Drug Price Control Order 2013

Bare Acts & Rules
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41
MINISTRY OF CHEMICALS AND FERTILIZERS

(Department of Pharmaceuticals)
ORDER
New Delhi, the 15th May, 2013
S.O. 1221(E).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: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.
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 sellers 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;
(n) "manufacturer" for the purpose of this Order means any person who manufactures, imports and 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;
42
[PART IISEC. 3(ii)]
(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.
(v) "non-scheduled formulation" means a formulation, the dosage and strengths of which are not specified in the
First Schedule;
(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.
.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.
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:
Step 1. 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.)
Step 2. 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
Hkkx II[k.M 3(ii)
43
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.
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):
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
Step 2. 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 step 1
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:
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.
44
[PART IISEC. 3(ii)]
Step 2. 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
Explanation.- where the scheduled formulation under consideration is coming under more than one subtherapeutic 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:
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
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.
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.
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
9. Reference data and source of market based data. (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.
(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.
Hkkx II[k.M 3(ii)
45
(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.
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
st
previous calendar year announced by Department of Industrial Promotion and Policy and on the 1 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
st
in the First Schedule of this order, fixed and notified under the provisions of the said order, up to 31 May, 2012, shall
th
remain effective for further one year i.e. up to the 30 May2013 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.
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.
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.
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.
46
[PART IISEC. 3(ii)]
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.
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.
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.
16. Revision of ceiling price of scheduled formulations. (1) The Government shall revise the ceiling prices of
st
scheduled formulations as per the annual wholesale price index (WPI) for preceding calendar year on or before 1 April
st
of every year and notify the same on the 1 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 subparagraph 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.
Hkkx II[k.M 3(ii)
47
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.
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,(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;
(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.
19. Fixation of ceiling price of a drug under certain circumstances.- Notwithstanding anything contained in this order,
the Government may, in case of extraordinary 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.
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.
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.
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
48
[PART IISEC. 3(ii)]
(c) promoting higher education and research in Pharmaceutical Sciences and Technology and for the purposes
incidental thereto.
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.
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 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.
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 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.
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.
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.
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.
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.
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
Hkkx II[k.M 3(ii)
49
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.
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.
32. Nonapplication of the provisions of this order in certain cases.- The provisions of this order shall not apply to, (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.
(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.
[File No. 31011/17/2012-PI-II]
SHAMBHU KALLOLIKAR, Jt. Secy.
SCHEDULE-I
(See Paragraphs-2(t),2(zb))
Symbols P, S and T appearing in NLEM 2011 denote essentiality at Primary, Secondary and Tertiary levels respectively.
NATIONAL LIST OF ESSENTIAL MEDICINES 2011
Section: 1 Anesthesia
1.1 General Anesthetics and Oxygen
Medicines
Category
Route of Administration
Strengths
Ether
S, T
Inhalation
--
Halothane with vaporizer
S, T
Inhalation
50
Isoflurane
S, T
Inhalation
Ketamine Hydrochloride
P, S, T
Injection
Nitrous Oxide
P, S, T
Inhalation
Oxygen
P, S, T
Inhalation
Thiopentone Sodium
S, T
Injection
Sevoflurane
Propofol
Medicines
Added Medicines
T
Inhalation
P,S,T
Injection
1.2 Local Anesthetics
Route of Administration/
Category
Dosage Form
[PART IISEC. 3(ii)]
10 mg / ml,
50 mg / ml
0.5 g, 1 g powder
1% oil suspension
Strengths
Bupivacaine
Hydrochloride
S, T
Injection
0.25%, 0.5%, 0.5%

to be mixed with
7.5% glucose solution
Lignocaine Hydrochloride
P, S, T
Topical Forms,
Injection,
Spinal
2-5%,
1-2%,
5% +7.5% Glucose
Lignocaine Hydrochloride
+ Adrenaline
P, S, T
Injection
1%, 2% +
Adrenaline1:200,000
Added Medicines
EMLA cream
T
Cream
1.3 Preoperative Medication and Sedation for Short Term Procedures
Medicines
Atropine Sulphate
Category
P, S, T
Dosage Form
Injection
Tablets
Injection,
Syrup,
Suppository
Diazepam
P,S,T
S, T
Midazolam
P, S, T
Injection
Morphine Sulphate
Promethazine
S, T
P, S, T
Injection
Syrup
Strengths
0.6 mg / ml
5 mg
5 mg / ml
2mg/5ml
5 mg
1 mg / ml
5 mg / ml
10 mg / ml
5 mg / 5 ml
Section: 2 - Analgesics , Antipyretics, Nonsteroidal Anti-inflammatory Medicines, Medicines used

to treat Gout and Disease Modifying Agents used in Rheumatoid Disorders
2.1: Non-Opioid Analgesics, Antipyretics and Nonsteroidal Anti-inflammatory Medicines
Medicines
Category
Strengths
Dosage Form
Acetyl Salicylic
P, S, T
Tablets
325, 350 mg
Hkkx II[k.M 3(ii)
51
Acid
T
T
Diclofenac
Ibuprofen
Paracetamol
Medicines
Morphine Sulphate
Tablets
Injection
Tablets
P, S, T
Syrup
P, S, T
Injection
P, S, T
Syrup
P, S, T
Tablets
P, S, T
Suppository
2.2 Opioid Analgesics
Category
Dosage Form
Injection
S, T
Tablets
Tramadol
S,T
Fentanyl
50 mg
25 mg / ml
200 mg, 400 mg
100mg/5ml
150 mg / ml
125 mg / 5ml
500 mg
80 mg, 170 mg
Strengths
10 mg / ml
10 mg
Added medicines
Injection
Cap
S,T
50 mg/ml
50 mg,100 mg
Injection
50ug/ml
2ml ampoule
2.3 Medicines used to treat Gout

Allopurinol
S, T
Tablets
100 mg
Colchicine
S, T
Tablets
0.5 mg
2.4 Disease modifying agents used in Rheumatoid disorders
Azathioprine
S, T
Tablets
50 mg
Methotrexate
S,T
Tablets
5mg, 7.5mg, 10mg
Sulfasalazine
S, T
Tablets
500 mg
Added medicines
Hydroxychloroquine
S,T
Tablets
200 mg
phosphate
Leflunomide
S,T
Tablets
10mg, 20 mg tab
Section: 3 Antiallergics and Medicines used in Anaphylaxis

