FDA Chief Says Indian Drugmakers Must Improve cGMP Quality

FDA Chief Says Indian Drugmakers Must Improve cGMP Quality

February 19th, 2014 // 2:57 pm @

Indian companies, which supply about 25% of all of the drugs that are used in the United States, have to take more responsibility for quality control as they export their products to foreign markets, according to FDA’s commissioner Margaret Hamburg. She also noted that FDA is going to ramp up cGMP audits in India.

Her comments came after she made a week long trip to India, and met with drug companies there about cGMP quality. The US is giving more and more scrutiny to generic drugs that come out of India. In the past year, FDA has banned imports from four plants in India that are run by Ranbaxy Labs and Wockhardt Ltd.

FDA is going to expand its inspection offices in India and will be training regulatory officials in India, and generally increase FDA inspections in overseas plants in that country, Hamburg noted in a TV interview in India this week. Until the last few years, FDA was not doing as many cGMP inspections in other countries as in the US. That is really starting to change, she said.

During her trip, the commissioner from FDA agreed to a new plan where Indian regulators will shadow inspectors from FDA on plant visits to observe how FDA conducts its inspections. She also strongly urged the Drug Controller General in India to go to international meetings on cGMP drug safety regulations.

She said that when she goes to meetings on drug safety around the world, India often is not there. Hamburg noted that is a loss for India and a loss for the world.

FDA is now going to create an Office of Pharmaceutical Quality to improve FDA’s oversight of all types of pharmacueticals, from brand name to over the counter. FDA is also working directly with the drug industry to come up with new standards and data that may signal which drug plants are straying from cGMP rules and need to be inspected.

At this time, India’s drug companies make 25% of drugs in the US.

FDA inspections of drug plants in India increased from 195 in 2012, from just 11 in 2002. Hamburg said FDA wants to level the playing field. Wherever that drug is made, if it is being brought to the US, FDA has to make sure that it is being made according to FDA standards and expectations.

Hamburg also met on Feb 11 in a closed door meeting with 16 drug company chiefs in India to talk about cGMP quality. Wockhart and Ranbaxy executives were there. Ranbaxy wanted permission to export drugs to the US from its banned plants but Hamburg would not budge on that, until Ranbaxy proves that those plants are meeting cGMP quality regs.


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