Bangalore, Sept 26, 2008: Ranbaxy’s woes don’t seem to be ending. The US Food and Drug Administration has ended purchasing Ranbaxy’s AIDS drugs made in Ranbaxy’s India facilities which the FDA says are ineligible to make drugs.
FDA has suspended funding for Ranbaxy’s generic drugs too, it is learned. The funding came from the President's Emergency Plan for AIDS Relief until the deficiencies are resolved, a prepared FDA release said.
According to the FDA, more than 30 generic drugs made by Ranbaxy, India's largest drugmaker, would be blocked at US borders because of manufacturing failures at the two Indian plants. According to the FDA, there is no evidence that Ranbaxy's medicines are harmful, though the violations could lead to defective products. The program provided $8.9 million for Ranbaxy's AIDS drugs last fiscal year, according to a FDA spokeswoman.
“Ranbaxy is working with the US government to resolve all of the issues and concerns that have been raised,'' said Charles M. Caprariello, spokesman, Ranbaxy.
The House Energy and Commerce Committee last week said it was investigating the safety and effectiveness of AIDS drugs supplied by Ranbaxy through the AIDS program.
Although the FDA's action applies only to the US market, the government decided to suspend funding for the AIDS drugs supplied overseas. According to the FDA, this barring of imports is in no way related to the US . criminal investigation examining whether the company fabricated data to get its medicines cleared for sale.
Meanwhile New Zealand’s drug regulator MedSafe, acting on the FDA’s directive, too said three Ranbaxy drugs being imported into New Zealand will be voluntarily quarantined by the distributors.
“Douglas Pharmaceuticals and Apotex New Zealand the two suppliers of the three Ranbaxy funded products have voluntarily agreed to hold the products, which are due in the country in October. Hence the products will be held at the companies’ own warehouses, and not released for distribution,” said a statement from the New Zealand Health Ministry.
Daiichi awaits India’s nod
In another unrelated report, Daiichi Sankyo, Japan’s third largest pharma company which acquired promoters stake in Ranbaxy three months ago said it is still awaiting approval from Indian market regulators to buy a controlling stake in India's Ranbaxy.
``There is a delay because India's Cabinet Committee on Economic Affairs hasn't been held. We don't know the date of the meeting yet. Daiichi also needs approval from the Reserve Bank of India, the nation's central bank, after the Cabinet review,'' said Daiichi Sankyo spokesman Yasuki Minobe.
Daiichi had offered to buy 34.8 percent of Ranbaxy from Malvinder Singh and his family, promoters of the company and up to 12.2 percent in new shares. This would give Daiichi Sankyo as much as a 67 percent stake, including yesterday's completion of a public tender offer for 20 percent of shares.
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