Union Health Secretary reviews drug quality and rational use of cough syrups with states and UTs

In response to recent concerns regarding the quality and administration of cough syrups, the Union Ministry of Health and Family Welfare convened a high-level meeting on 5 October 2025. The meeting was chaired by the Union Health Secretary, Punya Salila Srivastava, and included representatives from all States and Union Territories. The agenda focused on ensuring compliance with drug quality standards and promoting the rational use of cough syrups, particularly among children.

The review followed directions from the Union Minister of Health and Family Welfare, J.P. Nadda, who had earlier asked that the matter be discussed with States and UTs to facilitate necessary actions. The meeting was attended by Amit Agarwal, Secretary, Department of Pharmaceuticals; Dr Rajiv Bahl, Secretary, Department of Health Research and Director General, 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); and health and drug control officials from across States and UTs.

Three main agenda points were discussed: compliance with Schedule M and related quality standards in drug manufacturing units; rational use of cough syrups in children; and stronger regulation of retail pharmacies to prevent misuse of such formulations.

The meeting follows reports of child deaths in Chhindwara, Madhya Pradesh, allegedly linked to contaminated cough syrups. A cluster of cases and related deaths was reported by the Metropolitan Surveillance Unit (MSU), Nagpur, to the Integrated Disease Surveillance Programme (IDSP) and NCDC. In response, a Central team of experts from NCDC, National Institute of Virology (NIV), and Central Drugs Standard Control Organisation (CDSCO) visited Chhindwara and Nagpur to assess the situation. Clinical, environmental, entomological, and drug samples were collected and sent to NIV Pune, Central Drug Laboratory (CDL) Mumbai, and NEERI Nagpur for testing.

Preliminary findings ruled out common infectious diseases, with one positive case of Leptospirosis reported. Nineteen medicine samples were collected, of which ten have been analysed. Nine of these met quality standards, while one sample, identified as the cough syrup ‘Coldrif,’ was found to contain diethylene glycol (DEG) beyond the permissible limit. The syrup was traced to a manufacturing unit in Kancheepuram, Tamil Nadu. The Tamil Nadu Food and Drug Administration has taken regulatory action, and CDSCO has recommended cancellation of the manufacturing licence. Criminal proceedings have also been initiated.

The Union Health Secretary stressed the need for strict compliance with the Revised Schedule M by all drug manufacturers. States were advised to promote rational use of cough syrups, particularly in paediatric cases, as most coughs are self-limiting and do not require pharmacological treatment. The advisory issued by DGHS on the rational use of paediatric cough syrups was also discussed.

Risk-Based Inspections (RBI) have been initiated across 19 manufacturing units in six States to identify systemic gaps and strengthen quality assurance mechanisms. States and UTs were asked to ensure enhanced surveillance, timely reporting by all health facilities (government and private), and dissemination of the community reporting tool of IDSP-IHIP. Inter-state coordination for early reporting and joint response to health events was also emphasised.

Dr Rajiv Bahl advised that children should not be prescribed cough syrups or drug combinations due to potential side effects. He noted that the National Joint Outbreak Response Team is active and coordinating efforts between central agencies such as NCDC and ICMR, and recommended that States strengthen internal coordination for rapid response.

Dr Sunita Sharma stated that cough medications have minimal proven benefit in children and can pose risks. She highlighted the need to check for combined overdose and drug concentration levels. She also informed that guidelines for parents, pharmacists, and doctors would be prepared and shared with States.

Dr Rajeev Raghuvanshi reiterated that drug manufacturers must comply with the Revised Schedule M for Good Manufacturing Practices (GMP). He noted that certain firms under the government’s infrastructure upgradation scheme have been granted an extension until December 2025, and urged States to implement the revised GMP norms.

The Department of Pharmaceuticals informed that several manufacturing units have started utilising the Revamped Pharmaceuticals Technology Upgradation Assistance Scheme (RPTUAS) for GMP improvements.

The Principal Secretary (Health), Rajasthan, shared that their investigation indicates the four deaths reported were not linked to the quality of cough syrup. Awareness campaigns on the rational use of paediatric formulations are being conducted, and regulatory actions have been taken as a precaution. Further investigations are ongoing.

The Secretary, Medical Education (Maharashtra), stated that children admitted to medical institutions in Nagpur are receiving appropriate care.

States and UTs briefed the Ministry on their current efforts and best practices for strengthening drug quality control and administration.

The Union Health Secretary reiterated the importance of enhanced surveillance, community reporting, and inter-state coordination. The Ministry reaffirmed its commitment to maintaining high standards of drug quality and patient safety and directed all States and UTs to take swift, coordinated, and sustained actions to prevent recurrence of such incidents.