Extending Data Exclusivity To Improve IPR Regulatory Frameworks in the Pharmaceutical Industry: DPIIT

In a significant development in the pharmaceutical sector, sources close to the Department for Promotion of Industry and Internal Trade (DPIIT) have revealed their support for extending data exclusivity for biologics. Biologics, a relatively new class of medications derived from living cells, necessitate intricate manufacturing processes and unique handling techniques. Data exclusivity refers to the period during which the clinical trial data submitted by a pharmaceutical company for regulatory approval cannot be referenced by competitors seeking approval for generic versions of the same product. Extending this exclusivity period for biologics could have far-reaching implications for the industry, potentially affecting market competition and access to these vital medications. 

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