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THE PHARMA REVIEW (NOVEMBER - DECEMBER 2014)

Regulations Governing Biosimilars in India

Balamuralidhara V., K. Sirisha, Shilpi Khattri., & T. M. Pramod Kumar

Introduction: In India, apart from Central Drugs Standard Control Organization (CDSCO), the office of Drug Controller General of India (DCGI) the apex regulatory body under Government of India (GoI), two other competent authorities are involved in the approval process of biosimilars or Similar Biologics products (SBPs)1,2. 

 

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