In a move that could hurt drugmakers more, the government is likely to ban more fixed dose-combinations ( FDCs ), people in the know told ET. Last week, the government had banned 156 fixed-dose combinations-including antibiotics, antiallergics, painkillers, multivitamins and combination doses for treatment of fever and hypertension-after a review found they posed health risks in the biggest crackdown since 2016 when 344 FDCs were prohibited. An expert committee has been reviewing more FDCs and have found that they lack therapeutic justification and have recommended the government to ban them, added the person in the know.
A FDC contains two or more active ingredients in a fixed dose ratio. The committee has already heard the companies and found that "there is no therapeutic justification" for these FDC and they may involve "risk" to human beings. "Hence, in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC," another person said.
The union health and family welfare ministry last Thursday issued a gazette notification, prohibiting manufacture, sale and distribution of these medicines based on the recommendation of an expert panel that evaluated 324 fixed-dose combination drugs . You Might Also Like: Govt bans 156 fixed-dose combo drugs over risks Some of the popular FDCs include a combination of mefenamic acid and paracetamol injection used for pain relief, fever and swelling, and omeprazole magnesium and dicyclomine HCl u.