Question : Spurious and Substandard Drugs

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

(a) whether sale and marketing of spurious, substandard and expired drugs including ayurvedic/homoeopathic drugs and deaths therefrom have been reported in the country;

(b) if so, the details thereof indicating the value of drugs and the action taken against the offenders during each of the last three years and the current year, State/UTwise;

(c) whether the Government has any proposal under consideration for entering into international cooperation and a globaltreaty to deal with the menace of spurious and substandard drugs reaching the market;

(d) if so, the details thereof; and

(e) the other measures being taken by the Government to effectively deal with the menace of spurious, substandard and expired drugs?

ANSWER
THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND
FAMILY WELFARE
(SHRI ASHWINI KUMAR CHOUBEY)
(a) & (b): The Government has not received any report regarding deaths due to spurious, substandard and expired drugs.

The manufacture, sale and distribution of drugs in the country are regulated under the provisions of Drugs & Cosmetics Act, 1940 and Rules, 1945 thereunder through a system of licensing and inspection. Licenses for manufacture, sale and distribution of drugs are granted by the State Licensing Authorities (SLAs) appointed by respective State Governments. SLAs are legally empowered to take action against violation of any provision of the Act and Rules. As per information received from State/UTs, the details regarding the number of drug samples tested, number of drug samples reported spurious/adulterated and sub-standard, value of drugs seized and action taken by States/UTs are enclosed as Annexure-I. Such data in respect of expired drugs is at Annexure-II.

(c): No.

(d): Does not arise.

(e): The Government is committed to ensuring that the quality, safety and efficacy of drugs are not compromised. With this in view, the Government has taken a series of measures including strengthening legal provisions, workshops and training programmes for manufacturers and regulatory officials and measures such as risk based inspections.