Saturday, October 19, 2013

U.K. Drug Regulator Recalls 5 Drugs Made by India's Wockhardt

MUMBAI--U.K.'s drug regulator Thursday issued a recall for five prescription drugs made by India's Wockhardt Ltd. after manufacturing deficiencies were found at the plant in India where the drugs were made.

The recall is another setback for Indian firms, including Wockhardt, who have been seeking to take advantage of the growing demand in lucrative markets like the U.S. and the U.K. for generic alternatives to formerly patented drugs.

The recall follows the announcement Saturday that U.K.'s Medicines and Healthcare Products Regulatory Agency withdrew a so-called good manufacturing practices certificate for Wockhardt's plant in Chikalthana, on the outskirts of Aurangabad in the western state of Maharastra. The certificate is required to show that there are adequate quality controls at a facility.

Two Wockhardt spokesmen didn't immediately reply to requests for comment.

In a press release issued Thursday, the U.K. pharmaceutical watchdog said the recall was issued to pharmacies and wholesalers following a precautionary recall made by Wockhardt, who asked retail outlets to return five over-the-counter medicines, which include the diabetes drug Gliclazide.

Not all drug imports have been banned from the Wockhardt plant. The U.K. regulator will allow the company to continue to export 10 prescription drugs. "This is because, due to concerns over the continuity of supply, the benefits to patients of continuing to take these medicines outweigh the risk from any quality concerns with the medicine," said the regulator in a press release announcing the recall.

"There is no evidence that the medicines affected by the precautionary recall in the U.K. are defective," the regulator added.

U.K. inspectors cited inadequate record keeping and production controls as the reason for withdrawing the good manufacturing practices certificate.

In July, the regulator said it issued a precautionary recall of 16 drugs made by Wockhardt after finding manufacturing deficiencies at a separate Wockhardt plant in the central Indian city of Waluj. Drugs from the Waluj facility treated infections, hypertension, diabetes, epilepsy and other diseases. The regulator said at the time that the Waluj plant suffered from "poor cleaning practices" and defective ventilation systems. The inspection also found evidence of "forged documents relating to staff training records."

This was the second setback for the company and its Waluj factory. In May, the U.S. Food and Drug Administration imposed an import ban on products from the factory after it failed a safety inspection. The FDA didn't elaborate on the problems it found.

In September, the U.S. FDA said it is blocking imports of medicine made at one of India's Ranbaxy Laboratories Ltd. labs after it found "significant" violations of manufacturing rules, "including failure to adequately investigate manufacturing problems" during two plant inspections conducted in September and December 2012.

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