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Drugs Controller General of India issues directive to states, Union Territories

After 20 child deaths in MP from Coldrif syrup, DCGI orders strict testing of raw materials and formulations under Drugs Rules, 1945.

Sentinel Digital Desk

New Delhi: After 20 children’s deaths in Madhya Pradesh linked to Coldrif cough syrup, the Drugs Controller General of India (DCGI) has issued a directive to all States and Union Territories, calling for strict compliance with the Drugs Rules, 1945, for the testing of raw materials and finished pharmaceutical formulations. In a letter dated October 7, the Drugs Controller General of India (DCGI) Dr Rajeev Singh Raghuvanshi emphasised the “critical importance of testing new materials, including the excipients, before their use in the manufacturing of pharmaceutical formulations.”

The DCGI orders came in the wake of Madhya Pradesh’s cough syrup deaths, stating, “There have been recent reports of child deaths in Chhindwara, Madhya Pradesh, allegedly linked to contaminated cough syrups and concerns related to the quality of these cough syrups.” The directive follows inspections revealing lapses in compliance, where some manufacturers were reportedly failing to conduct adequate testing of raw materials and inactive ingredients before production. (ANI)

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