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Brazil’s drug regulator Anvisa has rejected Bharat Biotech International’s application for supplying Covaxin in the country after an inspection of the company’s facility at Hyderabad in March found violations of norms for good manufacturing practices.

During the inspection, different non-conformities were found, which denote a significant risk to manufacturing and product quality assurance, implying a health risk for users, the regulator said on Tuesday.

Anvisa, short for Agencia Nacional de Vigilancia Sanitari, said that Bharat Biotech has not validated the method used to inactivate, or kill, the virus, which may cause contamination of patients with the Sars-CoV2 virus itself. This is related to product safety, it said.

The regulator also pointed to lack of specific control methods to quantify the antigen content and potency of the vaccine, which may lead to variations in antigen content and consequently compromise its effectiveness. It also flagged lack of controls to guarantee the sterility and purity of the vaccine, both of which could affect its safety.

In Brazil, Bharat Biotech tied up with Precisa Medicamentos for supply of vaccine directly to the government. The firm had provided an action plan to the regulator on 17 March, but Anvisa said that the measures adopted so far are not sufficient to mitigate risks associated with non-conformities.

Bharat Biotech has in the Brazilian firm’s action plan proposed completion of studies and modifications to guarantee the safety and efficacy of the vaccine, Anvisa said. However, the regulator said that these will not have an impact on the efficacy and safety of what has been manufactured so far.

Bharat Biotech can reapply for the certification of its facilities and emergency use authorization after it completes the remediation process. “The requirements pointed out during inspection will be fulfilled. The timelines are under discussion and will be resolved," Bharat Biotech said, adding that the order for 20 million doses from Brazil is still active.

Gagandeep Kang, professor at Christian Medical College, said that the issues do not necessarily mean that the product has failed. “But these are things that the company has to take seriously and the Indian regulator should also take note and look into it," Kang added.

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