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NEW DELHI: Taking advantage of the opportunity provided by the Covid-19 pandemic to boost the healthcare system, the government has pushed through critical reforms to cut down the regulatory maze for faster clinical trials and boost research and innovation in vaccines, diagnostics and therapeutics.
The efforts, led by Niti Aayog, has ensured that Punebased CDAC will develop a common platform for regulatory approvals for clinical trials. A decision on such trials will have to be taken within 90 days and the platform will bring together all regulators on a real-time basis.
A series of meetings between the cabinet secretary and ministries deliberated on the Niti proposals and took steps with timelines to ensure India regains market share in pharma, biomedicine and diagnostics.
We had 16% share and now it is down to almost 1%. Over the years, stringent laws and regulations have killed the sector. Now, we have re-engineered the processes. We want to foster innovation and regain our market share,” Niti Aayog CEO Amitabh Kant told TOI.
To cut down the regulatory maze, the Central Drugs Standard Control Organisation will be the point of contact for all clinical trials and a panel headed by the health secretary and involving regulatory entities will meet once in 15 days or one month to decide on proposals.
“The platform will have all information and the panel will have to decide or give reasons for rejection. It will be on realtime basis and integrate the workflow of all regulators,” an official said, adding that the idea was to cut down the time for approvals from the current 4-5Read More – Source
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