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FOPE urges DCGI to review the list of 35 unapproved FDCs for manufacture and marketing
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Nandita Vijayasimha, Bengaluru
April 30 , 2025
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The Federation of Pharma Entrepreneurs (FOPE) has urged the Drugs Controller General of India (DCGI) to review the list of 35 unapproved fixed dose combination (FDC) drugs. Three weeks ago, the DCGI had released a list of 35 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).
These were later cancelled by the State Licensing Authorities (SLAs) or voluntarily surrendered by manufacturers following the issuance of show cause notices.
Here the DCGI called to ensure that the FDCs will not be allowed for manufacture, sale, & distribution in the country. If the companies failed to adhere, investigations would be conducted and necessary action will be taken as per the provision of NDCT (New Drugs and Clinical Trials) Rules 2019 under the Drugs & Cosmetics Act 1940.
Now some of these 35 FDCs include Combipack of each film coated extended release tablet contains: Mirabegron 25mg and Each film coated tablet contains: Solifenacin succinate 5mg, nefopam hydrochloride 30mg + paracetamol 325mg tablets, to name a few.
Here FOPE sees the ramifications to this and communicated to the DCGI that representing the pharmaceutical industry and allied sectors, predominantly pharma MSMES sector, contributing to the sector’s growth, it intends to raise concerns of this circular issued on April 11, 2025.
We would like to cite a few examples like Product at Sl. 29 which is glimepiride 1mg + metformin HCI 500mg tablets, this FDC was approved on November 13, 2002 in the list of approved products downloaded from CDSCO website. Metformin HCI 500mg voglibose IP 0.2mg tablets. This FDC was approved to Swiss Garnier Lifesciences, Mehatpur on October 26, 2009. Surprisingly approval of this FDC was not found on CDSCO website. The copy of pages of Indian Pharmacopoeia 2022, which shows that PR (prolonged release), SR (sustained release), CR (controlled release), and ER (extended release) are the same. In view of above few examples, we earnestly request to review the list & oblige, said Yogesh Vats, executive secretary, FOPE.
Furthermore, we wish to inform your good selves that many of these 35 products are used for chronic illnesses over long period of time and any withdrawal of these products from the market will not be in patient's interest, stated Harish K Jain president, FOPE and director Embiotic Labs.
Hence, till the review is complete, we request you to kindly withdraw your above-mentioned circular, said Jain.
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