Drug makers should test every batch of raw material, finished product, says regulatory body

The Central Drugs Standard Control Organisation (CDSCO) has issued a directive to the Drug Controllers of all States and Union Territories, calling for strict enforcement of the Drugs Rules, 1945, with specific emphasis on the mandatory testing of raw materials and finished pharmaceutical products.

The directive from the national regulatory body comes in the wake of the death of over 20 children in Madhya Pradesh and Rajasthan owing to adulterated cough syrups.

In an official communication issued on Wednesday (October 8, 2025), Dr. Rajeev Singh Raghuvanshi, the Drugs Controller General of India (DCGI) who heads the CDSCO, emphasised that manufacturers must test every batch of raw material, including excipients and active pharmaceutical ingredients (APIs), as well as the finished formulations before their release to the market.

The communication noted that recent inspection of cough syrup facilities exposed serious lapses by certain manufacturers, who failed to conduct the required batch-wise testing of raw materials and finished formulations, in violation of Rules 74(c) and 78(c)(ii) of the Drugs Rules, 1945.