Medicines
Category
Adrenaline Bitartrate
Chlorpheniramine Maleate
Dexchlorpheniramine
Maleate
Dexamethasone
P, S, T
P, S, T
P, S, T
Hydrocortisone Sodium
Succinate
Pheniramine Maleate
Prednisolone
Promethazine
Dosage Form
Injection
Tablets
Syrup
P, S, T
Strengths
1 mg / ml
4 mg
0.5 mg / 5 ml
P, S, T
Tablets
Injection
Injection
0.5 mg
4 mg / ml
100 mg
P, S, T
P, S, T
Injection
Tablets
P, S, T
Tablets
Syrup
22.75 mg / ml
5 mg, 10 mg, 20
mg
10 mg, 25 mg
5 mg / 5 ml
Added Medicines
Cetrizine
P,S,T
Tablets
Syrup
10mg
5 mg/ml
Section: 4 - Antidotes and Other Substances used in Poisonings
Medicines
Activated Charcoal
Medicines
4.1: Nonspecific
Category
Dosage Form
P,S,T
Oral
4.2: Specific
Category
Strengths
Strengths
52
Atropine Sulphate
Specific Antisnake venom
N-acetylcysteine
P,S,T
S, T
Dosage Form
Injection
Injection Polyvalent
Solution/ Lyophilyzed
Polyvalent Serum
Injection
Injection
100 mg/ml
500 mg
S, T
Injection
10 mg / ml
P,S,T
P,S,T
Calcium gluconate
Desferrioxamine
mesylate
Methylthioninium chloride
(Methylene blue)
Penicillamine
Dimercaprol
Flumazenil
Sodium Nitrite
Sodium Thiosulphate
Naloxone
Pralidoxime Chloride(2PAM)
[PART IISEC. 3(ii)]
S, T
S, T
T
S, T
S, T
P,S,T
P,S,T
Tablets or Capsules
Injection in oil
Injection
Injection
Injection
Injection
Injection
Added medicines:
P,S,T
Injection
1 mg/ml
250 mg
50 mg / ml
0.1 mg / ml
30 mg / ml
250 mg/ ml
0.4mg/ml
25 mg/ml
200 mg/ml(5 ml)
Section: 5 Anticonvulsants/ Antiepileptics

Medicines
Category
Carbamazepine
P, S, T
Dosage Form
Tablets
Syrup
Diazepam
P,S,T
Injection
Magnesium sulphate
Phenobarbitone
Phenytoin Sodium
S,T
P,S,T
ST
P,S,T
P,S,T
Injection
Tablets
Injection
Syrup
Capsules or Tablets
Syrup
Injection
Sodium Valproate
P,S,T
Tablets
Syrup
T
Lorazepam
Injection
Added Medicines
T
Injection
Strengths
100mg
200mg
100 mg/5ml
5 mg / ml
500 mg /ml
30 mg, 60 mg
200 mg/ml
20 mg/5ml
50 mg,
100mg
25mg/ml
50 mg/ml
200 mg,
500mg
200 mg/5ml
100 mg/ml
2mg/ml
Section: 6 Anti-infective Medicines

6.1 Anthelminthics
6.1.1 Intestinal Anthelminthics
Medicines
Category
Dosage Form
Albendazole
P,S,T
Tablets
Suspension
Added Medicines
Piperazine
P,S,T
Tablets
Solution
6.1.2 Antifilarials
Medicines
Category
Dosage Form
Diethylcarbamazine citrate
P,S,T
Tablets
6.1.3 Antischistosomals and Antitrematode Medicines
Medicines
Category
Strengths
400 mg
200 mg/ 5 ml
4.5 gm
750mg/5ml
Strengths
50 mg
Strengths
Hkkx II[k.M 3(ii)
Praziquantel
Medicines
Amoxicillin
Ampicillin
Dosage Form
S, T
Tablets
6.2 Antibacterials
6.2.1 Beta lactam medicines
Category
Dosage Form
S,T
Powder for suspension
Capsules
Capsules
Injection
P,S,T
Benzathine
Benzylpenicillin
Cefotaxime
P,S,T
Ceftazidime
Ceftriaxone
Cephalexin
S, T
S, T
P,S,T
Cloxacillin
Amoxicillin+Clavulinic acid
Cefixime
Medicines
Amikacin
Azithromycin
Ciprofloxacin
Hydrochloride
Co-Trimoxazole
(Trimethoprim +
Sulphamethoxazole)
S, T
Metronidazole
P,S,T
Clofazimine
Dapsone
Rifampicin
Medicines
Ethambutol
Injection
Suspension
P,S,T
P,S,T
Medicines
Injection
Injection
Injection
Syrup
Capsules
Capsules
P,S,T
Injection
Liquid
Added Medicines
T
Tablets
Injection
T
Tablet
6.2.2 Other antibacterials
Category
Dosage Form
S, T
Injection
Tablets
S,T
Suspension
Injection
P,S,T
Injection
Tablets
P,S,T
Tablets
Doxycycline
Erythromycin
Estolate
Gentamicin
Nitrofurantoin
Sulphadiazine
Vancomycin
Hydrochloride
53
P,S,T
P,S,T
S, T
Tablets
Syrup
Tablets
Injection
Tablet
Injection
Syrup
Tablets
Tablets
T
Injection
6.2.3 Antileprosy medicines
Category
Dosage Form
P,S, T
Capsules
P,S, T
Tablets
P,S, T
Capsules or Tablets
6.2.4 Antituberculosis medicines
Category
Dosage Form
P,S,T
Tablets
600 mg
Strengths
125 mg / 5 ml
250 mg, 500 mg
250 mg, 500 mg
125 mg / 5 ml
500 mg
6 lacs, 12 lacs
units
125 mg, 250 mg
500 mg
250mg, 1g
250 mg, 1 g
125 mg / 5 ml
250 mg, 500 mg
250 mg, 500 mg
250 mg
125mg/ 5 ml
625 mg
228.5mg/5ml
600mg, 1.2gm
100, 200mg
Strengths
250 mg / 2 ml
100, 250,500mg
100mg/5ml
500mg
200 mg /100 ml
250 mg, 500 mg
80 + 400 mg
160+800 mg
40 + 200 mg / 5
ml
100 mg
125 mg / 5 ml
250 mg, 500 mg
10 mg/ml, 40
mg/ml
200mg,400m
g
500mg/100ml
100mg/5ml
100 mg
500 mg
500 mg, 1 g
Strengths
50 mg, 100 mg
50 mg, 100mg
150 mg, 300 mg
Strengths
200 mg, 400 mg,
54
Isoniazid
P,S,T
Ofloxacin
S, T
Tablets
Syrup
Tablets
Syrup
Pyrazinamide
P,S,T
Tablets
Rifampicin
Streptomycin
Sulphate
P,S,T
Medicines
Amphotericin B
Clotrimazole
Capsules/Tablets
Syrup
P,S,T
Injection
6.3 Antifungal medicines
Category
Dosage Form
S, T
Injection
Pessaries
P,S,T
Gel
Fluconazole
Capsules or Tablets
Capsules or Tablets
Tablets
Nystatin
P,S,T
Pessaries
6.4 Antiviral medicines
6.4.1 Antiherpes medicines
Medicines
Category
Dosage Form
Tablets
Acyclovir
S, T
Injection
Suspension
6.4.2 Antiretroviral medicines
6.4.2.1 Nucleoside reverse transcriptase inhibitors
Medicines
Category
Dosage Form
Didanosine
S, T
Tablets
Lamivudine
S, T
Tablets
Lamivudine + Nevirapine +
Stavudine
S, T
Tablets
Lamivudine + Zidovudine
S, T
Tablets
Griseofulvin
S, T
P,S,T
Stavudine
S, T
Capsules
Zidovudine
S, T
Tablets
ADDED MEDICINES
S,T
Tablets
Stavudine+
Lamivudine
Zidovudine+
S,T
Tablets
Lamivudine+
Nevirapine
6.4.2.2 Non-nucleoside reverse transcriptase inhibitors
Medicines
Category
Efavirenz
S, T
Nevirapine
S, T
Medicines
Indinavir
Dosage Form
Capsules
Capsules
Suspension
6.4.2.3 Protease inhibitors

