PIL in Delhi HC to stop launch of Indian company’s stroke drug
Delhi high court on Wednesday sought the Centre and the drug controller general of India’s (DCGI) response on a PIL seeking to stop an Indian pharma company from launching a drug meant for treating stroke patients.delhi Updated: Aug 24, 2016 19:19 IST
Delhi high court on Wednesday sought the Centre and the drug controller general of India’s (DCGI) response on a PIL seeking to stop an Indian pharma company from launching a drug meant for treating stroke patients.
A bench of chief justice G Rohini and justice Sangita Dhingra Sehgal refused to pass an interim order staying the launch of the medicine, but said any such action taken would be subject to further order of the court.
With the direction, the bench listed the matter for hearing on August 31.
The petition has questioned the approval given to Indian drug company Gennova Biopharmaceuticals Ltd with regard to its biosimilar drug of Tenecteplase which is used for treating stroke patients.
The petitioner, Deep Das, has asked how could the biosimilar drug be approved when the innovator drug made by German pharma major Boehringer Ingelheim has not been approved.
He has sought revocation of the recommendations in favour of the biosimilar drug as well as the marketing approval granted to it.
His petition also seeks directions restraining the company from launching the medicine and if launched, a declaration ot the effect that it was done illegally.
According to the petition, DCGI had allowed Gennova to carry out clinical trials of the medicine in February 2009 and December 2013.