Monday, May 23, 2022

Bharat Biotech submits new request to Brazilian regulator on GMP issues for Covaxin – ET HealthWorld


Bharat Biotech, which faced a red flag from Brazil‘s health regulator for the supply of Covid-19 vaccine Covaxin to that country over the issues of Good Manufacturing Practices in its plant, has filed a new request to the Brazilian authorities for certification.

According to the National Health Surveillance Agency of Brazil Anvisa, Bharat Biotech made the request on May 25 and a day before the Ministry of Health of the South American country filed a new application for authorisation to import 20 million doses of the Covaxin.

Earlier, Anvisa denied permission to import Covaxin after its authorities found that the plant in which the jab is being made did not meet the Good Manufacturing Practice (GMP) requirements.

“Regarding the fulfillment of Good Manufacturing Practices by the manufacturer Bharat Biotech, one of the main aspects that motivated the previous decision, the company filed a new certification request at Anvisa, referring to the production line of the finished product…Complementing the previous information, a new request for certification of Good Manufacturing Practices for the biological input produced by Bharat Biotech was filed on Tuesday,” Anvisa said in a roughly translated Portuguese.

Bharat Biotech International Limited on February 26 said it has signed an agreement with the Brazilian government for the supply of 20 million doses of Covaxin during the second and third quarters of the current year.

However, the Brazilian health regulator refused to import the vaccine into the country citing GMP issues.

The vaccine maker had earlier stated that the requirements pointed out during inspection will be fulfilled, the timelines for fulfillment “is under discussion with the Brazil NRA and will be resolved soon.”

GMP certification of all stages of vaccine production is a prerequisite for the registration of the immunizer in Brazil.

For the exceptional import order, only the minimum data of Good Production Practices are analyzed, but without the need for the certificate in question, Anvisa further said.

Anvisa recently authorised the conduct of clinical trials of Covaxin in Brazil.

Approval for tests on the immuniser developed in India will serve to assess the efficacy, safety and consistency between vaccine batches, it said.

The study which was requested by Precis Farmacutica, a representative in Brazil for Bharat Biotech involves the application of two doses, 28 days apart, in 4,500 volunteers, in the states of So Paulo, Rio de Janeiro, Bahia and Mato Grosso in Brazil.





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...