New drug and clinical trial rules, 2019: an overview

Swathi A. Annapurna, Srinivasa Y. Rao

Abstract

Clinical trials are indispensable to the drug development method to confirm the effectiveness and safety of any new drug. India has undergone a big restrictive transformation about clinical trials. Numerous establishments taking part in a distinguished role in guiding the trial in India embody DCGI, DBT, ICMR, CBN, RCGM and GEAC. The government notified the new drugs and trial rules on 19 March 2019, to supersede part XA and schedule Y of the drugs and cosmetics rules 1945. Updating our knowledge about these is of utmost importance in today’s turbulent scenario that prevails in the pharmaceutical industry. Thus, this review gives an idea about the recent changes regarding the regulations of clinical trials.

Keywords

Clinical trials, New drug, BA/BE studies, Pre-submission meeting, Post-submission meeting

Full Text:

PDF

References

Ministry of health and family welfare (1940) the drugs and cosmetics act and rules. Available at: https://cdsco.gov.in/opencms/opencms/en/Acts-Rules/. Accessed on 20 July 2020.

CDSCO, ministry of health and family welfare (2001) good clinical practice: guidelines for clinical trials on pharmaceutical products in India, New Delhi. Available at: https://cdsco.gov.in/opencms/ opencms/en/Clinical-Trial/clinical-trials/. Accessed on 20 July 2020.

New drugs and clinical trials rules, 2019, ministry of health and family welfare, India. Available at: http://www.egazette.nic.in/WriteReadData/2019/200759.pdf. Accessed 19 July 2019. Accessed on 20 July 2020.

Clinical trials in India. Available at: http://www.theweek.in/health/cover/clinical-trials-research-india.html. Accessed on 20 July 2020.

Guidance for industry on preparation of common technical document for import/ manufacture and marketing approval of new drugs for human use. Available at: https://cdsco.gov.in/opencms/resources/ UploadCDSCOWeb/2018/UploadGazette_NotificationsFiles/CTD%20Guidance%20Final.pdf. Accessed on 20 July 2020.

Application for grant of permission to import or manufacture a new drug or to undertake clinical trial. Available at: https://cdsco.gov.in/opencms/export/ sites/CDSCO_WEB/Pdf-documents/New-Drugs/Checklist/Update_ Checklist_10July2018.pdf. Accessed on 20 July 2020.

New drugs and clinical trials rules. Available at: https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdfdocuments/NewDrugs_CTRules_2019.pdf. Accessed on 20 July 2020.

The supreme court order regarding the draft drugs and clinical trials rules. Available at: http://www.indiaenvironmentportal.org.in/content/458635/order-of-the-supreme-court-of-india-regarding-the-draftdrugs-and-clinical-trials-rules-2018-12092018/. Accessed on 20 July 2020.

Swasthya adhikar manch vs. union of India, written petition. Available at: https://www.casemine.com/ judgement/in/58117eca2713e179478bb3d4. Accessed on 20 July 2020.

Uncertainty on approvals sees exodus of clinical trials. Available at: http://www.livemint.com/ Industry/bQu4EtyMUgkAXEuDade3YN/ Uncertainty-on-approvals-sees-exodus-of-clinical-trials.html. Accessed on 20 July 2020.

Biocon forced to move clinical trials out of India. Available at: http://www.businessstandard.com/ article/companies/bioconforced- to-move-clinical-trials-out-of-india-114012400052_1. html. Accessed on 20 July 2020.