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Brazil's Covaxin order still active: Bharat Bio
Brazil’s Covaxin order still active: Bharat Bio
The regulator there flagged the issues relating to vaccine potency, sterilisation, viral inactivation and purity. It observed that the vaccine maker has not validated the method of analysis that proves that the virus was completely inactivated during manufacture
Shamirpet: Bharat Biotech has said that Brazil government's order of 20 million doses of Covid-19 Covaxin is still active and that it will fulfil certain requirements pointed out during the inspection by Brazilian health regulator Anvisa.
The city-based vaccine maker's clarification came after reports that Anvisa denied permission to import Bharat Biotech's Covaxin into the country.
The health regulator refused to grant a certification of Good Manufacturing Practices (GMP) to Covaxin, citing non-compliance with necessary standards. It suspended the request of Brazil's health ministry to import the vaccine.
GMP certification by Anvisa is a must for import and sale of drugs and vaccines in Brazil.The regulator, whose team visited Bharat Biotech's vaccine-making facility at Genome Valley in Hyderabad last month, reportedly found certain non-conformities indicating risk to vaccine's manufacturing and product quality assurance.
The regulator flagged the issues relating to vaccine potency, sterilisation, viral inactivation and purity. It observed that the vaccine maker has not validated the method of analysis that proves that the virus was completely inactivated during manufacture.
Bharat Biotech, however, maintained that the requirements pointed out during inspection will be fulfilled. It also clarified that the agreement with PrecisaMedicamentos, its Brazilian partner, will also continue.
Sources in Bharat Biotech told IANS that seeking more information or certain clarifications is common during inspections and regulatory procedures followed by drug regulators across the world.
"This is not uncommon. We will definitely be fulfilling the requirements pointed out during the inspection," they said.
Bharat Biotech had announced on February 26 that it signed an agreement with the Brazilian government for the supply of 20 million doses of Covaxin during the second and third quarters of 2021. The value of the deal is estimated at around Rs 2,140 crore
It was on January 12 that Bharat Biotech announced that it has signed an agreement with PrecisaMedicamentos for the supplies of Covaxin to Brazil.
This followed the visit by a team from PrecisaMedicamentos to Bharat Biotech facility in Hyderabad to discuss potential export possibilities of Covaxin, India's first Indigenous vaccine for Covid.
