NEW DELHI: Indian government has banned the manufacture, sale, and distribution of certain FDC cough syrups for children under four, following fresh safety concerns. The move comes after expert medical panels raised red flags over possible health risks posed by the combination of chlorpheniramine maleate and phenylephrine hydrochloride in young children.
The Drug Technical Advisory Board (DTAB) and the Subject Expert Committee reviewed the safety and efficacy of these fixed-dose combination (FDC) cough syrups. Their recommendation led to a formal government order restricting their use in kids aged below four, citing a lack of proven benefits and potential health hazards.
This action targets specific FDC medicines that blend chlorpheniramine maleate—an antihistamine used to treat allergies—and phenylephrine hydrochloride—a decongestant commonly found in cold medications. While both are approved for adults and older children, experts highlighted insufficient safety data for toddlers and infants, who are more vulnerable to side effects.
The ban aligns with global health trends where regulatory agencies have cautioned against using certain over-the-counter cough and cold medicines for very young children. In several countries, similar formulations have already been restricted for infants due to risks like increased heart rate, excessive drowsiness, or even breathing problems.
Healthcare professionals and paediatricians across India have welcomed the decision. They say it sends a clear message that safety standards must be child-specific and backed by robust data.
The Health Ministry has urged pharmaceutical companies to comply immediately and withdraw these products from the market to avoid confusion among parents and caregivers. The move is also expected to raise awareness about the importance of age-appropriate medication and proper dosing in paediatrics.
- T-Minic – manufactured by Haleon (formerly GSK Consumer)
- Wikoryl AF – produced by Alembic Pharmaceuticals
- Solvin Cold AF – from IPCA Laboratories
- Delcon – by Veritaz Healthcare
- Coriminic – manufactured by Wanbury Ltd.
These syrups combine chlorpheniramine maleate, an antihistamine, with phenylephrine hydrochloride, a decongestant. While effective in older children and adults, the combination poses potential risks for younger children, such as increased heart rate, drowsiness, and breathing difficulties.
