Ministry of Health proposes steep fee hike for drugs licences, registration, manufacturing

Drug makers may have to shell out significantly higher fees for a whole set of regulatory submissions in India in the New Year.

The Ministry of Health and Family Welfare has proposed multifold fee increases for product registrations, manufacturing and product licences and clinical trials.

A December 29 gazette notification said the Central government is of the opinion that circumstances have arisen that render it necessary to make the rules without consulting the Drugs Technical Advisory Board, which advises it on important policy decisions.

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