International Journal of Health Policy and Management

International Journal of Health Policy and Management

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

Document Type : Original Article

Authors
Abhay B. Kadam 1
Karen Maigetter 2, 3
Roger Jeffery 4
Nerges F. Mistry 1
Mitchell G. Weiss 2, 3
Allyson M. Pollock 5
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
10.15171/ijhpm.2016.44
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
Drug Inspectors
Inspections
Drug Regulation
Manufacturing and Sales Units
Drugs and Cosmetics
Act and Rules
Inspection Norms and Workforce Planning Norms
Subjects

 

 

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International Journal of Health Policy and Management
Volume 5, Issue 9
2016
Pages 535-542

  • Received Date 20 September 2015
  • Revised Date 15 April 2016
  • Accepted Date 16 April 2016
  • First Published Date 01 September 2016
  • Published Date 01 September 2016