.2 |
Lignocaine |
S,T |
Eye drop 4% |
|
15.1.3 |
Tropicamide |
S,T |
Eye drop 1% |
|
15.2-Radiocontrast media |
|||
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
15.2.1 |
Barium sulphate |
S,T |
Oral liquid 100% w/v Oral liquid 250% w/v |
|
15.2.2 |
Gadobenate |
T |
Injection 529 mg/ml |
|
15.2.3 |
Iohexol |
S,T |
Injection 140 to 350 mg iodine/ml |
|
15.2.4 |
Meglumine diatrizoate |
S,T |
Injection 60% w/v Injection 76% w/v |
|
Section 16-Dialysis solutions |
|||
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
16.1 |
Haemodialysis fluid |
S,T |
As licensed |
|
16.2 |
Intraperitoneal dialysis solution |
S,T |
As licensed |
|
Section 17-Disinfectants and
antiseptics |
|
||
|
17.1-Antiseptics |
|
|
|
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
17.1.1 |
Cetrimide |
P,S,T |
Solution 20% (Concentrate for
dilution) |
|
17.1.2 |
Chlorhexidine |
P,S,T |
Solution 5% (Concentrate for
dilution) |
|
17.1.3 |
Ethyl alcohol (Denatured) |
P,S,T |
Solution 70% |
|
17.1.4 |
Hydrogen peroxide |
P,S,T |
Solution 6% |
|
17.1.5 |
Methylrosanilinium chloride (Gentian
Violet) |
P,S,T |
Topial preparation 0.25% to 2% |
|
17.1.6 |
Povidone iodine |
P,S,T |
Solution 4% to 10% |
|
17.2-Disinfectants |
|
|
|
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
17.2.1 |
Bleaching powder |
P,S,T |
Containing not less than 30% w/w of
available chlorine (as per IP) |
|
17.2.2 |
Glutaraldehyde |
S,T |
Solution 2% |
|
17.2.3 |
Potassium permanganate |
P,S,T |
Crystals for topical solution |
|
Section 18-Diuretics |
|
|
|
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
18.1 |
Furosemide |
P,S,T |
Tablet 40 mg Oral liquid 10 mg/ml Injection 10 mg/ml |
|
18.2 |
Hydrochlorothiazide |
P,S,T |
Tablet 25 mg Tablet 50 mg |
|
18.3 |
Mannitol |
P,S,T |
Injection 10% Injection 20% |
|
18.4 |
Spironolactone |
P,S,T |
Tablet 25 mg Tablet 50 mg |
|
Section 19-Ear, nose and throat
medicines |
|
||
|
19.1 |
Budesonide |
P,S,T |
Nasal Spray 50 mcg/dose Nasal Spray 100 mcg/dose |
|
19.2 |
Ciprofioxaein |
P,S,T |
Drops 0.3% |
|
19.3 |
Clotrimazole |
P,S,T |
Drops 1% |
|
19.4 |
Xylometazoline |
P,S,T |
Nasal drops 0.05% Nasal drops 0.1% |
|
Section 20-Gastrointestinal medicines |
|||
|
20.1-Antiulcer medicines |
|||
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
20.1.1 |
Omeprazole |
P,S,T |
Capsule 10 mg Capsule 20 mg Capsule 40 mg Powder for oral liquid 20 mg |
|
20.1.2 |
Pantoprazole |
S,T |
Injection 40 mg |
|
20.1.3 |
Ranitidine |
P,S,T |
Tablet 150 mg Oral liquid 75 mg/5 ml Injection 25 mg/ml |
|
20.1.4 |
Sucralfate |
S,T |
Oral liquid 1 g |
|
20.2-Antiemetics |
|
|
|
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
20.2.1 |
Domperidone |
P,S,T |
Tablet 10 mg Oral liquid 1 mg/ml |
|
20.2.2 |
Metoclopramide |
P,S,T |
Injection 5 mg/ml |
|
20.2.3 |
Ondansetron |
S,T |
Tablet 4 mg Oral liquid 2 mg/5 ml Injection 2 mg/ml |
|
20.3-Anti-inflammatory medicines |
|
|
|
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
20.3.1 |
5-aminosalicylic acid |
S,T |
Tablet 400 mg Suppository 500 mg Retention Enema |
|
20.4-Antispasmodic medicines |
|
||
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
20.4.1 |
Dicyclomine |
P,S,T |
