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To be published in the Gazette of India,
Extraordinary, Part II, Section 3, Sub-section(ii) dated 15th May 2013
Ministry of Chemicals and Fertilizers
(Department of Pharmaceuticals)
New Delhi
Dated 15th _May 2013
25 Vaisakha Saka 1935
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)
(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 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 (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
(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. (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
(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 (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 (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: 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. 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 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
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 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 (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. 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. (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 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 30thMay'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. 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 (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. 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 (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 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 (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 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 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 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. 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 (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. 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 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 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. Non–application 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 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)
Joint Secretary to the Government of India
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
Strengths
Thiopentone Sodium 0.5 g, 1 g powder Added Medicines
1% oil suspension 1.2 Local Anesthetics
Medicines
Category
Strengths
Dosage Form
0.25%, 0.5%, 0.5% to be mixed with Added Medicines
1.3 Preoperative Medication and Sedation for Short Term Procedures
Medicines
Category
Strengths
Dosage Form
Atropine Sulphate Morphine Sulphate 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
Route of Administration/
Medicines
Category
Strengths
Dosage Form
Acetyl Salicylic 2.2 Opioid Analgesics
Route of Administration/
Medicines
Category
Strengths
Dosage Form
Added medicines
50ug/ml 2ml ampoule 2.3 Medicines used to treat Gout
2.4 Disease modifying agents used in Rheumatoid disorders
5mg, 7.5mg, 10mg Added medicines
Section: 3 – Antiallergics and Medicines used in Anaphylaxis
Route of Administration/
Medicines
Category
Strengths
Dosage Form
Adrenaline Bitartrate Chlorpheniramine Dexchlorpheniramine Hydrocortisone Sodium Pheniramine Maleate Added Medicines
Section: 4 - Antidotes and Other Substances used in Poisonings
4.1: Nonspecific
Route of Administration/
Medicines
Category
Strengths
Dosage Form
Activated Charcoal 4.2: Specific
Route of Administration/
Medicines
Category
Strengths
Dosage Form
Atropine Sulphate Specific Antisnake Injection Polyvalent Solution/ Lyophilyzed Polyvalent Serum Calcium gluconate Methylthioninium chloride (Methylene Tablets or Capsules Injection in oil Sodium Thiosulphate Pralidoxime Chloride(2- Added medicines:
N-acetylcysteine Section: 5 – Anticonvulsants/ Antiepileptics
Route of Administration/
Medicines
Category
Strengths
Dosage Form
Magnesium sulphate Phenytoin Sodium Capsules or Tablets Sodium Valproate Added Medicines
Section: 6 – Anti-infective Medicines
6.1 Anthelminthics
6.1.1 Intestinal Anthelminthics
Route of Administration/
Medicines
Category
Strengths
Dosage Form
Added Medicines
6.1.2 Antifilarials
Route of Administration/
Medicines
Category
Strengths
Dosage Form
