The Delhi High Court, on Friday directed the Drugs Controller General of India (DCGI) to continue with the process of granting a license to Cipla for the production of a generic version of Nexavar. However, division bench has directed Cipla, one of the respondents, not launch the drug without obtaining permission from the Court.
Bayer appeared before the division bench challenging the order of the single bench of the Delhi High Court. It was the opinion of the Court that the role of the Drug Controller is to ensure the observance of safety and good manufacturing practices at the time of manufacturing a drug, and held that the drug agencies are not competent to adjudicate on a possible patent infringement that could arise from the manufacture of a drug.
The High Court, while allowing an intervention application filed by the Indian Pharmaceutical Alliance, directed all parties, to file their written submission in two weeks. The matter is due for hearing on October 6.
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