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 used for treatment of abdominal pain. The review of these FDCs started in 2019 and the committee gave its report at the end of 2021, recommending banning 156 FDCs.
This was the largest FDC ban since 2016. According to the notification, the decision was taken following the recommendations of the Drug Technical Advisory Board (DTAB), the country's highest advisory body on drugs, and an expert committee formed by the government. "There are about 16 odd FDCs under the scanner now and a review by the expert committee is done.
They are likely to be banned anytime soon," the same person quoted earlier, said. In 2016, the government had imposed a ban after a report submitted by a panel led by Chandrakant Kokate, vice-chancellor of KLE University in Karnataka. The committee said these FDCs posed health risks and hence be banned, prompting some companies to challenge the government's ban in the court.
In December 2017, the Supreme Court referred the matter to the DTAB for a fresh review on whether these drugs should continue to be sold. The apex court suggested that the DTAB should decide whether the manufacture and sale of these drugs should be regulated, restricted or banned outright, and asked the committee to submit its report and recommendations to the government. (You can now subscribe to our Economic Times WhatsApp channel ).