Diethylcarbamazine citrate 6.1.3 Antischistosomals and Antitrematode Medicines
Route of Administration/
Medicines
Category
Strengths
Dosage Form
6.2 Antibacterials
6.2.1 Beta lactam medicines
Route of Administration/
Medicines
Category
Strengths
Dosage Form
Powder for suspension Powder for suspension Benzylpenicillin Added Medicines
Amoxicillin+Clavulinic Powder for suspension 6.2.2 Other antibacterials
Route of Administration/
Medicines
Category
Strengths
Dosage Form
Sulphamethoxazole) 6.2.3 Antileprosy medicines
Route of Administration/
Medicines
Category
Strengths
Dosage Form
Capsules or Tablets 6.2.4 Antituberculosis medicines
Route of Administration/
Medicines
Category
Strengths
Dosage Form
200 mg, 400 mg, 600 mg, Capsules/Tablets 6.3 Antifungal medicines
Route of Administration/
Medicines
Category
Strengths
Dosage Form
Capsules or Tablets Capsules or Tablets 6.4 Antiviral medicines
6.4.1 Antiherpes medicines
Route of Administration/
Medicines
Category
Strengths
Dosage Form
6.4.2 Antiretroviral medicines
6.4.2.1 Nucleoside reverse transcriptase inhibitors
Route of Administration/
Medicines
Category
Strengths
Dosage Form
Lamivudine Lamivudine + Nevirapine Lamivudine + Zidovudine ADDED MEDICINES
6.4.2.2 Non-nucleoside reverse transcriptase inhibitors
Route of Administration/
Medicines
Category
Strengths
Dosage Form
6.4.2.3 Protease inhibitors
Route of Administration/
Medicines
Category
Strengths
Dosage Form
6.5 Antiprotozoal Medicines
6.5.1 Antiamoebic and Antigiardiasis medicines
Route of Administration/
Medicines
Category
Strengths
Dosage Form
Diloxanide Furoate 6.5.2 Antileishmaniasis medicines
Route of Administration/
Medicines
Category
Strengths
Dosage Form
Pentamidine Isothionate Sodium Stibogluconate 6.5.3 Antimalarial Medicines
6.5.3.1 For curative treatment
Route of Administration/
Medicines
Category
Strengths
Dosage Form
Artesunate (To be used only in combination with Chloroquine phosphate Quinine sulphate Medicines added
6.5.3.2 For prophylaxis
Route of Administration/
Medicines
Category
Strengths
Dosage Form
Medicines added
6.5.4 Antipneumocystosis and Antitoxoplasmosis medicines
Route of Administration/
Medicines
Category
Strengths
Dosage Form
Sulphamethoxazole) Pentamidine Isothionate Section: 7 –Antimigraine medicines
7.1: For treatment of acute attack
Medicines
Category
Strengths
Dosage Form
Acetyl Salicylic Acid Dihydroergotamine 7.2: For Prophylaxis
Medicines
Category
Strengths
Dosage Form
Section: 8 – Antineoplastic, immunosuppressives and medicines
used in palliative care
8.1: Immunosuppressive medicines
Medicines
Category
Strengths
Dosage Form
8.2: Cytotoxic medicines
Medicines
Category
Strengths
Dosage Form
Alpha Interferon 100 mg/ 5 ml vial Added medicines
8.3: Hormones and antihormones
Medicines
Category
Strengths
Dosage Form
20 mg, 25 mg (as sodium phosphate 8.4: Medicines used in palliative care
Medicines
Category
Strengths
Dosage Form
Added Medicines
Section: 9 –Antiparkinsonism medicines
Route of Administration/
Medicines
Category
Strengths
Dosage Form
Section: 10 –Medicines affecting the blood
10.1: Antianaemia medicines
Route of Administration/
Medicines
Category
Strengths
Dosage Form
Tablets equivalent to 25mg elemental iron (as sulphate)/ml 10.2: Medicines affecting coagulation
Route of Administration/
Medicines
Category
Strengths
Dosage Form
Added Medicines
Section: 11 –Blood products and Plasma substitutes
11.1: Plasma Substitutes
Route of Administration/
Medicines
Category
Strengths
Dosage Form
11.2: Plasma fractions for specific use
Route of Administration/
Medicines
Category
Strengths
Dosage Form
Section: 12 –Cardiovascular medicines
12.1: Antianginal medicines
Medicines
Category
Administration/ Dosage
Strengths
Acetyl salicylic soluble/dispersible Sublingual Tablets 12.2: Antiarrhythmic medicines
Medicines
Category
Administration/ Dosage
Strengths
12.3: Antihypertensive medicines
Medicines
Category
Administration/ Dosage
Strengths
Sustained release tablets or capsules Added Medicines
12.4: Medicines used in heart failure
Medicines
Category
Administration/ Dosage
Strengths
12.5: Antithrombotic medicines
Medicines
Category
Administration/ Dosage
Strengths
Acetyl salicylic soluble/dispersible New Category - ADDED
12.6 Hypolipidemic Medicines
Section: 13 –Dermatological medicines (Topical)
