In India, the regulatory framework for investigational new drug (IND) is governed by the CDSCO under the DCGI. INDs are regulated by the New Drugs and Clinical Trials Rules, 2019 (with amendments in 2026). It ensures that investigational drugs undergo rigorous safety,...
Good clinical practice (GCP) provides guidelines for designing, conducting, recording, and reporting clinical trials that involve human participants. GCP sets standards that need to be followed by conducting clinical trials. It ensures that the rights, safety, and...
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