Category
Dosage Form
S, T
Capsules
[PART IISEC. 3(ii)]

600 mg, 800 mg
50 mg, 100 mg,
300 mg
100 mg/5ml
100 mg, 200 mg
50 mg / 5 ml
500 mg, 750 mg,
1000 mg, 1500
mg
50 mg, 150 mg,
300 mg,450 mg
100 mg / 5 ml
0.75 g, 1 g
Strengths
50 mg
100 mg, 200 mg,
2%
50 mg, 100 mg,
150 mg,
200 mg
125 mg, 250 mg
500,000 IU
100,000 IU
Strengths
200 mg, 400 mg
250 mg, 500 mg
400 mg / 5 ml
Strengths
250 mg, 400 mg
150 mg
150 mg + 200
mg+ 30 mg
150 mg + 300
mg
15 mg, 30
mg, 40 mg
100 mg, 300
mg
30mg+ 150mg
300mg+
150mg+
200mg
Strengths
200 mg,
600 mg
200 mg
50 mg / 5 ml
Strengths
200 mg, 400
Hkkx II[k.M 3(ii)
Nelfinavir
S, T
Capsules
Capsules
Ritonavir
S, T
Syrup
Saquinavir
S, T
Capsules
6.5 Antiprotozoal Medicines
6.5.1 Antiamoebic and Antigiardiasis medicines
Medicines
Category
Dosage Form
Diloxanide Furoate
P,S,T
Tablets
Metronidazole
P,S,T
Tablets
Injection
6.5.2 Antileishmaniasis medicines
Medicines
Category
Dosage Form
Amphotericin B
S, T
Injection
Pentamidine Isothionate
S, T
Injection
Sodium Stibogluconate
S, T
Injection
6.5.3 Antimalarial Medicines
6.5.3.1 For curative treatment
Medicines
Category
Dosage Form
Artesunate (To be used
only in combination with
P,S,T
Tablets
Sulfadoxine
+Pyrimethamine)
Tablets
Injection
Chloroquine phosphate
Syrup
P,S,T
Primaquine
P,S,T
Tablets
Pyrimethamine
P,S,T
Tablets
P,S,T
Tablets
Quinine sulphate
ST
Injection
Sulfadoxine +
Pyrimethamine
P,S,T
Tablets
Medicines added
Clindamycin
S,T
Tablet
6.5.3.2 For prophylaxis
Medicines
Category
Dosage Form
Medicines added
Mefloquine
S,T
Tablet
55
mg
250 mg
100 mg,
400 mg / 5ml
200 mg
Strengths
500 mg
200 mg, 400 mg
500 mg /100 ml
Strengths
50 mg
200 mg
100 mg / ml
Strengths
50 mg
150 mg base
40 mg / ml
50 mg / 5 ml
2.5 mg, 7.5 mg
25 mg
300 mg
300 mg / ml
500 mg + 25 mg
150, 300mg
Strengths
250 mg base
6.5.4 Antipneumocystosis and Antitoxoplasmosis medicines

Medicines
Category
Strengths
Dosage Form
80 + 400 mg
Tablets
P,S,T
Co-Trimoxazole
160+800 mg
(Trimethoprim +
40 + 200 mg / 5
Suspension
Sulphamethoxazole)
ml
Pentamidine Isothionate
S, T
Injection
200 mg
Section: 7 Antimigraine medicines
Medicines
Acetyl Salicylic Acid
Dihydroergotamine
Paracetamol
Medicines
Propranolol
hydrochloride
7.1: For treatment of acute attack

Category
Dosage Form
P,S,T
Tablets
S, T
Tablets
P,S,T
Tablets
7.2: For Prophylaxis
Category
Dosage Form
P,S,T
Tablets
Strengths
300 - 350 mg
1 mg
500 mg
Strengths
10 mg, 40 mg
56
[PART IISEC. 3(ii)]
Section: 8 Antineoplastic, immunosuppressives and medicines used in palliative care
Medicines
Azathioprine
8.1: Immunosuppressive medicines

