New Delhi: Generic drug makers Biocon and Mylan told the Delhi High Court that Swiss pharma major Roche’s civil suit, challenging DCGI approvals granted to them for marketing and selling their version of breast cancer medicine Trastuzumab, was not maintainable.
The submission by the two companies was made before a bench of Justices Siddharth Mridul and Deepa Sharma, which is hearing their appeals as well as that of Roche and the Drugs Controller General of India (DCGI) against a single judge order which had placed restrictions on Biocon and Mylan with regard to packaging and labelling their medicines.
As the single judge had not set aside the approvals granted by DCGI to the drugs of Biocon and Mylan, Roche had challenged the order of April 25, 2016.
Roche, which had innovated Trastuzumab, had claimed that the two firms had not carried out all the required tests prior to manufacture and sale of their medicines, as was done by it.
Biocon and Mylan have appealed against the single judge order as restrictions were imposed on the use of clinical data in the package insert of their drugs, Canmab and Hertraz, respectively.
DCGI, on the other hand, is aggrieved by the single judge’s direction to it that before granting approvals in future, it shall take into consideration the guidelines as well as the findings arrived at by the court.
Reliance, represented by advocate Bitika Sharma, which also makes a generic version of Trastuzumab is also before the high court seeking parity with Biocon and Mylan.
An earlier division bench, in an interim order of March 3, 2017, had allowed the two firms to sell their version of Trastuzumab for two kinds of breast cancer and metastatic gastric cancer in view of the DCGI approvals granted to them.
During the hearing today, senior advocate Amit Sibal, appearing for Mylan, said that the approvals granted to the companies by DCGI cannot be challenged in a civil suit.
DCGI, represented by central government standing counsel Amit Mahajan, told the court that the “approvals were validly granted”.
Sibal argued that once DCGI has approved the drugs of Biocon and Mylan, Roche cannot oppose it on the ground that the authority did not appropriately follow the regulations while granting the approvals.
He said that DCGI was the appropriate authority to decide which tests or trials need to be done before granting approval and its decisions cannot be challenged in a civil suit.
The court, however, said that a relief which can be sought by a writ petition can be asked for through a civil suit as well.
The issue raised in the appeals before the court is with regard to marketing and sale of generic breast cancer drugs, of Biocon and Mylan, which are claimed to be biosimilar to the Swiss company’s Trastuzumab sold under the name of Herceptin.
It is Roche’s contention that Biocon and Mylan cannot term their medicine as merely Trastuzumab and ought to call it Biocon’s Trastuzumab or Mylan’s Trastuzumab as these companies have not followed the entire protocol of tests and studies, as was done by it.