The Indian government has announced a streamlined approval process for certain categories of new drugs recognizing approvals from key global regulatory authorities. The Central Drugs Standard Control Organization (CDSCO) has published an order to this effect dated August 7, 2024.
It may be recalled that the New Drugs and Clinical Trial Rules, 2019 allows the Central Licensing Authority (CLA) to waive local clinical trials for approval of new drugs in certain circumstances. It can also waive the permission needed to to import or manufacture for sale or for distribution of new drug in India. CLA can specify countries to which it grants these waivers.
Therefore, in the exercise of these powers, CDSCO has specified this waiver for USA, UK, Japan, Australia, Canada, and the European Union (EU). As a result, these countries will be granted faster approval in India.
Drugs Eligible for Accelerated Approval
- Orphan drugs for rare diseases
- Gene and cellular therapy products
- Drugs for pandemic situations
- Drugs for special defense purposes
- Drugs with significant therapeutic advancements
This move is expected to expedite the availability of life-saving drugs in India, particularly for patients with rare diseases. It will also encourage pharmaceutical companies to invest in research and development for new drugs in the country.
The decision aligns with India’s efforts to become a global hub for pharmaceutical manufacturing and research.
