U.S. FDA to Coordinate More With Indian Regulators

The New York Times Blogs (India Ink)

February 18, 2014

Margaret A. Hamburg, the commissioner of the United States Food and Drug Administration (FDA), said Tuesday that the American regulator would be working more closely with its Indian counterparts through training programs to ensure that Indian drug exporters meet American standards.

The announcement follows increased FDA scrutiny of Indian drug makers over the past year, resulting in many warning letters to Indian companies, informing them that they did not meet the standards of the regulator. Hamburg has been in India for the past week meeting with the Indian regulators and government officials, policy makers and industry leaders who are involved in the regulation of medical and food products exported to the United States.

Hamburg announced at a news conference on Tuesday that the FDA would increase engagement with its Indian regulatory counterparts to better coordinate regulatory oversight, including holding seminars, webinars, meetings and training sessions.

"Training and capacity building was a theme heard over and over again from our counterpart regulatory authorities, industry and the research community," said Hamburg. "We're hoping to think about some new mechanisms of collaboration that will engage across industry, academia and the regulatory authorities in both of our countries."

The FDA inspected 160 Indian drug plants last year, which is three times the number inspected in 2009. Hamburg said the higher frequency of inspections and notices by the FDA was not a uniquely Indian phenomenon, but was part of a global effort by the regulator to have tighter oversight on drugs produced overseas.

Responding to criticism from Indian regulators about overregulation she said, "We are not here to tell the Indian regulator how to do their job. But for companies that want to sell their products in the U.S. marketplace, then they do need to comply with our standards and practices and expectations, and we think that through greater collaboration we can enhance understanding about what our standards and expectations are."

Hamburg also stressed the importance of Indian regulators engaging more deeply with international regulators.

"We work together as a coalition of international regulators to try to harmonize standards and approaches and share information, and often at those meetings India is not represented," said Hamburg. "As India is such an important player on the global scene, we really hope that they will join us at the table."

Last week, the FDA signed a statement of intent with India's health secretary, Keshav Desiraju, that said Indian inspectors would be allowed to observe firsthand the FDA's inspections of the manufacturing processes of pharmaceutical companies operating in India. As per the agreement, the Indian regulator would not be allowed to inform the company in advance of an inspection visit.

India's Central Drug Standard Control Organization, the country's drug regulator, has a staff of 323, about 2% the size of the FDA's.

Hamburg also said that because of the increased exports of Indian drugs to the United States, the American regulator is looking to increase its staff in India in the near future, from 12 inspectors to 19. She added that the FDA has been making an effort to address the backlog in the approvals and pending applications. As of January, the FDA had cleared 45% of the backlog, she said.

India is one of the largest exporters of over-the-counter and prescription drugs to the United States, and its pharmaceutical industry supplies 40% of the over-the-counter and generic prescription drugs consumed in the United States.

"Indian drug manufacturers are extremely cost-efficient and feature among the top 10 generic drug companies worldwide," said Sarabjit Kour Nangra, vice president of research for the pharmaceutical industry at Angel Broking in Mumbai. "So India is not a country the United States can ignore because of the economics of the business."

Even taking into account the recent FDA bans on certain Indian drugs, she said, exports to the United States by Indian drug makers continue to be robust.

Indian analysts said that most Indian pharmaceutical companies have been responsive to the FDA inspections and that they are making an effort to tighten operations and meet global standards.

"Many Indian companies are trying to adapt and have invested in making sure that they reach U.S. FDA standards," said Nangra. "America is one of the largest geographies for Indian drug makers and one in which they have a big market share."

However, she added that many Indian companies lacked people with expertise in world-class manufacturing and meeting the standards of the regulator.

Analysts said that increased stringency by the American regulator would lead to a significant increase in costs for Indian drug companies and make it harder for smaller pharmaceutical firms to enter the American market.

"The cost of doing business in the United States goes up because of compliance with FDA norms to the extent that it makes it more difficult for the smaller players," said Nitin Agarwal, director at IDFC Securities in India. "The United States is a difficult market to enter if you are a smaller firm and coming in late, but the focus on compliance now makes it a lot harder and more expensive."

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