Cough Syrup Deaths: CDSCO Calls for Strict Quality Control Amid Regulatory Lapses
CDSCO directs strict quality control after ColdRif cough syrup deaths in Madhya Pradesh raise concerns over ongoing regulatory lapses in India’s pharmaceutical sector.
ColdRif cough syrup manufactured by Sresan Pharmaceuticals linked to 22 child deaths in Madhya Pradesh; CDSCO urges strict compliance with drug quality standards.
The Central Drugs Standard Control Organisation (CDSCO) has fatally issued a warning to state drug controllers to comply with quality norms after 22 children died in Madhya Pradesh allegedly following the use of contaminated cough syrups. The last deaths have been linked to ColdRif syrup, manufactured by Sresan Pharmaceuticals of Tamil Nadu.
This action is clearly similar to previous warnings issued when India-made cough syrups were responsible for child deaths in Gambia and Uzbekistan and highlights deficits continuing in pharmaceutical quality control.
⚠️ Regulatory Failures Under Scrutiny
According to CDSCO, some pharmaceutical companies are skipping essential testing of raw materials and excipients, the inactive ingredients used to stabilize or deliver the active drug component.
In a letter dated October 7, Drugs Controller General of India Rajeev Singh Raghuvanshi stressed the importance of testing all raw materials before manufacturing. “This directorate has time and again emphasised the critical importance of testing of raw materials including the excipients before their use in pharmaceutical formulations,” the letter stated.
Inspections revealed that manufacturers do not test each batch of excipients, creating a persistent regulatory gap that has proved fatal in past cases.
💀 ColdRif Cough Syrup Tragedy
Investigations conducted by the Tamil Nadu government found diethylene glycol at 48.6% in ColdRif syrup — nearly 500 times the permissible limit — a highly toxic chemical that caused multiple child deaths in Chhindwara, Madhya Pradesh.
Following the deaths:
Sresan Pharmaceuticals’ owner was arrested, and the manufacturing unit has been sealed.
Madhya Pradesh’s Food & Drug Administration has banned the sale and distribution of ColdRif in the state.
CDSCO investigations indicate that many manufacturers omit batch testing for both active ingredients and excipients, violating India’s Drugs Rules of 1945, which mandate thorough testing to ensure safety.
🏭 Cutting Corners in Manufacturing
The findings mirror previous tragedies involving India-made cough syrups exported to Gambia and Uzbekistan in 2022 and 2023, where industrial-grade diethylene glycol was used instead of pharmaceutical-grade propylene glycol.
Experts say some manufacturers continue to skip mandatory testing to reduce costs, risking contamination and putting children’s lives in danger.
A senior industry leader, speaking on condition of anonymity, noted, “India has a complex drug regulatory system; a few exceptions will always exist. The government and the regulator are investigating the matter, and we should wait for the outcome of those investigations.”
Raghuvanshi has called on state controllers to sensitise manufacturers, implement robust vendor qualification systems, and ensure strict adherence to quality standards — the same recommendations made after the Gambia and Uzbekistan tragedies.
