Centre urges states and UTs to ensure rational use of cough syrups amid safety concerns, following child deaths linked to contaminated medicines. The Health Ministry emphasizes strict compliance with drug standards and enhanced pediatric surveillance.
In response to growing concerns over the quality and use of cough syrups, particularly among children, the Union Health Ministry has issued fresh directives to all states and Union Territories (UTs) to ensure the rational use of these medications. Most coughs, the ministry highlighted, are self-limiting and do not require pharmacological intervention.
A high-level meeting chaired by Health Secretary Punya Salila Srivastava convened on Sunday with representatives from all states and UTs to review compliance with drug quality norms and strengthen protocols for the administration of cough syrups in pediatric populations. This initiative follows earlier instructions from Health Minister J.P. Nadda, who emphasized the need for coordinated state-level action to address the matter effectively.
The move comes in the wake of recent reports of child deaths in Chhindwara, Madhya Pradesh, allegedly linked to contaminated cough syrups. The Metropolitan Surveillance Unit (MSU), Nagpur, under the Pradhan Mantri–Ayushman Bharat Health Infrastructure Mission (PM-ABHIM), had reported a cluster of cases to the Integrated Disease Surveillance Programme (IDSP) and the National Centre for Disease Control (NCDC), prompting immediate government attention.
In response, a central team of experts comprising epidemiologists, microbiologists, entomologists, and drug inspectors from the NCDC, National Institute of Virology (NIV), and Central Drugs Standard Control Organisation (CDSCO) visited Chhindwara and Nagpur. The team conducted a detailed assessment of the reported cases and deaths in coordination with Madhya Pradesh state authorities. Various clinical, environmental, entomological, and drug samples were collected and sent to premier laboratories including NIV Pune, Central Drugs Testing Laboratory (CDTL) in Mumbai, and NEERI Nagpur for chemical and microbiological testing.
Preliminary investigations ruled out common infectious diseases except for a single positive case of leptospirosis. Nineteen medicinal samples, consumed by affected children, were collected from private practitioners and local retail outlets. Chemical analysis of ten samples completed so far indicates that nine of them meet prescribed quality standards. However, one sample—the cough syrup “Coldrif”—was found to contain diethylene glycol (DEG) beyond permissible limits.
Following these findings, the Tamil Nadu Food and Drug Administration (FDA) took regulatory action against the manufacturing unit located in Kancheepuram, Tamil Nadu. CDSCO has recommended the cancellation of the unit’s manufacturing license, and criminal proceedings have been initiated.
Health Secretary Srivastava emphasized strict adherence to the Revised Schedule M regulations by all drug manufacturers. States were also advised to ensure the rational use of cough syrups, particularly in children, as most pediatric coughs do not require medicinal intervention. The advisory issued by the Directorate General of Health Services (DGHS) on the rational use of pediatric cough syrups was discussed in detail during the meeting.
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States and UTs were further instructed to enhance surveillance, ensure timely reporting from all health facilities—both government and private—and promote the use of the community reporting tool of IDSP-IHIP. Strengthened inter-state coordination was highlighted as a key strategy for early detection and joint action in response to outbreaks or unusual health events.
The Health Ministry’s proactive measures underline the government’s commitment to safeguarding children from potentially hazardous pharmaceuticals and promoting evidence-based administration of cough remedies. By ensuring compliance with quality standards, enhancing surveillance, and promoting rational use, authorities aim to prevent further incidents and restore public confidence in pediatric healthcare.
