New Delhi: In a nationwide crackdown on unapproved Fixed Dose Combinations (FDCs), the Drug Controller General of India (DCGI), has urged states and UTs to initiate appropriate investigation and regulatory action against the concerned manufacturers, marketers, and other stakeholders.
This is with regards to 90 FDCs include multi vitamins, folic acids, syrups, paracetamol, clotrimazole and betamethasone cream, diclofenac potassium and dicyclomine hydrochloride tablets.
“In 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 formu
lation, 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,” a letter by the DCGI states, as reported by ANI.
“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 adds.
“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 further states, on appropriate action against the sale and distribution of unapproved drugs.
Mentioning it as a serious concern, the drug regulator has said: “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.”