CDSCO Launches National Crackdown On Unapproved Medicines

The Central Drugs Standard Control Organisation (CDSCO) has now launched a nationwide crackdown on unapproved Fixed Dose Combination (FDCs) after 90 combination medicines that were being sold without mandatory central approval were busted last week. CDSCO, India's apex drug regulatory body in the country, made the shocking discovery after scrutinizing drug samples uploaded on the SUGAM portal, the government’s online system for drug testing data. Several of these samples were found to fall under the ‘new drug’ category but lacked approval from the central authority. As a result, the CDSCO wrote a letter to all states and union territory drug controllers, asking them to investigate manufacturers and marketers of these FDCs.The letter reads: "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. "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.FDCs are drugs that contain two or more active ingredients in a single formulation. The CDSCO has asked states to investigate and submit reports on the action taken at the earliest.What Made It To The Unapproved List Of FDCs?Cough And Cold MedicinesCough and cold combination medicines have formed the single largest group. At least 14 to 16 entries show combination of ingredients found in everyday pharmacy shelves: dextromethorphan, ambroxol, guaiphenesin, chlorpheniramine, phenylephrine, terbutaline, and menthol in various permutations. Several of these are sold as flavoured syrups for children. Budesonide-levosalbutamol inhalation suspension that is used for asthma and chronic obstructive pulmonary disease, too features in the list.Nutritional SupplementsThe next group is of the vitamins, minerals and other nutritional supplement which has roughly 18 to 20 entries. They include:Multivitamin capsulesIron-folic acid syrupsCalcium-vitamin D3-K2 combinationsAbapentin-methylcobalamin preparationAntifungal And Dermatological CombinationsThis group has accounted for at least 10 entries, which include antifungal creams that could lead to potential misuse and skin damage when sold without prescriptions.Anti-Diabetic MedicinesThis has accounted for six entries, and the combination includes:Glimepiride paired with metformin or pioglitazoneWhat Is India's Rule For FDCs?Under India's New Drugs and Clinical Trial Rules of 2019, any FDC is treated as a new drug and must have the central government's approval before it could be manufactured and sold. The regulator's letter noted that there were presence of unapproved drugs in the supply chain that could pose risks to public health. This also amounts to a violation of the Drugs and Cosmetics Act, 1940.“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," it said.DCGI urged states and UTs "to examine the unapproved FDCs in generic name as mentioned in the attached annexure". This is done to check whether any approval has been granted by the local office. "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 the manufacture, sale, and distribution of such unapproved drugs," the letter noted.

CDSCO Launches National Crackdown On Unapproved Medicines

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CDSCO Launches National Crackdown On Unapproved Medicines

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