India’s Union Health Ministry is demanding strict adherence from all pharmaceutical manufacturers to the updated Schedule M norms for drug production. The Ministry has issued a stern warning: any manufacturing units failing to comply will have their licenses revoked.
This crucial directive follows an urgent meeting held on Sunday (October 5, 2025) with all States and Union Territories. The meeting was prompted by a disturbing report from the Tamil Nadu Drugs Control Department, which identified dangerously high levels of diethylene glycol (DEG) in samples of a popular cough syrup, Coldrif.
Related: Syrup death toll mounts to 14 in Madhya Pradesh; government doctor held for prescribing adulterated syrup
The scrutiny of cough syrup brands began after the tragic deaths of over 10 children in Rajasthan and Madhya Pradesh recently.
Initial investigations over the past week have largely excluded common infectious diseases, with only one instance of leptospirosis confirmed. Authorities collected nineteen medicine samples that the affected children had consumed from private clinics and local pharmacies. Of the ten samples analyzed to date, nine were found to meet quality standards. However, one specific product, the cough syrup Coldrif, was found to contain diethylene glycol (DEG) exceeding acceptable limits. As a result, the Tamil Nadu Food and Drugs Administration has already taken regulatory action against the Kancheepuram-based manufacturing unit. The Central Drugs Standard Control Organisation has recommended the cancellation of its manufacturing license following inspections, and criminal proceedings are now underway, as confirmed by the Health Ministry on Sunday.
Immediately after a government drug testing laboratory revealed that a batch of Coldrif cough syrup was “not of standard quality” and “adulterated with diethylene glycol,” Tamil Nadu’s Drugs Control Department issued a swift stop-production order to the manufacturer.
A senior Health Ministry official noted that the report from the Madhya Pradesh drug regulatory authority is still pending.
During Sunday’s emergency meeting, sources within the Union Health Ministry revealed that the emphasis was placed on ensuring drug quality and promoting the rational use of cough syrups.
“The Union Ministry has demanded rigorous adherence to manufacturing standards and reiterated that licenses of non-compliant facilities will be revoked,” the official stated.
The updated Schedule M outlines a revised set of Good Manufacturing Practices (GMP) and regulations for pharmaceutical products in India, integral to the Drugs and Cosmetics Act of 1940.
These mandates include stricter quality systems, such as a comprehensive Pharmaceutical Quality System and robust Quality Risk Management, with a compliance deadline set for December 31, 2025. The revisions aim to bring Indian manufacturing standards in line with global GMP guidelines, prioritizing product quality and patient safety. This also necessitates new infrastructure, including advanced computerized storage systems and thorough equipment validation.
Furthermore, states have been advised to promote the judicious use of cough syrups, especially for children, as most coughs resolve naturally without the need for medication, according to the source.
The Ministry has additionally urged States and Union Territories to implement enhanced surveillance measures, ensure prompt reporting from all healthcare facilities, broadly publicize the Integrated Disease Surveillance Programme’s community reporting tool (now part of the Integrated Health Information Platform), and foster stronger inter-State collaboration for swift reporting and coordinated responses.