IntroductionIndia’s regulatory landscape for biologic and biosimilar medicines continues to evolve.In response to scientific advances and accumulated regulatory experience, the CentralDrugs Standard Control Organization (CDSCO) and the Department of Biotechnology(DBT) have jointly released the Draft Guidelines on Similar Biologics – RegulatoryRequirements for Marketing Authorization in India, 2025. These proposed guidelinesrevise the earlier 2016 version, building […]
The Indian Patent Office (IPO) published its Annual Report on March 31, 2025 spanning activities from April 2023 to March 2024. The report showcases significant growth in filing of applications, expedited examinations and active international collaboration. This article summarizes the main insights from the year’s patent activity. Rising Patent Filings In 2023–24, 92,168 patent applications […]