India simplifies clinical trial rules for Covid-19 vaccine manufacturing

Indian vaccine majors are already moving rapidly towards developing the right vaccine that would offer protection against Covid-19
The health ministry has allowed some relaxations to the Drugs and Cosmetics Act, 1940, and the subsequent rules. This has been done to make “suitable vaccines” available to meet emergency requirements arising due to the pandemic.


Simpler rules would help Indian players to get a vaccine to the market faster.


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.


Already, Indian vaccine majors are moving rapidly towards developing the right vaccine that would offer protection against Covid-19.


Hyderabad-based Bharat Biotech is developing a vaccine with the Indian Council of Medical Research (ICMR).


The researchers have recently indicated that the next month is a crucial stage in this development. Pune-based Serum Institute is in discussions with AstraZeneca that has booked millions of doses for Oxford's frontrunner Covid-19 vaccine candidate. Serum is trying to sign a deal with the British drug major and if everything goes well, it plans to make 100 million doses of the vaccine in India.



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