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HindustanTimes Wed,22 Oct 2014

Now, Indian regulators to inspect Ranbaxy’s plants

Himani Chandna Gurtoo , Hindustan Times  New Delhi, January 29, 2014
First Published: 23:18 IST(29/1/2014) | Last Updated: 02:42 IST(30/1/2014)

Watchdog Drug Controller General of India (DCGI) will soon begin inspecting Ranbaxy Laboratories’ plants in India to test these for manufacturing practices and hygiene norms in the latest string of run-ins with regulators faced by the generic pharmaceuticals company.

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The DCGI’s scrutiny is crucial for Indian companies as violations can lead to cancellation of manufacturing licenses that can potentially shut the door on selling drugs even in India.

“We will scan Ranbaxy and  Wockhardt thoroughly as the allegations levelled by US FDA are alarming,” G N Singh, drug controller general of India told HT. “In case of any violation, we will suspend their manufacturing activity.”

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The DCGI’s move comes less than a week after the USFDA blacklisted Ranbaxy Laboratories’ Toansa plant— the generic drug makers’ fourth factory to face such an import ban, effectively ruling out exports from its Indian plants.

Singh confirmed that DCGI will be sending a team of officials to inspect Ranbaxy’s Toansa plant shortly.  “We have ordered strict inspection for Toansa facility. And for other plants at Dewas, Poanta Sahib we have sent a notice to the company.”

Last year, US and British drug regulators had warned Wockhardt, for violations at its manufacturing facility in Maharashtra. Both Ranbaxy and Wockhardt did not respond to HT’s mails. Experts, however, said that the chances of a USFDA-type of blacklisting by DCGI of Indian pharma plants were remote because of different product standarisation rules and tolerance thresholds on purity.

Indian purity standards ask for only 99.9% whereas USFDA thresholds are more, he said.

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