Strict compliance with the Drugs Rules, 1945, for testing of raw materials and finished formulations.

CDSCO has reiterated the statutory requirement under the Drugs and Cosmetics Act, 1940 and Drugs Rules, 1945 that every manufacturer must test each batch or lot of raw materials, including critical excipients such as propylene glycol, glycerol and sorbitol, before use in manufacturing. Each batch of the finished product must also be tested prior to release.   The directive follows observations from inspections and investigations indicating non-compliance with mandatory testing requirements. State and Union Territory Drug Controllers have been instructed to ensure manufacturers carry out comprehensive testing, maintain records as prescribed in Schedule U, and strengthen vendor qualification programs.   Manufacturers are required to procure raw materials and excipients only from approved and reliable sources to ensure the quality, safety and efficacy of drug products. The matter has been accorded high priority for implementation across all manufacturing units.