The Drug Controller General of India (DCGI) has launched a nationwide crackdown on unapproved Fixed Dose Combinations (FDCs).
In a letter accessed by ANI, the regulator has asked state and Union Territory drug controllers to examine 90 FDCs sold under generic names and verify whether they have received the necessary approvals.
These include commonly used medicines such as multivitamins, folic acid syrups, Paracetamol, Clotrimazole and Betamethasone creams, as well as combinations like Diclofenac Potassium and Dicyclomine Hydrochloride tablets.
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.”
“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.
Highlighting the seriousness of the issue, the regulator added, “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.” (ANI)