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Notes

Three points on the route, explained with the text of the rules that create them.

Why this site names no medicine

India’s marketing code counts information from a manufacturer as promotion and forbids promotion before marketing approval. What that means for a site like this one.

When is a medicine a new drug in India?

A medicine approved for years abroad can still be a new drug in India. The definition in the New Drugs and Clinical Trials Rules, 2019, and what follows from it.