Tablet 10 mg Oral Solution 10mg/5ml Injection 10 mg/ml |
|
20.4.2 |
Hyoscine butylbromide |
P,S,T |
Tablet 10 mg Injection 20 mg/ml |
|
20.5-Laxatives |
|
|
|
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
20.5.1 |
Bisacodyl |
P,S,T |
Tablet 5 mg Suppository 5 mg |
|
20.5.2 |
Ispaghula |
P,S,T |
Granules/Husk/Powder |
|
20.5.3 |
Lactulose |
S,T |
Oral liquid 10 g/15 ml |
|
20.6-Medicines used in diarrhoea |
|
|
|
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
20.6.1 |
Oral rehydration salts |
P,S,T |
As licensed |
|
20.6.2 |
Zinc sulphate |
P,S,T |
Dispersible Tablet 20 mg |
|
20.7-other medicines |
|
|
|
|
20.7.1 |
Somatostatin |
T |
Powder for Injection 3 mg |
|
|
Section 21-Hormones, other endocrine
medicines and contraceptives |
||
|
21.1-Adrenal hormones and synthetic
substitutes |
|
||
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
21.1.1 |
Dexamethasone |
S,T |
Tablet 0.5 mg Injection 4 mg/ml |
|
21.1.2 |
Human chorionic gonadotropin |
T |
Injection 1000 IU Injection 5000 IV |
|
21.1.3 |
Hydrocortisone |
P,S,T |
Tablet 5 mg Tablet 10 mg Injection 100 mg/ml |
|
21.1.4 |
Methylprednisolone |
S,T |
Tablet 8 mg Tablet 16 mg Tablet 32 mg Injection 40 mg/ml |
|
21.1.5 |
Prednisolone |
P,S,T |
Tablet 5 mg Tablet 10 mg Tablet 20 mg |
|
21.2-Contra |
ceptives |
|
|
|
21.2.1-Hormonal contraceptives |
|
|
|
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
21.2.1.1 |
Ethinylestradiol (A) + Levonorgestrel |
P,S,T |
Tablet 0.03 mg (A) + 0.15 mg (B) |
|
21.2.1.2 |
Ethinylestradiol (A) + Norethisterone |
P,S,T |
Tablet 0.035 mg (A) + 1 mg (B) |
|
21.2.2-Intrauterine devices |
|
|
|
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
21.2.2.1 |
Hormone releasing IUD |
T |
Contains 52 mg of Levonorgestrel |
|
21.2.2.2 |
IUD containing Copper |
P,S,T |
As licensed |
|
21.2.3-Barrier methods |
|
|
|
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
21.2.3.1 |
Condom |
P,S,T |
As per the standards prescribed in
Schedule R of Drugs and Cosmetics rules, 1945 |
|
21.3-Estrogens |
|
|
|
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
21.3.1 |
Ethinylestradiol |
P,S,T |
Tablet 0.01 mg Tablet 0.05 mg |
|
21.3.2 |
Levonorgestrel |
P,S,T |
Tablet 0.75 mg |
|
21.4-Medicines used in diabetes
mellitus |
|
||
|
21.4.1-Insulins and other
antidiabetic agents |
|
||
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
21.4.1.1 |
Glimepiride |
P,S,T |
Tablet 1 mg Tablet 2 mg |
|
21.4.1.2 |
Insulin (Soluble) |
P,S,T |
Injection 40 IU/ml |
|
21.4.1.3 |
Intermediate Acting (NPH) Insulin |
P,S,T |
Injection 40 IU/ml |
|
21.4.1.4 |
Metformin |
P,S,T |
Tablet 500 mg Tablet 750 mg Tablet 1000 mg (Immediate and controlled release) |
|
21.4.1.5 |
Premix Insulin 30:70 Injection
(Regular: NPH) |
P,S,T |
Injection 40 IU/ml |
|
21.4.2-Medicines used to treat
hypoglycemia |
|||
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
21.4.2.1 |
Glucose |
P,S,T |
Injection 25% |
|
21.5-Ovulation Inducers |
|||
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
21.5.1 |
Clomiphene |
T |
Tablet 50 mg Tablet 100 mg |
|
21.6-Progestogens |
|||
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
21.6.1 |
Medroxyprogester oneacetate |
