After WHO Alert, India Tightens Scrutiny On 700 Cough Syrup Units

A month after the World Health Organisation (WHO) issued a global alert on three cough syrups linked to the deaths of children in Madhya Pradesh’s Chhindwara, the Government has moved to tighten surveillance on more than 700 cough syrup manufacturers across the country.

At least 26 children in Chhindwara, Pandhurna and Betul—most of them under five—are suspected to have died of acute kidney failure after being given Coldrif cough syrup. The tragedy comes against the backdrop of earlier incidents in which Indian-made cough syrups have been implicated in child deaths abroad.

“Over 700 cough syrup manufacturers have undergone an intensive audit in coordination with State authorities. Market surveillance of syrup formulations by Central and State drug regulators has been significantly stepped up,” after a spate of child deaths in Madhya Pradesh linked to contaminated syrups, Union Minister of State for Health Anupriya Patel informed Parliament on Tuesday.

In her written reply to the Rajya Sabha, she said that in a bid to tighten oversight, the Indian Pharmacopoeia Commission, Ghaziabad, has amended the Indian Pharmacopoeia (IP) 2022 to mandate compulsory testing for Diethylene Glycol (DEG) and Ethylene Glycol (EG) in oral liquid formulations at the final-product stage—beyond the existing raw-material checks.

The Centre, Patel said, conducted a detailed investigation into the Madhya Pradesh deaths and collected 19 samples from treating clinicians and nearby pharmacies. Laboratory analysis traced the contamination to dangerously high levels of DEG in Syrup Coldrif, manufactured by Sresan Pharmaceutical in Kancheepuram, Tamil Nadu.

Alarming lab findings showed DEG levels of 46.28 per cent weight by volume (w/v) in the Coldrif samples consumed by the deceased children—hundreds of times higher than the permissible limit of 0.1 per cent. Four samples were also declared Not of Standard Quality (NSQ).

A subsequent inspection of Sresan Pharmaceutical uncovered “multiple critical and major Good Manufacturing Practices (GMP) violations, including unhygienic storage conditions.” The CDSCO, along with the Tamil Nadu government, cancelled the firm’s manufacturing licence and initiated criminal action.

Madhya Pradesh, Tamil Nadu, Odisha and Puducherry have immediately banned and recalled Coldrif. “A criminal case has been registered by the Madhya Pradesh Government, and stringent action has been taken, including the arrest of those involved,” Patel told the House.

An advisory has also gone out to all State and UT Health Departments and healthcare institutions, urging rational use of paediatric cough syrups. Drug regulators nationwide have been directed to strictly enforce testing norms, maintain heightened vigilance against spurious and substandard medicines, and act immediately on violations.

However, much remains to be done. For, yet these measures, while prompt, highlight a deeper and recurring concern. Despite repeated warnings and earlier tragedies, toxic contamination continues to slip through India’s pharmaceutical supply chain, laying bare chronic regulatory gaps and systemic oversight failures.

The deaths in Madhya Pradesh mirror earlier episodes that have eroded global confidence in Indian drug exports. In 2022, nearly 70 children in The Gambia and 18 in Uzbekistan died after consuming contaminated syrups made by Indian companies.

In Uzbekistan, victims had been given Dok-1 Max, produced by Noida-based Marion Biotech. Tests found the syrup adulterated with ethylene glycol (EG), a toxic industrial chemical. A few months earlier, a similar catastrophe struck The Gambia, where the World Health Organization (WHO) linked dozens of child deaths to four syrups made by Maiden Pharmaceuticals Ltd.

“Laboratory analysis of samples of each of the four products confirm unacceptable amounts of diethylene glycol and ethylene glycol as contaminants,” the WHO had warned.

“Toxic effects include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state and acute kidney injury, which may lead to death.”

Last month, the WHO had issued an alert against three cough syrups that caused deaths of children in Madhya Pradesh, urging national regulatory authorities worldwide to immediately notify it if they are detected in their country.

These syrups included specific batches of Coldrif, Respifresh TR, and ReLife, manufactured by Sresan Pharmaceutical, Rednex Pharmaceuticals, and Shape Pharma, respectively.