# Current Regulatory Requirements For Conducting Clinical Trials In India For Investigational New Drugs/New Drug (Version 3.0)

- Institution: CDSA THSTI DBT
- Department: Multidisciplinary
- Taught by: Prof. D. K. Sable, Prof. Rubina Bose, Prof. 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
- Level: Undergraduate
- Language: English
- Subjects: Medicine and health
- Source: [NPTEL](https://nptel.ac.in/courses/127106137)
- Licence: [CC BY-NC-SA](https://nptel.ac.in/faq) (Non-commercial use only.)
- Syllabus: [at the source](https://nptel.ac.in/courses/127106137)
- Who can watch: Teens profiles and older (sources give no ratings; placed by Invisible Network from the source's own words)

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…

## Lectures

1. [Course overview](https://invisiblenetwork.ai/learn/nptel/127106137/c768e48423ba) (YouTube)
2. [Overview of Indian regulatory system](https://invisiblenetwork.ai/learn/nptel/127106137/10c784283aa3) (YouTube)
3. [Overview of Drugs & Cosmetics Act and Rules thereunder](https://invisiblenetwork.ai/learn/nptel/127106137/b9c51876d83e) (YouTube)
4. [Overview of New Drugs and Clinical Trials Rules, 2019](https://invisiblenetwork.ai/learn/nptel/127106137/d1efe3745397) (YouTube)
5. [PRE-CLINICAL DATA REQUIREMENTS](https://invisiblenetwork.ai/learn/nptel/127106137/683e2ce25239) (YouTube)
6. [RULES GOVERNING CLINICAL TRIALS](https://invisiblenetwork.ai/learn/nptel/127106137/fdcce4c14ce0) (YouTube)
7. [Phases of clinical trial, forms, and fees](https://invisiblenetwork.ai/learn/nptel/127106137/125b7c5253d2) (YouTube)
8. [Regulatory pathway and data requirements for NDCT, 2019](https://invisiblenetwork.ai/learn/nptel/127106137/1b94d8456a82) (YouTube)
9. [BA/BE study and study centers: Legal provisions](https://invisiblenetwork.ai/learn/nptel/127106137/960ad709e520) (YouTube)
10. [Guidelines to conduct BA/BE studies](https://invisiblenetwork.ai/learn/nptel/127106137/25eb033e5896) (YouTube)
11. [Ethics Committee registration and re-registration](https://invisiblenetwork.ai/learn/nptel/127106137/c85f5aeea70e) (YouTube)
12. [Ethical Considerations](https://invisiblenetwork.ai/learn/nptel/127106137/bdb9f2f108b4) (YouTube)
13. [Good Clinical Practice](https://invisiblenetwork.ai/learn/nptel/127106137/13fdf8ec39da) (YouTube)
14. [Requirements for import/ manufacture of new drug/ IND for conducting clinical trials in India](https://invisiblenetwork.ai/learn/nptel/127106137/d9f846a98703) (YouTube)
15. [Requirements for import/ manufacture of new drug/ IND for sale/ distribution & unapproved new drug for patients](https://invisiblenetwork.ai/learn/nptel/127106137/5b2c420ffa10) (YouTube)
16. [Important issues](https://invisiblenetwork.ai/learn/nptel/127106137/5d898e26dec4) (YouTube)
17. [Special concern](https://invisiblenetwork.ai/learn/nptel/127106137/f887064af555) (YouTube)
18. [Clinical trial related guidelines (NDCT Rules)](https://invisiblenetwork.ai/learn/nptel/127106137/e201b2c8aaec) (YouTube)
19. [Content of Proposed Clinical Trial Protocol](https://invisiblenetwork.ai/learn/nptel/127106137/f74d5db57981) (YouTube)
20. [Content of a Clinical Trial Report](https://invisiblenetwork.ai/learn/nptel/127106137/578c6e284722) (YouTube)
21. [Post Marketing Assessment & Clinical Trial Compensation](https://invisiblenetwork.ai/learn/nptel/127106137/9a84a68caa5a) (YouTube)
22. [Common observations during submission of CT/BA/BE protocol](https://invisiblenetwork.ai/learn/nptel/127106137/43a61dd16652) (YouTube)
23. [Common observations during CT/BA/BE centre inspections](https://invisiblenetwork.ai/learn/nptel/127106137/e6e40d3cdb29) (YouTube)
24. [Drug development process: Overview](https://invisiblenetwork.ai/learn/nptel/127106137/aa2959846c76) (YouTube)
25. [Salient feature of NDCT 2019 - what's new in NDCT?](https://invisiblenetwork.ai/learn/nptel/127106137/a7727800d4b5) (YouTube)
26. [Online Submission 23A: SUGAM](https://invisiblenetwork.ai/learn/nptel/127106137/30b5dcedcc64) (YouTube)
27. [ONLINE SUBMISSION (CTRI)](https://invisiblenetwork.ai/learn/nptel/127106137/9d685d168c94) (YouTube)
28. [TABLES GIVEN IN NDCT 2019 AND ITS CONTENT](https://invisiblenetwork.ai/learn/nptel/127106137/34e664d49918) (YouTube)