Amit Jaju, Senior Managing Director, India in an interview with Thomas C Thottathil outlined the steps Indian pharma companies should follow to be compliant with global regulatory requirements
Intranasal vaccines are easier to administer in mass immunisation campaigns and help reduce or stop transmission
The vaccines are currently only authorised for emergency use in the country
However, these won’t be available at the nearest chemist store soon
Covaxin has proven to be safe, well-tolerated, and immunogenic in paediatric subjects in phase II/III study. Neutralizing antibodies in children on an average 1.7 times higher than in adults
It will be marketed under the brand name Molunamax
The Subject Expert Committee (SEC), on Covid-19 of the Central Drugs Standard Control Organisation (CDSCO) on Monday recommended granting permission to manufacture and market anti-Covid pill molnupiravir for restricted emergency use
All the recommendations have been sent to the Drugs Controller General of India (DCGI) for final approval.
The approval of shelf life extension is based on the availability of additional stability data, which was submitted to the CDSCO
Jardiance is the first SGLT2-inhibitor therapy to prove reduction in risk of cardiovascular death in people with type-II diabetes and established cardiovascular disease
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