India’s drug regulator flags 90 unapproved FDCs, directs states to take action

New Delhi: India's drug regulator has launched a nationwide crackdown on unapproved fixed-dose combination (FDC) drugs, flagging circulation of at least 90 such medicines and directing states to take immediate action against their manufacturers, marketers and distributors.

The move comes after an analysis of lab testing data for 2025 on the regulator's online platform Sugam detected several unapproved drug samples.

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In a communication sent last week, Drugs Controller General of India (DCGI) Rajeev Singh Raghuvanshi instructed state regulators to show zero tolerance to ensure such drugs are not available in the market and submit an action taken report at the earliest.

According to the rules, no new drug should be manufactured for sale without prior approval from the licensing authority, the Central Drugs Standard Control Organisation (CDSCO).

The flagged drugs include unapproved FDCs used for treating diabetes, multi-vitamins and multi-mineral capsules, iron and folic acid and magnesium tablets, among others.

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The presence of unapproved drugs in the supply chain is a matter of "serious concern," posing potential risks to public health and safety, the DGCI said. "It also indicates non-compliance with the provisions of the Drugs and Cosmetics Act, 1940 and rules made thereunder."

He has asked state drug regulators to examine the unapproved drugs and if they have been approved by state authorities.

"In case the manufacturer has submitted the new drug permission, which is mandatory as per Rule 83 of NDCT Rules, 2019 before grant of manufacturing licence, please provide the copy of the same," the letter said. "You are further requested to submit an action taken report (ATR) to this office a t the earliest. This matter may be accorded top priority in the interest of public health."

A parliamentary standing committee of the health ministry, in its 59th report in 2012, had observed that some of the state licensing authorities issued manufacturing licences for several FDCs without prior clearance from the central drug authority, resulting in circulation of many FDCs not tested for safety and efficacy.