DRUGS (PRICES CONTROL) ORDER, 1995
(1) This Order may be called the Drugs (Prices Control) Order, 1995.
(2) It shall come into force on the date of its publication in the Official Gazette.
In this order, unless the context otherwise requires,-
(a) bulk drug means any pharmaceutical, chemical, biological or plant product including its salts, esters, stereo-isomers and derivatives, conforming to pharmacopoeial or other standards specified in the Second Schedule to the Drugs and Cosmetics Act, 1940 (23 of 1940), and which is used as such or as an ingredient in any formulation;
(b) capital employed means net fixed assets plus working capital of a manufacturer in relation to manufacture of bulk drugs;
(c) ceiling price means a price fixed by the Government for scheduled formulation in accordance with the provisions of para. 9.
(d) dealer means a person carrying on the business of purchase or sale or drugs, whether as a wholesaler or retail
(1) The Government may with a view to regulate the equitable distribution and increasing supplies of a bulk drug specified in the First Schedule and making it available at a fair price, from different manufacturers, after making such inquiry as it deems fit, fix from time to time by notification in the Official Gazette, a maximum sale price at which such bulk drug shall be sold:
Provided that for the purpose of enquiry, in addition to the information required to be furnished by the manufacturers under this Order, the manufacturers shall provide any such additional information as may be required by the Government and shall allow for inspection of their manufacturing premises for verification through on the spot study of manufacturing processes and facilities and records thereof, by the Government.
(2) While fixing the maximum sale price o
Every manufacturer, producing a scheduled bulk drug shall furnish to the Government,-
(a) a list of all scheduled bulk drugs produced by him within thirty day of the commencement of this Order and indicate, the detail of the cost of each of such bulk drugs in From I;
(b) the details of the cost of each scheduled bulk drug produced by him, including such bulk drug which has been produced after the commencement of this Order, in From I by the 30th September, every year.
Every manufacturer, producing a non-scheduled bulk drug shall furnish to the Government.-
(a) a list of all such bulk drugs produced by him within thiry days of the commencement of this Order and indicate the details of the cost of each of such bulk drugs in Form II:
(b) the details of the cost of each non-scheduled bulk drug produced by him, including such bulk drug which has been produced after the commencement of this Order, in Form II:
Provided that, for purpose of this paragraph, the Government, may after making such inquiry as it may deem necessary in public interest, fix or revise the price of any non-scheduled bulk drug and the manufacturer or importer of such bulk drug shall [give effect to the price so fixed or revised, within fifteen days of receipt of the order and not sell the suc
(1) With a view to achieving adequate production and regulating the equitable distribution, the Government may, from time to time, by general or special order, direct any manufacturer of any bulk drug to sell such bulk drug to such other manufacturers of formulations as may be specified in such order:
Provided that while making nay such order, the Government shall have regard to all or any of the following factors, namely:
(i) the requirement for captive consumption of such manufacturer, and
(ii) the requirement of other manufacturers.
(1) For the purpose of making any order under sub-paragraph (1), the Government may call for such information from manufacturer, importer or distributor, of bulk drugs, as it may consider necessary and such manufactur
The retail price of a formulation shall be calculated by the Government in accordance with the following formula, namely,-
R.P. = (M.C. + P.M> + P.C.) X (1 + MAPE/100) + ED.
Where-
R.P. means retail price;
M.C. means material cost and includes the cost of drugs and other pharmaceutical aids used including overages, if any plus process loss thereon specified as a norm form time to time by notification in the Official Gazette in this behalf;
C.C means a conversion cost worked out in accordance with established producers of costing and shall be fixed as a norm every year by notification in the Official Gazette in this behalf;
P.M. means cost of the packing materia
(1) The Government may, from time to time, by order, fix the retail price of a scheduled formulation in accordance with the formula laid down in para. 7.
(2) Where the Government fixed or revises the price of any bulk-drug under the provisions of this Order and a manufacturer utilises such bulk drug in his scheduled formulations he shall, within thirty days of such fixation or revision, make an application to the Government in Form III for price revision of all such formulations and the Government may, if it considers necessary, fix or revise the price such formulation.
(3) The retail price of a formulation once fixed by the Government under sub-paragraphs (1) and (2) shall not be increased by any manufacturer except with the prior approval of the Government.
