The Indian government has decided to render an urgent hike in costs for new drug registration, licensing and clinical trials. The notification has left some wiggle room for debate in the clinical and pharma fraternity. The Ministry of Health and Family Welfare has proposed skyrocketing hike in fees for product registrations, licensing and clinical trials. As a general protocol, the government implements any revision of price or cost of the drug or related regulatory activity on the recommendation of the Drugs Technical Advisory Board.
But this time, this policy decision came into December 29 gazette notification without consulting the Drugs Advisory Board, as the government thought it is necessary to render in immediate basis. However, the process of consultation will be realized within 6 months of implementation of the rule. The increase proposed in the new rules for site registrations…
