Bharat Biotech has said that they will fulfill the requirements that have been pointed out by the Brazil national regulatory agency (NRA) after it refused to grant a certification of good manufacturing practices (GMP). Brazil NRA refused to grant the GMP citing non-compliance with necessary standards. The company said that Brazil's coronavirus vaccine order of 20 million is still intact.
"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. The 20 million dose order from the Brazilian Govt is still active. The agreement with Precisa Medicamentos is based on a long term partnership and will continue," said a Bharat Biotech spokesperson.
Brazil's health regulator Anvisa (Agencia Nacional de Vigilencia Sanitaria) refused to grant the GMP certification. The refusal to grant the certification means that the export of Covaxin to the country would face a delay. It must be mentioned here that a GMP certification is necessary in Brazil for companies looking to sell drugs or vaccines.
Anvisa said in its website that the inspectors found 12 major and 14 minor violations that indicate a significant risk to vaccine manufacturing and product quality assurance.
The health regulator reportedly highlighted concerns regarding vaccine potency, viral inactivation, sterilisation and purity. The regulator said that Bharat Biotech did not validate the method of analysis that proved that the virus was completely inactivated during manufacture meaning that live viruses might be present in the vaccine and cause contamination. Anvisa said that Bharat Biotech did not take all precautions to guarantee sterility of the product. As the product is injectable it could cause bacterial infection, stated the regulator.
(Edited by Anwesha Madhukalya)