New Delhi: Following a crackdown on 156 fixed dose combination (FDC) drugs after finding them without therapeutic justification and even unsafe in several cases, a top official in the Central Drugs Standard Control Organisation (CDSCO) said Friday that a ban may follow soon on 34 more such formulations. FDCs contain a combination of two or more active pharmaceutical ingredients (APIs) in a single form, which are usually manufactured and distributed in a fixed ratio. In a notification issued earlier this month, the government banned 156 FDCs, used in treating common conditions such as fever, allergies, hypertension, colds, skin disorders, and pain across several therapeutic categories.
“A large number of FDCs had been approved by state licensing authorities, without permission from CDSCO, which were thoroughly reviewed by experts. Based on their recommendations, action is being taken,” a senior CDSCO official said. While 344 such FDCs were banned in 2018, another 156 have been banned this month.
“But a third lot comprising 34 FDCs which are mostly vitamin combinations are still being evaluated and a decision on them will follow soon,” the official quoted above said. Consequent to the 59th report of the Parliamentary Standing Committee on the functioning of CDSCO in 2012, the Union government had constituted the Chandrakant Kokate committee to examine FDCs which were licensed by states without prior approval of the Drug Controller General of India (DCGI). According to t.