In view of concerns relating to the quality and administration of cough syrups, the government on Sunday directed states to ensure rational use of cough syrups, particularly among children, as most coughs are self-limiting and do not require pharmacological treatment.
The Health Ministry convened a high-level meeting under the chairmanship of the 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 populations.
The matter had been earlier reviewed by Health Minister J.P. Nadda, who had directed that the matter may be discussed with states/UTs to ensure necessary actions.
The meeting follows recent reports of child deaths in Chhindwara, Madhya Pradesh, allegedly linked to contaminated cough syrups.
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 (IDSP), National Centre for Disease Control (NCDC) from a Block in Chhindwara District, Madhya Pradesh.
Taking cognisance of the situation, a Central team of experts comprising epidemiologists, microbiologists, entomologists and drug inspectors from the 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 Drugs Testing Laboratory (CDTL) in Mumbai and NEERI Nagpur for laboratory testing.
Preliminary findings ruled out common infectious diseases except for one positive case of Leptospiriosis. Nineteen medicine samples, which had been consumed by children, were collected from treating private practitioners and nearby retail stores.
The chemical analysis so far indicates that out of 10 samples analysed till date, nine meet quality standards.
“However, one of them, viz, cough syrup ‘Coldrif’, contains DEG beyond the permissible limit. Subsequently, regulatory action has been taken by the Tamil Nadu – FDA on the Unit, which is located in Kancheepuram, Tamil Nadu. Cancellation of the manufacturing licence has been recommended by CDSCO based on inspection findings. Criminal proceedings have also been initiated,” according to the ministry.
The Health Secretary emphasised strict compliance with the Revised Schedule M by all drug manufacturers. States were also advised to ensure rational use of cough syrups, particularly among children, as most coughs are self-limiting and do not require pharmacological treatment.
The advisory issued by the DGHS on the rational use of cough syrups in paediatric populations was also discussed.
States and UTs were also advised 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.
