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Combination product move in India is precursor to a split regulatory system

This article was originally published in Clinica

Executive Summary

A dual device-pharma regulatory system for medical devices appears likely to emerge in the Indian market. In the latest meeting of the agency that is overseeing the development of India's nascent regulatory system, devices that can be combined with pharmaceutical compounds - including orthopaedic implants and catheters - were mooted as candidates to be listed under the category of "drug" rather than "medical device". The debate will continue at the agency's next meeting scheduled for July, according to Pharmabiz.

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