Noting "serious issues" in a plea opposing Reliance Life Sciences' move to launch a breast and gastric cancer drug allegedly similar to that made by Swiss pharma major Roche's subsidiary Genentech Inc., Delhi High Court has directed the Indian firm 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 and added that the matter will be heard on a day-to-day basis.
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"After small hearing, it appears to the court that serious issues are raised in the matter. The Authority (DCGI) has granted the approval to the defendant No.3 (Reliance Life Sciences) on June 2, 2015. The product has not been launched.
"The explanation given by the defendant No.3 would have to be considered after filing of the reply. Let the reply be filed within ten days...Till the next date of hearing, the defendant No.3 is directed not to launch the drug in question in the market," the court said.
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 sold under the names - Herclon and Herceptin.
