Current Regulatory Requirements for Conducting Clinical Trials in India for Investigational New Drugs/New Drug (Version 3.0)

By Prof. D. K. Sable, Prof. Rubina Bose, Professor Y. K. Gupta, Prof. Nandini K. Kumar, Late Shri Arun Kumar B. Ramteke, Prof. Neha Chawla, Prof. M. Vishnu V. Rao, Prof. Atul Juneja, Prof. Tulsi Adhikari, Prof. Mohua Maulik | CDSA,THSTI,DBT

Learners enrolled: 343

ABOUT THE COURSE:

This course is co-developed by the Clinical Development Services Agency (CDSA), BRIC-THSTI and the Central Drugs Standard Control Organisation (CDSCO), with NPTEL.

CDSA is a centre of BRIC-THSTI, and was created with a mandate to support and nurture clinical product development and clinical research capacity in India. It fills a unique niche in the publicly funded clinical research landscape in the country as being the only such public agency established by the Department of Biotechnology, Government of India. THSTI is an autonomous institution under the Department of Biotechnology (DBT), Ministry of Science & Technology, Government of India.

CDSCO is the National Regulatory Authority (NRA) of India, 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.

A thorough knowledge and understanding of regulatory guidelines is a prerequisite for conducting regulatory clinical trials, including those related to new drug development. This is particularly important in light of the numerous changes and amendments to clinical trial and new drug approval regulations in India in recent years.

This course was initially launched as a four-week program in early 2019 (Version 1), comprising 12 lectures. Between January and March 2019, 1,047 participants enrolled in the course.

On March 19, 2019, the New Drugs and Clinical Trials (NDCT) Rules, 2019 were released. The subsequent version of the course (Version 2) was updated to reflect the changes and amendments introduced through the NDCT Rules, 2019. To incorporate the latest regulatory updates and feedback from Version 1 participants, CDSA conducted a series of brainstorming sessions in collaboration with CDSCO. The updated version draws on key issues identified during six face-to-face national workshops on regulatory compliance for accelerating innovations, conducted by CDSA between December 2018 and July 2019 under the aegis of DBT, CDSCO, NITI Aayog, and BIRAC-NBM. Additional inputs were gathered from an interactive session on the NDCT Rules, 2019 organized by CDSA and CDSCO at THSTI in May 2019.

The current version (Version 3) comprises of 24 lectures delivered over a period of eight weeks. It includes eight weekly assignments and a final exit assessment. The online course is free of charge. However, participants who wish to obtain a certificate must opt for the certification examination, which requires payment of a nominal fee. The exam is entirely optional.

COURSE OBJECTIVES AND EXPECTED LEARNING OUTCOME:

Upon successful completion of this online course, participants will be able to:

Understand the current regulatory framework outlined in the New Drugs and Clinical Trials (NDCT) Rules, 2019 for the conduct of clinical trials involving new drugs or investigational new drugs (INDs) intended for manufacture or import in India.
Identify and describe the essential documents required for regulatory approval and conduct of clinical trials and new drug/IND applications
Appreciate the scope, relevance, and application of key trial-related guidelines, including Good Clinical Practice (GCP) and the National Ethical Guidelines for Biomedical and Health Research Involving Human Participants (2017)

TARGET AUDIENCE:

This course is designed for individuals from both industry and academia who are involved in or interested in clinical trials and new drug development (including research and development, manufacturing, or import) in India. It is particularly suitable for:

Investigators and clinical researchers
Regulatory affairs professionals
Members of institutional ethics committee members
Clinical trial team members
Professionals from the pharmaceutical, biotechnology, and contract research sectors

PRE-REQUISITES :

There are no mandatory pre-requisites for enrolling in this course. However, it is best suited for individuals with a scientific or medical background (such as BSc, MSc, PhD, BPharm, MPharm, BAMS, BHMS, BDS, MDS, MBBS, MD, or DM). Professionals currently working in the areas of drug development, clinical trials, or biomedical research may find the course particularly beneficial.

ORGANIZATIONS THAT WILL VALUE THE COURSE:

Pharmaceutical Companies
Research and Academic Institutions
Biomedical Research Organizations
Regulatory Authorities
Medical Colleges
Contract Research Organizations (CROs)

ABOUT THIS COURSE OFFERING:

This is a re-run of the course, and most of the core reading material remains the same as in Version 2.0. However, Version 3.0 includes several new components:

Updated weekly assignments
A revised final exit assessment
Planned LIVE interactive sessions (pre-scheduled)
Additional lectures to enhance learning

All new sessions and updates will be communicated in advance. We welcome your feedback to help us improve the course further.

Summary

Course Status :	Upcoming
Course Type :	Elective
Language for course content :	English
Duration :	8 weeks
Category :	Multidisciplinary
Credit Points :	2
Level :	Undergraduate/Postgraduate
Start Date :	21 Jul 2025
End Date :	12 Sep 2025
Enrollment Ends :	28 Jul 2025
Exam Registration Ends :	15 Aug 2025
Exam Date :	20 Sep 2025 IST
NCrF Level	4.5 — 8.0

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, 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 Rules, 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 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

Prof. D. K. Sable, Deputy Drugs Controller (India), CDSCO HQ, New Delhi
Prof. Rubina Bose, Deputy Drugs Controller (India), CDSCO, HQ, New Delhi
Professor Y. K. Gupta, Principal Adviser DNDi; Former Dean (Academics), AIIMS, New Delhi, Former Adviser, CDSA-THSTI, DBT
Prof. Nandini K. Kumar, Former Deputy Director General Sr. Grade, Indian Council of Medical Research (ICMR), Adjunct Faculty, CDSA, THSTI, DBT
Late Shri Arun Kumar B. Ramteke, Former Joint Drugs Controller (India), CDSCO; Consultant, Regulatory Affairs, CDSA, THSTI, DBT
Dr. Neha Chawla, Head-Training, CDSA, BRIC-THSTI, DBT
Prof. M. Vishnu V. Rao, Former Scientist G & Director, ICMR – National Institute of Medical Statistics (NIMS); Administrator, Clinical Trial Registry - India (CTRI)
Prof. Atul Juneja, Scientist E, ICMR-NIMS; Coordinator, CTRI
Prof. Tulsi Adhikari, Scientist E, ICMR-NIMS; Coordinator, CTRI
Prof. Mohua Maulik, Consultant, ICMR-NIMS

1) COURSE DEVELOPMENT TEAM :

Late Shri Arun Kumar B. Ramteke, Former Joint Drugs Controller (India), CDSCO; Consultant, Regulatory Affairs, CDSA, THSTI, DBT
Dr. Neha Chawla, Head-Training, CDSA, BRIC-THSTI, DBT
Professor.Dr. Nitya Wadhwa, Senior Professor, THSTI and Faculty In-Charge, CDSA, THSTI, DBT
Professor Usha Menon, Adjunct Professor CDSA, THSTI, DBT, Professor MRC CTU at University College London

2) TEACHING ASSISTANCE :

Ms. Nidhi Mishra, Administrator Training, CDSA, BRIC-THSTI, DBT

3) TECHNICAL ASSISTANCE :

Mr. Taneja, IIT Delhi
Ms. Bharati, IIT Bombay
Mr. Tushar Deshpande, IIT Bombay
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 : September 20, 2025 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

Please note that assignments encompass all types (including quizzes, programming tasks, and essay submissions) available in the specific week.

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.

Once again, thanks for your interest in our online courses and certification. Happy learning.

- NPTEL team