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MNC drugmakers push for 10-yr exclusivity for trial data
Business Standard
|November 22, 2025
First entities’ data filed for novel drugs needs protection: OPPI
The Organisation of Pharmaceutical Producers of India (OPPI), which represents research-based global pharmaceutical companies in the country, is seeking an exclusivity period of 10 years after market authorisation for protection of regulatory data of first entities who have filed for novel drugs.
This comes after the Central Drug Standards Control Organisation (CDSCO) sought comments from pharma industry stakeholders on rules that require the first applicant to conduct clinical trials and bioequivalence studies, while the subsequent filers could skip the trials and have an easier path to obtaining approvals for a product launch.
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