The Central Drugs Standard Control Organisation (CDSCO) on October 27, 2026, has reiterated the statutory requirement under the Drugs and Cosmetics Act, 1940 and the Rules thereunder, requiring drug manufacturers to test every batch or lot of raw materials, including critical excipients such as propylene glycol, glycerol and sorbitol, as well as every batch of finished drug products. Such testing must be conducted either in the manufacturer's own laboratory or in a laboratory approved by the Licensing Authority. Manufacturers are also required to maintain test records and registers in accordance with Schedule U.
Accordingly, all manufacturers are directed to ensure mandatory batch-wise testing of raw materials and finished formulations and implement robust vendor qualification procedures by procuring raw materials and excipients exclusively from reliable and approved vendors. The concerned authorities have been requested to give the matter top priority and ensure strict compliance across all manufacturing units within their respective jurisdictions.
[File No. DC-DT-15011(11)/144/2025-eoffice, e-file 28466]
