Big Pharma is getting bitten by its deals with Indian generics-makers. One recent example, of course, is Japan's Daiichi Sankyo, which last month felt tremors from Indian unit Ranbaxy as the latter entered a consent decree with the FDA to settle long-standing GMP matters, as we reported. Ranbaxy set aside $500 million for liabilities; Daiichi lowered net income and profit projections and cut pay for executives and directors.
Livemint reports that some Big Pharma companies "made the wrong choices in selecting their local partners." It quotes an executive with an Indian pharma lobbying group who said "some of the foreign buyers are now regretting their deals in India, though a larger part of such instances were due to their own decision to select wrong partners."
Ranbaxy's regulatory transgressions stretch back to well before its acquisition by Daiichi. The manufacturing and FDA-relationship problems that Daiichi inherited—not to mention the cost to fix them—led The Wall Street Journal to label the deal a "fail."
Livemint notes other deals in which Big Pharma suffered at the hands of the Indian generics-makers it chose. Among them: Pfizer's ($PFE) two Indian partnerships, which stalled due to manufacturing noncompliance, says Livemint. Aurobindo Pharma and Claris Lifesciences both failed FDA audits.
Another example in the report is Sanofi-Aventis ($SNY), whose Shantha Biotechnics acquisition lost its certification by the World Health Organization. WHO took the action in 2010 after the discovery of white sediment in some vials of a children's vaccine; the vials were recalled and destroyed. Shantha is now fighting its way back into WHO's good graces; in October, the drugmaker earned pre-qualification status for cholera and tetanus vaccines.
The lobbyist quoted in the report noted also, however, that the problem is not specific to India. Even U.S. drugmakers and Big Pharma companies have been served warnings by regulators, according to the report.
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