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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.

Clinical trial

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 for such products, including permitting abbreviated data at the pre-screening stage for regulatory approval of a new drug application, provided the applicant

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