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[REG-03] Indian Pharmacopoeia (IP 2022), CDSCO, New Drugs & Clinical Trials (NDCT) Rules 2019 & Ethics Committees
REG-03 • 12. Pharmaceutical Jurisprudence & Indian Pharmacy LawLearning Objectives
Trace the history and structure of the Indian Pharmacopoeia (1st Ed 1955 → 9th Ed IP 2022, published by the Indian Pharmacopoeia Commission [IPC], Ghaziabad).; Detail Phases I, II, III, and IV of clinical trials, BA/BE studies, Institutional Ethics Committees (IEC registration with CDSCO/DHR), and Serious Adverse Event (SAE) reporting timelines under NDCT Rules 2019.; Apply ICH E6(R2/R3) Good Clinical Practice (GCP) and ICH Common Technical Document (CTD Modules 1–5) structure.
Chapter Overview & Core Explanation
Before any new medicine reaches Indian patients, it must pass rigorous clinical trials overseen by the Drugs Controller General of India (DCGI / CDSCO) and independent Ethics Committees, and meet official quality standards published in the Indian Pharmacopoeia.
Key Exam & Clinical Takeaways
- Under NDCT Rules 2019, any Serious Adverse Event (SAE) in a clinical trial must be reported to the DCGI (CLA), Sponsor, and Ethics Committee within 24 hours of occurrence, with a full report within 14 calendar days.
- Periodic Safety Update Reports (PSURs) for newly approved drugs in India are submitted every 6 months for the first 2 years, and annually for the subsequent 2 years (total 4 years).