Category
Dosage Form
T
Tablets
Cyclosporine
Medicines
Actinomycin D
Alpha Interferon
Bleomycin
Busulphan
Capsules
Concentrate for Injection

8.2: Cytotoxic medicines
Category
Dosage Form
T
Injection
T
Injection
T
Injection
T
Tablets
Strengths
50 mg
10 mg, 25 mg,
50 mg, 100 mg
100 mg/ml
Strengths
0.5 mg
3 million IU
15 mg
2 mg
10 mg / vial
50 mg / vial
Cisplatin
Injection
Cyclophosphamide
Tablets
Injection
Cytosine
arabinoside
Injection
Danazol
Doxorubicin
T
T
Capsules
Injection
100 mg/vial
500 mg/vial
1000 mg/vial
50 mg, 100 mg
10 mg, 50 mg
Etoposide
Capsules
Injection
100 mg
100 mg/ 5 ml vial
Flutamide
5-Fluorouracil
Folinic Acid
Gemcitabine
hydrochloride
L- Asparaginase
Melphalan
T
T
T
Tablet
Injection
Injection
Injection
T
T
Injection
Tablet
250 mg
250 mg / 5 ml
3 mg / ml
200 mg
1 gm
5000 KU.
2 mg, 5 mg
Mercaptopurine
Tablet
Injection
50 mg
100 mg / ml
Methotrexate
Tablet
Injection
2.5 mg
50 mg / ml
Mitomycin-C
Paclitaxel
Procarbazine
Vinblastine
sulphate
Vincristine
T
T
T
Injection
Injection
Capsules
10 mg
30 mg / 5 ml
50 mg
Injection
Carboplatin
Injection
Added medicines
Injection
Dacarbazine
Daunorubicin
Ifosfamide
Mesna
Oxaliplatin
Imatinib
T
T
T
T
T
T
Injection
Injection
Injection
Injection
Injection
Tablets
50 mg, 200 mg
500 mg
10 mg
1 mg / ml
150 mg, 450 mg
vial
500 mg
20 mg vial
1 gm/2ml vial
200 mg
50 mg vial
100 mg, 400 mg
Hkkx II[k.M 3(ii)

Chlorambucil
Medicines

T
Tablets
8.3: Hormones and antihormones
Category
Dosage Form
Tablets
57
2 mg
Strengths
5 mg
Prednisolone
S, T
Raloxifene
Tamoxifen
Citrate
Tablets
20 mg, 25 mg (as
sodium phosphate or
succinate)
60 mg
Tablets
10 mg, 20 mg
Medicines
Injection
8.4: Medicines used in palliative care

Category
Dosage Form
Morphine
Sulphate
Ondansetron
S, T
Filgrastim
Allopurinol
T
T
Tablets
Tablets
Injection
Syrup
Added Medicines
Injection
Tablets
Strengths
10 mg
4 mg, 8 mg
2 mg/ml
2 mg/5 ml
1 ml vial
100 mg
Section: 9 Antiparkinsonism medicines
Medicines
Bromocriptine
Mesylate
Levodopa+
Carbidopa
Trihexyphenidyl
Hydrochloride
Dosage Form
Strengths
S, T
Tablets
1.25 mg, 2.5 mg
P,S,T
Tablets
100 mg+10 mg
250 mg+25 mg
100 mg+25 mg
2 mg
Category
P,S,T
Tablets
Section: 10 Medicines affecting the blood
Medicines
Cyanocobalamin
Ferrous
Sulphate/
Fumrate
Folic Acid
Iron Dextran
Pyridoxine
Medicines
Heparin Sodium
10.1: Antianaemia medicines

Category
Dosage Form
P, S,T
Injection
P,S,T
Tablets
Oral solution
P,S,T
Tablets
S, T
Injection
P,S,T
Tablets
10.2: Medicines affecting coagulation
Category
Dosage Form
Strengths
1 mg/ml
Tablets equivalent to
60 mg elemental iron
25mg elemental iron
(as sulphate)/ml
1 mg , 5mg
50 mg iron/ml
10 mg
Strengths
S, T
Injection
1000 IU/ml
5000 IU/ ml
S, T
Injection
10 mg/ml
Injection
Tablets
Added Medicines
Injection
10 mg/ml
5 mg
Protamine
Sulphate
Phytomenadione
Warfarin sodium
P, S, T
S, T
Enoxaparin
40mg, 60mg
58
[PART IISEC. 3(ii)]
Section: 11 Blood products and Plasma substitutes
Medicines
Dextran-40
Dextran-70
Fresh frozen
plasma
Hydroxyethyl
Starch
(Hetastarch)
Polygeline
Medicines
Albumin
Cryoprecipitate
Factor VIII
Concentrate
Factor IX
Complex
(Coagulation
Factors II,VII, IX,
X)
Platelet Rich
Plasma
11.1: Plasma Substitutes

Category
Dosage Form
P,S,T
Injection
P,S,T
Injection
T
S, T
Strengths
10%
6%
Injection
Injection
S, T
Injection
11.2: Plasma fractions for specific use
Category
Dosage Form
S, T
Injection
S, T
Injection
6%
3.5%
Strengths
5%, 20 %
S, T
Injection
Dried
S, T
Injection
Dried
S, T
Injection
Section: 12 Cardiovascular medicines
Medicines
12.1: Antianginal medicines

