A committee led by cabinet secretary Rajiv Gauba has also decided to set up a nodal coordination committee to ensure expeditious disposal of all applications with the decision binding on all regulators. “The proposal was cleared by the committee in the first week of June,” a top government official told ET.
New Delhi: The government has designated the Central Drugs Standard Control Organisation (CDSCO) as the first point of registration for clinical trials of all drugs and vaccines, a move expected to cut the approval time to three months from 12 months.
A committee led by cabinet secretary Rajiv Gauba has also decided to set up a nodal coordination committee to ensure expeditious disposal of all applications with the decision binding on all regulators.
“The proposal was cleared by the committee in the first week of June,” a top government official told ET.
The proposal to hasten clearances in the short-term was mooted by the Niti Aayog in the wake of the Covid-19 pandemic.
“Regulatory cholesterol, which was severely impacting innovation in pharma and biotech sector, has now been addressed,” NITI Aayog CEO Amitabh Kant said. “By streamlining regulatory pathways in CDSCO and ICMR, we have brought all institutions and regulators together through a series of meetings by cabinet secretary and in NITI Aayog.”
The official quoted earlier said the government will soon come out with medium and long-term measures to expedite the approval process as it looks to attract foreign capital and boost local pharma.
Single-window
The cabinet secretary-led panel has suggested multiple regulators and authorities dealing with approvals to revisit their approval process. The idea, the official said, is to eliminate unnecessary processes.
Following this decision, all clinical trial applications will be first registered with CDSCO, which will issue a common identification number. This number will be used to track the application at each stage.
Each application will be scrutinised and sent to the respective committees for approval. The nodal coordination committee, under the health secretary and comprising secretaries of all committees and ministries concerned, will meet once in 15 days during the pandemic and once in a month after that to clear any proposals stuck at different levels.
