Global drug imports from India need better standards

The Indian pharmaceutical sector is beset with compliance problems. This is demonstrated via a series of import bans into the U.S. imposed by the U.S. Food and Drug Administration (FDA).

To date, GMP Publishing reports, 39 separate drug manufacturers have been prevented from importing material. In 2015 alone, six pharmaceutical companies have failed inspections into Good Manufacturing Practice (GMP). The list of failings relates to manufacturing issues and record keeping.The Financial Times, in an editorial, says the restrictions are of economic significance — they hold back the development of the pharmaceutical sector in India. The Indian government is keen that this sector of industry acts as a high-flyer for economic growth. India is the third largest global pharmaceutical products producer. The company has some 10,000 manufacturing sites, although only around 1,500 have passed inspections by U.S. medicines inspectors.

To find out more, see my review of key GMP issues here.