1The Foundation for Research in Community Health (FRCH), Pune, India
2Department of Epidemiology and Public Health, Swiss Tropical and Public Health Institute (Swiss TPH), Basel, Switzerland
3University of Basel, Basel, Switzerland
4Centre for South Asian Studies, School of Social and Political Science, University of Edinburgh, Edinburgh, UK
5Global 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.
Greene W. The Emergence of India's Pharmaceutical Industry and Implications for the US Generic Drug Market; 2007.
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.
Bate R. Cheap Indian generic drugs: Not such good value after all? American Enterprise Institute. Published February 2013.
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
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
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
Drugs and Cosmetics Act 1940 and Drugs and Cosmetics Rules 1945. 2013.
Hathi C. Hathi Committee Report. Government of India;1975.
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.
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.
Top