(4) Any manufacturer, who desires
(1) Notwithstanding anything contained in this Order, the Government may, from time to time, by notification in the Official Gazette, fix the ceiling price of a scheduled formulation in accordance with the formula laid down in para 7 keeping in view the cost or efficiency, or both, of major manufacturers of such formulations and such price shall operate as the ceiling sale price for all such packs including those sold under generic name and for every manufacturer of such formulations.
(2) The Government may, either on its own motion or on application made to it in this behalf by a manufacturer in Form III or Form IV, as the case may be, after calling for such information as it may consider necessary by notification in the Official Gazette, fix a revised ceiling price for a scheduled formulation.
(3) With a view to enabling the manufactur
Notwithstanding anything contained in this Order,-
(a) the Government may, after obtaining such information as may be considered necessary from a manufacurer or importer, fix or revise the retail price of one or more formulations markedted by such manufacturer or importer, including a non-scheduled formulation, in such manner as the pre-tax return on the sales turnover of such manufacturer or importer does not exceed the maximum pre-tax return specified in the Third Schedule;
(b) The Government may, if it considers necessary so to do in public interest, after calling for such information by order fix or revise the retail price of any formulation including a non-scheduled formulation:
(c) The Government may, if it considers necessary so to do in public interest, by order include any bulk drug i
Where any manufacturer or importer of bulk drug or formulation fails to submit the application for price fixation or revision, as the case may be, or to furnish information as required under this Order. Within the time specified therein, the Government may, on the basis of such information as may be available with it, by order fix a price in respect of such bulk drug or formulation as the case may be.
(1) Notwithstanding anything contained in this Order, the Government may be notice, require the 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 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 an
Notwithstanding anything ocntained in this Order, the Government shall by notice, require the manufacturers, importers or distributors, 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 under the provisions of this Order.
(1) Every manufacturer or importer shall carry into effect the price of a bulk drug or formulation, as the case may be, as fixed by the Government from time to time, within fifteen days from the date of notification in the Official Gazette or receipt of the order of the Government in this behalf by such manufacturer or importer.
(2) Every manufacturer, importer or distributor of a 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 retail price of that behalf, with the words retail price not to exceed preceding it, and local taxes extra succedding it, 1[and under Government Prices Control on a red strip] in the case of scheduled formulations:
Provided that in the case of a container consisting of smaller saleable packs,
(1) Every manufacturer, importer or distributor of a non-scheduled formulation intended for sale shall display in indelible print mark, on the label of container of the formulaiton and the minimum pack thereof offered for retail sale, the retail price of the formulaiton with the words 2[retail price not to exceed] preceding it and the words 3[local taxes extra succeeding it 4[and the words not under Price Control on a green strip]:
Provided that in the case of a container consisting of smaller saleable packs, the retail price of such smaller pack shall also be displayed on the label of each smaller pack and such price shall not be more than the pro-rata retail price of the main pack rounded off to the nearest paisa.
(2) Every manufacturer or importer shall issue a price list and supplementary price list, if required of the non-scheduled
No person shall sell any bulk drug or 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, plus all local taxes, if any payable.]
No dealer shall sell loose quantity of any formulation at a price which exceeds the pro-rata price of the formulation plus 5 per cent, thereof.
Subject to the provisions of the Drugs and Cosmetics Act, 1940 (23 of 1940) and the Rules framed 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 purpose such drug.
(1) A manufacturer, distributor or wholesaler shall sell a formulation to a retailer, unless otherwise permitted under the provisions of this Order or nay order made thereunder, at a price equal to the retail price, as specified by an order or notified by the Government (excluding excise duty, if any), minus sixteen per cent thereof in the case of scheduled drugs.
(2) Notwithstanding anything contained in sub-paragraph (1), the Government may by a general or special order fix, in public interest, the price of formulation sold to the wholesaler or retailer in respect of any formulation the price of which has been fixed or revised under this Order.
(1) Every manufacturer and importer shall maintain in such form as may be specified by the Government records, relating to the sales turnover of individual bulk drugs manufactured or imported by him, as the case may be, and the sales turnover of formulations pack wise 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 such records or to inspect such records at the premises of the manufacturer or importer.
(2) Every manufacturer or importer shall, within six months of the close of the accounting year, submit to the Government information in respect of turnover and allocation of sales and expenses for that year in Form VI.
