Crackdown on Pharma Compliance Follows Tragic Cough Syrup Deaths in Madhya Pradesh

The fatalities of 20 children in Madhya Pradesh, reportedly caused by Coldrif cough syrup, have prompted the Drugs Controller General of India (DCGI) to enforce stringent compliance with the Drugs Rules, 1945. In his directive, dated October 7, DCGI Dr. Rajeev Singh Raghuvanshi highlighted the urgent need for rigorous testing of raw materials and excipients before their use in pharmaceutical formulations.

This directive follows alarming reports from Madhya Pradesh's Chhindwara area, while inspections have revealed significant lapses in compliance, with manufacturers allegedly neglecting to test their raw materials and excipients adequately.

The directive mandates that all manufacturers thoroughly test each batch of inactive and active pharmaceutical ingredients to ensure compliance. Manufacturers are required to maintain detailed records per Schedule U, and state drug controllers must guarantee these standards through inspections and circulars. The directive also emphasizes the importance of a robust vendor qualification system.

Meanwhile, S Ranganathan, owner of the company producing the implicated cough syrup, has been arrested, with legal proceedings underway. Authorities continue to address the situation as new details emerge about the incident's scale, underscoring the crucial importance of pharmaceutical safety and regulatory enforcement.

(With inputs from agencies.)