Cough Syrup Deaths: Over 700 Manufacturers Under Intense Scrutiny, Says Anupriya Patel

New Delhi: More than 700 cough syrup manufacturers across the country are under rigorous scrutiny following the deaths of several children in Madhya Pradesh linked to contaminated cough syrup, Union Minister of State for Health Anupriya Patel informed Parliament on Tuesday.

At least 26 children—mostly under the age of five—from the districts of Chhindwara, Pandhurna, and Betul reportedly died from kidney failure after consuming Coldrif cough syrup.

“Over 700 cough syrup manufacturers have been subjected to intensive audits in coordination with state authorities. The Central and State drug regulators have also increased market surveillance and sampling of syrup formulations,” Patel said in a written reply in the Rajya Sabha.

She added that, in addition to existing requirements for testing raw materials, the Indian Pharmacopoeia Commission in Ghaziabad has amended the Indian Pharmacopoeia (IP) 2022 to mandate testing for Diethylene Glycol (DEG) and Ethylene Glycol (EG) in oral liquid formulations at the finished-product stage before market release.

The Minister stated that the government conducted a detailed probe into the reported deaths, collecting 19 drug samples from private practitioners and nearby medical stores. Test results traced the contamination to Syrup Coldrif, manufactured by Sresan Pharmaceutical in Kancheepuram, Tamil Nadu.

DEG levels in the syrup consumed by the deceased children were found to be 46.28% weight by volume—dramatically exceeding the permissible limit of 0.1%. Four samples were also declared Not of Standard Quality (NSQ).

Subsequent inspections of Sresan Pharmaceutical’s facility revealed multiple critical and major violations of Good Manufacturing Practices (GMP), including unhygienic storage conditions. In response, the Central Drugs Standard Control Organisation (CDSCO), along with the Tamil Nadu government, initiated criminal proceedings and cancelled the company’s manufacturing licence.

Madhya Pradesh, Tamil Nadu, Odisha, and the Union Territory of Puducherry immediately banned and recalled Coldrif following the incident.

“A criminal case has been registered by the State of Madhya Pradesh, and strict action has been taken, including the arrest of those involved,” Patel added.

She further noted that an advisory has been issued to all State and Union Territory Health Departments and healthcare institutions to ensure the rational use of paediatric cough syrups.

The Drugs Controller has also directed all State and UT regulators to strictly enforce testing requirements, maintain heightened vigilance against spurious and substandard medicines, and take swift action whenever required.

With inputs from IANS