Category
Dosage Form
Acetyl salicylic
acid
P,S,T
Tablets
Diltiazem
Glyceryl Trinitrate
S, T
P,S,T
Tablets
Sublingual Tablets
Injection
Isosorbide 5
Mononitrate/
Dinitrate
Metoprolol
Clopidogrel
Medicines
Adenosine
Amiodarone
P,S,T
Tablets
Tablets
Injection
Added Medicines
T
Tablets
12.2: Antiarrhythmic medicines
Category
Dosage Form
S,T
Injection
P,S,T
S, T
Tablets
Injection
S, T
Tablets
Diltiazem
T
Esmolol
Lignocaine
Hydrochloride
Procainamide
Hydrochloride
Verapamil
S, T
T
S, T
Injection
Injection
Strengths
75mg, 100mg,
350 mg
soluble/dispersible
30 mg, 60 mg
0.5 mg
5mg/ml
10 mg,
20 mg
25 mg, 50 mg
1mg/ml
75 mg
Strengths
3 mg/ml
100 mg, 200 mg
50 mg/ml (3 ml
ampoule)
30 mg, 60 mg
5 mg/ ml
10 mg / ml
Injection
1%, 2%
Tablets
Injection
Tablets
250 mg
100mg/ml
40 mg, 80 mg
Hkkx II[k.M 3(ii)
Medicines
Amlodipine
Injection
12.3: Antihypertensive medicines
Category
Dosage Form
P,S,T
Tablets
Atenolol
P,S,T
Tablets
Enalapril
Maleate
Losartan
Potassium
Methyldopa
P,S,T
T
S, T
Tablets
Injection
Tablets
P,S, T
Tablets
Capsules
Tablets
Sustained release tablets
or capsules
Injection
Nifedipine
S, T
Sodium
Nitroprusside
59
2.5mg/ml
Strengths
2.5 mg,
5 mg
50 mg,
100 mg
2.5 mg, 5mg
1.25mg/ml
25 mg,
50 mg
250 mg
5 mg, 10mg
10mg, 20mg
10mg, 20mg
50 mg/ 5 ml
Added Medicines
Hydrochlorthiazide
Medicines
Digoxin
Dobutamine
Dopamine
Hydrochloride
Medicines
Acetyl salicylic
acid
P,S,T
Tablets
12.4: Medicines used in heart failure

Category
Dosage Form
Tablets
S, T
Injection
Elixir
S, T
Injection
S,T
Injection
12.5: Antithrombotic medicines
Category
Dosage Form
P,S,T
Tablets
S, T
Injection
S, T
Injection
Injection
Heparin Sodium
Streptokinase
Urokinase
Atorvastatin
New Category - ADDED

12.6 Hypolipidemic Medicines
P,S,T
Tablets
12.5,
25 mg
Strengths
0.25 mg
0.25 mg/ml
0.05 mg/ml
50 mg / ml
40 mg / ml
Strengths
75mg,
100mg,
350 mg
soluble/dispersible
1000 IU /ml
5000 IU/ml
750,000 IU
15,00,000
IU
500,000
IU/ml
10,00,000 IU/ml
5 mg, 10 mg
Section: 13 Dermatological medicines (Topical)
Medicines
Miconazole
Medicines
Acyclovir
Framycetin
Sulphate
Methylrosanilinium
Chloride (Gentian
13.1: Antifungal medicines

Dosage Form
P,S,T
Ointment or Cream
13.2: Antiinfective medicines
Category
Dosage Form
S, T
Cream
Category
P,S,T
P,S,T
Strengths
2%
Strengths
5%
Cream
0.5%
Aqueous solution
0.5%
60
Violet)
Neomycin +
Bacitracin
Povidone Iodine
Silver
Sulphadiazine
Medicines
Betamethasone
Dipropionate
Calamine
[PART IISEC. 3(ii)]
P,S,T
Ointment
5 mg + 500 IU / g
P,S,T
Solution or Ointment
5%
P,S,T
Cream
1%
13.3: Antiinflammatory and antipruritic medicines

Category
Dosage Form
P,S,T
Cream / Ointment
Strengths
0.05%
P,S,T
Lotion
13.4: Astringent Medicines
Medicines
Category
Strengths
Dosage Form
Zinc Oxide
P,S,T
Dusting Powder
13.5: Medicines affecting skin differentiation and proliferation
Medicines
Category
Strengths
Dosage Form
Coal Tar
P,S,T
Solution
5%
Dithranol
T
Ointment
0.1-2%
Glycerin
P,S,T
Solution
Salicylic Acid
P,S,T
Solution
5%
13.6: Scabicides and Pediculicides
Medicines
Category
Strengths
Dosage Form
Benzyl benzoate
P,S,T
Lotion
25 %
Added Medicines
Cream
5%
Permethrin
S,T
Lotion
1%, 5%
Section: 14 Diagnostic agents
Medicines
Fluorescein
Lignocaine
Tropicamide
Medicines
14.1: Ophthalmic medicines

Category
Dosage Form
S, T
Eye drops
S, T
Eye Drops
S, T
Eye drops
14.2: Radiocontrast media
Category
Dosage Form
Barium Sulphate
S, T
Suspension
Calcium Ipodate
Iopanoic Acid
Meglumine
Iothalamate
Meglumine
Iotroxate
Propyliodone
S, T
S, T
Injection
Tablets
S, T
Injection
S, T
Solution
S, T
Oily, suspension
Sodium Iothalamate
Sodium Meglumine
Diatrizoate
S, T
S, T
Injection
Injection
Strengths
1%
4%
1%
Strengths
100% w/v, 250%
w/v
3g
500 mg
60% w/v (iodine
=280 mg / ml)
5-8 g iodine in 100250 ml
500-600 mg / ml
70% w/v(Iodine
=420 mg / ml)
60% w/v(Iodine
conc. =292 mg /
ml), 76% w/v(Iodine
conc. =370 mg / ml)
Section: 15 Disinfectants and antiseptics
Medicines
Acriflavin+Glycerin
15.1: Antiseptics
Category
Dosage Form
P, S, T
Solution
Strengths
Hkkx II[k.M 3(ii)
Benzoin Compound
P, S, T
Cetrimide
P, S, T
Solution
Chlorhexidine
Ethyl Alcohol 70%
P, S, T
P, S, T
Solution
Solution
Gentian Violet
P, S, T
Paint
Hydrogen Peroxide
Povidone Iodine
P, S, T
P, S, T
Medicines
Tincture
Solution
Solution
15.2: Disinfectants
Category
Dosage Form
Bleaching Powder
P, S, T
Powder
Formaldehyde
Solution
P, S, T
Solution
Glutaraldehyde
Potassium
Permanganate
61
S,T
Solution
P, S, T
Crystals for solution
20% (conc. for

