Tuesday, October 19, 2021

Centre fast tracks emergency approvals for foreign Covid-19 vaccines to augment India’s vaccination coverage – ET HealthWorld


With the aim to expand the basket of vaccines and accelerate the coverage of Covid vaccination in fighting the pandemic, the central government on Tuesday said that it has fast-tracked approvals for foreign manufactured Covid-19 vaccines that have received similar clearances.

The decision came after the National Expert Group on Vaccine Administration for Covid-19 (NEGVAC) recommended that vaccines for Covid-19, which have been developed, are being manufactured in foreign countries and which have been granted emergency approval for restricted use by USFDA, EMA, UK MHRA, PMDA Japan or which are listed in WHO (Emergency Use Listing) may be granted emergency use approval in India.

The first 100 beneficiaries of the foreign vaccines shall be assessed for seven days for safety outcomes before it is rolled out for further immunization programme within the country, the Union Ministry said.

The expert panel also mandated the requirement of post-approval parallel bridging clinical trial in place of conduct of local clinical trial as per the provisions prescribed under Second Schedule of the New Drugs & Clinical Trials Rules 2019.

This decision will facilitate quicker access to such foreign vaccines by India and would encourage imports including import of bulk drug material, optimal utilization of domestic fill and finish capacity etc., which will, in turn, provide a fillip to vaccine manufacturing capacity and total vaccine availability for domestic (use), the ministry said.

Currently, two vaccines i.e. Covaxin by Bharat Biotech International Limited and Covishield by Serum Institute of India, have received Emergency Use Authorization from Drugs Controller General of India.

On Monday, Russia’s Sputnik V became the third Covid-19 vaccine to receive permission from India’s drug regulator for the restricted emergency use with certain conditions.





Source link

Latest Articles

Widely used chemical linked to 1,00,000 US deaths per year: Study

NEW YORK: Daily exposure to phthalates, a group of chemicals used in everything from plastic containers to makeup, may lead to approximately 100,000 deaths...

Foods to Reduce Inflammation and Strengthen the Immune System

Did you know that you can greatly reduce inflammation and boost your immune system by simply incorporating more anti-inflammatory foods and beverages into your...

Personal Selling

INTRODUCTION Early sellers and traders were not held in high esteem. The Roman word for salesman meant ‘Cheater’ and...

Building Muscle on a Vegan Diet

There are a lot of  misconceptions surrounding veganism. The notion that those who practice it are lacking in protein and therefore muscles is the...

Electrodes in brain new hope for severe cases of epilepsy

Neurosurgeons at All India Institute of Medical Sciences have devised a new technique for operating on children suffering from a severe form of epilepsy...