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.
As an extreme example, Digital Journal reported last year that during an inspection of Marck Biosciencies’ plant in Kheda, India, the U.S. FDA found faked data, mold and rotting frogs. This particular example may be extreme, but it does highlight a concern with some facilities and the interpretation of an acceptable level of compliance with global drug production safety regulations.
In addition, three Mylan facilities in India are facing FDA inspection findings. At one of these facilities, in relation to medicines intended to be sterile, FDA found holes in gloves in an area intended for the aseptic preparation of medicines.
Furthermore, with two Ranbaxy plants in India the FDA has placed import bans on 30 medicines due to federal code violations. In a statement, Janet Woodcock, M.D., director, FDA’s Center for Drug Evaluation and Research, laid out the reason for the action: “With this action we are sending a clear signal that drug products intended for use by American consumers must meet our standards of safety and quality.”
The concerns are not only held by the U.S. regulators. In Europe, the European Medicines Agency has recommended suspending medicines from GVK Biosciences over flawed studies submitted for licensing. The ban extends to 700 different generic drug products.
To add to this, the Economic Times of India has noted that considerable investment is needed in order for pharmaceutical facilities to meet expected regulatory standards. The Indian Pharmaceutical Alliance, a trade association, is pledging to help spearhead to necessary changes.
