Last updated: March 6, 2014 8:54 pm

FDA warns India on drugs standards

America’s top drugs watchdog has urged New Delhi to work with US regulators to help raise standards in the Indian pharmaceuticals industry, amid mounting scrutiny of the country’s role in the global drugs supply chain.

Margaret Hamburg, commissioner of the Food and Drug Administration, urged her Indian counterparts to “come to the table” and co-operate on efforts to stamp out substandard and fake medicines after lapses in quality at Indian plants.

“It’s not good for them, it’s not good for the Indian pharmaceutical industry and, above all, it’s not good for patients if [Indian regulators] are not participating,” Ms Hamburg told the Financial Times, adding that they “need to step up their game”.

India has been dubbed “pharmacy to the world” because of its share of the global market for cheap generic drugs, including 40 per cent of all over-the-counter medicines sold in the US.

But as the US becomes more dependent on drugs from the sub-continent, regulators in Washington are looking harder at quality standards.

Ranbaxy, one of India’s biggest drugmakers by sales, has been all but barred from the US after FDA sanctions against all four of its domestic plants. At one facility, inspectors found flies “too numerous to count”.

Ms Hamburg stressed that the “very visible problems” at a handful of plants were not representative of the “many good companies” in India.

But she warned the entire Indian industry risked being tarnished if regulation was not strengthened: “If there are bad actors it undermines public trust in everyone.”

US concern over Indian drug quality threatens to play into bilateral trade tensions after disputes over protectionism and intellectual property.

Pharmaceuticals are among India’s biggest exports, worth $13bn in 2012.

Some in India suspect the US of using quality as a pretext to protect its domestic industry from Indian competition – a claim rejected by Ms Hamburg.

“We’re happy to have Indian drugs in the US market but only if they meet the same high standards we demand of our own companies.”

Ms Hamburg said she was hopeful of greater co-operation after “encouraging” talks with officials during a visit to New Delhi last month.

The FDA is planning to increase its number of inspectors in India from 12 to 19.

The agency, which regulates everything from food and tobacco to cosmetics and medical devices, has also increased its presence in China, where it has offices in Beijing, Shanghai and Guangzhou.

Ms Hamburg, commissioner since 2009, has been battling to increase international co-operation among regulators in response to the development of global supply chains.

Four-fifths of all active ingredients in medicines consumed in the US are made abroad.

“The FDA is responsible for monitoring products coming from several hundred thousand facilities around the world arriving through 300 ports of entry,” said Ms Hamburg. “There is a growing recognition that we are all in this together.”

Copyright The Financial Times Limited 2015. You may share using our article tools.
Please don't cut articles from and redistribute by email or post to the web.


Sign up for email briefings to stay up to date on topics you are interested in