• India Making Way For Separate Clinical Trials Rules

    In February 2018, the Indian Ministry of Health released draft New Drugs and Clinical Trials Rules after consultation with the Drugs Technical Advisory Board, the country’s highest technical body under the Drugs and Cosmetics Act. This article discusses key updates and proposed changes in the draft rules.


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.