The Central Drugs Standard Control Organisation (CDSCO) has initiated risk-based inspections of drug manufacturing units in six Indian states following reports of child fatalities linked to contaminated cough syrups. The inspections aim to identify potential quality lapses that may have contributed to these incidents and recommend corrective measures to strengthen manufacturing processes. The states under scrutiny include Himachal Pradesh, Uttarakhand, Gujarat, Tamil Nadu, Madhya Pradesh and Maharashtra, where 19 drug samples—including cough syrups, antipyretics and antibiotics—were produced.

These investigations follow multiple deaths among children in Madhya Pradesh’s Chhindwara district and in Rajasthan, allegedly caused by the consumption of contaminated cough syrups. A multidisciplinary team comprising experts from the National Institute of Virology, the Indian Council of Medical Research, the National Environmental Engineering Research Institute, CDSCO and AIIMS-Nagpur is analysing the samples and other evidence to determine the exact cause of the fatalities.

Preliminary results have shown that six samples tested by CDSCO and three by the Madhya Pradesh Food and Drugs Administration were free from diethylene glycol (DEG) and ethylene glycol (EG) contamination. However, these samples were not from the two primary cough syrups under investigation, including Coldrif, which remains the main focus of ongoing testing.

At the request of the Madhya Pradesh government, the Tamil Nadu Food Safety and Drug Administration conducted tests on Coldrif syrup manufactured by Sresan Pharma in Kanchipuram. The results revealed levels of diethylene glycol exceeding permissible limits. Following this, the Tamil Nadu government imposed a ban on the sale of Coldrif syrup and ordered its immediate withdrawal from the market.

This regulatory crackdown highlights growing concern over lapses in pharmaceutical manufacturing oversight and underscores the need for stronger enforcement of quality, safety and compliance standards across India’s drug production ecosystem. The findings of these inspections are expected to influence future regulatory priorities and reshape manufacturing norms within the industry.