PHARMACOVIGILANCE IN CLINICAL RESEARCH: PAST, PRESENT AND FUTURE

  • Pratibha Chauhan
  • Ashish Yadav
  • Babita Kirodian

Abstract

The growing clinical research after the product patents rights for the pharmaceutical industries as per the trade related aspects of intellectual property rights agreement and adverse drug reaction monitoring of the marketed drugs have raised many ethical and regulatory issues regarding the promotion of new drugs in Indian markets. It becomes vital to understand the history, growth and evolution of the regulatory aspects of drugs which are handled by multiple Ministries and Departments of the Government of India. Although amendment to Schedule Y, registration of Ethics committee, registration of Clinical Trials, Speeding up review process, Pharmacovigilance (PhV) programme for India and Inspection of clinical trial sites have been started by the various regulatory agencies. India’s growing partaking in multinational trials, this artifact explores potential areas of Indian pharmacovigilance, requiring reform and provides recommendations for building a robust safety reporting system. (1) Despite global focus on Development Safety Update Report, local regulators are not yet insistent on real-time update of a drug's cumulative safety profile. Issues like reporting requirements for generic trials, pregnancy reporting and lenient timeline for death/life-threatening events need attention. (2)

Keywords: GCP, CDSCO, DSUR, adverse drug reaction (ADR), Development safety update report, Pharmacovigilance (PhV) expedited reporting, serious adverse event, suspected unexpected serious adverse reaction.

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References

1. Imran M, Najmi A, Rashid M, Tabrez S, Shah M. Clinical research regulation in India-history, development, initiatives, challenges and controversies: Still long way to go. Journal of Pharmacy and Bioallied Sciences. 2013; 5(1):2.
2. Brahmachari B, Fernandes M, Bhatt A. Pharmacovigilance for clinical trials in India: Current practice and areas for reform. - PubMed - NCBI [Internet]. 2016 [cited 2016 Oct 10]. Available from:
https://www.ncbi.nlm.nih.gov/pubmed/21731854
3. Clinical Research Regulation in India [Internet]. Scribd; 2016 [cited 2016 Oct 10]. Available from: https://es.scribd.com/doc/207479435/Clinical-Research-Regulation-in-India
4. MAITI RM R. Clinical trials in India. Pharmacological Research. 2007; 56(1):1-10.
5. Jayasheel BG. Carrying out clinical trials in India. [Internet]. RAJ Pharma; 2010 Jun [cited 2016 Oct 10]. Available from:
http://www.acunovalife.com/pdf/whitepapers/RAJ_Pharma%20June%202010_Jayasheel%20final.pdf. [Ref list]
6. John A. India’s attractive again for clinical trials: Quintiles CEO - Times of India [Internet]. The Times of India; 2016 [cited 2016 Oct 10]. Available from:
http://timesofindia.indiatimes.com/business/india-business/Indias-attractive-again-for-clinical-trials-Quintiles-CEO/articleshow/51716878.cms
7. Glorious metamorphosis: compelling reasons for doing clinical research in India [Internet]. Worldcat.org; 2016 [cited 2016 Oct 10]. Available from:
http://www.worldcat.org/title/glorious-metamorphosis-compelling-reasons-for-doing-clinical-research-in-india/oclc/589018032?page =citation
8. Eleventh Five Year Plan (2007-2012) New Delhi: Oxford University Press. Social Sector: Volume II; Planning Commission, Government of India; 2008 [Ref list]
9. Law Relating to Drugs & Cosmetics [Internet]. Cdsco.nic.in; 2016 [cited 2016 Oct 10]. Available from:
http://www.cdsco.nic.in/html/GCP1.html
10. Amended Schedule Y [Drug and Cosmetic act (2nd amendment) rules] [Internet]. New Delhi: 2005 Jan 20 [cited 2016 Oct 12]. Available from: http://www.cdsco.nic.in/html/scheduleY%20(Amended%20Version2005)%20original.htm . [Ref list]
11. ICMR, Ethical Guidelines for Biomedical Research on Human Participants [Internet]. ICMR; 2006 [cited 2016 Oct 11]. Available from:
http://www.icmr.nic.in/ethical_guidelines.pdf. [Ref list]
12. CDSCO, Good Clinical Practices for Clinical Research in India, Schedule Y (Amended Version – 2005) [Internet]. CDSCO; 2005 [cited 2016 Oct 13]. Available from:
http://cdsco.nic.in/html/GCP1.html. [Ref list]
13. Nundy S, Gulhati CM. A new colonialism?--Conducting clinical trials in India. N Engl J Med. 2005 Apr 21; 352(16):1633-6.[PubMed] [Ref list]
14. Thatte UM, Bavdeka SB. Clinical Research in India: Great expectations. J Postgrad Med. 2008; 54:318-23. [PubMed] [Ref list]
15. Ghooi RB. Trials and tribulations of clinical research teaching and training. Perspect Clin Res. 2010 Oct; 1(4):139-42. [PubMed] [Ref list]
16. Srinivasan S. A stinging indictment of India's Drug regulatory Authority. Economic and Political weekly. 2012; 47:10-3. [Ref list]
17. Pharmacovigilance programme of India. [Internet] CDSCO, Ministry of Health and Family Welfare, Government of India; 2010 Nov [cited 2016 Oct 12]. Available from:
http://www.cdsco.nic.in/pharmacovigilance_intro.htm. [Ref list]
18. Indian Pharmacopoeias Commission. [Internet]. NCC Pharmacovigilance programme of India; 2012 [cited 2016 Oct 12]. Available from:
http://www.ipc.gov.in/index1.asp?linkid=222. [Ref list]
19. Chemtech Foundation [Internet]. Pharma Biotech; 2016 [cited 2016 Oct 11]. Available from:
http://www.chemtech-online.com/P%26B/vijay_march13.html
20. Indian Pharmacopoeia commission [Internet]. Pharmacovigilance Programme of India; 2010 [cited 2016 Oct 13]. Available from:
http://ipc.nic.in/writereaddata/linkimages/pvpi-2611733527.pdf
21. Food and Drug Administration. Guidance for Industry and Investigators: Safety Reporting Requirements for IND and BA/BE studies [Internet]. Draft guidance; 2010. [cited 2016 Oct 11]. Available from:
http://wwwfdagov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM227351pdf [accessed on 2010 Dec 10] [Ref list]
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How to Cite
Chauhan, P., A. Yadav, and B. Kirodian. “PHARMACOVIGILANCE IN CLINICAL RESEARCH: PAST, PRESENT AND FUTURE”. International Journal of Drug Regulatory Affairs, Vol. 4, no. 4, Feb. 2018, pp. 1-6, doi:https://doi.org/10.22270/ijdra.v4i4.188.