New Delhi, Oct 6 (UNI) In the wake of the recent deaths of 12 children in Madhya Pradesh and Rajasthan, allegedly linked to contaminated cough syrups, the union Health Ministry is set to issue fresh guidelines on the rational use of cough medications, particularly for paediatric use.
The guidelines, aimed at parents, pharmacists, and healthcare providers, are expected to be shared with states and union Territories shortly, a Ministry official said.
The decision follows a high-level review meeting chaired by union Health Secretary Punya Salila Srivastava, yesterday attended by senior officials from Central and state drug regulatory authorities, health departments, and key institutions such as the Indian Council of Medical Research (ICMR).
The DGHS had recently cautioned against the use of cough syrups in children below two years of age, stating that most acute cough illnesses in this group are self-limiting and do not require medicines.
In a parallel move, the Ministry has initiated Risk-Based Inspections (RBI) of 19 pharmaceutical manufacturing units across six states. These inspections aim to identify systemic lapses in manufacturing practices and to bolster the existing quality assurance mechanisms.
States and union Territories have also been directed to enhance disease surveillance mechanisms and ensure timely reporting of unusual health events. Wider dissemination of the Integrated Disease Surveillance Programme (IDSP-IHIP) community reporting tool has been recommended, along with improved inter-state coordination for early detection and joint response to potential outbreaks.
The meeting reiterated the need for strict adherence to the revised Schedule M — the updated Good Manufacturing Practices (GMP) norms for drug manufacturers. Officials emphasised that stringent action would be taken against units found in violation.
The urgency comes after reports confirmed that Coldrif, a cough syrup manufactured in Tamil Nadu, contained diethylene glycol (DEG) beyond permissible limits. Following an inspection by regulatory authorities, the manufacturing licence of the concerned unit in Kancheepuram has been recommended for cancellation. Criminal proceedings have also been initiated, officials said.
Of the 10 syrup samples analysed so far, 9 were found to meet quality standards. Coldrif was the only one to test positive for DEG contamination, based on samples collected from private practitioners and local pharmacies.
Highlighting the minimal clinical benefit of cough syrups in children and the associated risks, Dr. Sunita Sharma, Director General of Health Services (DGHS), stressed the need for rational use of such medications in the paediatric population. She noted that irrational combinations and overlapping drug dosages can lead to serious side effects.
She added that dedicated guidelines on the rational use of cough syrups are being drafted and will be disseminated to doctors, pharmacists, and caregivers in the coming weeks.
Echoing the concern, Dr Rajiv Bahl, Secretary, Department of Health Research and Director General, ICMR, advised against the routine prescription of combination cough syrups for children, urging states to strengthen coordination across agencies for timely intervention during medical emergencies.
