Amid growing concerns over recent fatalities among infants caused due to contaminated cough syrups, the Indian Pharmacists Association has reportedly restricted pharmacies from dispensing these products to children under two.
The advisory makes it clear that no cough syrup or combination containing antihistamines, decongestants, antitussives, or expectorants should be given to this age group, even with a doctor’s prescription or over-the-counter request, according to a report by The Economic Times.
“All Pharmacists working in community and hospital harms IRS are hereby advised to strictly comply with the guidelines issued by the Ministry of Health & Family Welfare (MOHFW) and the Central Drugs Standard Control Organisation (CDSCO) regarding the non-use of cough and cold preparations in children below two (2) years of age,” the report quoted the advisory.
In cases where cough syrup is prescribed for a child under two, the pharmacist must responsibly bring it to the notice of the prescriber and recommend a review in line with MOHFW guidelines, it said.
It also directed pharmacists to inform parents and caregivers about the hazards of using these cough medications in infants and to propose safer, non-pharmaceutical options -- including good hydration, saline nasal drops, humid air, and medical consultation with a pediatrician.
“These preparations have been associated with serious and potentially life-threatening adverse effects in infants, such as respiratory depression, excessive sedation, and toxicity,” the advisory said.
The union health ministry on October 5 convened a high-level meeting, under the chairmanship of 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 populations.
The matter had been earlier reviewed by union minister JP Nadda, who had directed that the matter may be discussed with states/UTs to ensure necessary actions.
The union 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.
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