Noting “serious issues” in a plea opposing Reliance Life Sciences’ move to launch a breast and gastric cancer drug reportedly similar to that made by Roche’s subsidiary Genentech Inc., the Delhi High Court has directed the former not to release the product in the market till the next date of hearing.
Justice Manmohan Singh observed that Reliance’s drug — TrastuRel — was approved by the Drug Controller General of India (DCGI) in June this year, but till date it has not been launched and said the company’s explanation for this would be considered after it files its response.
The court directed the Indian company to file its reply within 10 days and listed the matter for further hearing on November 17, adding that the matter will be heard on a day-to-day basis.
“After a small hearing, it appear that serious issues are raised in the matter. The DCGI has granted the approval to the defendant No.3 (Reliance Life Sciences) on June 2, 2015. The product has not been launched.
During arguments, senior advocate Rajiv Nayar, appearing for Genentech, contended that the Swiss company has moved the plea “on account of the imminent threat and credible apprehension of the approval and launch of a purported bio-similar version” of its breast cancer drug, Trastuzumab.
“Neither clinical tests of Phase I and Phase II has been conducted by the defendant No.3, nor registered with the DGCI,” Nayar said.
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