The Directorate General of Health Services has issued a strong advisory to all states and Union Territories, urging strict testing and regulatory oversight of pharmaceutical products. The directive follows the tragic deaths of 20 children linked to contaminated batches of Coldrif cough syrup. In the past 24 hours alone, four more deaths were reported from Madhya Pradesh. Investigations revealed that certain cold syrups, not recommended for children under four, were still being sold in the market.
Toxicology reports found that the affected batches of Coldrif syrup contained diethylene glycol (DEG) at nearly 500 times above the permissible limit, confirming it as the cause behind the deaths reported in Chhindwara. Six more children remain critically ill in hospitals.
The drug regulator highlighted severe lapses in quality control, noting that manufacturers had failed to conduct mandatory batch testing before releasing the product. Some syrups had reportedly been sold without meeting basic safety standards.
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In its advisory, the Directorate stressed strict adherence to Rules 74(c) and 78(c)(ii) of the Drugs Rules, which mandate rigorous testing of every batch of raw materials and finished products. Manufacturers have been directed to maintain proper records and use raw materials only from approved and reliable vendors.
“All states and UT drug controllers are requested to take measures to ensure testing before manufacture and release of the batch to the market,” the directive read. It added that monitoring during inspections, issuing circulars, and implementing vendor qualification systems were essential steps going forward.
A Special Investigation Team has been formed to probe the incident, and a case has been registered against the Tamil Nadu-based manufacturer of Coldrif. Authorities have also arrested Dr Praveen Soni, a paediatrician in Chhindwara, and sealed his family’s clinic.
However, Indian Medical Association president Dr Dilip Bhanushal came to Soni’s defence, blaming the tragedy on failures by the pharmaceutical company and broader systemic weaknesses in drug regulation.
Madhya Pradesh Chief Minister Mohan Yadav has taken administrative action, suspending Drug Inspectors Gaurav Sharma (Chhindwara) and Sharad Kumar Jain (Jabalpur), along with Deputy Director of Food and Drug Administration Shobhit Koshta. State Drug Controller Dinesh Maurya has been transferred.
Nineteen syrup samples consumed by the children were collected for testing. Of the ten reports received so far, one was found substandard, while the remaining nine met the prescribed quality standards.
In response, the Union Health Ministry has initiated risk-based inspections of drug manufacturing units across six states, aiming to identify and correct safety lapses.
Several states have also launched their own measures. In Rajasthan, authorities have begun door-to-door surveys, public awareness drives on safe medicine use, and imposed restrictions on certain syrups. A technical committee has been formed to investigate child health issues, and warning labels have been mandated for syrups that could be harmful to children and pregnant women.
In Uttar Pradesh, officials seized Coldrif and related products from the same Tamil Nadu manufacturer after receiving alerts about a contaminated batch. In Maharashtra, the Food and Drug Administration has banned the sale and distribution of Batch No. SR-13 of Coldrif syrup after detecting toxic contamination.
The incident has sparked public outrage and political criticism. Congress leader Sachin Pilot has demanded a judicial inquiry, expressing concern that a government probe may not uncover the full truth. The Congress
