CDSCO issues regulatory policies for sampling of drugs, cosmetics and medical devices

The Central Drugs Standard Control Organisation (CDSCO) has issued final regulatory guidelines to streamline sampling procedures and maintain a centralized database. These guidelines empower drug inspectors to select samples and locations efficiently, considering identified risks and available data. Emphasis is placed on covering diverse areas, including rural and tribal regions, and curating a monthly list of Non-Standard Quality (NSQ) and spurious drugs. Inspectors are directed to develop monthly and annual sampling plans, ensuring comprehensive coverage across various product categories. They must collect a minimum of 10 samples monthly, prioritizing essential tests if quantity is limited. Timely forwarding of samples to laboratories is mandated, along with maintaining thorough records of sampling activities. The guidelines advocate for risk-based sampling and collaboration among states to combat substandard products effectively. Adherence to these guidelines enhances public trust in pharmaceutical quality and safety.