Expert panel recommends banning 16 more FDCs over safety concerns: Report

The government is planning to ban additional fixed-dose combinations (FDCs) this month, as an expert panel has concluded that they lack therapeutic justification, according to a report by The Economic Times.

Currently, around 16 FDCs are under scrutiny. The expert committee is preparing to submit its findings to the drug regulator soon. FDCs are pharmaceutical formulations that combine two or more active ingredients in specific fixed proportions.

Citing a government official, the business-daily said that the review process has been ongoing for a considerable period, and the report will be submitted shortly.

Earlier in April, pharmaceutical companies were asked to present their arguments to the committee. After hearing their cases, the panel determined that there was ‘no therapeutic justification’ for these FDCs and noted potential risks to human health.

In the interest of public safety, it is therefore deemed necessary to ban the production, sale, and distribution of these FDCs, The Economic Times reported.

The FDCs will be prohibited once the committee’s recommendations are finalised, the report added.

Previously, a panel led by Chandrakant Kokate, vice-chancellor of KLE University, Karnataka, deemed these FDCs ‘irrational’. However, a sub-committee headed by Nilima Kshirsagar, professor and head of clinical pharmacology at GS Medical College KEM Hospital in Mumbai, has been reviewing the safety, efficacy, and therapeutic value of the FDCs.

FDCs banned in August

In August, the government banned 156 FDCs, including antibiotics, antiallergics, pain relievers, multivitamins, and combination treatments for fever and hypertension, citing health risks. This action marked the largest such crackdown since 2016 when 344 FDCs were banned.

The Union Ministry of Health and Family Welfare issued a notification, prohibiting the manufacturing, sale, and distribution of these medicines based on the recommendations of an expert panel that reviewed 324 FDCs. The review of these FDCs began in 2019, with the final report issued in late 2021, recommending the ban of 156 FDCs. This ban represents the most extensive FDC prohibition since 2016.

According to the notification, the decision followed the advice of the Drug Technical Advisory Board (DTAB), the country’s top advisory body on pharmaceuticals, and a government-appointed expert committee.

Some widely-used FDCs are combinations like mefenamic acid and paracetamol injections for pain relief, fever, and inflammation, as well as omeprazole magnesium and dicyclomine HCl for treating abdominal pain.