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 4-5 years to about 90 days.
Officials said stringent controls on the sector had driven the industry out of the country and firms had to go to Brazil and the US for clinical trails. The department of biotechnology will explore the option of setting up institutions for large animal testing while CDSCO has been asked to consider regulating clinical research organisations.
“At this point, we will work within existing laws to see how much can be improved within the current regulatory norms,” an official said.