UK Watchdog Restricts Drugs from Indias Wockhardt

UK Watchdog Restricts Drugs from India's Wockhardt

In recent months both the U.S. and UK watchdogs issued import alerts on drugs made at another Wockhardt manufacturing unit in Waluj, Maharashtra in western India, citing quality concerns.

MUMBAI -- In the third such plant to face restrictions, Britain's health regulator has restricted exports from a factory of Indian pharmaceutical firm Wockhardt, the company said Tuesday.

Britain's Medicines and Healthcare Products Regulatory Agency (MHRA) has cancelled Wockhardt's "good manufacturing practices" certificate for a factory in Kadaiya (Daman) in western India for noncompliance with its manufacturing standards.

The factory will however be allowed to test, make and supply to Britain certain drugs critical to public health, the statement to the stock exchanges said Tuesday.

The fresh blow comes days after the MHRA recalled five drugs made by Wockhardt from a plant in Chikalthana in Maharashtra state.

In recent months both the U.S. and UK watchdogs issued import alerts on drugs made at another Wockhardt manufacturing unit in Waluj, Maharashtra in western India, citing quality concerns.

It said it did not make any products for the United States market from the Kadaiya plant.

India's government has defended its lucrative generic drug industry, which accounts for nearly $15 billion in annual exports, as safe and tightly regulated.

India's pharma giant Ranbaxy, after facing a lengthy legal battle in the United States, was hit by a new setback last month.

The US Food and Drug Administration (FDA) banned imports from Ranbaxy's "ultra modern" Mohali plant in northern India in September, whose renovation was supposed to mark a turning point for the Indian generics giant after years of run-ins with U.S. regulators.

Now three of Ranbaxy's plants have been hit by an import ban to the United States, its largest market. In May, Ranbaxy had pleaded guilty to U.S. charges of selling adulterated antibiotic, epilepsy and other drugs, and agreed to a record $500-million fine.

Copyright Agence France-Presse, 2013

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