High Court of Delhi

Roche Products v. Drugs Controller General of India and ors

25.04.2016

Civil

Delhi High Court to delve into Drug Controller irregularities

The Delhi High Court deferred a dispute regarding the development, classification and promotion of bio-similar drugs to 2 June 2016. Brought by Roche Products, the plaint raised concerns about irregularities by the Drug Controller General of India in granting approval to Biocon Limited and Mylan Pharmaceuticals for a bio-similar drug in five days - a process which usually takes much longer than that due to deliberation by three separate bodies, before it reaches the DCGI. The drug in question is Trastuzumab, used for treatment of breast cancer.

The Court accepted Roche’s arguments, ruling that “approvals…are not on the basis of the adherence of the Guidelines of 2012 and rules framed”. However, final finding would be arrived at upon completion of trial. The Defendants were allowed to continue manufacturing and marketing their drug claiming bio-similarity with Roche’s drug, but with certain provisos on indication used on packaging.

Tags : trastuzumab bio-similar dcgi roche

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