The Foundation for Research in Community Health (FRCH), Pune, India.
Department of Epidemiology and Public Health, Swiss Tropical and Public Health Institute (Swiss TPH), Basel, Switzerland.
Int J Health Policy Manag. 2016 Sep 1;5(9):535-542. doi: 10.15171/ijhpm.2016.44.
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.
良好的药品监管需要建立一个有效的制造和销售单位监测和检查系统。尽管印度全国委员会自 1975 年以来就一直认识到这一原则，但由于药品检查员的持续短缺，印度的药品监管工作仍面临着挑战。印度制药业的发展及其庞大的出口市场使这一问题更加严峻。
本研究的重点是对马哈拉施特拉邦的案例研究，该邦拥有印度 29%的制药单位和 38%的药品出口。本文回顾了印度的监管规定，将国际、国家和州的检查规范与实际检查员人数和检查次数进行了比较。进行了 26 次关键知情人访谈，以确定短缺的原因。
2009-2010 年，马哈拉施特拉邦有 55%的药品检查员核定员额空缺。根据马谢尔卡委员会的建议，这导致短缺了 83%的检查员。对制造和销售单位的检查中，实际完成的不到所需检查的四分之一。尽管印度制药业不断发展且日趋复杂，但《印度药品和化妆品法》及其规则和条例并未对药品检查员和劳动力规划规范做出规定。
马哈拉施特拉邦食品和药物管理局（FDA）未能达到马谢尔卡委员会建议的劳动力规划规范。需要立法以及政治和运营支持来实现所需的变革。
