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| Zydus Cadila R&D building in India--Courtesy of Zydus Cadila |
Wockhardt, Ranbaxy, Dr. Reddy's--these are just three of the 7 on the FDA's laundry list of Indian companies under scrutiny for poor quality control. And now India's Zydus Cadila has recalled 10,200 bottles of its allergy drug promethazine hydrochloride after a high blood pressure medication was discovered in one of them, the FDA said today.
The company's U.S. unit issued a voluntary recall on May 8, a Zydus spokeswoman confirmed with Reuters. The FDA has classified the recall as Class II, meaning that while the presence of atenolol--the high blood pressure medication--is not too severe, it may cause temporary or medically reversible adverse health consequences.
The Zydus recall is emblematic of a larger regulatory issue as some Indian manufacturers continue to lapse in quality control. Drug products from Wockhardt plants in India have been banned by the FDA and restricted by the U.K. and EU. The FDA has also slapped import alerts on plants belonging to Ranbaxy Laboratories, India's largest generics maker, and Sun Pharmaceuticals. After suffering years of quality control problems at Ranbaxy, its majority owner--Daiichi Sankyo--decided to sell of the company to Sun Pharma.
FDA commissioner Margaret Hamburg urged the country to clean up shop during a visit in February, sparking some soul-searching among the Indian pharma industry. Last week, India's Drugs Controller General G.N. Singh made a promise to invest half a billion dollars over three years in making regulatory improvements.
Bottling mixups, however, are anything but localized to Indian manufacturers. In January 2012, the FDA issued an advisory when high-powered opioids from Endo Pharmaceuticals ($ENDP) found their way into packages of recalled Novartis ($NVS) meds. Just the next month, Pfizer ($PFE) recalled a million packets of its birth control after a packaging mishap that left the active and inactive pills out of order.
- get more from Reuters