The infarction by Ranbaxy, fined $500 million by the US FDA for the sale of adulterated generic drugs in the U.S., is a setback for India’s IPR battles and for incoming Japanese investment. Japan has been a late-comer to the Indian market, and Daichii Sankyo’s 2008 purchase of 64% of Ranbaxy $4.8 billion made a big splash – and a sign of more to come from Japan. The adulteration occurred six years ago under the previous ownership; but it will make Japan more cautious about new outlays in India.
The timing is unfortunate from both the IPR and China angles. Generics comprise the bulk of India’s pharma exports, and the industry has been pushing for IPR regulation globally to be applied with sensitivity to allow developing countries access to affordable life-saving drugs; now there will have to be an additional thrust for vigilant regulatory oversight, especially in India. Japan will be cautious at the very point when Indo-Japan ventures should receive a boost, given the increasing assertiveness of China with both countries.
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