India has waived the requirement for local clinical trials to fast-track the approval of new medicines, particularly those already approved in other major markets. This decision is aimed at accelerating availability to innovative treatments and therapies to benefit patients, whilst maintaining regulatory standards.

The following article originally appeared in The Pharma Letter.

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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