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How India's regulatory pitfalls helped Covishield and Covaxin get rapid approval - Vimarsana News

How India's regulatory pitfalls helped Covishield and Covaxin get rapid approval

Text Size: A+ The year 2021 in India began with a flurry of events around the Covid-19 vaccine. The Indian government conducted dry runs for the vaccines, and two vaccines Covishield (Oxford University-AstraZeneca) and Covaxin (Bharat Biotech) were granted accelerated regulatory approval by the Central Drugs Standard Control Organisation (CDSCO). The process of granting these vaccines regulatory approval has been a subject of intense scrutiny. The grant of these approvals and the scrutiny involved in the process has been marred with several concerns as these vaccines are yet to complete ...

License required to import, manufacture medical devices - Vimarsana News

License required to import, manufacture medical devices

License required to import, manufacture medical devices ANI | Updated: Dec 29, 2020 14:45 IST New Delhi [India], December 29 (ANI): Importers and manufacturers required to take licence from the Central Licensing Authority or State Licensing Authority for the import and manufacture of nebulizers, BP monitoring devices, digital thermometers, and glucometer with effect from January 1, said Central Drugs Standard Control Organisation. "Representation has been received requesting to extend the implementation of the notification for another three to six months...

Source: aninews.in
License required to import, manufacture medical devices: CDSCO - Vimarsana News

License required to import, manufacture medical devices: CDSCO

Importers and manufacturers required to take licence from the Central Licensing Authority or State Licensing Authority for the import and manufacture of nebulizers, BP monitoring devices, digital thermometers, and glucometer with effect from January 1, said Central Drugs Standard Control Organisation. "Representation has been received requesting to extend the implementation of the notification for another three to six months because a lot of procedural work is to be done such as the resolution of queries, an audit of facilities by the regulators, and notified bodies, as the case may be, tes...