All states and UTs asked to ensure compliance with Revised Schedule M; Health Ministry stresses rational use of cough syrups as most childhood coughs are self-limiting
New Delhi: In the wake of recent incidents linked to the use of contaminated cough syrups, the Union Ministry of Health and Family Welfare held a high-level meeting chaired by Union Health Secretary Punya Salila Srivastava with all States and Union Territories to review drug quality compliance, enforcement of Revised Schedule M norms, and the rational use of cough syrups, especially among children.
The review meeting, held in coordination with top health and pharmaceutical officials, follows directives from Union Health Minister J.P. Nadda, who earlier ordered an inter-state review after reports of child deaths in Chhindwara, Madhya Pradesh, allegedly linked to a contaminated cough syrup.
The meeting was attended by Amit Agarwal, Secretary (Pharmaceuticals), Dr Rajiv Bahl, DG ICMR, Dr Sunita Sharma, DGHS, Dr Rajeev Raghuvanshi, DCGI, and senior state officials from all Health Departments and Drug Control authorities.
Key Focus Areas of the Meeting
- Strict compliance with Revised Schedule M and other GSR standards to ensure quality control across drug manufacturing units.
- Rational use of cough syrups in children, avoiding irrational combinations and unnecessary medication.
- Enhanced regulation of retail pharmacies to curb misuse and over-the-counter sales of unsafe formulations.
Central Team Findings
Following the Madhya Pradesh incident, a multi-agency team of experts from NCDC, NIV, and CDSCO conducted a detailed investigation in Chhindwara and Nagpur.
Preliminary lab results confirmed that out of 10 tested samples, one cough syrup brand, “Coldrif,” contained Diethylene Glycol (DEG) beyond permissible limits. The Tamil Nadu FDA has initiated action against the Kancheepuram-based manufacturer, including license cancellation and criminal proceedings.
Union Health Secretary’s Directives
Health Secretary Punya Salila Srivastava stressed that all pharmaceutical companies must strictly adhere to the revised Schedule M guidelines for Good Manufacturing Practices (GMP).
States and UTs were advised to:
- Strengthen drug quality surveillance and real-time reporting under the IDSP-IHIP system.
- Ensure timely submission of test results from public and private laboratories.
- Promote rational prescription and use of paediatric cough syrups, since most childhood coughs are self-limiting and do not need medication.
Expert Observations
Dr Rajiv Bahl (ICMR) cautioned that children should not be prescribed cough syrups unnecessarily due to potential adverse side effects, and highlighted that the National Joint Outbreak Response Team is already operational to assist states.
Dr Sunita Sharma (DGHS) noted that paediatric cough syrups offer minimal proven benefits but carry high risks, and announced upcoming guidelines for doctors, pharmacists, and parents to promote safer practices.
Dr Rajeev Raghuvanshi (DCGI) reiterated that manufacturing units must align with revised GMP standards, adding that firms availing government support under the Revamped Pharma Technology Upgradation Scheme have been granted time till December 2025 to comply.
State Updates
- Rajasthan Health Secretary reported that their inquiry found no direct link between cough syrup quality and the four child deaths, but awareness drives on rational paediatric use are underway.
- Maharashtra officials informed that children hospitalized in Nagpur are receiving optimal care.
Conclusion
The Union Health Ministry reaffirmed its commitment to patient safety and drug quality, urging states to take swift and coordinated action to prevent recurrence of such tragedies.
About the Author
