Comparative Analysis of New Drugs and Clinical Trial Rules 2019 and its impact on Approval process of Oncology Drugs

  • Shagun Sharma
  • Khushbu Sharma
  • Pooja Verma
  • Shivali Rahi
  • Arpana Rana

Abstract

With the aim to make India as the hub for Clinical Trials and promote a transparent and faster drug approvals process for the early availability and accessibility of drugs in the country the New Drugs and Clinical Trials Rules were published on March 19, 2019. The subsequent amendments were also proposed from time to time from March 2019 till June 2022 to make the regulations and the processes more robust.


The ‘New CT Rules’ replaced the Part XA and Schedule Y of the Drugs and Cosmetics Rules 1945. The NDCT rules will be applicable to all Investigational New Drugs, Biologicals, New Drugs, and Subsequent New Drugs.  These rules also laid down the procedures for the effective working of Ethics Committees. The ‘New Rules’ comes up with many desirable changes that will bring transparency, predictability and well defined requirements to speed up the drug approval process in India. The New CT Rules provides a defined protocol so that decision making becomes uniform and that mainly focuses on the Quality & Safety of Clinical Trials. With these rules in place the regulatory system aims to make India a global clinical hub, approvals for the drugs with predictable, transparent and effective regulations and to make faster availability of new drugs to Indian population. In this article, we have highlighted the key developments/changes in the revised regulatory pathway for clinical trials in India and brought the comparative analysis of what has changed from the previous rules till date as subsequent amendments were also notified from time to time. Also, the present work aims at providing the impact of NDCT rules 2019 and subsequent amendments on approval process of drugs for life threatening diseases, unmet medical need and rare Diseases like Cancer. 


By these rules in place Indian pharmaceutical industry would be able to bring a number of medicines which could be promising and effective in treating this pandemic for which no country in the world has been able to find any cure so far. The clause for local CT waiver, accelerated approval, reduced times for CT application is like a boon for developing new drugs in India. This will ensure faster availability of drugs in the country for life threatening diseases, unmet medical needs and rare disease like Cancer. Thus, proving it right that NDCT rules and subsequent amendments brought to the rules will be developing the country’s reputation across the globe and will harmonize the regulations in line with the International standards.

Keywords: NDCT Rules 2019, CT Waiver, Orphan Drugs, Unmet medical need, Deemed approval, Clinical Trial, CTRI

Downloads

Download data is not yet available.

References

1. New Drugs and Clinical Trial Rules, 2019, GSR 227 [E] CDSCO [Internet].CDSCO; 2019 Mar [cited 2022 March 10th]. Available from:
https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdfdocuments/NewDrugs_CTRules_2019.pdf
2. Cressey D. News Article 2012, Aug 21 “India shakes up rules on Clinical Trials” [Internet].Nature news; 2012 Aug 21 [cited 2022 Mar 10]. Available from:
https://www.nature.com/articles/nature.2012.11223.pdf
3. Sapra A, Lenin B and Jain K, Cyril A M et al. “India: New Drugs and Clinical Trials Rules, A Regulatory Overview. 2019 Jul 31.
4. Jesani A and Srinivasan S et al. “New Drugs and Clinical Trials Rules, 2019: The market trumps ethics and participant rights’’ Indian Journal of Medical Ethics. 2019 Apr-Jun;4(2):89-91.
5. Dubey A, Kotian B and Shriram RG et al. “New Drugs and Clinical Trials Rules: Towards Fast-track Accessibility of New Drugs to the Indian Population” Indian Journal of Pharmaceutical Education and Research (IJPER). 2019 Oct. – Dec.;53(4):451-459.
6. Jain P and Chauhan R. et al. “India’s New Drugs and Clinical Trials Rules: An Industry Perspectives” Regulatory affairs Professionals Society, Regulatory focus; 2019 Jul 19
7. Jadhav S and Ghooi R. et al. “New Drug and Clinical Trial Rules 2019- Two Steps Forward and One Back” Indian Journal of Pharmacy Practice. 2009 July –Sept.;12(3):209-214.
8. Veeda Clinical Research. “Current regulatory landscape for drug approvals and clinical trials in India’’ Veeda Clinical Research Private Limited; 2019 Jun.
9. Bhatt A. et al. “New clinical trial rules: Academic trials and tribulations’’ J. Perspectives in Clinical Research. 2019 July - Sept.;10(3):103-105.
10. Shivaprakash G and Pallavi LC. et al. “New Drugs and Clinical Trial Rules 2019, What is New? Our Views from Ethical Perspective” Journal of The Association of Physicians of India. 2019 Oct;67(10):75-76.
11. Gazette Notifications, CDSCO Draft GSR 354 (E) dated 5 June 2020 [Internet]. CDSCO; June 2020 [cited 2022, Feb 09]. Available from:
https://cdsco.gov.in/opencms/opencms/en/Notifications/Gazette-Notifications/
12. Gazette Notifications, CDSCO, Final GSR 605 (E) [Internet]. CDSCO; 2021 Aug 31 [cited 2022, Feb 09]. Available from:
https://cdsco.gov.in/opencms/opencms/en/Notifications/Gazette-Notifications/
13. Gazette Notifications, CDSCO [Internet]. Draft GSR 524 (E) dated 2 Aug 2021 and Final GSR 21 (E) dated 18 Jan 2022 CDSCO; 2022 Feb [cited 2022, March 10]. Available from:
https://cdsco.gov.in/opencms/opencms/en/Notifications/Gazette-Notifications/
14. Gazette Notifications, CDSCO, Draft GSR 767(E) dated 27 Oct 2021 and Final GSR 14 (E) dated 13 Jan 2022 [Internet]. CDSCO; 2022 Jan 22 [cited 2022, March 10]. Available from:
https://cdsco.gov.in/opencms/opencms/en/Notifications/Gazette-Notifications/
15. Gazette Notifications, CDSCO Draft GSR 32(E) dated 21 Jan 2022 [Internet]. CDSCO; 2022 Jan 21 [cited 2022, March 10]. Available from:
https://cdsco.gov.in/opencms/opencms/en/Notifications/Gazette-Notifications/
16. Gazette Notifications, CDSCO, S.O. 553(E) dated 9 Feb 2022 [Internet]. CDSCO; Feb 2022 [cited 2022, March 10]. Available from:
https://cdsco.gov.in/opencms/opencms/en/Notifications/Gazette-Notifications/
Statistics
135 Views | 268 Downloads
How to Cite
Sharma, S., K. Sharma, P. Verma, S. Rahi, and A. Rana. “Comparative Analysis of New Drugs and Clinical Trial Rules 2019 and Its Impact on Approval Process of Oncology Drugs”. International Journal of Drug Regulatory Affairs, Vol. 10, no. 2, June 2022, pp. 112-30, doi:10.22270/ijdra.v10i2.543.