The Central Drugs Standard Control Organisation (CDSCO) on Sunday recommended the cancellation of the manufacturing licence of a Tamil Nadu pharmaceutical company based on the findings during an inspection, according to a statement issued by the Union Health Ministry.
The recommendation follows a probe into child deaths in Madhya Pradesh allegedly linked to contaminated cough syrups.
Investigations found that one cough syrup, Coldrif, contained diethylene glycol (DEG) beyond permissible limits. Criminal proceedings against the company have also been initiated, according to a ministry press note.
The findings have prompted the Central government to call for a nationwide review of drug quality and paediatric cough syrup in use following reports of child deaths in Madhya Pradesh’s Chhindwara district allegedly linked to the same formulation.
Chairing a high-level meeting with state health officials, Union Health Secretary Punya Salila Srivastava stressed the need for “strict compliance with the revised Schedule M by all drug manufacturers.”
She also urged states to ensure that cough syrups are used “rationally, particularly among children, as most coughs are self-limiting and do not require pharmacological treatment.”
A Central investigation team from the NCDC, CDSCO, and the National Institute of Virology earlier found that out of ten medicine samples tested, nine met quality standards, while Coldrif failed DEG analysis. The unit in Kancheepuram, Tamil Nadu, also faces criminal proceedings, officials said.
Dr. Rajiv Bahl, Director-General of ICMR, cautioned that “children should not be prescribed cough syrups or drug combinations to prevent side effects”, adding that the National Joint Outbreak Response Team is coordinating efforts with states.
Dr. Sunita Sharma, DGHS, emphasized the need for public guidance, saying, “Cough medications have minimal proven benefit in children but carry significant risks. Guidelines for parents, pharmacists, and doctors will soon be issued.”
The Ministry has also directed states to conduct risk-based inspections and strengthen drug safety surveillance to prevent a recurrence of such incidents.