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 Govermnent 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 -

• enter and search any place,
• 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;
• 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, 1973 (2 of 1974), relating to search and seizure shall, so far as may be, apply to searches and seizures under this Order.

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.

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.

Penalties :
Any contravention of any of the provisions of this Order shall be punished in accordance with the provision of the Essential Commodities Act, 1955 (10 of 1955).

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;

Delegation of powers :
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 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.

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 or Order made, direction given, notice issued 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.

sd/- 

Vinod Valsh 

Joint Secretary to

the Government of India 

(No. 5(4)/94-PI-II)

Display of Prices of Non-Scheduled formulations and Price List

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 "maximum retail price" preceding it and the words 'inclusive of all taxes' succeeding it:

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.

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.

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 excise duty and all local taxes, if any, payable in the case of Scheduled formulations and maximum retail price inclusive of all taxes in the case of non-Scheduled formulations.

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 percent thereof.

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 -

• no manufacturer or distributor shall withhold from sale or refuse to sell to a dealer any drug without good and sufficient reasons; 
• no dealer shall withhold from sale or refuse to sell any drug available with him to a customer intending to purchase such drug. 

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 percent 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. 

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 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 sale of drugs and shall make available such records for inspection by the Government or any officer authorised in this behalf by the Government.

Can consumer ask for the price list of medicines being sold by a chemist/retailer ?

Ans. Yes. Every retailer is required to display the price list and the supplementary price list furnished by the manufacturer/ 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.

Is it mandatory for a chemist/ retailer to issue cash receipt for sale of medicines ?

Ans. Yes. Every chemist/ retailer is required to issue a receipt for sale of medicines and maintain the copies of cash/ credit memos.

The Narcotic Drugs and Psychotropic Substances Rules, 1985

GSR 177(E) dated 24.3.2006-Narcotic Drugs and Psychotropic Substances (National Fund for Control of Drug Abuse) Rules, 2006 In exercise of the powers conferred by Section 76 read with Section 7A of the Narcotic Drugs and Psychotropic Substances Act, 1985 (61 of 1985), the Central Government notified Narcotic Drugs and Psychotropic Substances (National Fund for Control of Drug Abuse) Rules, 2006, which will come into force from 24.3.2006. GSR 104 (E) dated 25th Feb, 2005 In exercise of the powers conferred by Section 9, read with Section 76 of the Narcotic Drugs and Psychotropic Substances Act, 1985 (61 of 1985), the Central Government has amended the Narcotic Drugs and Psychotropic Substances Rules, 1985,in the Rule 67 in sub-rule (1), for the word and figure 'Form 7", the word and figure 'Form 6" shall be substituted; after sub-rule 4, the following proviso shall be inserted, namely:- "Provided that consignment note in Form 6 shall not apply in cases where the sale of the psychotropic Substance is accompanied by a sale bill or invoice or cash memo or any other document duly signed by the consignor or his authorized signatory, which shall include the following information about the consignment: (a) name, address and licence number of the consignor and the consignee; (b) description, batch number and quantity; (c) mode and particulars of transport: Provided further that such document shall be preserved by consignor and consignee for a period of two years for inspection by the officers referred to in sub-rule (4) above. GSR 639 (E) dated 13.10.2006- Narcotic Drugs and Psychotropic Substances (Amendment) Rules, 2006

In exercise of the powers conferred by Section 76 read with Section 8 and 9 of the Narcotic Drugs and Psychotropic Substances Act, 1985 (61of 1985) the central Govt made the Rules to amend the Narcotic Drugs and Psychotropic Substances Rules, 1985. The Govt has inserted a new provision after provision to Rule 66 (2), permitting individuals to possess more than hundred dosages for long term personal use prescribed by a RMP. In Chapter VII A in the heading “for medical and scientific purpose” the words “for medical, Scientific and training purpose” shall be substituted. After the Rule 67 A, new Rule 67 B (1) and 67 C are inserted. For existing Schedules I, II and III new Schedules are substituted.

GSR 736 (E) Dated 22.12.2005

Narcotic Drugs and Psychotropic Substances (Amendment) Rules, 2005 published to insert in Rule 36 (2A) after “Pholcodine and their respective salts” the words “from Indian opium, if the Central Government determines that such licence is necessary in public interest and is in consonance with India’s obligations under International treaties, conventions or protocols” .

GSR 633(E) dated 17-10-2005

In pursuance of rule 8 of the Narcotic Drugs and Psychotropic Substances Rules, 1985, the Central Government notified general conditions for grant of licence for cultivation of opium poppy on account of the Central Government during the Opium Crop year commencing on the 1st day of October, 2005 and ending with the 30th day of September, 2006.

GSR 634(E) dated 17-10-2005

In pursuance of Rule 5 of the Narcotic Drugs and Psychotropic Substances Rules, 1985, the Central Government notified tracts in the States of Madhya Pradesh, Rajasthan and Uttar Pradesh as the tracts within which poppy may be cultivated on account of the Central Government during the opium year commencing on the 1st day of October, 2005 and ending on the 30th September, 2006.

           

   

Amendment to Drugs & Cosmetics Act Deferred

IMPORTANT NEWS

The much talked about amendment in the Drugs and Cosmetics Act, that was to regulate the indiscriminate use of antibiotics, has been deferred by Union Health Minister Ghulam Nabi Azad. Health Ministry sources confirmed that at a meeting on Wednesday, the minister had decided on a review of the policy for the time-being.

The amendment would have introduced a new Schedule HX to the Act and would have made prescription-based sales compulsory for 74 listed drugs. Azad has reportedly said the policy that had been drafted by the office of the Drug Controller General of India (DCGI) — the drug regulatory authority under the ministry — was "not practical" considering the dearth of qualified doctors in rural areas.

"The amendment has not been dropped, it is just deferred for the time being," a ministry spokesperson confirmed. According to a senior official, "In the absence of sufficient number of doctors, making prescription-based sales compulsory for common drugs would affect patients adversely."

The schedule would also be compulsory for doctors to issue double prescriptions, one copy of which had to be retained by chemists for at least two years, while the other would be part of DCGI records, to check the over-the-counter sales of antibiotics.

These prescriptions would provide a suitable way to maintain a count of antibiotic use, which has been totally absent in the country. To regulate the availability of antibiotics, the schedule also lists 16 other drugs, which would have to be sold directly by the manufacturers to tertiary care hospitals.

Chemists had raised objections citing the lack of doctors and tertiary care centres in rural areas.