‘Coldrif’: Centre Reviews Drug Quality and Cough Syrup Safety with States After Child Deaths

New Delhi, 5th October 2025: Amid growing concerns over the safety and misuse of cough syrups, particularly among children, the Union Ministry of Health and Family Welfare held a high-level meeting with health officials from all States and Union Territories to review compliance with drug quality norms and promote the rational use of cough syrups.

The meeting, chaired by Union Health Secretary Punya Salila Srivastava, followed directives from Union Health Minister J.P. Nadda, who had asked for immediate consultations with States and UTs to ensure strict enforcement of safety and manufacturing standards.

Senior officials including Amit Agarwal, Secretary of the Department of Pharmaceuticals; Dr Rajiv Bahl, Director General of ICMR and Secretary of Health Research; Dr Sunita Sharma, Director General of Health Services; Dr Rajeev Raghuvanshi, Drugs Controller General of India; and Dr Ranjan Das, Director of the National Centre for Disease Control (NCDC), attended the meeting along with State Health Secretaries, Drug Controllers, and NHM Mission Directors.

Focus on Drug Quality, Rational Use, and Retail Regulation

The discussion focused on three major areas — adherence to Schedule M norms for good manufacturing practices, discouraging the irrational use of cough syrups in children, and strengthening retail pharmacy regulations to prevent misuse of such formulations.

The review meeting came in the wake of the recent child deaths in Chhindwara district of Madhya Pradesh, which were allegedly linked to contaminated cough syrup. The Metropolitan Surveillance Unit (MSU), Nagpur, under the Pradhan Mantri–Ayushman Bharat Health Infrastructure Mission (PM-ABHIM), had reported a cluster of similar cases to the Integrated Disease Surveillance Programme (IDSP).

Central Team Conducts Probe in Madhya Pradesh and Maharashtra

Following the incident, a central team of experts — including epidemiologists, microbiologists, entomologists, and drug inspectors from NCDC, National Institute of Virology (NIV) and Central Drugs Standard Control Organisation (CDSCO) — visited Chhindwara and Nagpur to investigate the reported deaths. The team collected clinical, environmental, and pharmaceutical samples for testing at NIV Pune, Central Drug Laboratory Mumbai, and NEERI Nagpur.

Preliminary reports ruled out infectious diseases, except for one case of leptospirosis. Out of 19 drug samples tested from local pharmacies and private clinics, 10 were analyzed so far. While nine samples met prescribed quality standards, one cough syrup — ‘Coldrif’ — was found to contain diethylene glycol (DEG) beyond permissible limits.

Following this finding, the Tamil Nadu FDA took regulatory action against the manufacturer located in Kancheepuram, and CDSCO recommended cancellation of the company’s license. Criminal proceedings have also been initiated against the unit.

Health Ministry Calls for Strict Enforcement and Surveillance

The Union Health Secretary instructed all States to ensure strict adherence to the revised Schedule M for pharmaceutical manufacturing and to monitor the rational use of paediatric cough syrups, noting that most coughs in children are self-limiting and do not require medication. The advisory on safe use of cough syrups among children, issued earlier by the DGHS, was also discussed during the meeting.

Officials informed that risk-based inspections are being conducted across 19 manufacturing units in six States to identify systemic gaps and improve quality assurance. States were also advised to strengthen disease surveillance, ensure timely reporting by both public and private healthcare facilities, and improve coordination for faster outbreak response.

Experts Emphasize Caution in Paediatric Prescriptions

Dr Rajiv Bahl advised doctors not to prescribe cough syrups or multiple drug combinations to children to avoid adverse effects. He said the National Joint Outbreak Response Team is fully operational to coordinate between central agencies such as NCDC and ICMR and assist States whenever needed.

Dr Sunita Sharma reiterated that cough syrups offer minimal benefits in children but carry significant risks. She said guidelines are being prepared for parents, pharmacists, and medical practitioners to promote responsible use and prevent overdose cases.

Dr Rajeev Raghuvanshi urged States to ensure that manufacturers fully comply with Good Manufacturing Practices (GMP) under the revised Schedule M. He added that companies availing benefits under the Revamped Pharmaceuticals Technology Upgradation Assistance Scheme (RPTUAS) have been given time till December 2025 to upgrade their facilities.

States Share Updates and Preventive Measures

Health officials from Rajasthan informed that preliminary findings suggest the four child deaths reported there were not linked to drug quality. However, an awareness campaign on safe paediatric drug use has been launched as a precautionary measure.

Officials from Maharashtra reported that children admitted to various hospitals in Nagpur are receiving the best possible treatment and that the situation is under close monitoring.

Centre Reaffirms Commitment to Drug Safety

The Health Secretary underlined the importance of enhanced surveillance, wider use of IDSP’s community reporting tools, and stronger inter-state coordination to detect and prevent such incidents. The Union Health 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 action to prevent the recurrence of similar tragedies.