Indian government takes action over dubious fixed-dose combinations

In a bid to weed out potentially unsafe combinations, the Central Drugs Standards and Control Organization (CDSCO), headed by the Drug Controller General of India (DCGI), is to assess the safety and efficacy of several fixed dose combination drugs permitted for sale in the country, reports The Pharma Letter’s India correspondent.

The CDSCO has been looking to regularize the segment, and has insisted that both small and large manufacturers get its approval before they manufacture FDCs. However, many small companies like Naxpar Pharma, Restech Pharma, Unix Biotech and others have continued to flaunt the directive, and have gone ahead with their FDC production. Some leading firms like Cipla, Intel, Cadila, Aristo and Torrent are also on the list.

The FDC drugs that have found their way into the market without the approval from the DCGI, and under licences issued by state drug regulators, include antidepressants, muscle relaxants, anti spasmodics and painkillers.