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Take note! Popular anti-cold fixed drug combination banned by Centre for children under 4 years – Times of India

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India’s drug regulator has prohibited the use of a popular anti-cold medicine cocktail for children under the age of four. The decision, made by a panel of experts, comes with the requirement for pharmaceutical companies to include a warning on the medicine label and package insert. In a letter dated December 18, the drug regulator advised against administering the fixed-dose combination (FDC) of chlorpheniramine maleate and phenylephrine to children under the age of four.
This ban affects several pharma companies, including GlaxoSmithKline, Glenmark, Alembic Pharma, and IPCA Laboratories, who will now have to carry this warning.
The scrutiny of fixed-dose combinations (FDCs) in India began in 2016. A committee, led by CK Kokate, reviewed the safety, efficacy, and therapeutic justification of various combinations. The combination of chlorpheniramine maleate IP 2mg and Phenylephrine HCI IP 5mg per ml was initially considered “rational” by the Kokate committee. Consequently, a ‘no-objection’ certificate was issued in 2015, allowing its manufacturing and marketing.
However, concerns were raised regarding the promotion of anti-cold drug formulations for infants, prompting a reevaluation. In 2016, the Indian government banned 344 FDCs based on the Kokate committee’s report, which deemed them “irrational” stating that they pose health risks. Some pharmaceutical companies and groups challenged the government’s decision in court.
In 2012, a parliamentary standing committee of the health ministry had already highlighted the issue of state licensing authorities granting manufacturing licenses for numerous FDCs without proper clearance from the central drug authority. This resulted in the availability of untested FDCs, raising concerns about their safety and efficacy.
Read From ET | Ban on anti-cold cocktail medicine
The recent ban on the use of the popular anti-cold medicine cocktail for children under four is a measure taken by the drug regulator to ensure the well-being of young patients. Pharmaceutical companies are now required to comply with the warning label mandate.



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