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Correcting India's chronic shortage of drug inspectors to ensure the production and distribution of safe, high-quality medicines

Kadam, Abhay B. and Maigetter, Karen and Jeffery, Roger and Mistry, Nerges F. and Weiss, Mitchell G. and Pollock, Allyson M.. (2016) Correcting India's chronic shortage of drug inspectors to ensure the production and distribution of safe, high-quality medicines. International journal of health policy and management, 5 (9). pp. 535-542.

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Official URL: http://edoc.unibas.ch/44421/

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Abstract

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.; 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.; 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.; 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.
Faculties and Departments:09 Associated Institutions > Swiss Tropical and Public Health Institute (Swiss TPH)
09 Associated Institutions > Swiss Tropical and Public Health Institute (Swiss TPH) > Former Units within Swiss TPH > Cultural Epidemiology (Weiss)
UniBasel Contributors:Maigetter, Karen and Weiss, Mitchell G.
Item Type:Article, refereed
Article Subtype:Research Article
Publisher:Kerman Univ. of Medical Sciences
ISSN:2322-5939
Note:Publication type according to Uni Basel Research Database: Journal article
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Last Modified:28 Nov 2016 10:55
Deposited On:28 Nov 2016 10:55

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