Regulatory requirement and approval procedures for drugs
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The document outlines the regulatory requirements and approval procedures for drugs in India according to The New Drug and Clinical Trials Rules, 2019. It discusses the need to obtain approval to manufacture or import new drugs or investigational new drugs for clinical trials, bioavailability or bioequivalence studies. Approval is also required to conduct clinical trials or import or manufacture new drugs for sale in the country. The rules aim to regulate all aspects of new drugs from initial manufacturing and importation to clinical trials and final sale in India.
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