New Delhi: 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.
"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.
Nayar said that Reliance's drug was granted approval by DGCI without having been adequately tested as per Drugs and Cosmetics Act and the Rules, as well as the Guidelines on Similar Biologies, 2012.
"Neither clinical tests of Phase I and Phase II have been conducted by the defendant No.3 nor the same are registered with the defendant No.1 (DGCI)," Nayar said and added that approvals were granted on the basis of clinical test of Phase III which itself is contrary to the Rule 122 of the Drugs Act and the Biosimilar Guidelines.
Senior advocate Pratibha M Singh, appearing for Reliance, while admitting that approval was granted in June this year and the drug has not yet been launched, said the approval of the label and carton was granted recently.
She also said that the Swiss company was "misleading" the court as the approvals were granted as per Rules under the Act and as per the Biosimilar Guidelines.
She said conducting of clinical trials of Phase I and II takes number of years and added that the drug authority may or may not exempt or abbreviate the two phases by exercising its discretion.
In the present case, the "discretion is exercised in favour of the defendant No.3 to exempt Phase I and Phase II as per Rules," she told the court.