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

By Dr D. K. Sable, Dr Rubina Bose, Professor Y. K. Gupta, Dr Nandini K. Kumar, Shri Arun Kumar B. Ramteke, Dr Sucheta Banerjee Kurundkar, Dr M. Vishnu V. Rao, Dr Atul Juneja, Dr Tulsi Adhikari, Dr Mohua Maulik | CDSA,THSTI,DBT

Learners enrolled: 2671

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 OUTCOME

Upon 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 India
Essential documents required for the conduct and approval of clinical trials, new drug/IND
Essence and purpose of important trial-related guidelines, such as Good Clinical Practice (GCP), national ethical guidelines for biomedical & health research for human participants (2017), etc

TARGET 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 organizations

This 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.

Summary

Course Status :	Completed
Course Type :	Elective
Language for course content :	English
Duration :	8 weeks
Category :	Multidisciplinary
Credit Points :	2
Level :	Undergraduate/Postgraduate
Start Date :	15 Feb 2021
End Date :	09 Apr 2021
Enrollment Ends :	15 Feb 2021
Exam Date :	24 Apr 2021 IST

Note: This exam date is subject to change based on seat availability. You can check final exam date on your hall ticket.

Page Visits

Course layout

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

Books and references

Drugs & Cosmetics Act, 1940 and Rules thereunder 1945, New Drugs and Clinical Trial Rules, 2019, Related Guidance documents available at CDSCO website.

Instructor bio

1. Dr D. K. Sable, Assistant Drugs Controller (India), CDSCO HQ, New Delhi

2. Dr Rubina Bose, Deputy Drugs Controller (India), CDSCO, West Zone, Mumbai

3. Professor Y. K. Gupta, Principal Adviser (Projects), CDSA, THSTI, DBT

4. Dr Nandini K. Kumar, Former Deputy Director General Sr. Grade, Indian Council of Medical Research (ICMR), Adjunct Faculty, CDSA, THSTI, DBT

5. Shri Arun Kumar B. Ramteke, Former Joint Drugs Controller (India), CDSCO; Consultant, Regulatory Affairs, CDSA, THSTI, DBT

6. Dr Sucheta Banerjee Kurundkar, Director Training, CDSA, THSTI, DBT

7. Dr M. Vishnu V. Rao, Scientist G & Director, ICMR – National Institute of Medical Statistics (NIMS); Administrator, Clinical Trial Registry - India (CTRI)

8. Dr Atul Juneja, Scientist E, ICMR-NIMS; Coordinator, CTRI

9. Dr Tulsi Adhikari, Scientist E, ICMR-NIMS; Coordinator, CTRI

10. Dr Mohua Maulik, Consultant, ICMR-NIMS

1) COURSE DEVELOPMENT TEAM :

1. Dr Sucheta Banerjee Kurundkar, Director Training, CDSA, THSTI, DBT

2. Shri Arun Kumar B. Ramteke, Former Joint Drugs Controller (India), CDSCO; Consultant, Regulatory Affairs, CDSA, THSTI, DBT

3. Dr. Nitya Wadhwa, Assistant Professor, THSTI and Faculty In-Charge, CDSA, THSTI, DBT

4. Professor Usha Menon, Strategy Lead, Adjunct Professor CDSA, THSTI, DBT, Professor MRC CTU at University College London

2) TEACHING ASSISTANCE :

1. Ms Vandana Chawla, Training Manager, CDSA, THSTI, DBT

2. Mr Jitender Ahuja, Training Coordinator, CDSA, THSTI, DBT

3) TECHNICAL ASSISTANCE :

1. Mr Taneja, IIT Delhi

2. Ms Bharati, IIT Bombay

3. Mr Tushar Deshpande, IIT Bombay

4. Mr Amin, IIT Bombay

Course certificate

• The course is free to enroll and learn from. But if you want a certificate, you have to register and write the proctored exam conducted by us in person at any of the designated exam centres.
• The exam is optional for a fee of Rs 1000/- (Rupees one thousand only).
• Date and Time of Exams: 24th April 2020, Morning session 9am to 12 noon; Afternoon Session 2pm to 5pm.
• Registration url: Announcements will be made when the registration form is open for registrations.
• The online registration form has to be filled and the certification exam fee needs to be paid. More details will be made available when the exam registration form is published. If there are any changes, it will be mentioned then.
• Please check the form for more details on the cities where the exams will be held, the conditions you agree to when you fill the form etc.

CRITERIA TO GET A CERTIFICATE:
• Average assignment score = 25% of average of best 6 assignments out of the total 8 assignments given in the course.
• Exam score = 75% of the proctored certification exam score out of 100
• Final score = Average assignment score + Exam score

YOU WILL BE ELIGIBLE FOR A CERTIFICATE ONLY IF AVERAGE ASSIGNMENT SCORE >=10/25 AND EXAM SCORE >= 30/75.
• If one of the 2 criteria is not met, you will not get the certificate even if the Final score >= 40/100.
• Certificate will have your name, photograph and the score in the final exam with the breakup.It will have the logos of NPTEL and IIT Madras. It will be e-verifiable at nptel.ac.in/noc.
• Only the e-certificate will be made available. Hard copies will not be dispatched.

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