PIL in HC to stop launch of Indian company's stroke drug

Delhi High Court today 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 prosecution, a secret information was
received on July 7, 2005 that Sharafat, suspected to trade in narcotics with his gang members in Delhi on a large scale, was to come to his residence.

Based on the information, a raid was conducted and Sharafat was found. He was also alleged to have in his possession a loaded pistol and a packet of 500 grams of 'heroin or smack'.
Delhi Police had said that since it was alleged that Sharafat was the chief of a crime syndicate and was amassing wealth through illegal trade of narcotics, provisions under MCOCA were invoked.
Later sanction was granted by the Additional Commissioner of Police for prosecution of Sharafat and other accused -- Mohd Saleem, Sheikh Hannan, and Najma Sheikh (first wife of Sharafat) and subsequently, the first charge sheet was filed on December 10, 2005.

During investigation, prosecution had sought sanction against Zohra for alleged commission of offence under section 4 (for possessing unaccountable wealth on behalf of member of organised crime syndicate) of MCOCA and a supplementary charge sheet was filed against her on September 8, 2006 and she was arrested on June 12, 2006.
She had later applied for regular bail and it was dismissed by the sessions court last year, after which she moved the high court.