dilution)
5% (conc. for dilution)
0.5%,
1%
6%
5%, 10%
Strengths
Contains not less
than 30 % w/w of
available chlorine (as
per I.P)
Dilute 34 ml of
formaldehyde
solution with water to
produce 100 ml (As
per I.P)
2%
Section: 16 Diuretics
Medicines
Furosemide
Category
P,S,T
Dosage Form
Injection
Tablets
Hydrochlorothiazide
P,S,T
Tablets
Mannitol
Spironolactone
P,S,T
P,S,T
Injection
Tablets
Strengths
10 mg/ ml
40mg
25 mg,
50 mg
10%, 20%
25 mg
Section: 17 Gastrointestinal medicines
17.1: Antacids and other Antiulcer medicines
Medicines
Category
Aluminium Hydroxide
+ Magnesium
Hydroxide
P,S,T
Omeprazole
Ranitidine
P,S,T
P,S,T
Pantoprazole
Famotidine
Medicines
Domperidone
Metoclopramide
Dosage Form
Strengths
Tablet
Suspension
Capsules
Injection
Added Medicines
T
Injection
P,S,T
Tablets
17.2: Antiemetics
Category
Dosage Form
Tablets
P,S,T
Syrup
Tablets
P,S,T
Syrup
Injection
10 mg, 20 mg, 40 mg
25 mg / ml
40 mg
20 mg
Strengths
10 mg
1 mg / ml
10 mg
5 mg / 5 ml
5 mg / ml
62
Promethazine
P,S,T
Tablets
Elixir or Syrup
Injection
[PART IISEC. 3(ii)]
10 mg, 25 mg
5 mg / 5 ml
25 mg / ml
Added Medicines
Ondansetron
S,T
Tablet
Syrup
Injection
17.3: Antiinflammatory Medicines

Category
Dosage Form
Added Medicines
Medicines
5-Amino salicylic Acid
(5-ASA)
Medicines
Dicyclomine
Hydrochloride
Hyoscine Butyl
Bromide
Medicines
Bisacodyl
Ispaghula
Medicines
Oral Rehydration
Salts
S,T
Tablets
17.4: Antispasmodic medicines

Category
Dosage Form
Tablets
P,S,T
Injection
Tablets
P,S,T
Injection
17.5: Laxatives
Category
Dosage Form
P,S,T
Tablets, Suppository
P,S,T
Granules
17.6: Medicines used in diarrhorea
17.6.1 Oral dehydration salts
Category
Dosage Form
P,S,T
Powder for solution
4mg, 8 mg
2 mg/ml
2mg/ml
Strengths
400mg
Strengths
10 mg
10 mg / ml
10 mg
20 mg / ml
Strengths
5 mg
Strengths
Glucose: 13.5 g/L
Sodium chloride: 2.6
g/L
Potassium chloride:
1.5 g/L
Trisodium citrate
dihydrate+: 2.9 g/L
Powder for dilution in
200ml; 500 ml;
1000ml. (As per I.P)
Medicines
17.6.2 Antidiarrhoeal medicines

Dosage Form
Category
Strengths
Medicines added
Zinc Sulfate
P,S,T
Syrup
20 mg/5ml
Section: 18 Hormones, other endocrine medicines and

contraceptives
18.1: Adrenal hormones and synthetic substitutes
Category
Dosage Form
Tablets
Dexamethasone
S,T
Injection
Hydrocortisone
P, S,T
Injection
Medicines
Strengths
0.5mg
4mg/ml
100 mg / ml
Hkkx II[k.M 3(ii)
Sodium Succinate
Methyl Prednisolone
S,T
Injection
Prednisolone
P, S,T
Tablets
Medicines
Category
Testosterone
Medicines
Ethinylestradiol +
Levonorgesterol
Ethinylestradiol +
Norethisterone
Hormone Releasing
IUD
18.2: Androgens
Dosage Form
Capsules
Injection
P,S,T
18.3: Contraceptives
18.3.1: Hormonal Contraceptives
Category
Dosage Form
Medicines
25mg/ml(as
propionate)
Strengths
P,S,T
Tablets
0.035 mg +1.0 mg
Levonorgesterol Releasing
18.3.2: Intrauterine devices

Dosage Form
P,S,T
Ethinylestradiol
40mg(as
undecanoate)
0.03 mg +0.15
mg
IUD containing
Copper
Medicines
Strengths
Tablets
Category
Condoms
40 mg/ ml
5mg,
10mg,
20mg
P,S,T
Medicines
Medicines
63
18.3.3: Barrier Methods

Category
Dosage Form
P,S,T
18.4: Estrogens
Category
Dosage Form
P,S,T
Tablets
18.5: Medicines used in Diabetes mellitus

18.5.1: Insulins and other Antidiabetic agents
Category
Dosage Form
IUD
Strengths
Strengths
Strengths
0.01mg
0.05mg
Strengths
P,S,T
Tablets
2.5 mg,
5mg
P,S,T
Injection
40 IU / ml
P,S,T
Injection
40 IU / ml
Metformin
P,S,T
Tablets
500mg
Premix Insulin 30:70

injection
P,S,T
Glibenclamide
Insulin Injection
(Soluble)
Intermediate
Acting(Lente/NPH
Insulin)
Added medicines
Medicines
Glucagon
25% Dextrose
Injection
18.5.2 Medicines used to treat hypoglycemia

Category
Dosage Form
T
Injection
Added medicines
P,S,T
Injection
18.6 Ovulation Inducers
40IU/ml
Strengths
1mg/ml
100 ml
64
[PART IISEC. 3(ii)]
Medicines
Category
Dosage Form
Strengths
Clomiphene citrate
Tablets
50mg,
100mg
Medicines
Category
Medroxy
Progesterone Acetate
Norethisterone
18.7 Progestogens
Dosage Form
P,S,T
Tablets
P,S,T
Tablets
Strengths
5mg,
10mg
5mg
18.8 Thyroid and antithyroid medicines

Medicines
Category
Route of Administration /
Dosage Form
Carbimazole
P,S,T
Tablets
Levothyroxine
P,S,T
Tablets
Iodine
Drugs
Tuberculin,
Purified Protein
derivative
Drugs
S,T
Solution
Section: 19 Immunologicals
19.1: Diagnostic agents
Category
Dosage Form
P,S,T
Injection
19.2: Sera and immunoglobins

