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Sector rules · 20 January 2026

Test licence timeline cut from 90 to 45 days under amended NDCT Rules

Amendments to the New Drugs and Clinical Trials Rules notified on 20 January 2026 (G.S.R. 46(E)) cut the statutory timeline for test licences from 90 to 45 days.

Effective or announced 20 January 2026Impact for foreign investors: medium

What changed

The NDCT Rules 2019 were amended on 20 January 2026 by G.S.R. 46(E). The statutory timeline for a test licence fell from 90 to 45 days. The health ministry expects at least 90 days to be saved in drug development.

Who it affects

Pharma companies running development, clinical or test programmes in India, and CDMOs serving them.

What to do

Update development timelines for India-based work, and confirm CDSCO’s processing practice under the new timeline. Separate licensing rules still apply to devices, where Class C and D manufacturing licences carry a 60-day inspection timeline.

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