Express Pharma

DCG(I) bans 344 drugs constituting fixed dose combinations, but will it hold?

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Abhijeet Das, Senior Associate, Singhania and Partners, opines that there are multiple fronts on which the aggrieved pharma companies can contest the ban

On March 10, 2016, vide its notifications bearing S.O. 705(E) through S.O. 1048(E) (Notifications), the pharmaceutical sector was dealt a clinical blow from the Ministry of Health and Family Welfare which prohibited “the manufacture for sale, sale and distribution for human use” of 344 drugs constituting fixed dose combinations (FDCs). The Notifications were issued under the aegis of Section 26A of the Drugs and Cosmetics Act, 1940 (Act). This was swiftly followed by a circular dated March 12, 2016, whereby the Drugs Controller General (India) (DCGI), went on to reiterate the prohibi