New Delhi: The Drugs Controller General of India (DCGI) has informed the drug controllers of states and Union Territories that the antidiabetic fixed dose combination (FDC) of voglibose 0.2 mg and metformin Hcl 500mg, as sustained release (SR) form, has been approved and it is being excluded from the list of 35 drugs the authority earlier asked to consider as new drug.
The move comes in connection with the DCGI’s direction in April 14, 2025 to the state and UT drug controllers to act upon a list of 35 FDCs, which fall under the definition of new drug, which has been licensed by the state drug regulators without prior evaluation of safety and efficacy as per the provisions of the New Drugs and Clinical Trials (NDCT) Rules, 2019.
In a latest communication to the drugs controllers, the DCGI Dr Rajeev Singh Raghuvanshi, said that one of the FDCs, namely voglibose 0.2 mg and metformin Hcl (as SR form) 500mg mentioned as 31st in the list of 35 FDCs in its previous communication, has been found to be approved by the CDSCO. He added that this was also recorded by the Delhi High Court in a hearing related to FDCs, on July 14, 2025.
“Accordingly, the FDC i.e voglibose 0.2 mg and metformin Hcl (as SR form) 500mg (at S.No. 31) stands excluded from the list of unapproved FDCs in letter dated 11.04.2025,” he added.
It may be noted that in his communication with the drug controllers on April 11, he also asked them to review their approval process for such FDCs for strict adherence.
The DCGI had released a list of 35 such unapproved FDCs which were earlier licensed by the State or UT drug controllers for manufacture, sale and distribution without evaluation of safety and efficacy by Central Drugs Standard Control Organisation (CDSCO) and later on cancelled by the State Licensing Authorities (SLAs) or voluntarily surrendered by manufacturers following the issuance of show cause notices.
This include combinations including metformin hydrochloride 500 mg as extended release from along with glimepiride 3 mg, and dapagliflozin 10 mg; dextromethorphan hydrobromide 10 mg along with phenylephrine hydrochloride 5 mg per 5 ml syrup and diphenhydramine hydrochloride 12.5 mg and phenylephrine hydrochloride 5 mg per 5 ml syrup; and a capsule comprising rosuvastatin calcium IP equivalent to rosuvastatin 20 mg as immediate release pellets, clopidogrel bisulphate IP equivalent to clopidogrel 75 mg as immediate release pellets and aspirin 150 mg as gastro-resistant pellets, among others.
The drug regulator has said that it has been raising concerns since January, 2013, regarding the grant of manufacturing licenses for sale of the FDC drugs that fall under the definition of a new drug in the country without due approval from DCGI. The same issue was raised from time to time through multiple letters to the respective SLAs that granted permission for manufacturing and marketing of unapproved FDCs.
“With reference to the above subject, it has come to the notice of this Directorate that certain fixed dose combination (FDC) drugs have been licensed for manufacture, sale, and distribution without prior evaluation of safety and efficacy as per the provision of NDCT Rules, 2019, under the Drugs & Cosmetics Act, 1940. This poses a serious risk to public health and safety,” said DCGI Dr Rajeev Singh Raghuvanshi in a letter to all State and UT drug controllers.
The approval of such unapproved FDCs compromises patient safety and may lead to adverse drug reactions, drug interactions, and other health hazards due to the absence of scientific validation. Upon issuance of show cause notices to the manufacturers, they have stated that these licenses were granted by the respective SLAs and the companies have not violated any Rules.
“This has resulted in a lack of uniform enforcement of the provision of the NDCG Rules 2019 under the Drugs & Cosmetics Act, 1940 across the country,” said Raghuvanshi.
Considering the scenario, the DCGI sought all state and UT drug controllers to review their approval process for such FDCs and ensure strict compliance of the provisions of the Act and Rules, keeping in mind that public health and safety must remain the top priority.
Releasing the list of 35 FDCs, it added that all State and UT drug controllers are requested to ensure that these FDCs and any other unapproved FDCs shall not be allowed for manufacture, sale and distribution in the country and also conduct the investigation and take necessary action as per the provision of NDCT Rules, 2019 and the same shall be intimated to the DCGI’s office.