13.1: Antifungal medicines
Medicines
Category
Strengths
Dosage Form
Ointment or Cream 13.2: Antiinfective medicines
Medicines
Category
Strengths
Dosage Form
Aqueous solution (Gentian Violet) Solution or Ointment 13.3: Antiinflammatory and antipruritic medicines
Medicines
Category
Strengths
Dosage Form
Cream / Ointment 13.4: Astringent Medicines
Medicines
Category
Strengths
Dosage Form
13.5: Medicines affecting skin differentiation and proliferation
Medicines
Category
Strengths
Dosage Form
13.6: Scabicides and Pediculicides
Medicines
Category
Strengths
Dosage Form
Added Medicines
Section: 14 –Diagnostic agents
14.1: Ophthalmic medicines
Route of Administration/
Medicines
Category
Strengths
Dosage Form
14.2: Radiocontrast media
Route of Administration/
Medicines
Category
Strengths
Dosage Form
Oily, suspension w/v(Iodine conc. Section: 15 –Disinfectants and antiseptics
15.1: Antiseptics
Medicines
Category
Administration/ Dosage
Strengths
Acriflavin+Glycerin Ethyl Alcohol 70% 15.2: Disinfectants
Medicines
Category
Administration/ Dosage
Strengths
Contains not less than 30 % w/w of Bleaching Powder available chlorine solution with water to produce 100 ml Crystals for solution Section: 16 –Diuretics
Medicines
Category
Administration/ Dosage
Strengths
Section: 17 – Gastrointestinal medicines
17.1: Antacids and other Antiulcer medicines
Medicines
Category
Administration/ Dosage
Strengths
10 mg, 20 mg, 40 Added Medicines
17.2: Antiemetics
Medicines
Category
Administration/ Dosage
Strengths
Added Medicines
17.3: Antiinflammatory Medicines
Medicines
Category
Administration/ Dosage
Strengths
Added Medicines
5-Amino salicylic 17.4: Antispasmodic medicines
Medicines
Category
Administration/ Dosage
Strengths
17.5: Laxatives
Medicines
Category
Administration/ Dosage
Strengths
Tablets, Suppository 17.6: Medicines used in diarrhorea
17.6.1 Oral dehydration salts
Medicines
Category
Administration/ Dosage
Strengths
Powder for solution Glucose: 13.5 g/L Oral Rehydration 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) 17.6.2 Antidiarrhoeal medicines
Medicines
Category
Administration/ Dosage
Strengths
Medicines added
Section: 18 –Hormones, other endocrine medicines and
18.1: Adrenal hormones and synthetic substitutes
Medicines
Category
Strengths
Dosage Form
Sodium Succinate Methyl Prednisolone 18.2: Androgens
Medicines
Category
Strengths
Dosage Form
18.3: Contraceptives
18.3.1: Hormonal Contraceptives
Medicines
Category
Strengths
Dosage Form
Ethinylestradiol + Ethinylestradiol + Hormone Releasing 18.3.2: Intrauterine devices
Medicines
Category
Strengths
Dosage Form
18.3.3: Barrier Methods
Medicines
Category
Strengths
Dosage Form
18.4: Estrogens
Medicines
Category
Strengths
Dosage Form
Ethinylestradiol 18.5: Medicines used in Diabetes mellitus
18.5.1: Insulins and other Antidiabetic agents
Medicines
Category
Strengths
Dosage Form
Insulin Injection Acting(Lente/NPH Added medicines
Premix Insulin 30:70 18.5.2 Medicines used to treat hypoglycemia
Medicines
Category
Strengths
Dosage Form
Added medicines
18.6 Ovulation Inducers
Medicines
Category
Strengths
Dosage Form
Clomiphene citrate 18.7 Progestogens
Medicines
Category
Strengths
Dosage Form
Progesterone Acetate 18.8 Thyroid and antithyroid medicines
Medicines
Category
Administration /
Strengths
Dosage Form
Section: 19 Immunologicals
19.1: Diagnostic agents
Category
Strengths
Dosage Form
Purified Protein 19.2: Sera and immunoglobins
Category
Strengths
Dosage Form
19.3: Vaccines
19.3.1: For Universal Immunisation
Category
Administration/ Dosage
Strengths
Oral Poliomyelitis 19.3.2: For Specific Group of Individuals
Category
Administration/ Dosage
Strengths
Section: 20 – Muscle Relaxants (Peripherally acting) and
Cholinesterase Inhibitors
Category
Administration/ Dosage
Strengths
Succinyl choline Added drugs
Section: 21 – Ophthalmological Preparations
21.1: Anti-infective agents
Route of Administration/ Dosage
Medicines
Category
Strengths
21.2: Antiinflammaory agents
Route of Administration/ Dosage
Medicines
Category
Strengths
21.3: Local Anaesthetics
Route of Administration/ Dosage
Medicines
Category
Strengths
21.4: Miotics and Antiglucoma medicines
Route of Administration/ Dosage
Medicines
Category
Strengths
21.5: Mydriatics
Route of Administration/ Dosage
Medicines
