Govt planning more crackdowns on vitamin and mineral combination drugs

The government banned 14 FDCs in June that affected around Rs 824 crore of the domestic pharmaceuticals market

The government is preparing to take action against fixed-dose combination (FDC) drugs that contain vitamins and minerals, some of which experts warn are irrational and unsafe, according to a report by the Economic Times (ET).

To assess the safety, efficacy, and therapeutic justification of these drugs, a committee led by CK Kokate, former vice-chancellor of KLE University, Belgaum, was established. The Drugs Technical Advisory Board (DTAB), India's technical board on drugs, has requested a report from the committee based on their evaluation.

This report will reportedly be sent to the Directorate General of Health Services (DGHS) with a recommendation by the committee, however, the final decision lies with the health ministry.

Efforts to crack down on FDCs in the country have been ongoing since 2016.

Earlier this month, Business Standard had reported the government banned 14 FDC affecting around 72 pharmaceutical companies. The ban that was enacted in "larger public interest" also affected around Rs 824 crore of the domestic pharmaceuticals market.

The bans were a result of a recommendation from an expert committee that said the FDCs had no "therapeutic justification."

“Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of these FDC under section 26A of the Drugs and Cosmetics Act, 1940,” read a notification by the health ministry.

The health ministry had also banned 349 FDCs in March 2016 after the Kokate committee found the drug combinations to be "irrational" and posed risks to health.

The Supreme Court had referred the matter to the DTAB for a review after drug companies challenged the ban. However, the DTAB, in a meeting held in July 2018, reinforced the ban on 343 of the 349 drugs. The market value of the 349 drugs was estimated to be approximately Rs 2,000 crore at that time.