Wednesday, September 17, 2008

Ranbaxy? Wow.



The effluent has finally hit the fan. Ranbaxy has stonewalled the FDA for ages to keep records relating to quality audits at its manufacturing facility in Paonta Sahib secret, but the FDA seems to have lost patience: yesterday it banned the importation of anything produced at Ranbaxy's plants at both Dewas and Paonta Sahib. From an FDA press release:
The Warning Letters identify the agency's concerns about deviations from U.S. current Good Manufacturing Practice (cGMP) requirements at Ranbaxy's manufacturing facilities in Dewas and Paonta Sahib (including the Batamandi unit), in India. Because of the extent and nature of the violations, FDA today issued an Import Alert, under which U.S. officials may detain at the U.S. border, any active pharmaceutical ingredients (API) (the primary therapeutic component of a finished drug product) and both sterile and non-sterile finished drug products manufactured at these Ranbaxy facilities and offered for import into the United States....

Earlier today, the FDA informed Ranbaxy that until it resolves the deficiencies at each of these two facilities and the plants come into compliance with U.S. cGMP requirements, FDA's drug compliance office will recommend denial of approval of any New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs) that list the Paonta Sahib or Dewas plants respectively as the manufacturer of APIs or finished drug products.
That's shocking. As the FDA's press release says, Ranbaxy is one of the biggest importers of generics into the US. The action casts doubt on the standards of all Indian drug manufacturers, who have worked for years to improve their reputation. It was only months ago that the heparin disaster raised the possibility that offshoring might be proceeding to quickly. Anyone considering outsourcing the manufacture of their API to India will factor this example into their calculation of risk. They will already be considering the rising costs of India and China, where inflation is over 10%.

I wonder how Daiichi Sankyo feels about their acquisition now-- as if it hadn't been hard enough to get Japanese to use generics....

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