Category
Dosage Form
Strengths
5mg,
10mg
50g,
100 g
8 mg / 5 ml
Strengths
1 TU, 5 TU
Strengths
Anti-D
immunoglobin
(human)
S, T
Injection
300 g
Polyvalent
Antisnake
Venom
P,S,T
Injection
10 ml
Antitetanus
Human
immunoglobin
P,S,T
Injection
250 IU, 500 IU
Diphtheria
Antitoxin
S, T
Injection
10,000 IU
Rabies
immunoglobin
P,S,T
Injection
150 IU / ml
19.3: Vaccines
Drugs
B.C.G Vaccine
D.P.T Vaccine
Hepatitis B
Vaccine
Measles Vaccine
Oral Poliomyelitis
vaccine (LA)
19.3.1: For Universal Immunisation

Category
Dosage Form
P,S,T
Injection
P,S,T
Injection
P,S,T
Injection
P,S,T
Injection
P,S,T
Solution
Strengths
Hkkx II[k.M 3(ii)
Drugs
Rabies Vaccine
Tetanus Toxoid

19.3.2: For Specific Group of Individuals
Category
Dosage Form
P,S,T
Injection
P,S,T
Injection
65
Strengths
Section: 20 Muscle Relaxants (Peripherally acting) and

Cholinesterase Inhibitors
Drugs
Category
Atracurium
besylate
S, T
Neostigmine
S,T
Pyridostigmine
S, T
Succinyl choline
chloride
S,T
Vecuronium
P,S,T
Dosage Form
Strengths
Injection
Tablets,
Injection
Tablets,
Injection
10 mg / ml
15 mg,
0.5mg/ml
60 mg,
1mg/ml
Injection
50 mg/ml
Added drugs
Injection
2 mg/ml
Section: 21 Ophthalmological Preparations
Medicines
Chlorampheni
col
Ciprofloxacin
Hydrochloride
Gentamicin
Miconazole
Povidone
Iodine
Sulphaceta
mide
Sodium
Medicines
Prednisolone
Acetate
Prednisolone
Sodium
Phosphate
21.1: Anti-infective agents

Route of Administration/ Dosage
Category
Form
P,S,T
Drops/Ointment
0.4%, 1%
P,S,T
Drops/Ointment
0.3%
P,S,T
P,S,T
Drops
Drops
0.3%
1%
S,T
Drops
0.6%
P,S,T
Drops
10%,20%
21.2: Antiinflammaory agents

Category
Form
Drops
0.1%
P,S,T
Drops
1%
Category
Tetracaine
Hydrochloride
P,S,T
Acetazolamide
Betaxolol
Hydrochloride
21.3: Local Anaesthetics

Form
Drops
21.4: Miotics and Antiglucoma medicines

Category
Form
S,T
Tablets
T
Drops
Pilocarpine
S,T
Drops
Timolol
Maleate
P, S, T
Medicines
Strengths
P,S,T
Medicines
Medicines
Strengths
Category
Drops
21.5: Mydriatics
Form
Strengths
0.5%
Strengths
250 mg
0.25%,
0.5%
2%,
4%
0.25%,
0.5%,
Strengths
66
Atropine
Sulphate
Homatropine
Phenylephrine
[PART IISEC. 3(ii)]
P,S,T
Drops/Ointment
1%
P,S,T
P,S,T
Drops
Drops
2%
5%
21.6: Ophthalmic Surgical Aids

Medicines
Category

Form
Strengths
Methyl
Cellulose
Injection
2%
Section: 22 Oxytocics and Antioxytocics

22.1: Oxytocics
Medicines
Category
Dosage Form
Strengths
Methyl
Ergometrine
P,S,T
Tablets
Injection
0.125mg
0.2mg/ml
Mifepristone
Tablets
200mg
Oxytocin
S,T
Injection
5 IU/ ml,
10IU/ml
Added medicines
T
Tablets
22.2: Antioxytocics
Category
Dosage Form
Misoprostol
Medicines
Terbutaline
Sulphate
S,T
Added Medicines
S,T
P,S,T
Nifedipine
Betamethasone
100ug
Strengths
Tablets
Injection
2.5 mg
0.5 mg/ml
Tablets
Injection
10 mg
4 mg/ml
Section: 23 Peritoneal Dialysis Solution

Medicines
Intraperitoneal
Dialysis Solution
Category
Dosage Form
Strengths
4Of approximate
composition
Section: 24 Psychotherapeutic Medicines
Medicines
Chlorpromazine
hydrochloride
Haloperidol
Olanzapine
24.1: Medicines used in Psychotic Disorders

Category
Dosage Form
Tablets
P,S,T
Syrup
Injection
S, T
Injection
Added medicines
T
Tablets
24.2: Medicines used in mood disorders
Strengths
25 mg, 50mg, 100mg
25mg/5ml
25mg/ml
5mg/ml
5mg,10mg
Hkkx II[k.M 3(ii)
67
24.2.1: Medicines used in Depressive disorders

Category
Dosage Form
P,S,T
Tablets
Medicines
Amitriptyline
Fluoxetine
hydrochloride
Imipramine
P,S,T
Lithium
Carbonate
25 mg
Capsules
20 mg
P,S,T
Tablets
24.2.2: Medicines used in Bipolar disorders
Category
Dosage Form
Medicines
Strengths
25 mg, 75 mg
Strengths
Tablets
300 mg
Added Medicines
Sodium
Valproate
200 mg,
500mg
Tablets
P,S,T
24.3: Medicines used for Generalized Anxiety and Sleep Disorders

Medicines
Category
Strengths
Dosage Form
0.25 mg,
Alprazolam
P,S,T
Tablets
0.5 mg
2 mg,
Diazepam
P,S,T
Tablets
5mg
24.4: Medicines used for obsessive compulsive disorders and panic attacks
Medicines
Category
Strengths
Dosage Form
Added Medicines
Fluoxetine
P,S,T
Capsules
20 mg
hydrochloride
Section: 25 Medicines acting on the respiratory tract
Medicines
25.1: Antiasthmatic medicines

