Abstract
This article examines the biogeneric regulatory environments in the emerging markets of China and India. We review what biogeneric companies must do to have their products registered and approved for sale in both China and India. In recent years, sweeping changes to both drug regulatory landscapes have occurred, and we evaluate the effects of these changes on the biogenetics sector. We weigh the costs and benefits of producing biogenetics in China versus producing them in India, and we conclude that both nations provide unique opportunities for biogeneric companies.
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