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Cited by 42Biomedical Ethics and RegulationHealthcare RegulationPharmaceutical industry and healthcare

Clinical research regulation in India-history, development, initiatives, challenges and controversies: still long way to go

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Imran, Mohammed, Najmi, AbulK, Rashid, MohammadF, Tabrez, Shams, Shah, MushtaqA·2013·Journal of Pharmacy And Bioallied Sciences
DOI 10.4103/0975-7406.106553PMC PMC3612334
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Abstract

The Central Drugs Standard Control Organisation and its chairman Drug Controller general of India are bequeathed to protect the citizens from the marketing of unsafe medication. The startling findings, of the 59(th)report of the Parliamentary Standing Committee on Health and Family Welfare, have uncovered the lax standards followed by the regulatory authorities in India. 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. Many controversial group of medicines; unauthorised and irrational FDCs not relevant to India's medical needs, are available which are not sold in any of the countries with matured regulatory bodies. 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 Contract Research Organisations, 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. However due to casual approach in marketing approval for sale of the drugs, the unethical steps taken by some pharmaceutical companies and medical practitioners has reiterated the need to get appropriate understanding of present regulation of drugs and clinical research especially regarding the practical rules and regulations.

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Research works printed but not linked: 2

  1. [1]Confederation of Indian Industry. Background paper Conference on Clinical research: Roadmap for India, New Delhi 2003 9 24-25 Last accessed on 2012 Jul 07 Available from: http://www.icriindia.com/pdf/conference.on.clinical.research.road.map.for.india.pdf
  2. [10]Social Sector: Volume II; Planning Commission, Government of India Eleventh Five Year Plan (2007-2012) 2008 New Delhi Oxford University Press

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Authors
Imran, M., Najmi, A., Rashid, M., Tabrez, S., & Shah, M.
Affiliations
Jamia Hamdard (IN)
Corresponding author
Imran, Mohammed
ORCID
Venue
Journal of Pharmacy And Bioallied Sciences
Publisher
Ovid Technologies (Wolters Kluwer Health)
Published
2013
Volume
5
Issue
1
Pages
2
ISSN
0975-7406 (ISSN-L)
DOI
10.4103/0975-7406.106553
PMC
PMC3612334
OpenAlex
W1976739527
Cited by
42
References
22
Citations by year
2026: 1 · 2025: 3 · 2024: 3 · 2023: 3 · 2022: 8 · 2021: 3 · 2020: 2 · 2019: 1 · 2018: 1 · 2017: 3 · 2016: 3 · 2015: 6 · 2014: 5
FWCI
3.25
Type
journal article
Language
en
Open access
Licence
public-domain
Locations
  • Journal of Pharmacy And Bioallied Sciences (publishedVersion, public-domain)
  • Europe PMC (PubMed Central) (publishedVersion, cc-by-nc-sa)
  • PubMed Central (publishedVersion, cc-by-nc-sa)
  • PubMed (publishedVersion)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
Funders
Atomic Energy Regulatory Board
Topics
  • Health Sciences › Medicine › Physiology › Biomedical Ethics and Regulation
  • Health Sciences › Health Professions › Health Information Management › Healthcare Regulation
  • Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmaceutical industry and healthcare
Keywords
clinical research regulation, drug regulation, pharmaceutical patents, TRIPS Agreement, adverse drug reaction monitoring, pharmacovigilance, fixed-dose combination, clinical trial registration, drug marketing approval, pharmaceutical industry ethics

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