Covaxin is produced by Bharat Biotech.
New Delhi:
The issues raised by the World Health Organisation (WHO) over the production of Indian-made coronavirus vaccine Covaxin will be addressed within a week, government sources told NDTV on Monday, adding that the UN body had found three shortcomings with the manufacturing process which do not affect the efficacy of the drug.
“The GMP (Good Manufacturing Practice) certification by the WHO is a voluntary certification. The WHO has clarified that there is no question about the safety and efficacy of Covaxin. GMP certificates are required for medicines, vaccines or diagnostic kits that are exported abroad or distributed by UN agencies,” an official told NDTV.
“The WHO team found three shortcomings regarding GMP in the manufacturing unit of Bharat Biotech. And so, the procurement has been suspended. Bharat Biotech will fix the GMP deficiencies within a week and report it to DCGI (Drugs Controller General of India) and WHO,” they said.
“Among the important things that Bharat Biotech has to do to rectify involve the cleaning of the metal vats in which the inactivated virus is produced to make the vaccine and the training of people tasked with various roles in the production,” the official said.
The World Health Organization on Sunday confirmed it had suspended the supply of Covaxin, produced by Hyderabad-based Bharat Biotech, through UN procurement agencies and recommended to countries that received the Covid vaccine to take action as appropriate.
A statement issued by WHO on Saturday said the suspension is in response to the outcomes of its post-EUL (emergency use authorisation) inspection held between March 14 and 22, and the need to conduct process and facility upgrade to address recently identified GMP deficiencies.
Covaxin supply will be interrupted due to the suspension of production for export, WHO said.
The risk assessment to date does not indicate a change in the risk-benefit ratio. The data, available to WHO, indicate the vaccine is effective and no safety concern exists, WHO said.
Bharat Biotech on April 1 announced the temporary slowing down of production of its COVID-19 vaccine Covaxin across its manufacturing facilities, having completed its supply obligations to procurement agencies and foreseeing the decrease in demand.
During the recent WHO inspection, Bharat Biotech agreed with the former’s team on the scope of the planned improvement activities and indicated that they will be executed as soon as possible.
The company 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 and WHO.
In the interim and as a precautionary measure, the company has indicated its commitment to suspend its production of Covaxin for export, WHO said.