P,S,T |
Tablet 5 mg Tablet 10 mg |
|
21.6.2 |
Norethisterone |
P,S,T |
Tablet 5 mg |
|
21.7-Thyroid and antithyroid
medicines |
|||
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
21.7.1 |
Carbimazole |
P,S,T |
Tablet 5 mg Tablet 10 mg |
|
21.7.2 |
Levothyroxine |
P,S,T |
Tablet 12.5 mcg to 150 mcg* (Several
strengths are available in market such as 12.5, 25, 50, 62.5, 75, 88, 100,
112 mcg. Therefore it was Considered to give a range of available strengths) |
|
Section 22-Immunologicals |
|||
|
In case of these biologicals,
irrespective of variation in source, composition and strengths, all the
products of the same vaccine/sera/immunoglobulin, as approved by licensing
authority are considered as included in this schedule. However, considering
the source, process, technology and other relevant aspects, different
products of the same biologicals should be considered differently for
purposes such as procurement policy, pricing, etc. |
|||
|
22.1-Diagnostic agents |
|||
|
|
Medicine |
Level of Healthcare |
|
|
22.1.1 |
Tuberculin, Purified Protein
derivative |
P,S,T |
|
|
22.2-Sera and immunoglobulins
(Liquid/Lyophilized) |
|||
|
|
Medicine |
Level of Healthcare |
|
|
22.2.1 |
Anti-rabies immunoglobulin |
P,S,T |
|
|
22.2.2 |
Anti-tetanus immunoglobulin |
P,S,T |
|
|
22.2.3 |
Anti-D immunoglobulin |
S, T |
|
|
22.2.4 |
Diphtheria antitoxin |
P,S,T |
|
|
22.2.5 |
Hepatitis B immunoglobulin |
S,T |
|
|
22.2.6 |
Human normal immunoglobulin |
T |
|
|
22.2.7 |
Snake venom antiserum a) Soluble/liquid polyvalent b) Lyophilized polyvalent |
P,S,T |
|
|
22.3-Vaccines |
|||
|
(a) All the vaccines which are under
Universal Immunization Programme of India (UIP) will be deemed included in
this schedule. Presently, the UIP has BCG, DPT, OPV, measles, Hepatitis B,
Japanese encephalitis & Pentavalent Vaccines. |
|||
|
(b) The new vaccines, which have been
approved by National Technical Advisory Group on Immunization NTAGI) and
planned to be given under UIP, will be deemed to be included as and when
listed in UIP. These vaccines are inactivated polio vaccine (IPV), Measles
Rubella (MR) and Rota virus vaccine. |
|||
|
In future, the vaccines which are
under consideration, if and when included in UIP, will also be deemed (c) included from the date of inclusion
in UIP. These are pneumococcal and HPV vaccines. |
|||
|
22.3.1-For universal immunisation |
|||
|
|
Medicine |
Level of Healthcare |
|
|
22.3.1.1 |
BCG vaccine |
P,S,T |
|
|
22.3.1.2 |
DPT + Hib + Hep B vaccine |
P,S,T |
|
|
22.3.1.3 |
DPT vaccine |
P,S,T |
|
|
22.3.1.4 |
Hepatitis B vaccine |
P,S,T |
|
|
22.3.1.5 |
Japanese encephalitis vaccme |
P,S,T |
|
|
22.3.1.6 |
Measles vaccine |
P,S,T |
|
|
22.3.1.7 |
Oral poliomyelitis vaccme |
P,S,T |
|
|
22.3.1.8 |
Tetanus toxoid |
P,S,T |
|
|
22.3.2-For Specific Group of
Individuals |
|
||
|
|
Medicine |
Level of Healthcare |
|
|
22.3.2.1 |
Rabies vaccine |
P,S,T |
|
|
|
Section 23-Muscle relaxants and
cholinesterase inhibitors |
||
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
23.1 |
Atracurium |
S,T |
Injection 10 mg/ml |
|
23.2 |
Baclofen |
S,T |
Tablet 5 mg Tablet 10 mg Tablet 20 mg |
|
23.3 |
Neostigmine |
S,T |
