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The New Drugs and Clinical Trial Rules of India: A Regulatory Highlights

The New Drugs and Clinical Trial Rules (NDTC), 2019 were recently issued, emphasising the changes on the regulatory aspects relating to clinical trials. The final document was published by MOHFW, and covers the clinical trials, BA/BE, ethics committee and biomedical research. These rules also supplant part XA and schedule Y of the D&C Act. This study by Kamireddy Karuna at Jagadguru Sri Shivratreeshwara University et al. includes a major outlook on the changes that occurred in the regulatory aspects for conducting clinical trials in India.

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