India's regulator asks drugmakers to justify 19 fixed-dose combinations

Seeking to assess the rationality and status of fixed-dose combination (FDCs) drugs licensed prior to 1988, India's Central Drugs Standard Control Organization (CDSCO) has asked stakeholders to submit information on the safety and efficacy of 19 FDCs that bagged the green signal pre-1988. Asking pharmaceutical companies to justify their cocktail of medicines, the CDSCO has opened old wounds, reports The Pharma Letter’s India correspondent.

Some of the popular brands that have come under the scanner include Abbott's (NYSE: ABT) Phensedyl and Tixylix, Piramal Enterprises' Saridon, Cipla’s (BSE: 500087) Cofdex, Nocold and Bromolin, Griffon's Grilinctus, Glenmark’s (BSE: 532296) Ascoril C, Intas Laboratory's Despol and Reckitt Benckiser's (LSE: RB) D-Cold, among several others.

The criticism is pharma companies tend to sell unscientific or irrational combinations of medicine to push up their revenue, with the CDSCO asking companies if the FDCs are pharmacoeconomically sound.