Tablet 15 mg Injection 0.5 mg/ml |
|
23.4 |
Succinylcholine |
S,T |
Injection 50 mg/ml |
|
23.5 |
Vecuronium |
S,T |
Powder for Injection 4 mg Powder for Injection 10 mg |
|
|
Section 24-Medicines for neonatal
care |
||
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
24.1 |
Alprostadil |
T |
Injection 0.5 mg/ml |
|
24.2 |
Caffeine |
S,T |
Oral liquid 20 mg/ml Injection 20
mg/ml |
|
24.3 |
Surfactant |
S,T |
Suspension for intratracheal
instillation (As liensed) |
|
|
Section 25-0 phthalmological
Medicines |
||
|
25.1-Anti-infective medicine |
|
|
|
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
25.1.1 |
Acyclovir |
P,S,T |
Ointment 3% |
|
25.1.2 |
Ciprofioxacin |
P,S,T |
Drops 0.3% Ointment 0.3% |
|
25.1.3 |
Erythromycin |
P,S,T |
Ointment 0.5% |
|
25.1.4 |
Gentamicin |
P,S,T |
Drops 0.3% |
|
25.1.5 |
Natamycin |
P,S,T |
Drops 5% |
|
25.1.6 |
Povidone iodine |
P,S,T |
Drops 0.6% Drops 5% |
|
25.2-Antiinflammatory medicine |
|||
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
25.2.1 |
Prednisolone |
P,S,T |
Drops 0.1% Drops 1% |
|
25.3-Local a |
naesthetics |
|
|
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
25.3.1 |
Proparacaine |
P,S,T |
Drops 0.5% |
|
25.4-Miotics and anti glaucoma
medicines |
|
||
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
25.4.1 |
Acetazolamide |
P,S,T |
Tablet 250 mg |
|
25.4.2 |
Pilocarpine |
P,S,T |
Drops 2% Drops 4% |
|
25.4.3 |
Timolol |
P,S,T |
Drops 0.25% Drops 0.5% |
|
25.5-Mydriatics |
|
|
|
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
25.5.1 |
Atropine |
P,S,T |
Drops 1% Ointment 1% |
|
25.5.2 |
Homatropine |
P,S,T |
Drops 2% |
|
25.5.3 |
Phenylephrine |
P,S,T |
Drops 5% Drops 10% |
|
25.5.4 |
Tropicamide |
P,S,T |
Drops 1% |
|
25.6-Ophthalmic surgical aids |
|
|
|
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
25.6.1 |
Hydroxypropyl methylcellulose |
T |
Injection 2% |
|
25.7-Miscellaneous |
|
|
|
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
25.7.1 |
Carboxymethylcellulose |
P,S,T |
Drops 0.5% Drops 1% |
|
|
Section 26-Oxytocics and Antioxytocics |
||
|
26.1-Oxytocics and abortifacient |
|
|
|
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
26.1.1 |
Dinoprostone |
S,T |
Tablet 0.5 mg Gel 0.5 mg |
|
26.1.2 |
Methylergometrine |
P,S,T |
Tablet 0.125 mg Injection 0.2 mg/ml |
|
26.1.3 |
Mifepristone |
T |
Tablet 200 mg |
|
26.1.4 |
Misoprostol |
T |
Tablet 100 mcg Tablet 200 mcg |
|
26.1.5 |
Oxytocin |
S,T |
Injection 5 IU/ml Injection 10 IU/ml |
|
26.2-Medicines used in pre term
labour |
|||
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
26.2.1 |
Betamethasone |
P,S,T |
Injection 4 mg/ml |
|
26.2.2 |
Nifedipine |
S,T |
Tablet 10 mg |
|
|
Section 27-Psychotherapeutic
medicines |
||
|
27.1-Medicines used in psychotic
disorders |
|
||
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
27.1.1 |
Clozapine |
T |
Tablet 25 mg Tablet 50 mg Tablet 100 mg |
|
27.1.2 |
Fluphenazine |
S,T |
Depot Injection 25 mg/ml |
|
27.1.3 |
Haloperidol |
S,T |
Tablet 5 mg Tablet 10 mg Tablet 20 mg Oral liquid 2 mg/5ml |
|
27.1.4 |
Risperidone |
P,S,T |
Tablet 1 mg Tablet 2 mg Tablet 4 mg Oral liquid 1 mg/ml |
|
27.2-Medicines used in mood disorders |
