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Indian regulator welcomes US FDA co-operation

This article was originally published in Clinica

Executive Summary

Surinder Singh, the head of India’s drug and medical device regulatory body has welcomed input from the US FDA, which earlier this year agreed with the country’s health ministry to collaborate on setting up a US style regulatory system for India (see Clinica Nos 1294, p 13 & 1303, p 10). Dr Singh highlighted medical devices and clinical trials as priority areas for US help, according to the Press Trust of India. Both areas are in need of greater comprehensiveness. Historically, the government has limited its role in clinical trials to the provision of licences and the scrutinising of data; and medical device regulations are currently under development, with legislation to establish a new centralised regulatory body awaiting approval from parliament. Three other areas will also receive input from US FDA advisors, according to Dr Singh: new drugs; pharmacology; healthcare IT; and IT-enabled services in the healthcare setting.

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