Drug Price In India
14. Carrying into effect the price fixed or
revised by the Government, its display and proof
thereof:-
[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 formulation, notified in the Official Gazette or ordered by the Government in this behalf, with the words "retail price not to exceed" preceding it, and "local taxes extra" succeeding it, in the case of Scheduled formulations :
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 prorata retail price of the main pack rounded off to the nearest paisa.
[3] Every manufacturer or importer 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 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.
15. Display of prices of non-Scheduled formulations and price list thereof:-
[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 formulation and the minimum pack thereof offered for retail sale the retail price of that formulation with the words "retail price not to exceed" preceding it and the words "local taxes extra" succeeding it. *(1)
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 shall not to be more than the prorata 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 formulations in Form V to the dealers, State Drugs Controllers and the Government indicating changes, from time to time.
[3] Every retailer and dealer shall display the price list and the supplementary price list, if any, as furnished by the manufacturer or importer, on a conspicuous part of the premises where he carries on business in a manner so as to be easily accessible to any person wishing to consult the same.
16. Control of sale prices of bulk drugs and formulations:- 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.*(1)
17. 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 plus 5 per cent thereof.
18. 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 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 purchase such drug.
19. Price of formulations sold to the dealer:-
[1] A manufacturer, distributor or wholesaler shall sell a formulation to a retailer, unless otherwise permitted under the provisions of this Order or any 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 be 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.
(20) Maintenance of records and production thereof for inspection:-
[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 month 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 sale of drugs and shall make available such records for inspection by the Government or any officer authorised in this behalf by the Government.
(21) Power of entry, search and seizure:-
[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 himself that the provisions of this Order have been compiled with -
[a] Enter and search any place;
[b] Seize any drug, alongwith the containers, packages or covering 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 covering, 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 provision of section 100 of the Code of Criminal Procedure, 19/3 (2 of 1974), relating to search and seizure shall, so far as may be, apply to searches and seizures under this Order .
22. Power to review:- Any person aggrieved by any notification issued or order made under paragraphs 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, as the case may be, at a price exceeding the price fixed by the Government of which a review has been applied for.
(23) Power to issue guidelines and directions:-
[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.
24. Penalties:- Any contravention of any of the provisions of this Order shall be punished in a accordance with the provision of the Essential Commodities Act, 1955 ( 10 of 1955).
25.Power to exempt:-
[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: -
26. Delegation of powers:- The Government may, be notification in the Official Gazette, direct that all or any of the powers conferred upon it by this order, other than those contained in paragraphs 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.
(27) Repeal and saving:-
[1] The Drugs (Prices Control) Order, 1987 is hereby repealed.
[2] Notwithstanding such repeal, anything done or any action taken, including any notification order made, direction given, notice issue or exemption 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.
(Vinod Vaish)
Joint Secretary to the Government of India
The First Schedule
(Bulk Drugs)
SULPHAMETHOXAZOLE
The Second
Schedule (Forms)
The Third
Schedule
Specified maximum pre-tax return on sales turnover of manufacturers or importers of formulations:-
CATEGORY A:
Large units with turnover exceeding Rs.6 Crores per annum:
CATEGORY B:
Medium sized units with turnover between Rs.1 Crore to Rs. 6 Crores per annum:
CATEGORY C: Other units with turnover of less than Rs. 1 crore per anum:
(Vinod Vaish)
Joint Secretary to the Government of India
[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 formulation, notified in the Official Gazette or ordered by the Government in this behalf, with the words "retail price not to exceed" preceding it, and "local taxes extra" succeeding it, in the case of Scheduled formulations :
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 prorata retail price of the main pack rounded off to the nearest paisa.
[3] Every manufacturer or importer 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 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.
15. Display of prices of non-Scheduled formulations and price list thereof:-
[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 formulation and the minimum pack thereof offered for retail sale the retail price of that formulation with the words "retail price not to exceed" preceding it and the words "local taxes extra" succeeding it. *(1)
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 shall not to be more than the prorata 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 formulations in Form V to the dealers, State Drugs Controllers and the Government indicating changes, from time to time.
[3] Every retailer and dealer shall display the price list and the supplementary price list, if any, as furnished by the manufacturer or importer, on a conspicuous part of the premises where he carries on business in a manner so as to be easily accessible to any person wishing to consult the same.
16. Control of sale prices of bulk drugs and formulations:- 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.*(1)
17. 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 plus 5 per cent thereof.
18. 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 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 purchase such drug.
19. Price of formulations sold to the dealer:-
[1] A manufacturer, distributor or wholesaler shall sell a formulation to a retailer, unless otherwise permitted under the provisions of this Order or any 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 be 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.
(20) Maintenance of records and production thereof for inspection:-
[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 month 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 sale of drugs and shall make available such records for inspection by the Government or any officer authorised in this behalf by the Government.
