India waives local clinical trials requirement to fast-track new medicines

9 August 2024

In a significant move aimed at expediting access to life-saving medications for Indian patients, the Indian government has waived the requirement for conducting local clinical trials for drugs that have already received approval from regulatory authorities in the USA, UK, Japan, Australia, Canada, or the European Union.

Effective immediately, the decision will expedite the availability of new medications.

By recognizing the rigour of regulatory processes in countries like the USA, UK, and EU, India is all set to leverage international data to streamline its drug approval process.

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