The Directorate has emphasized strict adherence to Drugs Rules, 1945, mandating batch-wise testing of all raw materials and finished pharmaceutical products. This follows reports of child deaths linked to contaminated cough syrups. Inspections revealed non-compliance by manufacturers in testing excipients and APIs. State/UT Drug Controllers must ensure compliance through inspections, awareness, and vendor qualification systems. Only approved, reliable raw material sources should be used. Authorities must report actions taken accordingly.
The Directorate has reiterated the importance of strict compliance with the Drugs Rules, 1945, particularly regarding the testing of raw materials and finished pharmaceutical formulations. This follows alarming reports of child fatalities in Chhindwara, Madhya Pradesh, allegedly linked to contaminated cough syrups.
Inspections and investigations have revealed that several manufacturers are failing to test each batch of excipients and active pharmaceutical ingredients (APIs) before use, as well as the final products, thereby violating prescribed standards. As per Rules 74(c) and 78(c)(ii), licensees are mandated to conduct batch-wise testing either in their own laboratories or in those approved by the licensing authority, and maintain detailed records as outlined in Schedule U.
All State and Union Territory Drug Controllers are urged to enforce these regulations by monitoring compliance during inspections, issuing awareness circulars, and ensuring manufacturers implement robust vendor qualification systems. Only raw materials and excipients from reliable, approved vendors should be used.
Authorities are requested to acknowledge receipt of this directive and report the actions taken to uphold drug safety and quality standards.