Cough syrup deaths: Govt tells states, UTs to enforce quality norms strictly

Union health secretary urges states to enhance pharmaceutical surveillance after 12 child deaths linked to contaminated cough syrups; strict action promised.

New Delhi

Cough syrup deaths: Govt tells states, UTs to enforce quality norms strictly

Union health secretary on Sunday directed states to enhance surveillance of all pharmaceutical manufacturing units functioning within their jurisdiction for compliance of good manufacturing practices and take strict action against the defaulters.

The health secretary, Punya Salila Srivastava, chaired a high-level meeting with states and Union territories on quality and rational use of cough syrups following 12 deaths reported recently of children in Madhya Pradesh and Rajasthan allegedly linked to consuming contaminated cough syrups.

“In view of recent concerns relating to the quality and administration of cough syrups, the Union ministry of health and family welfare convened a high-level meeting under the chairmanship of the Union health secretary, Punya Salila Srivastava, with all states and Union Territories to review compliance with drug quality norms and promote the rational use of cough syrups, especially in paediatric population,” read the health ministry statement on the review meeting.

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 Integrated Disease Surveillance Programme, National Centre for Disease Control from a block in Chhindwara District, Madhya Pradesh.

Earlier, health minister JP Nadda reviewed the matter with experts and officials concerned and directed the health secretary to further discuss it with the states and Union territories to ensure necessary action.

Among the key issues discussed were ensuring pharmaceutical manufacturers comply with schedule M and other GSR provisions relating to quality standards in drug manufacturing units; rational use of cough syrups in children, including the need to avoid irrational combinations and inappropriate formulations; and strengthening regulation of retail pharmacies to prevent sale and misuse of such formulations.

Schedule M relates to the Good Manufacturing Practices (GMP) guidelines under the Drugs and Cosmetics Act, 1945, for pharma manufacturers to ensure product quality and safety. It looks at requirements for premises, equipment, and processes. The centre recently revised the guidelines to align with international standards keeping in view increasing pharma exports from India.

“Taking cognizance of the situation, a central team of experts comprising epidemiologists, microbiologists, entomologists, and drug inspectors from the National Centre for Disease Control, National Institute of Virology, Pune, 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,” said the health ministry.

According to the statement, preliminary findings ruled out common infectious diseases except for one positive case of Leptosprirosis. Nineteen medicine samples that had been consumed by children were collected from treating private practitioners and nearby retail stores. The chemical analysis so far indicates that of 10 samples analysed to date nine meet quality standards. However, one of them—cough syrup ‘Coldrif’— contained DEG beyond permissible limit, said the statement. Subsequently, regulatory action has been taken by Tamil Nadu – FDA on the unit which is located in Kancheepuram, Tamil Nadu. Cancellation of the manufacturing license has been recommended by CDSCO based on inspection findings. Criminal proceedings have also been initiated, the ministry said.