Covaxin GMP issue: Bharat Biotech submits fresh request

Hyderabad BHARAT Biotech which faced a red flag from Brazil's health regulator for supply of Covid-19 vaccine Covaxin to that country over the issues of "Good Manufacturing Practices" in its plant, has filed a new request with 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 roughly translated Portuguese.

Bharat Biotech International Limited on February 26 said it has signed an agreement with the Brazilian government for 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 told P T I that the requirements pointed out during inspection will be fulfilled, the timelines for fulfillment "is under discussion with the Brazi lNRA and will be resolved soon."