Question : Spurious- Substandard and Expired Medicines

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

(a) whether the Government has taken note of the circulation/marketing of spurious, poor quality and expired medicines in Government hospitals and in open market across the country;

(b) if so, the number of such cases detected during each of the last three years and the current year State/UT-wise along with the number of cases inquired into, raids conducted and action taken against the defaulters, drugs manufacturers;

(c) whether Government is considering to chalk out a mechanism to tap and crackdown on fake and substandard drugs, if so, the details thereof;

(d) whether the Government proposes to popularise drug labels identified by All India Association of Chemists and Druggists, if so, the details thereof; and

(e) the other corrective measures taken by the Government in this regard?

ANSWER
THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND
FAMILY WELFARE
(SHRI ASHWINI KUMAR CHOUBEY)
(a) to (c): No report regarding circulation and marketing of spurious, poor quality and expired medicines has been received from Central Government hospitals.
The manufacture, sale and distribution of drugs in the country is 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 stringent action against violation of provision of the Act and Rules.
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In order to ensure the quality of drugs in the country, both the Central Drugs Standard Control Organisation (CDSCO) and the state drug regulators pick up a large number of samples of drugs from all over the country and have them tested and analysed in the laboratories of the Central and State Governments. In a few cases, the samples tested and analysed do not meet the prescribed standards. The details of the drugs that do not meet the standards are immediately notified by the Central or State regulator concerned.

As per information received from States/UTs, the details of the cases of sub-standard, spurious/ adulterated drugs, number of prosecution launched etc. and action taken against the offender during last three years are enclosed as Annexure-I. Such data in respect of cases of expired drugs detected during the last three years is placed at Annexure-II.

(d): There is no proposal for labeling requirements based specifically on the suggestion of All India Organisation of Chemists and Druggists. However, in order to have a drug authentication system through technology based information on label of the top 300 pharmaceuticals brands, the matter was deliberated in the 79th meeting of Drugs Technical Advisory Board (DTAB) held on 16th May, 2018.
(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.
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