Revised Regulatory Guidelines For Sampling Of Drugs, Cosmetics & Medical Devices By Drugs Inspectors Of Central & State Drug Authorities

On 9 February 2024, the Central Drugs Standard Control Organization ssued comprehensive regulatory guidelines for sampling of drugs, cosmetics, and medical devices by central and state drug inspectors. The framework aims to standardize and rationalize sampling procedures, ensuring uniformity across jurisdictions. It emphasizes preparation of monthly and annual sampling plans, covering urban, rural, and tribal areas, with risk‑based selection of products and outlets to detect Not of Standard Quality (NSQ) and spurious drugs. Inspectors must collect at least ten samples monthly, including nine drug samples and one cosmetic or medical device, in specified quantities. The guidelines mandate timely forwarding of samples to laboratories, disclosure of supply chain details, and use of the SUGAM Lab Portal for documentation. A centralized database will track sampling outcomes, NSQ reports, and spurious alerts, published monthly on the CDSCO website. This initiative strengthens surveillance, enhances transparency, and safeguards public health by ensuring quality medicines and regulated distribution practices.