The Directorate General of Health Services Central Drugs Standard Control Organization (CDSCO) issued a circular dated 09th February, 2024 that outlines regulatory guidelines for the sampling of drugs, cosmetics, and medical devices by drugs inspectors of Central and State Drug Authorities in India.
It emphasizes the importance of good quality medicines and the risks associated with substandard or spurious products, highlighting the adverse effects on patients and the healthcare system. The complex drugs regulation process in India involves various approvals, inspections, and post-marketing surveillance activities to ensure compliance with Good Manufacturing Practices (GMP) and the Drugs & Cosmetics Act. The guidelines aim to optimize resources by focusing on high-risk parameters during sampling and emphasize the need for comprehensive monitoring and databases to track NSQ (Not of Standard Quality) and spurious products.
The detailed guidelines cover various aspects of sampling, including sampling plans, sample selection, sampling locations, the number and quantity of samples, timelines, and the role of testing laboratories. It stresses the importance of a structured sampling plan, risk-based sample selection, and covering diverse locations, including rural areas. The guidelines also specify the quantities of samples required for different product categories for complete analysis, including drugs, cosmetics, vaccines, and biological/medical devices. Additionally, it outlines the timeline for forwarding samples to the laboratory, obtaining methods of analysis, and reporting NSQ and spurious alerts to ensure timely regulatory actions.
Furthermore, the guideline addresses the role of testing laboratories and provides a list of notified laboratories for drugs, cosmetics, and medical devices at central and state levels. It also includes annexures detailing the quantities of samples required for complete analysis of drugs, cosmetics, vaccines, and biological/medical devices. The circular’s comprehensive nature reflects a commitment to ensuring the quality and efficacy of products available in the market through uniform drug sampling methodology for drugs inspectors under state and central drug regulatory authorities in India.