Category
Strengths
21.6: Ophthalmic Surgical Aids
Route of Administration/ Dosage
Medicines
Category
Strengths
Section: 22 – Oxytocics and Antioxytocics
22.1: Oxytocics
Route of Administration/
Medicines
Category
Strengths
Dosage Form
Added medicines
22.2: Antioxytocics
Route of Administration/
Medicines
Category
Strengths
Dosage Form
Added Medicines
Section: 23 – Peritoneal Dialysis Solution
Route of Administration/
Medicines
Category
Strengths
Dosage Form
Dialysis Solution Section: 24 – Psychotherapeutic Medicines
24.1: Medicines used in Psychotic Disorders
Route of Administration/
Medicines
Category
Strengths
Dosage Form
25 mg, 50mg, 100mg Added medicines
24.2: Medicines used in mood disorders
24.2.1: Medicines used in Depressive disorders
Route of Administration/
Medicines
Category
Strengths
Dosage Form
24.2.2: Medicines used in Bipolar disorders
Route of Administration/
Medicines
Category
Strengths
Dosage Form
Added Medicines
24.3: Medicines used for Generalized Anxiety and Sleep Disorders
Route of Administration/
Medicines
Category
Strengths
Dosage Form
24.4: Medicines used for obsessive compulsive disorders and panic attacks
Route of Administration/
Medicines
Category
Strengths
Dosage Form
Added Medicines
Section: 25 – Medicines acting on the respiratory tract
25.1: Antiasthmatic medicines
Route of Administration/
Medicines
Category
Strengths
Dosage Form
sodium succinate Added Medicines
25.2: Antitussives
Route of Administration/
Medicines
Category
Strengths
Dosage Form
Codeine phosphate Dextromethorphan Section: 26 – Solutions correcting water, electrolyte and acid-base
26.1: Oral
Route of Administration/
Medicines
Category
Strengths
Dosage Form
Powder for Solution 26.2: Parenteral
Medicines
Category
Strengths
Dosage Form
26.3: Miscellaneous
Medicines
Category
Strengths
Dosage Form
Section: 27 – Vitamins and Minerals
Medicines
Category
Strengths
Dosage Form
Multivitamins (As per Schedule V of Drugs and Cosmetics Rules) 50000 IU, 100000 Vitamin D (Ergocalciferol) Added Medicines
SCHEDULE-II
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)
Name of the formulation: Name and address of the manufacturer/importer : Name of the Marketing Company, if any: Composition as per label claimed and approved by Drug Control Authorities: 5. Drugs Control Authority Permission Number and Date (copy to be enclosed): Date of commencement of production / import: Type of formulation (Tablets/ Capsules/ Syrup/ Injection/ Ointment/ Powder etc.): Size of packs (10's/ 100's/ 1 ml/ 2 ml/ 10 ml/ 5 gms/ 10 gms etc.) 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/ The information furnished above is correct and true to the best of my knowledge and belief.
Authorized Signatory:
SCHEDULE-II
PROFORMA FOR SUBMISSION OF REVISED-PRICES FOR SCHEDULED FORMULATIONS
(See paragraph 16) Name and address of the manufacturer / importer / distributor. Name and address of the marketing company, if any. Product Composition Price to retailer (incl. of E.D.) Maximum Retail Price (incl. (Formulation and its dosage of scheduled 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:
Authorised Signatory:
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: …………………
Name of the
Production/Import Level
Domestic Sale
Scheduled
/Strength
Formulation
Previous
Current Year
Previous
Current Year
Name of the
Installed
Production/Import Level
Domestic Sale
Bulk Drug/API
Capacity
Previous
Current Year
Previous
Current Year
Scheduled
Formulation
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: Authorised Signatory:
Date: Name:
Designation:
SCHEDULE-II
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:

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. Name of the Product (Formulation and its dosage Composition approved by Price to retailer Maximum Retail Price (incl. Drug Control Authorities (incl. of E.D.) (Rs.) of E.D.&Taxes) (Rs.) Scheduled Formulations
Own Manufactured Formulations Purchased/Imported Formulations Name of the Product (Formulation and its Composition approved by Price to retailer Maximum Retail Price (incl. Drug Control Authorities (incl. of E.D.) (Rs.) of E.D.&Taxes) (Rs.) 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.

Authorised Signatory:

Source: http://idma-assn.org/pdf/drug-price-control-order-2013.pdf