Cough syrup contamination: Health Ministry directs strict compliance with revised Schedule M norms

The Union Health Ministry has sought strict compliance from all drug manufacturers, in line with the revised Schedule M norms for pharmaceutical products in India. Licences of non-compliant units would be cancelled, the Ministry has warned.

The direction comes after an emergency meeting with all States and Union Territories on Sunday (October 5, 2025) evening, following a report by the Tamil Nadu Drugs Control Department, which found above permissible levels of diethylene glycol (DEG) in samples of Coldrif, a cough syrup brand.

Testing of cough syrup brands was initiated following the death of more than 10 children in Rajasthan and Madhya Pradesh recently.

Preliminary findings in past week have ruled out common infectious diseases, except for one positive case of leptospirosis. Nineteen medicine samples consumed by the children were collected from private medical practitioners and nearby retail stores. The chemical analysis so far indicates that out of the 10 samples analysed till date, nine met quality standards. However, one of them, namely, the cough syrup Coldrif contained DEG beyond the permissible limit. Subsequently, regulatory action has been taken by the Tamil Nadu Food and Drugs Administration on the unit, which is located in Kancheepuram. Cancellation of the manufacturing license has been recommended by Central Drugs Standard Control Organisation based on findings upon inspection. Criminal proceedings have also been initiated, the Health Ministry said on Sunday.

Tamil Nadu’s Drugs Control Department issued an immediate stop production order to the manufacturer of the Coldrif brand of cough syrup following an analysis by a government drug testing laboratory, which found a batch to be “not of standard quality” and “adulterated with diethylene glycol”.

“The report from the Madhya Pradesh drug regulatory authority is still awaited,’’ a senior Health Ministry official said.

Speaking on the outcomes of Sunday’s emergency meeting called by the Union Health Ministry, sources in the Ministry said that maintaining quality, and rational use of cough syrup, had been reiterated.

“The Union Ministry has sought strict compliance to manufacturing norms and warned that licences of non-compliant units will be cancelled,’’ the official said.

The revised Schedule M is an updated set of Good Manufacturing Practices (GMP) and regulations for pharmaceutical products in India, a part of the Drugs and Cosmetics Act, 1940.

It mandates enhanced quality systems, including a Pharmaceutical Quality System, and Quality Risk Management, with a compliance deadline of December 31, 2025. The revisions align Indian standards with international GMP guidelines, emphasising product quality and safety, and require new infrastructure, including computerised storage systems and equipment validation. 

Additionally, States have been asked to ensure rational use of cough syrups, particularly among children, as most coughs are self-limiting and do not require pharmacological treatment, the source said.

The Ministry has also asked States and Union Territories to ensure enhanced surveillance; timely reporting by all health facilities; wider dissemination of the community reporting tool of the Integrated Disease Surveillance Programme as it is merged into the Integrated Health Information Platform; and strengthened inter-State coordination for early reporting and joint action.