The Hindu Business Line : Drug, cosmetic rules amended

THE Government has amended Drugs and Cosmetics Rules, 1945 to bring about changes in Schedule K, which 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. Now it is proposed to include the following classes of drugs under this schedule with specified conditions of exception.

These include entry number 5 A, pertaining to the drugs supplied by a hospital or dispensary maintained or supported by the Government or local body, which is proposed to be amended so that the drugs purchased from the licenced manufacturer or dealer or which have been received as transferred stocks from hospital stores.

An official statement adds that records of such purchases shall be maintained. The condition is proposed to be stipulated to ensure that the quality of drugs purchased by hospital and dispensary only from authorised stores for supply to the patients.

Further entry number 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 under this entry -- Desogesterl 0.150 mg, Ethinyloestradiol 0.030 mg, Levonorgestrel 0.1 mcg, Ethinloestradial 0.02 mg.

The statement adds that these are low concentration contraceptive pills and are proposed to be included under the schedule for the promotion of family planning programmes.

Besides, the supply of first aid kit along with motor vehicles by the manufacturer or its distributors 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 dealer of motor vehicles from the provision of sale licence for storing or supplying first aid kits along with the motor vehicle provided these items are procured from a dealer licenced under the Drugs and Cosmetics Rules.

The Government has invited objections and suggestions to the rules from the public within 45 days for its consideration.

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