(3) Every dealer, manufacturer or importer shall maintain the cash memo or credit memo, books of account and records of purchase and sal
(1) Any Gazetted Officer of the Central Government or of a State Government authorised by a general or special order by the Central Government or, as the case may be, by the State Government in this behalf may, with a view to securing compliance with this Order or to satisfy him self that the provisions of this Order have been complied with,-
(a) Either and search any place;
(b) Seize any drug, along with the containers, packages or coverings in which the drug is found, in respect or 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 doc
Any person aggrieved by any notification issued or order made under paras 3, 5, 8, 9 or 10 may apply to the Government for a review of the notification or order within fifteen 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, importer or distributor, as the case may be, shall sell a bulk drug or formulation, a the case may be, at a price exceeding the price fixed by the Government of which a review has been applied for.
(1) The Government may , for the purpose of implementing the provisions of this Order, authorise any officer, by a general or special order, to inspect the premises of any manufacturer, importer, distributor or dealer and such manufacturer, importer, distributor or dealer shall allow such authorised officer and make available all relevant information required for the purpose.
(2) The Government may , from time to time, issue such guidelines and directions, consistent with the provisions of this Order to any manufacturer or importer as may be necessary to carry out the provisions of this Order and such manufacturer or importer shall comply with such guidelines and directions.
Any contravention of any of the provisions of this Order shall be punished in accordance with the provisions of the Essential Commodities Act, 1955 (10 of 1955).
(1) Government may, having regard to the factors mentioned in sub-paragraph (2) and subject to such conditions as it may specify by an order in the Official Gazette, exempt any manufacturer from the operation of all or any of the provisions of this Order.
(2) While granting exemption under sub-paragraph (1), the Government shall have regard to all or any of the following factors,-
(a) number of workers employed:
(b) amount of capital invested;
(c) range/group and type of products manufactured;
(d) sales turnover;
(e) production of bulk drugs from basic stage by a process developed throhgh indigenous research and development, and which is significantly different
The Government may, by notification in the Official Gazette, direct that all or any of the powers conferred upon it by this Order, other than those contained in paras. 22, 23 and 25 shall, subject to such restrictions, exceptions and conditions, as may be specified in the direction, be exercisable also by such Officer or authority as may be specified in the notification.
(1) The Drugs (Prices Control) Order, 1987 is hereby repealed.
(2) Notwithstanding such repeal, anything done or any action taken, including nay notification or Order made, direction given, notice issued or exempting granted under the Drugs (Prices Control) Order, 1987, shall, in so far as it is not inconsistent with the provisions of this Order, be deemed to have been done, taken, made, given, issued or granted, as the case may be, under the corresponding provisions of this Order.
[See paras 2 and 3]
BULK DRUGS
1. Sulphamethoxazole 40. Gentamycin
2. Penicillins 41. Dextropropoxyphene
3. Tetracycline 42. Halognated Hydroxyquinoline
4. Rifamipicin 43. Pentazocine
5. Streptomycin 44. Captopril
6. Ranitidine 45. Naproxen
7. Vitamin C 46. Pyrental
8. Betamethasone 47. Sulphadoxine
9. Metronidazole 48. Norfloxacin
10. Cholroquine 49. Cefadroxyl
11. Insulin 50. Panthonates & Pant
FORMS
FORM I
(To be submitted in Duplicate)
[See paras 2, 3 and 4]
Form of information/application for fixation or revision of prices of Scheduled bulk drugs.
1. Name of the Bulk Drug.
2. Name of the Manufacturer.
3. Address of the Registered/Head Office of the Manufacturer.
4. Address of the Factory.
5. Capacity under Industrial Licence/Small Scale Industry/Registration/ Industrial Entrepreneur Memorandum acknowledgement;
[See para 10]
Specified maximum pre-tax return on slaes turnover of manufacturers or importers of formulations:-
Category A:
Laruge units with turnover exceeding Rs. 6 croses per annum:
(a) having no basic drug manufacturing activity nor any research activity ______________ eight per cent.
(b) Having basic drug manufacturing activity at five per cent or more of the turnover but no research activity _________ nine per cent.
(c) Having basic drug manufacturing activity at five per cent or more of the turnover and engaed in approved research and development work related to new drugs ___________ ten per cent.
Category B:
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