How safe are generic drug manufacturers in India? Well it doesn’t seem so safe for those manufacturers. Company after company from India are getting banned from selling generics in the US. India is trying to change the way they manufacture generics. So as part of their attempt to improve, Indian regulators will be told when the U.S. Food and Drug Administration is inspecting plants that produce generic drugs in that country, and will join to observe FDA standards. This is a nice learning process but at what cost?
For years, doctors, researchers and patient advocates have complained that substandard generic drugs are leaking into the U.S. medical system from overseas. Doctors have stated that generic drugs made by India-based companies for heart failure often don’t work the way they should, opening questions about the FDA’s ability to keep track of India’s growing generic business. For example: testing labs have examined generic versions of Lipitor from 15 countries, and found manufacturing impurities which sometimes rendered the drugs ineffective.
Generic manufacturers don’t always replicate the manufacturing process used by brand-name companies resulting in changes to even just a few atoms that can cause the drug to become ineffective. One doctor, in one case he switched a man in his late 70s with fluid retention from a generic drug made by one Indian company to another made by a different company and the man responded by losing 15 pounds of fluid in a week.
Pay to Play
In 2012, the FDA was given the power to collect fees from generic-drug makers in part to pay for an increase in inspections of facilities outside the U.S. While India’s government has cleared the way for the FDA to increase the number of its staff members to 19 from 12. As the FDA ramps up overseas inspections the hope is the issue of drug quality will improve.
So far generic-drug makers Ranbaxy Labs and Wockhardt Ltd have been banned from selling medicines in the U.S. from Indian plants due to quality concerns. In the latest incident, a fourth Ranbaxy facility was banned from U.S. exports after FDA inspectors found drugs were re-tested to gain favorable results after initial analyses failed. SO they can’t manufacture properly nor can you be sure it was tested properly.
Unfortunately the many Indian companies that understand good manufacturing and quality processes have been overshadowed by recent lapses in quality at a handful of pharmaceutical firms.
Do you avoid generics?