In view of recent reports of child deaths in Chhindwara, Madhya Pradesh, allegedly linked to contaminated cough syrups, the Union Health Secretary has directed all drug manufacturers to strictly comply with the Revised Schedule M for Good Manufacturing Practices (GMP).

States were advised to ensure rational use of cough syrups, particularly among children, as most coughs are self-limiting and do not require pharmacological treatment.

Union Health Secretary Punya Salila Srivastava issued the directive during a high-level meeting with state health authorities and union territories to review compliance with drug quality norms and promote the rational use of cough syrups, especially in paediatric populations. 

The meeting was attended by senior officials including Amit Agarwal, Secretary, Department of Pharmaceuticals; Dr Rajiv Bahl, Secretary, Department of Health Research and DG, ICMR; Dr Sunita Sharma, Director General of Health Services (DGHS); Dr Rajeev Raghuvanshi, Drugs Controller General of India (DCGI); Dr Ranjan Das, Director, National Centre for Disease Control (NCDC); as well as health secretaries, drug controllers, NHM mission directors, and other key stakeholders from across states and union territories.

Srivastava informed that Risk-Based Inspections (RBI) have already been launched at 19 manufacturing units in six states to identify systemic gaps and strengthen quality assurance mechanisms.

States and UTs were also directed to ensure enhanced surveillance, timely reporting by all health facilities (both government and private), wider dissemination of the community reporting tool of IDSP-IHIP, and strengthened inter-state coordination for early reporting and joint action in the context of outbreak response and unusual health events.  

DCGI Dr Raghuvanshi reiterated the need for drug manufacturing units to strictly comply with the Revised Schedule M. He noted that firms that have applied for the government’s infrastructure upgradation scheme have been given an extension till December 2025 and urged states to implement the revised GMP norms strictly.

The Department of Pharmaceuticals added that many mmanufacturing units have started availing of the Revamped Pharmaceuticals Technology Upgradation Assistance Scheme (RPTUAS) for GMP upgradation.

The Union Health Ministry reaffirmed its commitment to ensuring the highest standards of drug quality and patient safety, calling on states and UTs to take swift, coordinated, and sustained action to prevent recurrence of such incidents.

The Metropolitan Surveillance Unit (MSU), Nagpur, established under the Pradhan Mantri–Ayushman Bharat Health Infrastructure Mission (PM-ABHIM), had reported a cluster of cases and related deaths to IDSP, NCDC from a Block in Chhindwara District, Madhya Pradesh. Chhindwara, Madhya Pradesh.

Following this, a Central team of experts comprising epidemiologists, microbiologists, entomologists and drug inspectors from the National Centre for Disease Control (NCDC), National Institute of Virology (NIV) and Central Drugs Standard Control Organisation (CDSCO) visited Chhindwara and Nagpur and undertook a detailed analysis 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 NIV Pune, Central Drug Laboratory (CDL) Mumbai, and NEERI Nagpur for laboratory testing.

Preliminary findings ruled out common infectious diseases except for one positive case of Leptosprirosis. Nineteen medicine samples consumed by affected children were collected from treating private practitioners and nearby retail stores. Of the ten samples analysed so far, nine met quality standards. However, one sample—cough syrup ‘Coldrif’—was found to contain diethylene glycol (DEG) beyond the permissible limit. 

Subsequently, regulatory action has been taken against the manufacturing unit in Kancheepuram, Tamil Nadu, by the state FDA. The CDSCO has recommended cancellation of the unit’s manufacturing license based on inspection findings, and criminal proceedings have been initiated.