Question : Over the Counter Medicines

Will the Minister of HEALTH AND FAMILY WELFARE be pleased to state:

(a) whether the Government proposes to come out with list of Over the Counter (OTC) medicine in a separate schedule;

(b) if so, the details thereof;

(c) whether Drugs and Cosmetics Act is likely to be amended and views of Drug Consultative Committee have been obtained;

(d) if so, the details thereof; and

(e) the criteria likely to be adopted for the medicines of switching from prescription drugs to OTC category and the time by which a final decision is likely to be taken in this regard?

ANSWER
THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND
FAMILY WELFARE
(SHRI ASHWINI KUMAR CHOUBEY)

(a) to (e): Schedule K of the Drugs and Cosmetics Rules, 1945 already provides the list of certain medicines which are exempted from the requirements of obtaining sale license under the Drugs and Cosmetics Act and Rules made thereunder subject to the conditions as mentioned therein.

State Licensing Authorities (SLAs) appointed by respective State governments are empowered to monitor/track the sale of drugs including the drugs allowed to be sold without prescription and take action in case of non-compliance.