Lapses by few drugmakers clouded good manufacturing practices by others: USFDA chief

NEW DELHI: The US Food and Drug Administration (FDA) commissioner Margaret Hamburg has said during her ongoing visit to India that recent lapses by a few drugmakers in the country have clouded good manufacturing practices followed by other domestic companies.

"Unfortunately the many Indian companies that understand good manufacturing and quality processes have been overshadowed by (the) recent lapses in quality at a handful of pharmaceutical firms," Hamburg wrote in her blog on Wednesday.

The US drug regulator has over the past year hauled up leading India-based firms, including Ranbaxy, Wockhardt and Strides, for failure to comply with good manufacturing practices.

Hamburg said in her blog that while the FDA would take appropriate action against any company that did not meet its requirements, the body was willing to work with the firms to help them address the issues they faced in their bid for compliance. All consumers deserve access to safe and affordable drugs and should not have to sacrifice quality to get that, she said in her blog on her first official visit to the country. The blog appeared a day after she met chief executives of leading Indian pharma companies at a meeting hosted by industry lobby Ficci.

Separately, after she returns to the US, a group of experts will brief Congressmen on February 26 on the perils of 'substandard and falsified medicines with a focus on India's quality control failures'. Harry Lever, a Cleveland Clinic cardiologist who will be addressing Congressmen, told Bloomberg that he would tell the senators that generic drugs made by India-based companies for heart failure often don't work the way they should, raising questions about the FDA's ability to keep track of India's growing generic business.

Hamburg had on Monday met health and family welfare minister Ghulam Nabi Azad, and commerce and industry minister Anand Sharma besides top bureaucrats. Later in the day, she also met Drug Controller General of India GN Singh.

"Officials at India's ministry of health and family welfare share this goal. In the spirit of continued collaboration and a commitment to quality, our agencies signed the first-ever statement of intent," Hamburg said.