After MP child deaths, 700+ cough syrup makers under govt scanner over DEG contamination risk

The health ministry said central and state drug regulators have increased market-surveillance sampling of all syrup formulations

More than 700 cough syrup manufacturers across India have come under intensified audits and surveillance after child deaths in Madhya Pradesh were linked to contaminated formulations, Minister of State for Health Anupriya Patel told the Rajya Sabha on Tuesday, PTI reported.

The health ministry said central and state drug regulators have increased market-surveillance sampling of all syrup formulations, while states have been instructed to tighten testing and compliance checks under the Drugs Rules, 1945.

A central team, including experts from the National Centre for Disease Control, National Institute of Virology, and CDSCO, visited Chhindwara and Nagpur to investigate the cluster of reported deaths. Nineteen drug samples were collected from private practitioners and local retail stores; four were declared not of standard quality (NSQ), Patel said.

The immediate trigger was the detection of 46.28 percent w/v diethylene glycol (DEG) in Syrup Coldrif, manufactured by Sresan Pharmaceuticals in Tamil Nadu and reportedly consumed by the deceased children.

Why did this happen now?

Following the contamination finding, CDSCO inspected the Kancheepuram-based manufacturer. Patel said regulators found “critical and major” GMP violations, including unhygienic storage conditions. Tamil Nadu’s state drug controller subsequently cancelled the firm’s manufacturing licence. A criminal case has also been registered in Madhya Pradesh, with arrests made.

Madhya Pradesh, Tamil Nadu, Odisha and Puducherry ordered immediate bans and recalls of the implicated batches, PTI reported.

The health ministry said the Indian Pharmacopoeia Commission has amended IP 2022 to mandate DEG and EG testing at the finished-product stage, not just raw materials, before market release.

Context

India has faced repeated questions on cough syrup quality since 2022, when DEG/EG-linked fatalities involving products exported to Gambia and Uzbekistan prompted global warnings. The latest domestic incident sharpens scrutiny over small- and mid-scale manufacturers, which account for a large share of India’s paediatric syrups.