NEW DELHI: In response to concerns about the deaths of children due to substandard cough syrups in Rajasthan and Madhya Pradesh, the central government swung into action as the Union Health Ministry held a high-level meeting on Sunday with all the States and Union Territories to ensure compliance with drug quality standards.
At least 16 children have died in Madhya Pradesh, and two in Rajasthan, allegedly linked to contaminated cough syrups.
The meeting, which was held by Union Health Secretary Punya Salila Srivastava, discussed three key points, including compliance with general statutory rules regarding quality standards in drug manufacturing, rational use of cough syrup for children and strengthening the regulation of retail pharmacies.
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 the Integrated Disease Surveillance Programme of the National Centre for Disease Control (NCDC) from a Block in Chhindwara District of Madhya Pradesh.
“Taking cognisance of the situation, a Central team of experts comprising epidemiologists, microbiologists, entomologists and drug inspectors from 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,” said a statement by the Union Health ministry, adding that “Preliminary findings ruled out common infectious diseases except for one positive case of Leptospirrosis.
Nineteen medicine samples, which children had consumed, were collected from treating private practitioners and nearby retail stores.
The chemical analysis to date indicates that out of 10 samples analysed, 9 meet the quality standards. However, one of them, viz, cough syrup ‘Coldrif’, contains DEG beyond the permissible limit.
Subsequently, the Tamil Nadu FDA has taken regulatory action against the unit located in Kancheepuram, Tamil Nadu.
The ministry said CDSCO has recommended the cancellation of the manufacturing license based on inspection findings. “Criminal proceedings have also been initiated.”
The Centre has also initiated Risk-Based Inspections across 19 manufacturing units in six states to identify systemic gaps and strengthen quality assurance mechanisms.
Dr Rajiv Bahl, Secretary, Department of Health Research, advised that children should not be prescribed cough syrups or any combination of drugs to prevent side effects.
