In­dia bans 328 com­bi­na­tion drugs

BioSpectrum (Asia) - - Regulatory News -

The cen­tral govern­ment in In­dia has banned 328 com­bi­na­tion drugs lead­ing to a blow for both do­mes­tic and for­eign phar­ma­ceu­ti­cal firms. At the same time, the ban has been cheered by health ac­tivists wor­ried about grow­ing an­tibi­otic re­sis­tance due to the mis­use of medicines. The tech­ni­cal and ad­vi­sory board formed by the govern­ment has found that there was no ther­a­peu­tic jus­ti­fi­ca­tion for the ingredients con­tained in 328 fixed-dose com­bi­na­tions (FDCs) and th­ese FDCs may in­volve risk to hu­man be­ings.

In 2016, the govern­ment had banned about 350 such FDCs, but the in­dus­try mounted var­i­ous le­gal chal­lenges that prompted the Supreme Court to call for a re­view by an ad­vi­sory board.

Ac­cord­ing to the pres­i­dent of the In­dian Drug Man­u­fac­tur­ers’ As­so­ci­a­tion (IDMA), Deep­nath Roy­chowd­hury, the or­der would have an im­pact on a mar­ket worth an es­ti­mated Rs 16 bil­lion a year for such drugs, which are pro­duced by both small and large phar­ma­ceu­ti­cal com­pa­nies.

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