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Roche plea in HC on cancer drug not maintainable:Mylan, Biocon

Press Trust of India  |  New Delhi 

Generic drug makers and today told the High that Swiss pharma Roche's civil suit, challenging DCGI approvals granted to them for marketing and selling their version of breast Trastuzumab, was not maintainable.

The submission by the two companies was made before a bench of Justices and Deepa Sharma, which is hearing their appeals as well as that of and the Drugs Controller General of (DCGI) against a order which had placed restrictions on and with regard to packaging and labelling their medicines.

As the had not set aside the approvals granted by DCGI to the drugs of and Mylan, 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 have appealed against the 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

Reliance, represented by Bitika Sharma, which also makes a generic version of is also before the high 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 for two kinds of breast and metastatic gastric in view of the DCGI approvals granted to them.

During the hearing today, senior 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 Amit Mahajan, told the court that the "approvals were validly granted".

Sibal argued that once DCGI has approved the drugs of Biocon and Mylan, 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 drugs, of Biocon and Mylan, which are claimed to be biosimilar to the Swiss company's sold under the name of Herceptin.

It is Roche's contention that Biocon and Mylan cannot term their 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.

(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)

First Published: Wed, January 10 2018. 19:15 IST