ARTICLES BY BOBBY GEORGE

  • Conducting Clinical Trials In India: Opportunities And Challenges
    India’s Draft Pharmaceutical Policy — A Game Changer
    9/26/2017

    The Indian pharmaceutical sector is largely fueled by exports. Over the last five years, many changes have affected the pharmaceutical sector, which have necessitated a fresh, comprehensive national policy to maintain and enhance its global competitive edge in quality and prices. 

  • Changes In Regulatory Requirements For Biosimilar Development In India
    Changes In Regulatory Requirements For Biosimilar Development In India
    11/22/2016

    In August 2016, India’s Central Drugs Standard Control Organization (CDSCO) and the Department of Biotechnology revised the September 2012 Guideline for Similar Biologics. The revision was done to keep pace with ever changing global standards and to streamline the regulatory process for the authorization of biosimilars in India. What do biosimilar makers need to know?

Bobby_George

Bobby George

Bobby George, Ph.D., is head of regulatory affairs at Reliance Life Sciences (Navi Mumbai, India). He is responsible for regulatory services across all of the company’s business verticals (pharmaceuticals, biosimilars, plasma proteins, etc.). He has a doctorate in pharmacology and over 20 years of industry experience. He has written 34 publications in peer-reviewed journals and three book chapters. George recently authored and published a book titled “The Act that Wasn’t,” in which he deliberates on the “Acts” (laws) and “acts” (wrong deeds) of those in the drug and healthcare industry, citing several examples of the unholy nexus between stakeholders.