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

The Union Health Ministry has sought strict compliance from all drug producers, according to the revised Schedule M norms for pharmaceutical merchandise in India. Licences of non-compliant items could be cancelled, the Ministry has warned.

The route comes after an emergency assembly with all States and Union Territories on Sunday (October 5, 2025) night, following a report by the Tamil Nadu Drugs Control Department, which discovered above permissible ranges of diethylene glycol (DEG) in samples of Coldrif, a cough syrup model.

Testing of cough syrup manufacturers was initiated following the demise of greater than 10 kids in Rajasthan and Madhya Pradesh just lately.

Preliminary findings in previous week have dominated out widespread infectious ailments, aside from one optimistic case of leptospirosis. Nineteen drugs samples consumed by the kids have been collected from non-public medical practitioners and close by retail shops. The chemical evaluation to this point signifies that out of the ten samples analysed until date, 9 met high quality requirements. However, one in every of them, specifically, the cough syrup Coldrif contained DEG past the permissible restrict. Subsequently, regulatory motion has been taken by the Tamil Nadu Food and Drugs Administration on the unit, which is positioned in Kancheepuram. Cancellation of the manufacturing license has been really helpful by Central Drugs Standard Control Organisation primarily based on findings upon inspection. Criminal proceedings have additionally been initiated, the Health Ministry mentioned on Sunday.

Tamil Nadu’s Drugs Control Department issued an instantaneous cease manufacturing order to the producer of the Coldrif model of cough syrup following an evaluation by a authorities drug testing laboratory, which discovered a batch to be “not of ordinary high quality” and “adulterated with diethylene glycol”.

“The report from the Madhya Pradesh drug regulatory authority continues to be awaited,’’ a senior Health Ministry official mentioned.

Speaking on the outcomes of Sunday’s emergency assembly known as by the Union Health Ministry, sources within the Ministry mentioned that sustaining high 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 items will probably be cancelled,’’ the official mentioned.

The revised Schedule M is an up to date set of Good Manufacturing Practices (GMP) and laws for pharmaceutical merchandise in India, part of the Drugs and Cosmetics Act, 1940.

It mandates enhanced high quality techniques, together with a Pharmaceutical Quality System, and Quality Risk Management, with a compliance deadline of December 31, 2025. The revisions align Indian requirements with worldwide GMP tips, emphasising product high quality and security, and require new infrastructure, together with computerised storage techniques and gear validation. 

Additionally, States have been requested to make sure rational use of cough syrups, notably amongst kids, as most coughs are self-limiting and don’t require pharmacological therapy, the supply mentioned.

The Ministry has additionally requested States and Union Territories to make sure enhanced surveillance; well timed reporting by all well being amenities; wider dissemination of the group reporting software of the Integrated Disease Surveillance Programme as it’s merged into the Integrated Health Information Platform; and strengthened inter-State coordination for early reporting and joint motion.