CDSCO issues sampling guidelines to ensuring quality and efficacy of drugs, cosmetics

CDSCO has issued new guidelines to ensure the quality and efficacy of drugs and cosmetics through uniform drug sampling methodologies for inspectors across state and central regulatory authorities.

• Sections 22 & 23 of Drugs & Cosmetics Act 1940 detail procedures for routine drug quality surveillance

Key Highlights:

• Establishment of a centralized database for outlets selling ‘not of standard quality’ or spurious drugs.
• Monthly and annual sampling plans prepared by drug inspectors in consultation with the controlling authority.
• Sampling locations to cover the entire jurisdiction/area under their office.

Need for sampling of drugs, cosmetics and medical devices:

• Need for sampling of drugs, cosmetics, and medical devices due to persistent quality concerns.
• Reports of deaths in Gambia and Uzbekistan linked to Indian cough syrup highlight the urgency.
• Absence of a defined methodology for sample selection or sampling location currently.
• Random sampling with individual knowledge of drug inspectors in practice.
• Coverage gap identified, with existing practices focusing on big brands in urban/suburban areas, neglecting rural and remote locations.

Drug regulation in India:

• Drug regulation in India based on Drugs and Cosmetics Act (DC Act), 1940, and Drugs and Cosmetics Rules, 1945.
• CDSCO, created under the Ministry of Health and Family Welfare, ensures safety, efficacy, and quality standards
• Drug Controller General of India (head of CDSCO) approves licenses for specified drug categories.

Ref: Source