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India Eases Approval Process For HIV, Hepatitis Combinations

 
• By Anju Ghangurde

India has outlined measures to fast track the regulatory process for certain combination products for HIV and hepatitis, and thereby facilitate early access to these treatments.

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India has eased its regulatory requirements for combination products for HIV and hepatitis B and C – essentially those products recommended for concomitant use by the World Health Organization – to facilitate quicker access to these treatments in the country. The combination hepatitis therapies concerned would need be relevant to disease sub-types in the Indian population.

A government notice, which has been anticipated for some time now, outlined the broad contours of the proposed regulatory relaxations...

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