Daijiworld Media Network – New Delhi

New Delhi, Oct 5: The Central Drugs Standard Control Organisation (CDSCO) has launched risk-based inspections of drug manufacturing units across six states following the deaths of children in Madhya Pradesh and Rajasthan, allegedly due to contaminated cough syrups.

Nineteen samples — including cough syrups, antibiotics, and antipyretics — were collected from units in Himachal Pradesh, Uttarakhand, Gujarat, Tamil Nadu, Madhya Pradesh, and Maharashtra. The inspections, initiated on Friday, aim to identify lapses in drug quality and suggest process improvements to prevent future incidents, the Health Ministry said.

A multidisciplinary expert team, including members from the National Institute of Virology, ICMR, NEERI, CDSCO, and AIIMS Nagpur, is analysing samples to determine the exact cause of the deaths in and around Chhindwara, Madhya Pradesh. Six samples tested by CDSCO and three by the Madhya Pradesh FDA were found free of Diethylene Glycol (DEG) and Ethylene Glycol (EG) contaminants, though these did not include the two suspected syrups, including Coldrif, that remain under investigation.

Following testing, Tamil Nadu authorities found excess DEG in Coldrif syrup from the Sresan Pharma manufacturing unit in Kanchipuram, prompting an immediate sale ban and market withdrawal. The Madhya Pradesh government also banned Coldrif syrup statewide, while inspections continue at the company’s Sunguvarchathram facility.

Madhya Pradesh Chief Minister Mohan Yadav described the deaths as “extremely tragic” and announced a state-level investigation, assuring that the guilty will be held accountable. Currently, 13 children, including eight from Chhindwara and Nagpur, are undergoing treatment, while nine children have already died due to suspected renal failure.

Kerala has suspended Coldrif sales as a precaution, although preliminary checks indicated the flagged batch was not sold in the state, Health Minister Veena George said. Meanwhile, the Food Safety and Drug Administration in Tamil Nadu has found other cough syrup samples from a Chennai-based firm adulterated, halting production and seeking an explanation from the manufacturer.

In Rajasthan, the state drug controller has been suspended, and distribution of medicines by Jaipur-based Kaysons Pharma, along with all cough syrups containing Dextromethorphan, has been halted following reports of two child deaths. An expert committee has been constituted to probe the matter further.

The Union Health Ministry reiterated that cough and cold medications are not recommended for children under two years, and use in older children should be closely supervised with proper dosing and adherence to clinical guidelines. Officials also noted that drugs potentially harmful to children and pregnant women will now carry clear warning labels.

Intensive inspections and testing are ongoing across states to ensure the safety of pediatric medications and prevent further tragedies.