Last Updated on May 14, 2025 by The Health Master
FDCs
FDCs
The Federation of Pharma Entrepreneurs (FOPE) has reached out to the Drugs Controller General of India (DCGI) to reconsider a notification issued recently about 35 fixed-dose combination drugs (FDCs).
FOPE claims that these 35 FDCs received product and manufacturing approval from various State or Union Territories Drug Licensing Authorities.
Still, they did not receive central approval with claims of safety and efficacy from the Central Drugs Standard Control Organisation (CDSCO).
Industry In Panic Mode Over Unexpected Order
This circular—which was released on 11-04-2025—will allow for the discontinuation of manufacturing, sale, or distribution of such 35 FDCs in Indian markets.
According to the DCGI, 35 such FDCs had either had their licensed approvals revoked by subsequent SLAs or voluntarily surrendered by manufacturers through issued show-cause notices post-detection at the central level.
Furthermore, those still attempting to manufacture such FDCs will have additional investigations with further action taken according to New Drugs and Clinical Trials (NDCT) Rules 2019 as per the Drugs & Cosmetics Act of 1940.
Specific Medications Banned
The specific drugs banned include mirabegron (25mg extended-release tablet) and solifenacin succinate (5mg film-coated tablet) in a combipack regularly prescribed and nefopam hydrochloride (30mg) and paracetamol (325mg) in the form of a single tablet.
This ban creates a negative atmosphere for many within the medicoscientific community as it disturbs producers and consumers reliant on such treatments.
FOPE Notifies DCGI of Member Concerns to Reassess Ban
FOPE sees this as true from its members and has conveyed to the DCGI that such a note sent on April 11, 2025, is an error in judgment that’s been rendered.
The concerns are misplaced, and should this proceed, patients will end up suffering.
Furthermore, FOPE noted that where the Indian Pharmacopoeia 2022 is concerned, prolonged release (PR), sustained release (SR), controlled release (CR), and extended release (ER) are the same as well.
With such discrepancies, FOPE’s executive secretary, Yogesh Vats, requested the DCGI to vet the list and take these comments into consideration.
Patient Compromise
Finally, to add weight to the justification that such a decision should be changed, FOPE president and Embiotic Labs director Harish K. Jain stated that it’s the patients who will suffer.
A good number of these 35 FDCs are used for long-term management of chronic ailments.
Thus, Jain feels that removing these products from the market at this time would not benefit patients and their therapeutic approaches for disease control.
Circular Withdrawal Appeal at the Earliest
FOPE thereafter appealed to the DCGI to withdraw the above circular, as it appears to be unwarranted and inconvenient for established patients with chronic conditions.
Until the new list is confirmed, humanitarian efforts should be made not to deprive legitimate necessary drugs to those who use them in good faith.
Q. What are fixed-dose combination (FDC) drugs?
A combination of two or more active pharmaceutical ingredients (APIs) in a single dosage form is called an FDC drug.
Q. Why is the DCGI reviewing these 35 FDCs?
These FDCs were initially licensed by state authorities without central evaluation by the CDSCO, raising concerns about their safety and efficacy.
Q. What action is FOPE requesting from the DCGI?
FOPE is urging the DCGI to review the list of 35 FDCs and, until the review is complete, to withdraw the circular banning their manufacture, sale, and distribution.
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