India monitors Bharat Biotech’s ‘remedial’ steps

India is monitoring the corrective measures being taken by Hyderabadbased Bharat Biotech to address deficiencies in its facilities that the World Health Organization flagged while suspending procurements of Covaxin, people aware of the matter have said.

There is, however, no plan to suspend the use of Covaxin in India, these people added, saying that they see no concern regarding the safety or efficacy of the vaccine, which is among the two most widely used in the country till now.

“They (Bharat Biotech) have shared their formal response of more than 50 typewritten pages, addressed to World Health Organisation with Drugs Controller General of India also.

CDSCO (Central Drugs Standard Control Organisation) is monitoring the rectification process started by them to address the Good Manufacturing Practices (GMP) deficiencies,” said a central government official aware of the matter, asking not to be named.

GMP certifications are part of the approval process of a biological product like a vaccine and involves the assessment of whether equipment and protocols in place for their use are to accepted standards in order to avoid risks such as that of contamination. On April 2, the WHO said it was suspending supply of Covaxin through UN agencies due to “the need to conduct process and facility upgrade to address recently identified GMP deficiencies”.

India is “not reviewing Covaxin use (under the national vaccination programme). The safety and efficacy of the product has been established. WHO also attests it,” the official quoted above added.

A day before the WHO announced the suspension, Bharat Biotech issued a statement saying it “agreed with the WHO team on the scope of the planned improvement activities and indicated that they will be executed as soon as practical…”

Details of the exact issue is yet to be made available. Neither the WHO nor Bharat Biotech detailed whether the problems were at specific or all facilities.

“Risk of contamination is one issue when talking about quality control but it doesn’t seem WHO has found that major an issue during its inspection.

There are other minor issues like record keeping, room temperature, maintenance etc but when talking about vaccines even these minor issues cannot be ignored,” said Dr NK Mehra, senior immunologist.