Pharma research approval system to be put on fast track

Source: The Economic Times, Nov 17, 2016

NEW DELHI: The BJP-led NDA government will set up a single window approval system that will clear in 30 days what four different committees took 3-4 years in a major boost to innovation in medical research and will help improve India’s sagging reputation in the area of ease of doing business.

The government think-tank Niti Aayog has written to Health Ministry to restructure the entire approval process for innovation in medical research as part of the government’s move to make India a hub for innovation and manufacturing.

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“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,” said Niti Aayog in a letter written by CEO Amitabh Kant.

Kant could not be reached out for comments.

The Aayog’s proposal has got support from the committee of secretaries set up on the prodding from the PMO to overhaul the pharmaceuticals sector in the country. The committee, comprising Kant, pharmaceutical secretary Jai Priye Prakash, health secretary CK Mishra and DIPP secretary Ramesh Abhishek, in a meeting last month decided to carry out a complete business process re-engineering of new drugs and clinical trial.

According to the letter addressed to health secretary CK Mishra, a copy of which is available with ET, the Aayog suggested half-a-dozen measures to reengineer business process for government in a way that it encourages innovation in medical research.

“Permission/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 USA,” Kant’s letter said.
The Aayog has also proposed establishing of a single window system of application to get approvals from various agencies, abolishment of role of the Review Committee on Genetic Manipulation (RCGM) at R&D stage and strengthening of the Institutional Biosafety Committee.

“Top priority should be given by various agencies for any innovative product developed in India, age old procedures need to be re-examined to encourage innovation in India and pre-approval meetings with various agencies should be considered to understand their requirement and plan for roadmap for getting approvals,” the letter proposed.

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