Tag: DCGI
January 30, 2023
Intellectual Property | Patent
Intellectual Property | Patent
Exports under the Bolar Exception: A Key Arrow in the I...
India is the largest producer of generic drugs in the world, and thus, it is no surprise that a great deal of patent litigation in India has centred on the manufacture of generics. While there are provisions in the law that permit the use of patented drugs for research and development (“R&D”) and for obtaining regulatory approvals, permissibility around the export of such drugs for similar purposes can be in the grey. ......
April 21, 2020
Intellectual Property | Other | Pharmaceuticals
Intellectual Property | Other | Pharmaceuticals
Changes to the Regulatory Framework for Clinical Trials...
The total cost for bringing a new prescription drug to market is about USD 2 to 3 billion (DiMasi et al.). A significant portion of this cost is incurred in conducting clinical trials. The global clinical trials market size is expected to reach USD 69.8 billion by 2027, exhibiting a 5.1% compound annual growth rate (‘CAGR’) during the forecast period. ...