Earlier, if a company intended to manufacture and stock vaccine for Covid-19, which is under clinical trial, it had to follow a complex process for marketing authorisation (for sale or distribution). Several applications were to be made for conducting clinical trials. Upon completion of the trials, the firm had to again follow a series of application processes. A prior permission was also required from the Central Licensing Authority under the New Drugs and Clinical Trials Rules, 2019, to manufacture the vaccine.
Now, the health ministry has said some of the rules shall be “deferred in public interest” to meet the situation. “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," said a government official.
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