India's drug regulator asks Dr Reddy's for more data, as it reviews emergency use of Covid-19 vaccine Sputnik V
Feb 24, 2021, 17:25 IST
The Central Drug Standard Control Organisation's (CDSCO)Subject Expert Committee has asked Dr Reddy's Laboratories to present additional data of immunogenicity while reviewing its application for Emergency Use Authorisation (EUA) of Russian Covid vaccine Sputnik V in India, sources said.
Dr Reddy's had applied for EUA before the CDSCO, and its application was reviewed by the SEC on Wednesday, a source told.
Meanwhile, the committee has also asked Hyderabad-based Bharat Biotech to submit efficacy data of Covaxin before seeking its trial on children.
The firm had sought permission from the Drug Controller General of India to conduct vaccine's trial on the children.
In September 2020, Dr Reddy's partnered with the Russian Direct Investment Fund (RDIF) to conduct the clinical trials of the Sputnik V and for its distribution rights in India. The vaccine is currently undergoing the Phase 3 clinical trial in India.
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Dr Reddy's had applied for EUA before the CDSCO, and its application was reviewed by the SEC on Wednesday, a source told.
Meanwhile, the committee has also asked Hyderabad-based Bharat Biotech to submit efficacy data of Covaxin before seeking its trial on children.
The firm had sought permission from the Drug Controller General of India to conduct vaccine's trial on the children.
In September 2020, Dr Reddy's partnered with the Russian Direct Investment Fund (RDIF) to conduct the clinical trials of the Sputnik V and for its distribution rights in India. The vaccine is currently undergoing the Phase 3 clinical trial in India.
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SEE ALSO:
INTERVIEW: Dassault Aviation has an India IT services unit offering defence MSMEs a digital ‘trial room’ where they can test their products to bag more contracts
These Indian states now require you to carry a COVID-19 negative test report for entry
Vested Finance CEO shares his guide to US stock investing for Indians
Global consulting firm ZS says it plans to hire 3000 employees in India this year