Indian drug regulator examining WHO move on Covaxin, may seek update from company

New Delhi, April 4, 2022: 

In the light of the World Health Organisation (WHO)’s move to suspend supply of Covaxin produced by Hyderabad- headquartered Bharat Biotech, through UN procurement agencies, those in the Indian vaccine industry feel the focus will now increasingly be on the Indian drug regulator – the office of the Drugs Controller General of India (DCGI) and on its next steps. However Financial Express Online reliably learns that the Indian drug regulator is examining the developments with respect to Covaxin in the light of the World Health Organisation (WHO)’s move to suspend supply of Covaxin produced by Hyderabad- headquartered Bharat Biotech, through UN procurement agencies. It is also learnt that the Indian drug regulator is internally examining the developments and that it may ask Bharat Biotech to submit to the regulator their next course of action for the issues around the GMP (good manufacturing practices) compliance raised by the WHO. The crucial word doing the rounds is CAPA – corrective and preventive action – that the company may need to take and update the global and local agencies that seek clarification.

The WHO had on Saturday stated that the suspension was in response to the outcomes of WHO’s inspection of the Bharat facilities between March 14th and 22nd (WHO suspends Covaxin supply to UN agencies) pointing to a need for the company “to conduct process and facility upgrade to address the recently identified GMP deficiencies.” The WHO also stated that there will be interruption of supply of Covaxin due to the suspension of production for export.” It however does also state that “Bharat has committed to comply by addressing the GMP deficiencies and is developing a corrective and preventive action plan, for submission to the Drugs Controller General of India DCGI and WHO. In the interim and as a precautionary measure, Bharat has indicated its commitment to suspend its production of Covaxin for export.”

The WHO however does add that “the data, available to WHO, indicate the vaccine is effective and no safety concerns exists.”

However, those in the industry point out that GMP has many elements to it and it is not any specific correction that one could refer or state where usually challenges could occur as GMP could cover several aspects and range across equipment, processes, operational practices, documentations and several other areas and unless details are known it may not be right to speculate. Financial Express