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India to Halve Drug Trial Approval Time, Streamline Overseas Endorsements

India to Halve Drug Trial Approval Time, Streamline Overseas Endorsements

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by Newsdesk

AI-Generated Summary

India's health ministry has proposed new rules to halve drug trial approval times from 90 to 45 days, aiming to accelerate pharmaceutical innovation and patient access. The reforms include a simplified online notification system for many studies, while maintaining stringent safety norms for high-risk drugs. This strategic move is expected to significantly boost India's role in the global clinical trials industry and facilitate pharmaceutical exports.

In a nutshell

These regulatory changes reflect India's proactive strategy to enhance its position as a global pharmaceutical hub by reducing bureaucratic delays and aligning with international drug development standards. The balanced approach, combining accelerated approvals with continued safety oversight for critical drug categories, aims to foster innovation while protecting public health.


Source: Livemint

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by Newsdesk

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