DCGI orders nationwide crackdown on 90 unapproved FDC drugs

The Drug Controller General of India (DCGI) has initiated a nationwide crackdown on 90 unapproved fixed-dose combination (FDC) drugs, citing serious public health concerns.
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The Drug Controller General of India (DCGI) has launched a nationwide crackdown on unapproved Fixed Dose Combination (FDCs). The drug regulator has requested to examine the 90 FDCs in the generic name, whether approval is granted by the state or UT drug controllers, according to a letter accessed by ANI. These drugs include Multi vitamins, folic acids, syrups, Paracetamol, Clotrimazole and Betamethasone Cream, Diclofenac Potassium and Dicyclomine Hydrochloride Tablets, etc.

Regulator flags unapproved drugs as ‘new drugs’

According to the letter, “The SUGAM lab testing data for the year 2025, a large number of drug samples (FDCs) are detected as unapproved and fall under the category of ‘New Drug’. No new drug shall be manufactured for sale unless it is approved by the Licensing Authority ‘as defined in Rule 3 of New Drugs and Clinical Trial Rules, 2019, Further, as per Rule 80 of New Drugs & Clinical Trial Rules 2019, a person who intends to manufacture new drug in the form of API or Pharmaceuticals formulation, as the case may be, for sale or distribution, shall make an application for grant of permission to the Central Licensing Authority in Form CT-21 along with a fee as specified in Sixth Schedule.”

Public health risks and legal violations highlighted

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

“Accordingly, please initiate appropriate investigation and regulatory action against the concerned manufacturers, marketers, and other stakeholders, as deemed fit. Kindly ensure strict monitoring and enforcement to prevent manufacture, sale, and distribution of such unapproved drugs,” the letter states, on appropriate action against the sale and distribution of unapproved drugs.

Urgent action and compliance report sought

Considering the matter in public interest drug regulator has mentioned it as a serious concern, “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 a copy of the same. You are further requested to submit an action taken report (ATR) to this office at the earliest. This matter may be accorded top priority in the interest of public health.”

Published on March 23, 2026