Correcting India’s Chronic Shortage of Drug Inspectors to Ensure the Production and Distribution of Safe, High-Quality Medicines

Document Type : Original Article

Authors

1 The Foundation for Research in Community Health (FRCH), Pune, India

2 Department of Epidemiology and Public Health, Swiss Tropical and Public Health Institute (Swiss TPH), Basel, Switzerland

3 University of Basel, Basel, Switzerland

4 Centre for South Asian Studies, School of Social and Political Science, University of Edinburgh, Edinburgh, UK

5 Global Public Health Unit, Queen Mary University of London, London, UK

Abstract

Background
Good drug regulation requires an effective system for monitoring and inspection of manufacturing and sales units. In India, despite widespread agreement on this principle, ongoing shortages of drug inspectors have been identified by national committees since 1975. The growth of India’s pharmaceutical industry and its large export market makes the problem more acute.
 
Methods
The focus of this study is a case study of Maharashtra, which has 29% of India’s manufacturing units and 38% of its medicines exports. India’s regulations were reviewed, comparing international, national and state inspection norms with the actual number of inspectors and inspections. Twenty-six key informant interviews were conducted to ascertain the causes of the shortfall.
 
Results
In 2009-2010, 55% of the sanctioned posts of drug inspectors in Maharashtra were vacant. This resulted in a shortfall of 83%, based on the Mashelkar Committee’s recommendations. Less than a quarter of the required inspections of manufacturing and sales units were undertaken. The Indian Drugs and Cosmetics Act and its Rules and Regulations make no provisions for drug inspectors and workforce planning norms, despite the growth and increasing complexity of India’s pharmaceutical industry.
 
Conclusion
The Maharashtra Food and Drug Administration (FDA) falls short of the Mashelkar Committee’s recommended workforce planning norms. Legislation and political and operational support are required to produce needed changes.

Highlights

 

 

Watch the Video Summary here. 

 

Keywords

Main Subjects

Full Text

 

 

References

  1. Greene W. The Emergence of India's Pharmaceutical Industry and Implications for the US Generic Drug Market; 2007.
  2. Parliamentary Standing C. 59th report on the functioning of the Central Drugs Standard Control Organisation (CDSCO): Department Related Parliamentary Standing Committee on Health and Family Welfare (2011-2012). New Delhi, Rajya Sabha;2012.
  3. Bate R. Cheap Indian generic drugs: Not such good value after all? American Enterprise Institute. Published February 2013.
  4. Bate R, Tren R, Mooney L, et al. Pilot study of essential drug quality in two major cities in India. PLoS One. 2009;4(6):e6003. Doi:10.1371/journal.pone.0006003
  5. Brhlikova P, Harper I, Jeffery R, Rawal N, Subedi M, Santhosh M. Trust and the regulation of pharmaceuticals: South Asia in a globalised world. Global Health. 2011;7:10. doi:10.1186/1744-8603-7-10
  6. Caudron JM. Substandard medicines in resource-poor settings: a problem that can no longer be ignored. Tropical Medicine & International Health. 2008;13(8):1062-1072. Doi:10.1111/j.1365-3156.2008.02106.x
  7. Nelson D. Britain ignored warnings of Indian whistleblower at heart of drugs scandal. The Telegraph. June 13,2013. http://www.telegraph.co.uk/news/worldnews/asia/india/10119371/Britain-ignored-warnings-of-Indian-whistleblower-at-heart-of-drugs-scandal.html
  8. Vidya K, Unnikrishnan CH. Ranbaxy fallout: Indian pharma under the microscope. Live mint website. http://www.livemint.com/Industry/nTIfqyG87wxdlz8txCa6HL/Indian-pharma-under-the-microscope.html. Published May 23, 2013.
  9. Department of Pharmaceuticals. Annual report 2011-2012. http://pharmaceuticals.gov.in/AnnualReportEnglish.pdf. Published on 2012.
  10. Government of M. Medical Education and Drugs Department, Annual Plan 2011-2012. Mumbai; 2011.
  11. FDA prohibits Ranbaxy's Toansa, India facility from producing and distributing drugs for the U.S. market. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm382736.htm. Published 2014.
  12. DCGI asked to check quality of drugs sold by Ranbaxy. The Hindu, Business Line website. http://www.thehindubusinessline.com/economy/dcgi-asked-to-check-quality-of-drugs-sold-by-ranbaxy-govt/article5051958.ece. Published August 23, 2013
  13. Drugs and Cosmetics Act 1940 and Drugs and Cosmetics Rules 1945. 2013.
  14. Hathi C. Hathi Committee Report. Government of India;1975.
  15. Mashelkar C. Mashelkar Committee Report, Report of the Expert Committee on a Comprehensive Examination of Drug Regulatory Issues, Including the Problem of Spurious Drugs. New Delhi: Government of India; 2003.
  16. Lentin C. Lentin Commission Report, Report of the Commission of Inquiry (Re Deaths of Patients in J J Hospital at Bombay in January- February 1986 due to alleged reaction of drugs); 1988.
  17. Planning Commission. The report of the working group on Drugs and Pharmaceuticals for the formulation of the Twelfth Five Year Plan (2012-2017). http://planningcommission.gov.in/aboutus/committee/wrkgrp12/health/WG_4drugs.pdf. Published 2012.
  18. World Health Organization (WHO). Multicountry Study on Effective Drug Regulation. Geneva: WHO; 2002.
  19. Ramesh S. Even after one year of SC directive, Madras HC yet to hold final hearing in controversial DCGI case. Pharmabiz website. http://www.pharmabiz.com/NewsDetails.aspx?aid=77035&sid=1.Published August 08, 2013.
  20. Dey S. Drug regulator to periodically inspect all clinical trial sites. Business Standard website. http://www.business-standard.com/article/companies/drug-regulator-to-periodically-inspect-all-clinical-trial-sites-113050600006_1.html. Published May 6, 2013.

Files

History

  • Receive Date: 20 September 2015
  • Revise Date: 15 April 2016
  • Accept Date: 16 April 2016
  • First Publish Date: 01 September 2016

Share

How to cite

Statistics