Govt simplifies clinical trial rules to expedite COVID-19 vaccine development: Report

In a bid to make vaccines available to meet the emergency demand due to the novel coronavirus pandemic, the Union Health Ministry has permitted some relaxations to the Drugs and Cosmetics Act, 1940, and the subsequent rules, Business Standard has reported.

The new process is likely to help Indian pharmaceutical companies develop and get a COVID-19 vaccine to the market faster.

Earlier, if a pharmaceutical company intended to manufacture and stock a vaccine for COVID-19, it had to follow a complex process for marketing authorisation.

Several applications had to be made for conducting clinical trials of the vaccine. The company would have to again follow a series of application processes after the trials had completed.

Permission was also required from the Central Licensing Authority under the New Drugs and Clinical Trials Rules, 2019, to manufacture the vaccine.

Now, some of the rules have been “deferred in public interest” to the ongoing pandemic. “We are in talks with vaccine makers here. So far, it looks like some of the global candidates, like the Oxford one, may be available sooner than the others. There are some key Indian candidates, too. The government will take an inter-departmental approach to ensure that the right vaccine candidate is available for Indians at the earliest," the newspaper quoted a government official as saying.

Moneycontrol could not independently verify the report.

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Several companies and research organisations are currently scrambling to come up with a vaccine against the novel coronavirus, or SARS-CoV-2.

Brazil this month will start testing an experimental vaccine against the coronavirus being developed by researchers at the University of Oxford and AstraZeneca Plc.

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