Bharat Biotech submits new request to Brazilian regulator on GMP issues for Covaxin, Health News, ET HealthWorld
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.