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Current regulatory requirements for conducting clinical trials in India for investigational new drugs/new drug (Version 3.0)

NPTEL and AICTE via Swayam


The course is developed by Clinical Development Services Agency (CDSA) in partnership with the Central Drugs Standard Control Organisation (CDSCO). The course is developed with NPTEL.CDSA is an extramural unit of the Translational Health Science & Technology Institute (THSTI). THSTI is an autonomous institution under the Department of Biotechnology (DBT), Ministry of Science & Technology, Government of India. CDSA has a national mandate to enhance the capacity and capability of clinical development in India.CDSCO is the National Regulatory Authority (NRA) of India. It is under the Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India. CDSCO along with the state regulators are jointly responsible for grant of licenses of certain specialized categories of critical drugs such as blood and blood products, intravenous fluids, vaccines, and sera.It is a pre-requisite for anyone carrying out a clinical trial or involved in new drug development or research for the purpose of seeking regulatory approval in India to know about the current regulatory requirements. This is even more pertinent given the many changes and amendments in the clinical trial and new drug approval rules and regulations in India in recent years.Version 1 of this online course was launched in early 2019 with 12 lectures as a four-week course. It was attended by 1047 participants during Jan - Mar 2019. On March 19, 2019, the New Drugs and Clinical Trials (NDCT) Rules, 2019 were released. The current online course (Version 2) incorporates the changes and amendments that are part of these latest rules. A series of brainstorming sessions were conducted by CDSA with CDSCO for incorporating the new updates and the feedback received from version 1 participants. It also includes key issues that surfaced during the discussions at the six face-to-face programs (National workshop on regulatory compliance for accelerating innovations) that were conducted by CDSA (Dec 2018-July 2019) under the aegis of DBT, CDSCO, NITI Aayog, and BIRAC-NBM and inputs from the interactive session on NDCT Rules conducted by CDSA with CDSCO at THSTI (May 2019).This course (version 2) has 24 lectures spread over a period of 8 weeks. This course also involves 8 weekly assignments and a final exit assessment. Only those wishing to undertake the certification exams (which requires payment of a fee) need to opt for the latter. This online course is free. The exam is optional for a fee.COURSE OBJECTIVES AND EXPECTED LEARNING OUTCOMEUpon completion of this online course, the participants will understand:Current New Drugs and Clinical Trials Rules 2019 for conducting clinical trials of the new drug or investigational new drug (IND) to be manufactured or imported in IndiaEssential documents required for the conduct and approval of clinical trials, new drug/INDEssence and purpose of important trial-related guidelines, such as Good Clinical Practice (GCP), national ethical guidelines for biomedical & health research for human participants (2017), etcTARGET AUDIENCE :The course is suitable for individuals, both from industry (pharma, biotech, contract research organization) and academia who are involved or interested in Clinical trial and new drug development (R & D/manufacture/ import) in India. This includes investigators, regulatory affairs personnel, human ethics committee members, clinical trial team members/researchers.PRE-REQUISITES :There is no pre-requisite to undertake this course. It is suitable for personnel with scientific/medical background (BSc/MSc/PhD/B Pharm/M Pharm/BAMS/BHMS/BDS/MDS/MBBS/MD/DM). Personnel working in the area of drug development/clinical trials/research may benefit from this course.ORGANIZATIONS THAT WILL VALUE THE COURSE:Pharmaceutical companies, Research/Academic Institutions, Biomedical research organizations, Regulatory authorities, Medical colleges, Contract research organizationsThis is a RE-RUN Course, hence all the material provided is as per the earlier course, the reading material is the same for version 2.0 and version 3.0. The assignments, exit assessment, etc. are new. In Version 3.0, we are also trying to have a LIVE session (pre-scheduled) and have add-on lectures. All these will be informed. We would like to hear from you more so that we can continually improve.


Week 1 : Lecture 0: Course overview
Lecture 1: Overview of Indian drug regulatory system Lecture 2: Overview of drugs & cosmetics Act and Rules thereunder Lecture 3: Overview of New Drug and Clinical Trials Rules Rules, 2019
Week 2 : Lecture 4: Pre-clinical data requirements Lecture 5: Rules governing clinical trials Lecture 6A: Phases of clinical trial, forms, and fees Lecture 6B: Regulatory pathway and data requirements for NDCT, 2019
Week 3 : Lecture 7: BA/BE study and study centres: Legal provisions Lecture 8: Guidelines to conduct BA/BE studies Lecture 9: Ethics Committee registration and re-registration
Week 4 : Lecture 10: Ethical considerations Lecture 11: Good Clinical Practice Lecture 12A: Requirements for import/manufacture of new drug/IND for conducting clinical trials in India Lecture 12B: Requirements for import/manufacture of new drug/IND for sale/distribution and unapproved new drug for patients
Week 5 :Lecture 13: Important issues Lecture 14: Special concerns Lecture 15: Clinical trial related guidelines (NDCT Rules)
Week 6 :Lecture 16: Content of proposed clinical trial protocol Lecture 17: Content of a clinical trial report Lecture 18: Post marketing assessment and clinical trial compensation
Week 7 : Lecture 19: Common observations during submission of CT/BA/BE protocol Lecture 20: Common observations during CT/BA/BE centre inspections Lecture 21: Drug development process: Overview
Week 8 : Lecture 22: Salient feature of NDCT 2019 (What's new in NDCT?) Lecture 23A: Online submission (SUGAM) Lecture 23B: Online submission (CTRI) Lecture 24: Tables given in NDCT 2019 and its content

Taught by

Prof. Arun B.Ramteke, Prof. Sucheta Banerjee Kurundkar, Prof. Nandini K Kumar, Prof. Y. K. Gupta, P


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