UPDATE 1-U.S. regulator on India visit calls for greater drug safety collaboration

Tue Feb 18, 2014 7:44am EST
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* FDA chief says important for India to work with foreign regulators

* Indian regulator says will follow own quality standards

* FDA visit follows sanctions against Indian drugs firms

By Sumeet Chatterjee and Zeba Siddiqui

MUMBAI, Feb 18 (Reuters) - The head of the U.S. Food and Drug Administration (FDA) called for more collaboration among regulators to improve drug quality and safety as she wrapped up a visit to India after recent import bans on drugs from a handful of plants in the country.

In recent months the FDA has banned the import of drugs and drug ingredients from leading Indian manufacturers including Ranbaxy Laboratories and Wockhardt, citing quality concerns.

The bans threaten the image and market share of India's $14 billion pharmaceuticals sector in the United States. India is second only to Canada as a drug exporter to the United States, where it supplies about 40 percent of generic and over-the-counter drugs.

"We think this is a critical moment in time, when we have to think and act in new ways, and that requires real commitment as national regulators to work as a coalition of global regulators," FDA Commissioner Margaret Hamburg told reporters.

"And that is why it is so important that the Indian regulator really joins us at the table, because they are so important in the global marketplace for medical products."   Continued...