In a letter dated December 18, the drug regulator said that FDC (fixed-dose combination) chlorpheniramine maleate and phenylephrine should not be given to children aged under four. It also said that the firms manufacturing it should carry a warning in this regard on the medicine label and package insert. The decision was taken after a review by a sub-committee of experts.
The development means several pharma companies, including GlaxoSmithKline, Glenmark, Alembic Pharma and IPCA Laboratories, will have to carry the warning.
The crackdown on FDCs in the country started in 2016. A committee under the chairmanship of CK Kokate, former vice-chancellor of KLE University in Karnataka, was formed to review the safety, efficacy and therapeutic justification of this combination. The combination drop of chlorpheniramine maleate IP 2mg and Phenylephrine HCI IP 5mg per ml was declared as “rational” by the Kokate committee and a ‘no-objection’ certificate was issued by the drug regulator in 2015 for continuation of its manufacturing and marketing.
However, the matter came to the fore again after concerns were raised regarding the promotion of anti-cold drug formulations for infants.
In 2016, the Centre banned 344 FDCs, pursuant to the report submitted on January 20, 2015 in which the Kokate committee had deemed the FDCs as “irrational”. The committee said that these FDCs posed health risks and, hence, should be banned, pushing some of the companies and the pharma groups to challenge in court the government’s notification banning FDCs.In 2012, a parliamentary standing committee of the health ministry had observed in its report that some of the state licensing authorities issued manufacturing licences for a large number of FDCs without prior clearance from the central drug authority, resulting in the availability of several FDCs which were not tested for safety and efficacy.
