CDSCO launches risk-based inspections across six states after child deaths linked to cough syrup

CDSCO Launches Risk-Based Inspections Across Six States After Child Deaths Linked to Cough Syrup

The Central Drugs Standard Control Organisation (CDSCO) has launched risk-based inspections at pharmaceutical manufacturing facilities across six states after reports linked contaminated cough syrup to multiple child deaths in Madhya Pradesh. The Union Health Ministry confirmed on Saturday that 19 drugs, including cough syrups and antibiotics, are under scrutiny.

The inspections, which began on October 3, aim to identify lapses that may have contributed to drug quality failures and to recommend corrective measures to prevent similar tragedies. “The initiative is focused on ensuring stringent quality compliance and strengthening safety mechanisms in drug manufacturing,” the ministry said.

A multidisciplinary team, comprising experts from the National Institute of Virology, the Indian Council of Medical Research (ICMR), the National Environmental Engineering Research Institute (NEERI), AIIMS-Nagpur, and CDSCO, is still analysing drug samples and environmental factors to pinpoint the cause of deaths reported in and around Chhindwara, Madhya Pradesh.

Preliminary testing offered mixed findings. While six samples tested by CDSCO and three by the Madhya Pradesh Food and Drugs Administration (MPFDA) were found free of diethylene glycol (DEG) and ethylene glycol (EG)—toxic compounds associated with acute kidney injury—further analysis revealed contamination elsewhere.

At the request of the Madhya Pradesh government, the Tamil Nadu Food Safety and Drug Administration Department conducted parallel testing of Coldrif Cough Syrup, manufactured by Sresan Pharma in Kanchipuram. The results, shared late Friday evening, detected DEG beyond permissible limits in the samples.

Following the confirmation, the Tamil Nadu government banned the sale of the syrup with effect from October 1 and ordered its immediate removal from the market. “Inspections at the company’s facility in Sunguvarchathram, Kancheepuram, were carried out over the last two days, and fresh samples have been collected,” a state official said.

The regulator’s intensified inspections highlight growing concerns over recurring instances of contaminated syrups linked to child fatalities in India and abroad. Officials stressed that the current exercise is part of a broader effort to enforce compliance, strengthen oversight, and restore public confidence in Indian pharmaceuticals—particularly given the country’s role as a leading global exporter of generic medicines.