Category
Dosage Form
Beclomethasone Dipropionate
P,S,T
Inhalation
Hydrocortisone
sodium succinate
P,S,T
Injection
Salbutamol
sulphate
P,S,T
Tablets
Syrup
Inhalation
Strength
s
50 g,
250g/do
se
100 mg,
200mg,
400 mg
2mg, 4mg
2mg/5ml
100g/do
se
Added Medicines
Ipratropium
bromide
Medicines
P,S,T
Inhalation
25.2: Antitussives
Category
Dosage Form
Codeine phosphate
S,T
Tablets
Syrup
Dextromethorphan
P,S,T
Tablets
20g/met
ered dose
Strength
s
10mg
15mg/
5ml
30mg
Section: 26 Solutions correcting water, electrolyte and acid-base

disturbances
26.1: Oral
Medicines
Oral
Rehydration
Salts
Medicines
Category
Dosage Form
P, S, T
Powder for Solution
26.2: Parenteral
Category
Strengths
As per IP
Strengths
68
[PART IISEC. 3(ii)]
Dosage Form
Glucose
Glucose with
sodium chloride
Normal Saline
N/2 Saline
N/5 Saline
Potassium
Chloride
Ringer Lactate
Sodium
Bicarbonate
P, S, T
Injection
5% isotonic, 10%,
15%.
P, S, T
Injection
5% + 0.9%
P, S, T
S, T
S, T
Injection
Injection
Injection
0.9%
P, S, T
Injection
11.2% Sol.
Injection
As per IP
P, S, T
P, S, T
Injection
26.3: Miscellaneous
Category
Dosage Form
Medicines
Water for
Injection
P, S, T
Injection
As per IP
Strengths
2 ml, 5 ml, 10 ml
Section: 27 Vitamins and Minerals

Medicines
Category
Ascorbic Acid
Calcium
carbonate
P,S,T
Dosage Form
Tablets
P,S,T
Tablets
P,S,T
Tablets
Nicotinamide
Pyridoxine
Riboflavin
Thiamine
P,S,T
P,S,T
P,S,T
P,S,T
Tablets
Tablets
Tablets
Tablets
Vitamin A
P,S,T
Tablets
Capsules
Multivitamins (As per

Schedule V of Drugs and
Cosmetics Rules)
Injection
P,S,T
Capsules
Added Medicines
Vitamin D (Ergocalciferol)
Calcium
gluconate
P,S,T
Injection
Strengths
100 mg, 500 mg
250 mg, 500 mg
50 mg
25 mg
5 mg
100 mg
5000 IU,
50000 IU, 100000
IU,
50000 IU/ml
0.25 mg, 1 mg
100mg/ml in 10 ml
ampoule
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 (10s/ 100s/ 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
Hkkx II[k.M 3(ii)
69
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:
SCHEDULE-II
FORM - II
PROFORMA FOR SUBMISSION OF REVISED-PRICES FOR SCHEDULED FORMULATIONS
(See paragraph 16)
1.
2.
Name and address of the manufacturer/importer/distributor.

Name and address of the marketing company, if any.
Sl. No.
(1)
Name of the
Product
(Formulation
and its
dosage
forms)
Composition
of scheduled
formulation/
new drug
Pack
Size
(2)
(3)
(4)
Scheduled Formulations
Own Manufactured Formulations
WPI
change
w.r.t.
preceding Year
(5)
Price to retailer
(incl. of E.D.)
(Rs.)
Maximum
Retail Price
(incl. of
E.D.&Taxes)
(Rs.)
PreRevised
Revised
(6)
(7)
PreRevised
(8)
Ceiling
Price
(Notified)
(Rs.)
Effective
Batch
No.
and
date
(10)
(11)
Revised
(9)
Purchased/Imported Formulations
Notes:- In case of purchased formulation, name of the manufacturer shall be indicated.

Place:
Authorised Signatory:
Name:
Designation:
Date:
SCHEDULE-II
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 :
70
[PART IISEC. 3(ii)]
TABLE-A
Name of the Scheduled

Formulation
Composition/Strength
(1)
(2)
(3)
(4)
1st Quarter
(6)
3rd Quarter
(8)
4th Quarter
(9)
1st Quarter
(11)
Domestic Sale
Current Year
2nd Quarter
(12)
3rd Quarter
(13)
4th Quarter
(14)
Previous Year
(10)
Unit(No/kg/Ltr)
Production/Import
Level
Current Year
2nd Quarter
(7)
Previous Year
(5)
Dosage Form
TABLE-B
Name of the Bulk Drug/API used in
Scheduled Formulation
(1)
Previous Year
st
(4)
1 Quarter
(5)
Previous Year
st
(9)
1 Quarter
(10)
Unit (Kg/ Ltr)
Installed Capacity
(2)
(3)
Production/Import
Level
Current Year
nd
2 Quarter
(6)
3 Quarter
(7)
Domestic Sale
Current Year
nd
2 Quarter
(11)
3 Quarter
(12)
rd
4 Quarter
(8)
th
rd
4 Quarter
(13)
th
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:
Date:
Name:
Designation:
SCHEDULE-II
Hkkx II[k.M 3(ii)
71
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:
Authorized Signatory:
Place:
Name:
Date:
Designation:
SCHEDULE-II
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 Composition
Pack Size
(Formulation and its approved by Drug
dosage forms)
Control
Authorities
(1)
(2)
(3)
(4)
Scheduled Formulations
Own Manufactured
Price to
retailer
(incl. of
E.D.) (Rs.)
(5)
Maximum Retail
Price (incl. of
E.D.&Taxes) (Rs.)
(6)
72
[PART IISEC. 3(ii)]
Formulations
Purchased/Imported
Formulations
Sl. No.
(1)
TABLE-B
Name of the Product Composition
(Formulation and its approved by Drug
dosage forms)
Control
Authorities
(2)
(3)
Non-Scheduled Formulations
Own Manufactured
Formulations
Pack Size
(4)
Price to
retailer
(incl. of
E.D.) (Rs.)
(5)
Maximum Retail
Price (incl. of
E.D.&Taxes) (Rs.)
(6)
Purchased/Imported
Formulations
Notes:-
In case of purchased formulation, name of the manufacturer shall be indicated.
Place:
Date:
Name:
Designation:
Printed by the Manager, Government of India Press, Ring Road, Mayapuri, New Delhi-110064
and Published by the Controller of Publications, Delhi-110054.

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