New Delhi, Oct 6: Following the tragic deaths of 12 children in Madhya Pradesh and Rajasthan, allegedly linked to contaminated cough syrups, the Union Health Ministry is set to issue new guidelines on the rational use of cough medications, particularly for paediatric patients.
The guidelines, aimed at parents, pharmacists, and healthcare providers, will soon be shared with states and union territories, a ministry official said. The decision comes after a high-level review meeting chaired by Union Health Secretary Punya Salila Srivastava, attended by officials from central and state drug regulatory authorities, health departments, and institutions like the Indian Council of Medical Research (ICMR).
The Director General of Health Services (DGHS) had earlier cautioned against the use of cough syrups in children under two years, noting that most acute cough illnesses in this age group are self-limiting and do not require medications.
In parallel, the Ministry has launched Risk-Based Inspections (RBI) of 19 pharmaceutical units across six states to identify systemic lapses in manufacturing practices and strengthen quality assurance mechanisms. States and UTs have also been directed to enhance disease surveillance and ensure timely reporting of unusual health events, including wider use of the Integrated Disease Surveillance Programme (IDSP-IHIP) and improved inter-state coordination.
The meeting emphasized strict compliance with the revised Schedule M — the updated Good Manufacturing Practices (GMP) norms — with stringent action against violators. The urgency follows reports confirming that Coldrif, a cough syrup manufactured in Tamil Nadu, contained diethylene glycol (DEG) above permissible limits. The Kancheepuram unit’s manufacturing licence is under recommendation for cancellation, and criminal proceedings have been initiated.
Of the 10 syrup samples tested, nine met quality standards, with Coldrif being the only contaminated product.
Dr. Sunita Sharma (DGHS) highlighted the minimal clinical benefit of cough syrups for children and the serious risks associated with irrational combinations and overlapping doses, stressing the need for rational use in paediatrics. Dedicated guidelines will soon be disseminated to doctors, pharmacists, and caregivers.
Dr. Rajiv Bahl, Secretary of the Department of Health Research and DG of ICMR, also advised against routine prescription of combination cough syrups for children and urged states to strengthen inter-agency coordination for rapid response during medical emergencies. (Agencies)
