A package insert (PI) is a document provided along with the prescription or over-the-counter medication to provide additional information about the drug.
A single judge of the high court had on November 2 put on hold the launch of Reliance' drug, after Swiss pharma major Roche's subsidiary Genentech Inc opposed the release of the Indian company's medicine.
The order was passed after Reliance, represented by senior advocates Abhishek Manu Singhvi and Pratibha M Singh, raised the apprehension that in view of the single judge's order, DCGI might not process its application for PI approval.
It also told the bench that two other pharma firms Biocon and Mylan have been allowed by the single judge to launch their drugs which were bio-similar to that of Genentech.
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Earlier, Genentech had claimed before the single judge that Reliance's drug, similar to that of the Swiss company, 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.
This contention was opposed by Reliance which said the approvals were granted as per Rules under the Act and as per the Biosimilar Guidelines.
The Indian company's drug is similar to Genentech's cancer medicine, Trastuzumab sold under the names - Herclon and Herceptin.