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

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 ۱۹۷۵. 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 ۲۹% of India’s manufacturing units and ۳۸% 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 ۲۰۰۹-۲۰۱۰, ۵۵% of the sanctioned posts of drug inspectors in Maharashtra were vacant. This resulted in a shortfall of ۸۳%, 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.

کلیدواژه ها:

Drug Inspectors ، Inspections ، Drug Regulation ، Manufacturing and Sales Units ، Drugs and Cosmetics ، Act and Rules ، Inspection Norms and Workforce Planning Norms