There are about 16-odd FDCs under the scanner now. The expert committee will soon submit its report to the drug controller.
A FDC contains two or more active ingredients in a fixed dose ratio.
“The review has been going for a long time and the report will be submitted soon,” a senior official in the government said.
Earlier in April the companies were asked to give a presentation, representing their case. 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.”Once the recommendations by the committee are submitted, the FDCs will be banned,” added the person. They were earlier considered as “irrational” by a panel led by Chandrakant Kokate, vice-chancellor of KLE University in Karnataka. However, these FDCs have been under review by a sub-committee formed under the chairmanship of Nilima Kshirsagar, professor-head, clinical pharmacology, GS Medical College KEM Hospital, Mumbai to review the safety, efficacy and therapeutic justification of these drugs.
Earlier in August, the government had banned 156 FDCs – 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.
The Union health and family welfare ministry issued a gazette notification, prohibiting manufacture, sale and distribution of these medicines based on the recommendation of an expert panel that evaluated 324 FDCs.
Some of the popular FDCs included 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.
