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After submission of phase i data generated outside india to the licensing authority, permission may be granted to repeat phase i trials and/or to conduct phase ii trials and subsequently phase iii trials concurrently with other global trials for that drug. In 2025, india’s regulatory landscape for clinical trials continues to evolve — aligning closely with international standards while supporting the nation’s expanding biotech ambitions. The document provides a comprehensive overview of the regulatory framework governing clinical trials in india, detailing the roles of key organizations such as the central drug standard control organization (cdsco) and the drugs controller general of india (dcgi).
If the drug is already approved/marketed, phase iii trials as required under item 7 of appendix 1 usually are required After submission of phase i data generated outside india to the central licensing authority, permission may be granted to repeat phase i trials or to conduct phase ii trials and subsequently phase iii trial concurrently with other global trials for that drug. If the drug is not approved/marketed trials are generally allowed to be initiated at one phase earlier to the phase of trials in other countries.
What will we learn in lecture 8
So, we will learn, what is schedule y Its salient features then, schedule y related rules, fees required, appendices that is i to xii related forms and related rules So, this is the outline of lecture 8. Curious, what are schedule y drugs
Discover the indian regulatory framework for new drug clinical trials, its key guidelines, and its replacement by the 2019 rules. Reduce the number of unethical clinical trials being run by private hospitals and research laboratories for profit business The present compilation provides comprehensive and up to it also offers a dated information about schedule y and review the status of clinical trials in india.
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