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    India’s New Drugs and Clinical Trials Rules: An Industry Perspective

    This article highlights the recently published, revised regulatory pathway in India and focuses on the regulatory changes and their impact on industry and on clinical trials. The authors discuss product registration, changes to clinical trials rules, revisions to “new drug” definitions, postmarketing studies, orphan drug registration, ethics committees, fees and waivers and the importation and manufacture of unapproved new drugs.   Introduction   India’s Ministry o...