(21) Power of entry, search and seizure:-
[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 himself that the provisions of this Order have been compiled with -
[a] Enter and search any place;
[b] Seize any drug, alongwith the containers, packages or covering 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 covering, 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 provision of section 100 of the Code of Criminal Procedure, 19/3 (2 of 1974), relating to search and seizure shall, so far as may be, apply to searches and seizures under this Order .
22. Power to review:- Any person aggrieved by any notification issued or order made under paragraphs 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, as the case may be, at a price exceeding the price fixed by the Government of which a review has been applied for.
(23) Power to issue guidelines and directions:-
[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.
24. Penalties:- Any contravention of any of the provisions of this Order shall be punished in a accordance with the provision of the Essential Commodities Act, 1955 ( 10 of 1955).
25.Power to exempt:-
[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: -
- Number of workers employed
- Amount of capital invested
- Range/group and type of products manufactured
- Sales turnover
- Production of bulk drugs from basic stage by a process developed through indigenous research and development, and which is significantly different from known processes and results in cost reduction
- Production of a new drug which has not been produced elsewhere, if developed through indigenous research and development
26. Delegation of powers:- The Government may, be notification in the Official Gazette, direct that all or any of the powers conferred upon it by this order, other than those contained in paragraphs 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.
(27) Repeal and saving:-
[1] The Drugs (Prices Control) Order, 1987 is hereby repealed.
[2] Notwithstanding such repeal, anything done or any action taken, including any notification order made, direction given, notice issue or exemption 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.
(Vinod Vaish)
Joint Secretary to the Government of India
SULPHAMETHOXAZOLE
- PENICILLINS
- TETRACYCLINE
- RIFAMPICIN
- STREPTOMYCIN
- RANITIDINE
- VITAMIN C
- BETAMETHASONE
- METRONIDAZOLE
- CHLOROQUINE
- INSULIN
- ERYTHROMYCIN
- VITAMIN A
- OXYTETRACYCLINE
- PREDNISOLONE
- CEPHAZOLIN
- METHYLDOPA
- ASPIRIN
- TRIMETHOPRIM
- CLOXACILLIN
- SULPHADIMIDINE
- SALBUTAMOL
- FAMOTIDINE
- IBUPROFEN
- METAMIZOL (ANALGIN)
- DOXYCYCLINE
- CIPROFLOXACIN
- CEFOTAXIME
- DEXAMETHASONE
- EPHEDRINE
- VITAMIN B1 (THIAMINE)
- CARBAMAZEPINE
- VITAMIN B2 (RIBOFLAVIN)
- THEOPHYLLINE
- LEVODOPA
- TOLNAFTATE
- VITAMIN E
- NALIDIXIC ACID
- GRISEOFULVIN
- GENTAMICIN
- DEXTROPROPOXYPHENE
- HALOGENATED HYDROXYQUINOLINE
- PENTAZOCINE
- CAPTOPRIL
- NAPROXEN
- PYRENTAL
- SULPHADOXINE
- NORFOLOXACIN
- CEFADROXYL
- PANTHONATES & PANTHENOLS
- FURAZOLIDONE
- PYRITHIOXINE
- SULPHADIAZINE
- FRAMYCETIN
- VERAPAMIL
- AMIKACIN SULPHATE(deleted from dpco)
- GLIPIZIDE
- SPIRONOLACTONE
- PENTOXYFYLLINE
- AMODIAQUIN
- SULPHAMOXOLE
- FRUSEMIDE
- PHENIRAMINE MALEATE
- CHLOROXYLENOLS
- BECAMPICILLIN
- LINCOMYCIN
- CHLORPROPAMIDE
- MEBHYDROLINE
- CHLORPROMAZINE
- METHENDIENONE
- PHENYL BUTAZONE
- LYNESTRANOL
- SALAZOSULPHAPYRINE
- DIOSMINE
- TRIMIPRAMINE
- MEFENAMIC ACID(deleted from dpco)
Specified maximum pre-tax return on sales turnover of manufacturers or importers of formulations:-
CATEGORY A:
Large units with turnover exceeding Rs.6 Crores per annum:
- having no basic drug manufacturing activity nor any research activity - eight per cent
- having basic drug manufacturing activity at five per cent or more of the turnover but no research activity - nine per cent
- having basic drug manufacturing activity at five per cent or more of the turnover and engaged in approved research and development work related to new drugs - ten per cent
CATEGORY B:
Medium sized units with turnover between Rs.1 Crore to Rs. 6 Crores per annum:
- having no basic drug manufacturing activity nor any research activity - nine per cent
- having basic drug manufacturing activity at five per cent or more of the turnover but no research activity - eleven per cent
- having basic drug manufacturing activity at five per cent or more of the turnover and engaged in approved research and development work related to new drugs - thirteen per cent
CATEGORY C: Other units with turnover of less than Rs. 1 crore per anum:
- having only formulation activity - twelve per cent
- having basic drug manufacturing activity at five per cent or more of the turnover thirteen per cent
(Vinod Vaish)
Joint Secretary to the Government of India
