The Central Drugs Standard Control Organization (CDSCO) has directed all State and UT Drug Controllers to ensure strict compliance with the Drugs Rules, 1945, regarding the mandatory testing of raw materials and finished formulations.
The order, issued by the Drugs Controller General (India) on October 7, 2025, emphasizes the critical importance of testing every batch of ingredients used in pharmaceutical manufacturing to ensure quality and safety.
The directive comes in the wake of recent reports of child deaths in Chhindwara, Madhya Pradesh, allegedly linked to contaminated cough syrups, and broader concerns over the quality of certain drug formulations.
Key Violations and Rules Cited
CDSCO noted that recent inspections and investigations into drugs declared “Not of Standard Quality” revealed a widespread failure by manufacturers to adhere to the prescribed testing standards.
Manufacturers were found to be not carrying out testing of each batch of the excipients/inactive and active pharmaceutical ingredients (APIs) for verification of compliance with prescribed standards before using them in formulations and also in the finished products.
The circular references Drugs Rules, specifically Rule 74(c) and Rule 78(c)(ii). These rules mandate that the licensee must test each batch or lot of raw material and each batch of the final product in their own laboratory or an approved laboratory. Manufacturers must also maintain detailed records of these tests as specified in Schedule U.
Action Mandated for Drug Controllers
All State and UT Drug Controllers are requested to take immediate measures to ensure manufacturer compliance before drug batches are released to the market:
- Enhance monitoring during inspections to verify that testing protocols are being followed.
- Sensitize manufacturers through circulars and other means regarding the mandatory nature of raw material and finished product testing.
- Ensure manufacturers have a robust vendor qualification system in place and use raw materials, including excipients, only from reliable, approved vendors.
State and UT Drug Controllers are requested to acknowledge the receipt of the letter and intimate the CDSCO of the action taken in this regard.
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