The Union Ministry of Health and Family Welfare convened a high-level meeting under the chairmanship of Union Health Secretary to address recent concerns regarding the quality and administration of cough syrups, particularly in children. The meeting, attended by top officials from the Ministry of Health, Department of Pharmaceuticals, ICMR, and Drugs Controller General of India (DCGI), resulted in strict directives for all States and Union Territories.
Key Mandates and Directives
The discussions focused on three critical areas: drug quality compliance, rational use of medication, and strengthened surveillance.
1. Compliance with Revised Schedule M (GMP)
The Union Health Secretary and the DCGI emphasized the necessity for strict compliance with the Revised Schedule M for Good Manufacturing Practices (GMP) by all drug manufacturers.
States were directed to undertake a thorough exercise to identify non-compliant manufacturing units and take immediate and strict action against them.
The Department of Pharmaceuticals noted that many units are already utilizing the Revamped Pharmaceuticals Technology Upgradation Assistance Scheme (RPTUAS) for GMP upgradation. The DCGI urged states to strictly implement the revised GMP norms, noting that certain firms have an extension until December 2025 for infrastructure upgrades.
2. Rational Use of Cough Syrups in Children
The Ministry issued a strong advisory focusing on the unnecessary use of cough syrups in pediatric populations:
Dr. Rajiv Bahl (ICMR) stated that children should not be prescribed cough syrups or any combination of drugs to prevent side-effects.
Dr. Sunita Sharma (DGHS) stressed that cough medications have minimal proven benefit in children but carry significant risks. She highlighted the need to check medications to avoid combined overdose and concentration issues.
States were exhorted to ensure the rational use of cough syrups, particularly among children, as most coughs are self-limiting and do not require pharmacological treatment. Guidelines for parents, pharmacists, and doctors on rational use will be formulated and shared shortly.
3. Enforcement and Surveillance
The Ministry called for immediate steps to enhance coordination and regulatory action:
States were advised to ensure enhanced surveillance, timely reporting by all health facilities (government and private), and strengthened inter-state coordination for early reporting and joint action in the context of outbreaks or unusual health events.
States must ensure wider dissemination of the community reporting tool of IDSP-IHIP.
Risk-Based Inspections (RBI) have already been initiated across 19 manufacturing units in six States to identify systemic gaps.
Contamination Incident and Action Taken
The high-level meeting was convened following reports of child deaths in Chhindwara, Madhya Pradesh, allegedly linked to contaminated cough syrups.
A Central team of experts visited Chhindwara and Nagpur for a detailed analysis. Preliminary findings ruled out common infectious diseases, save for one case of Leptospirosis.
Out of 10 analyzed medicine samples consumed by the children, nine met quality standards. However, one sample, the cough syrup ‘Coldrif’, contained Diethylene Glycol (DEG) beyond the permissible limit.
Regulatory action was swiftly taken by the Tamil Nadu FDA against the unit located in Kancheepuram, Tamil Nadu. The CDSCO has recommended cancellation of the manufacturing license, and criminal proceedings have been initiated.
The meeting concluded with the Union Health Ministry reaffirming its commitment to drug quality and patient safety, directing all States and UTs to take swift, coordinated, and sustained action to prevent the recurrence of such incidents.