NEW DELHI: Brazil has refused permission to import 20 million doses of Bharat Biotech‘s Covaxin into the nation, saying that the manufacturing facility in India doesn’t meet the Good Manufacturing Practice (GMP) necessities.
The Brazilian authorities had signed a contract final month to purchase 20 million doses of the Indian drugmaker’s vaccine.
Bharat Biotech utilized for emergency use of the vaccine in Brazil on March 8.
National Health Surveillance Agency Anvisa in its web site stated it acquired a request from the Brazilian well being ministry to import 20 million doses of the India-made vaccine.
However, a call on that was suspended by the regulator due to the absence of some key paperwork.
” … considering the non-compliance with the requirements of Good Manufacturing Practices for Medicines, or the non-compliance with the petition procedures submitted for analysis, advocatedby current legislation,resolves: Refuse the Request (s) for Certification of Good Manufacturing Practices for Medicines of the company (ies) contained in the ANNEX,” a Brazilian authorities gazette stated on March 29.
Hyderabad-based Bharat Biotech stated it’s working in the direction of resolving the problems cited throughout the inspection.
It added that the order of 20 million doses from the Brazilian authorities has not been cancelled.
“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 corporate instructed PTI in an e mail reply.
To one other question, the vaccine maker stated it has submitted for EUA’s (emergency use authorisation) in additional than 40 nations and a number of other nations have already issued the authorisation and provides are in course of.
Covaxin had reported an interim efficacy of 81 per cent following Phase 3 medical trials.
Covaxin and Covishield are the 2 vaccines which can be at present in use in India.
(With inputs from PTI)