As part of its broader examination of the clinical research process within its borders, India’s drug regulator may consider changing the rules and regulations governing first-in-man studies of molecules discovered in other nations, according to Shirish D. Sherlekar, head of the life science practice at Mumbai-based Tata Consultancy Services (TCS). Currently, Phase I studies by international companies are limited largely to experimental therapies deemed to have a sufficient amount of safety data approved by the U.S. Food and Drug Administration (FDA) or other regulating body in the drug’s country of origin.

Public discourse on the issue is unlikely before the end of India’s elections in March, notes Debashis Ghosh, vice president and global head of life sciences and healthcare at TCS. Prior to that, a Central Drug Authority bill is expected to be introduced in Parliament that seeks to centralize licensing authority for regulating the healthcare sector, including pharmaceuticals. The bill has separate provisions for medical devices, which are currently undifferentiated from drugs in regulations, as they are by the FDA.

Source : Bio-it world

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