The Union Health Ministry has directed all pharmaceutical manufacturers across India to strictly adhere to the revised Schedule M norms under the Drugs and Cosmetics Act, 1940. The Ministry warned it will immediately cancel the licences of non-compliant units.
Emergency Meeting Follows Detection of Toxic Contaminant in Cough Syrup
The directive came after an emergency meeting with State and Union Territory health authorities on Sunday, October 5, 2025. The meeting followed a report from the Tamil Nadu Drugs Control Department, which detected above-permissible levels of diethylene glycol (DEG)—a toxic industrial solvent—in samples of Coldrif, a cough syrup brand.
Investigators discovered the contamination while probing the deaths of more than ten children in Rajasthan and Madhya Pradesh. Latest reports show 14 deaths in Madhya Pradesh, where authorities arrested a government doctor for prescribing the adulterated syrup.
Investigations Reveal Source of Contamination
Authorities collected 19 medicine samples from private practitioners and nearby retail stores for chemical analysis. Of the 10 samples tested so far, nine met quality standards, while one—Coldrif cough syrup—contained DEG beyond permissible limits.
Following the discovery, the Tamil Nadu Food and Drugs Administration (TN FDA) ordered the manufacturer, based in Kancheepuram, to halt production immediately. The Central Drugs Standard Control Organisation (CDSCO) has recommended cancellation of the company’s manufacturing licence and initiated criminal proceedings against those responsible.
“The report from the Madhya Pradesh drug regulatory authority is still awaited,” a senior Health Ministry official said.
States Asked to Intensify Quality Checks and Surveillance
During the emergency review, the Health Ministry emphasized the importance of maintaining strict manufacturing quality and promoting the rational use of cough syrups. “The Union Ministry has sought strict compliance to the revised norms and warned that licences of non-compliant units will be cancelled,” the official reiterated.
The Ministry also launched risk-based inspections of drug manufacturing firms across the country to prevent similar incidents.
Revised Schedule M: Strengthening Good Manufacturing Practices
As reported by The Hindu, the revised Schedule M outlines updated Good Manufacturing Practices (GMP) and quality control measures for pharmaceutical products in India. The new framework mandates enhanced quality systems, including Pharmaceutical Quality Systems and Quality Risk Management.
All manufacturers must comply by December 31, 2025. The updated guidelines align Indian pharmaceutical standards with international GMP norms, emphasizing stringent product safety and quality assurance. They also require advanced infrastructure such as computerised storage systems and validated equipment.
Guidelines on Rational Use of Cough Syrups
The Ministry has instructed States to promote rational prescription practices, particularly for children. Most coughs are self-limiting and do not require pharmacological treatment.
Enhanced Disease Surveillance and Coordination
In addition, States and Union Territories have been asked to strengthen disease surveillance and ensure timely reporting of adverse events from all health facilities. The Ministry urged wider dissemination of the community reporting tool under the Integrated Disease Surveillance Programme (IDSP), now merged into the Integrated Health Information Platform (IHIP).
Authorities have reinforced inter-State coordination to detect early, report transparently, and take swift joint action in future drug-related health emergencies
Towards Safer Pharmaceutical Practices
The Union Health Ministry is enforcing strict compliance with the revised Schedule M and enhancing surveillance mechanisms. These measures aim to restore confidence in India’s pharmaceutical safety standards. They also seek to prevent future tragedies caused by contaminated or substandard medicines.