After the tragic deaths of 20 children in Madhya Pradesh linked to contaminated cough syrup, India’s top drug regulator has directed all states and Union Territories to step up testing and monitoring of medicines before they reach the market.
The Central Drugs Standard Control Organisation (CDSCO) on Wednesday issued fresh instructions to state drug controllers, stressing strict compliance with existing rules for testing raw materials and finished pharmaceutical products.
The move follows reports from Chhindwara, where children who consumed Coldrif cough syrup suffered acute kidney failure, leading to multiple fatalities.
CDSCO Issues Fresh Directive
In its order, the CDSCO highlighted that under the Drugs Rules, particularly Rule 74(c) and Rule 78(c)(ii), license holders must ensure that every batch of raw material and final product is tested in approved laboratories, with proper records maintained as per Schedule U.
The regulator asked state authorities to enforce compliance through inspections and circulars, while also ensuring that pharmaceutical companies adopt robust vendor qualification systems and procure raw materials only from trusted, authorised suppliers.
IMA Slams Arrest of Paediatrician
Meanwhile, the Indian Medical Association (IMA) has raised objections to the arrest of a senior paediatrician in connection with the case, calling for urgent systemic reforms in drug quality monitoring instead of scapegoating doctors.
Dr Pravin Soni, a government paediatrician who also runs a private clinic in Parasia town, was arrested on Saturday night following an FIR filed by local health officer Dr Ankit Sallam. The complaint also named the Tamil Nadu-based manufacturer of Coldrif syrup.
Two other doctors, Dr Amit Thakur and Dr Aman Siddiqui, have been listed in the seven-page FIR lodged at Parasia police station.
The FIR invokes Sections 105 and 276 of the Bharatiya Nyaya Sanhita (BNS), relating to culpable homicide not amounting to murder and drug adulteration, along with Section 27A of the Drugs and Cosmetics Act, 1940, which covers the sale and manufacture of spurious medicines. The charges carry penalties ranging from 10 years in prison to life imprisonment.
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