|
||
|
27.2.1-Medicines used in depressive
disorders |
|
||
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
27.2.1.1 |
Amitriptyline |
P,S,T |
Tablet 10 mg Tablet 25 mg Tablet 50 mg Tablet 75 mg |
|
27.2.1.2 |
Escitalopram |
S,T |
Tablet 5 mg Tablet 10 mg Tablet 20 mg |
|
27.2.1.3 |
Fluoxetine |
P,S,T |
Capsule 10 mg Capsule 20 mg Capsule 40 mg Capsule 60 mg |
|
27.2.2-Medicines used in Bipolar
disorders |
|
||
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
27.2.2.1 |
Lithium |
S,T |
Tablet 300 mg |
|
27.2.2.2 |
Sodium valproate |
P,S,T |
Tablet 200 mg Tablet 500 mg |
|
27.3-Medicines used for Generalized
Anxiety and Sleep Disorders |
|||
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
27.3.1 |
Clonazepam |
P,S,T |
Tablet 0.25 mg Tablet 0.5 mg Tablet 1 mg |
|
27.3.2 |
Zolpidem |
P,S,T |
Tablet 5 mg Tablet 10 mg |
|
27.4-Medicines used for obsessive
compulsive disorders and panic attacks |
|||
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
27.4.1 |
Clomipramine |
S,T |
Capsule 10 mg Capsule 25 mg Capsule 75 mg |
|
27.4.2 |
Fluoxetine |
P,S,T |
Capsule 10 mg Capsule 20 mg Capsule 40 mg Capsule 60 mg |
|
Section 28-Medicines acting on the
respiratory tract |
|||
|
28.1-Antiasthmatic medicines |
|||
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
28.1.1 |
Budesonide |
P,S,T |
Inhalation (MDI/DPI) 100 mcg/dose Inhalation (MDI/DPI) 200 mcg/dose Respirator solution for use in
nebulizer 0.5 mg/ml Respirator solution for use in
nebulizer 1 mg/ml |
|
28.1.2 |
Budesonide (A)+ Formoterol (B) |
P,S,T |
Inhalation (MDI/DPI) 100 mcg (A) + 6
mcg (B) Inhalation (MDI/DPI) 200 mcg (A) + 6
mcg (B) Inhalation (MDI/DPI) 400 mcg (A) + 6
mcg (B) |
|
28.1.3 |
Hydrocortisone |
P,S,T |
Injection 100 mg Injection 200 mg |
|
28.1.4 |
Ipratropium |
P,S,T |
Inhalation (MDI/DPI) 20 mcg/dose
Respirator solution for use in nebulizer 250 mcg/ml |
|
28.1.5 |
Salbutamol |
P,S,T |
Tablet 2 mg Tablet 4 mg Oral liquid 2 mg/5 ml Inhalation (MDI/DPI) 100 mcg/dose Respirator solution for use in
nebulizer 5mg/ml |
|
28.1.6 |
Tiotropium |
P,S,T |
Inhalation (MDI) 9 mcg/dose Inhalation (DPI) 18 mcg/dose |
|
|
|
|
MDI-Metered dose inhaler DPI-Dry Powder inhaler |
|
Section 29-Solutions correcting
water, electrolyte disturbances and acid-base disturbances |
|||
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
29.1 |
Glucose |
P,S,T |
Injection 5% Injection 10% Injection 25% Injection 50% |
|
29.2 |
Glucose (A) + Sodium chloride (B) |
P,S,T |
Injection 5% (A) + 0.9% (B) |
|
29.3 |
Oral rehydration salts |
P,S,T |
As licensed |
|
29.4 |
Potassium chloride |
P,S,T |
Injection 150 mg/ml Oral liquid 500 mg/5 ml |
|
29.5 |
Ringer lactate |
P,S,T |
Injection (as per IP) |
|
29.6 |
Sodium bicarbonate |
P,S,T |
Injection (as per IP) |
|
|
|
P,S,T |
Injection 0.9% |
|
29.7 |
Sodium chloride |
S,T |
Injection 0.45% Injection 3% |
|
29.3-Miscellaneous |
|
|
|
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
29.3.1 |
Water for Injection |
P,S,T |
Injection |
|
Section 30-Vitamins and minerals |
|
|
|
|
|
Medicine |
Level of Healthcare |
Dosage form and strength |
|
30.1 |
Ascorbic acid (Vitamin C) |
P,S,T |
Tablet 100 mg Tablet 500 mg |
