AMENDMENT TO THE DRUGS & COSMETICS RULES

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The Government of India has amended Drugs & Cosmetics Rules, 1945 for the purpose to bring about changes in Schedule K.

Schedule K to the Drugs and Cosmetics Rules, 1945 lists the classes of drugs and the extent and conditions of exemption granted to these drugs from the provisions of Chapter IV of the Drugs and Cosmetics Act, 1940. The Chapter IV of the Act pertains to manufacture, sale and distribution of drugs. It is now proposed to include the following classes of drugs under this Schedule with specified conditions of exception.

1. Entry No 5A pertains to the drugs supplied by a hospital or dispensary maintained or supported by Government or local body is proposed to be amended so that the drugs purchased from the licenced manufacturer or dealers or have been received as transferred stocks from hospital stores. Records of such purchases shall be maintained. The condition is proposed to be stipulated to ensure that the quality drugs are purchased by hospitals and dispensary from authorised stores only for supply to the patients.
2. Entry No.15, gives the list of Chemical Contraceptives, which can be sold without a sale licence. It is now proposed to further include the Contraceptives having the following composition also under this entry:

i) Desogestrel 0.150 mg

Ethinyloestradiol 0.030 mg

ii) Levonorgestrel 0.1 mcg

Ethinyloestradiol 0.02 mg

These are low concentration Contraceptive pills and are proposed to be included under the Schedule for the promotion of Family Planning Programmes.

3. Supply of First Aid Kit along with motor vehicle by the manufacturer or its distributor at the time of first sale of vehicle has been made mandatory under the Motor Vehicle Rules, 1989. As this is a social legislation for providing medical aid to the occupants of motor vehicle in case of necessity, it has been proposed to exempt the manufacturer and dealers of motor vehicles from the provision of sale licence for storing or supplying First AIF Kits along with the motor vehicle provided these items are procured from a dealer licensed under the Drugs and Cosmetics Rules.

Objections and suggestions to the said rules are invited from the public within 45 days for consideration of the Government and these should be addressed to the Secretary, Health, Ministry of Health and Family Welfare, Nirman Bhavan, New Delhi.