Drugs (Prices Control) Order, 2013
(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
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.
(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 per cent 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 per cent 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
P(s) = Average Price to Retailer for the same strength and dosage of the medicine as calculated i
(1) The retail price of the new drug available in domestic market shall be calculated as provided in sub-paragraph (1) of Paragraph 4.
1[Provided that the retail price of a new drug or the new drug that contain molecules or components or ingredients, that have become off-patent or about to become off-patent under the Patents Act 1970 (39 of 1970), shall be fixed as per the provisions of sub-paragraph (3) of this paragraph.]
(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).
2[(3) (i) the retail price of the new drug shall be arrived at by reducing fifty per cent. of the price calculated under
(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 per cent 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:
Step 1: 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
While fixing a ceiling price of scheduled formulations and retail prices of new drugs, sixteen per cent of price to retailer as a margin to retailer shall be allowed.
(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
1[(1) The source of market based data shall be the data available with the pharmaceutical market data specialising company as decided by the Government and if the Government deems it necessary, it may validate such data by appropriate survey or evaluation.]
(2) The Government may in the due course of time come out with other appropriate mechanism of collecting or obtaining the market based data related to drugs and the decision of Government with respect to collection or obtaining of data shall be final.
(3) The market based data, for fixing the ceiling price of scheduled formulations for the first time after the notification of this Order, shall be the data of May, 2012.
(4) The market based data for fixing the retail price of new drugs available in the market, shall be the data available for the month ending immediately before six months of receipt of application for fixing the price of the new drug.
(5) The market based data for fixing the c
(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
(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.
(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.
1[(3) Notwithstanding anything contained in sub-paragraphs (1) and (2), in the case of injections or inhalation or any other medicine for which dosage form or strength or both are not specified in the Schedule-I of the Drugs (Prices Control) Order, 2013, the Government may fix and notify separate ceiling price or retail price for such formulations with specific therapeutic rationale, considering the type of packaging or pack size or dosage compliance or content in the pack namely liquid, gaseous or any other form, in the unit dosage as the case may be, conforming to Indian Pharmacopeia or other standards as specified in the Drugs and Cosme
(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 manufacturers 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 G
(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.
(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 "Pharm
(1) The Government shall revise the ceiling prices of scheduled formulations as per the annual wholesale price index (WPI) for preceding calendar year on or before 1st April of every year and notify the same on the 1st day of April every year.
(2) The manufacturers may increase the maximum retail price (MRP) of scheduled formulations once in a year, in the month of April, on the basis of the wholesale price index with respect to previous calendar year and no prior approval of the Government in this regard shall be required.
(3) Information about the revision, if carried out, shall be forwarded to the Government in either electronic or physical form in Form-II within a period of fifteen days of such revision and non-submission of information under this sub-paragraph shall be construed as non-revision of maximum retail price (MRP) and the concerned manufacturer shall be liable to deposit the amount charged over and above the pre-revised maximum retail price (MRP), along
(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.
The revision of ceiling prices on the basis of moving annual turnover value shall be carried out,--
1[(i) every five years from the date of fixing the ceiling price under this Order for formulations as specified under the Schedule I.]
(ii) when the number of manufacturers of a scheduled formulation, having price of a scheduled formulation more than or equal to seventy-five per cent of the ceiling price fixed and notified by the Government, has decreased by twenty-five per cent 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 per cent of the ceiling price fixed by the Government, has increased by twenty-five per cent 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" s
In the case of scheduled formulation or its molecules or components or ingredients, which are patented under the Patents Act 1970 (39 of 1970), the ceiling price, on expiry of the patent, shall be revised by reducing the present ceiling price by fifty per cent., and after one year, the ceiling price shall be revised again as per the provisions of sub-paragraph (1) of paragraph 4, based on the market data of the preceding month.
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.
(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 per cent of maximum retail price during preceding twelve months and where the increase is beyond ten per cent of maximum retail price, it shall reduce the same to the level of ten per cent 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.
(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.
(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 equ
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.
(1) For all the scheduled formulations having maximum retail price (MRP) higher than ceiling price (plus local taxes as applicable), the manufacturers 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
(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 1[or Form VI] to the dealers, State Drugs Controllers and the Government indicating changes, from time to time.
(3) Every retailer and dealer shall display the price list and the supplementary price list, if any, as furnished by the manufacturer or importer, on a conspicuous part of the premises where he carries on business in a manner so as to be easily accessible to any person wishing to consult the same.
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.
No dealer shall sell loose quantity of any formulation at a price which exceeds the pro-rata price of the formulation.
Subject to the provisions of the Drugs 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.
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.
(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, along with 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 pr
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.
The provisions of this Order shall not apply to,--
1[(i) a manufacturer producing a new drug patented under the Indian Patent Act, 1970 (39 of 1970), for a period of five years from the date of commencement of its commercial marketing by the manufacturer in the country.]
(ii) a manufacturer producing a new drug in the country by a new process developed through indigenous Research and Development and patented under the Indian Patent Act, 1970 (39 of 1970) (process patent) for a period of five years from the date of the commencement of its commercial production in the country.
(iii) a manufacturer producing a new drug involving a new delivery system developed through indigenous
Research and Development for a period of five years from the date of its market approval in India.
2[(iv) Drugs for treating orphan diseases as decided by the Ministry of Health and Family Welfare, Government of India:]
Provided that the provision
1[SCHEDULE I | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
(Symbols P, S and T appearing in this Schedule denote essentiality at Primary, Secondary and Tertiary levels respectively) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Section 1 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
1.1-General Anaesthetics and Oxygen | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Medicine | Level of Healthcare | Dosage form(s) and strength(s) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
1.1.1 | Halothane | S,T | Liquid for inhalation | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
1.1.2 | Isoflurane | S,T | S.FORM I
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