Health Policy

Government to restructure pharma research approval system

The Central government is planning to establish a single window approval system for medical research in an effort to boost innovation and ease of doing business in the pharmaceuticals sector.


The Government of India policy think-tank Niti Aayog has asked the Health Ministry to set up an approval system to clear medical research proposals in a 30 day time frame.

“There is a need to encourage and support innovators on approval procedures and regulatory requirements. I would appreciate your convening a meeting and restructuring the entire approval process,” a media report quoted Niti Aayog CEO Amitabh Kant as saying in a letter written to the Health Ministry.

“Permission or approvals within 30 days from the date of application for Indian Innovation projects who have applied for global patent. Failing to process application within 30 days, it will be presumed as approved like in the US,” Kant said.


Last month, the committee set up to overhaul the Indian pharmaceuticals sector decided to carry out a complete business process re-engineering of new drugs and clinical trial.

The panel comprised of Kant, Pharmaceutical Secretary Jai Priye Prakash, Health Secretary C K Mishra and DIPP Secretary Ramesh Abhishek.

The Niti Aayog has suggested half-a-dozen measures to reengineer business process for government so as to encourage innovation in medical research.

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