|
30.2 |
Calcium carbonate |
P,S,T |
Tablet 250 mg Tablet 500 mg |
|
30.3 |
Calcium gluconate |
P,S,T |
Injection 100 mg/ml |
|
30.4 |
Cholecalciferol |
P,S,T |
Tablet 1000 IU, Tablet 60000 IU Oral liquid 400 IU/ml |
|
30.5 |
Nicotinamide |
P,S,T |
Tablet 50 mg |
|
30.6 |
Pyridoxine |
P,S,T |
Tablet 10 mg Tablet 50 mg Tablet 100 mg |
|
30.7 |
Riboflavin |
P,S,T |
Tablet 5 mg |
|
30.8 |
Thiamine |
P,S,T |
Tablet 100 mg Injection 100 mg/ml |
|
30.9 |
Vitamin A |
P,S,T |
Capsule 5000 IU Capsule 50000 IU Capsule 100000 IU Oral liquid 100000 IU/ml Injection 50000 IU/ml |
|
[31- Coronary Stents |
|||
|
31.1 |
Bare Metal Stents (BMS) |
|
|
|
31.2 |
Drug Eluting Stents (DES) which
include metallic DES and Bioresorbable Vascular Scaffold (BVS)/ Biodegradable
stents] |
|
|
|
[32-Medicines for animal use |
|
|
32.1 |
Foot and Mouth Disease (Trivalent)
Oil adjuvant vaccine |
|
32.2 |
Brucella Abortus (S19 strain)
Vaccine, Live Freeze Dried] |
Explanation.
(1) Any dosage form
of a medicine, other than the dosage form included in this Schedule, but in
same strength and route of administration, which does not have significant
difference in terms of pharmacokinetics or pharmacodynamics or efficacy-safety
profile over the dosage form mentioned in the list shall be considered as
included. To elaborate, if a tablet is included, other dosage forms like
conventional tablets and capsules are considered as included. However, such
different dosage forms should be considered differently for purposes such as
procurement policy, pricing, etc. This principle also applies to all other
dosage forms e.g. oral liquid dosage forms, injectables, topical dosage forms,
etc.
(2) Innovation in
medicine must be encouraged. The formulations developed through incremental
innovation or novel drug delivery systems like lipid/liposomal formulations,
sustained release/controlled release etc. should be considered as included only
if specified in the list against any medicine. Such different formulations
should be considered differently for purposes such as procurement policy,
pricing, etc.
(3) In cases, where
vaccines or immunoglobulins or sera are listed in this Schedule, irrespective
of variation in source, composition and strength, all the products of the same
vaccines or immunoglobulins or sera as approved by the licensing authority are
considered included.
(4) In general,
medicines have been mentioned with respect to their active moieties, without
mentioning the salts and, in cases where there is significant difference
between the salts, the medicine finds mention as its specific salt.
(5) In cases where an
active moiety is available as different isomers or analogues or derivatives,
they are considered as separate entities, and inclusion of one does not imply
inclusion of all isomers or analogues or derivatives.
(6) For injectable
preparations, the pack size (single and multi-dose packs) has not been
mentioned. It is suggested that the single and multi-dose pack sizes be
considered as separate entities for purposes such as procurement/pricing
etc."
[10] Inserted
by Drugs (Prices Control) Amendment Order, 2021 vide Order No. SO2899(E) dated 20.07.2021.