Drug Approval Process in India: Complete Step-by-Step Guide
India isn’t just a pharma market. It’s the engine that powers global access to affordable medicine.
The country supplies 20% of the world’s generic drugs and meets over 60% of global vaccine demand. From small-molecule APIs to complex biologics, India manufactures and exports it all — at unmatched scale and cost.
But no product reaches shelves without passing through the country’s strict regulatory system. Every drug marketed in India must be approved by the Central Drugs Standard Control Organization (CDSCO). This authority functions under the Ministry of Health and Family Welfare.














