India’s Central Drugs Standard Control Organization (CDSCO) has deemed 31 fixed-dose combinations (FDCs) as rational some 14 years after India ordered the withdrawal of 294 FDCs only for manufacturers to mount a legal challenge.
Most of the FDCs deemed to be rational in the past week are part of the original 294 products targeted by the Indian authorities. The 31 products were assessed by India’s Drugs Technical Advisory Board (DTAB) and the Kokate Committee set up to review FDCs earlier this year following a referral from a high court.
Companies that have state licenses for their now rational FDCs — licences that enabled products to come to market without a review of their rationality by the national regulator — and lack no objection certificates from the Drugs Controller General of India need to file for CDSCO approval within six months. The companies need to file the CT-21 form that covers requests to manufacture new drug formulations.
CDSCO issued news of the rationality of the 31 FDCs on the day it released two related updates. Regarding the rationality of three other FDCs that were discussed by DTAB earlier this year, CDSCO has concluded they are rational, provided manufacturers comply with certain conditions such as restricted indications and the completion of in vitro assessments of efficacy.
The third update provided by CDSCO covers the need for further evidence about 19 FDCs. CDSCO is asking manufacturers of the products to run Phase IV clinical trials or post-marketing to generate data to support continued…