It could take a minimum of 6-8 months for Hyderabad-based Bharat Biotech — the producer of Covid-19 vaccine Covaxin — to improve its amenities to handle the Good Manufacturing Practice (GMP) deficiencies flagged by the WHOfirm sources mentioned.
On Saturday, the WHO had suspended the procurement of Covaxin by UN companies, asking Bharat Biotech for facility improve to handle the recognized GMP deficiencies. The WHO, nonetheless, had highlighted that Covaxin is efficient and no security concern exists.
Company sources informed The Indian Express that the particular improve couldn’t have been undertaken in the course of the pandemic because the provide of latest gear takes 15-18 months and it additionally requires full shutdown of the amenities, which may have resulted in delay within the provide of the vaccine.
“Equipment upgrade is not something you can buy off the shelf,” sources mentioned.
The firm sources mentioned that the WHO choice would not influence the availability of Covaxin as no orders from the UN companies are pending. They additionally mentioned the WHO directive would not have any influence on provide of the vaccine in roughly 25 nations, the place the corporate has obtained Emergency Use Authorization.
“The firm has not obtained any order until date from any of those UN companies. The firm has provided Covaxin to India’s immunization drive and 25 different nations. This order impacts solely the availability to UN companies,” sources mentioned.
“Bharat Biotech amenities weren’t designed for producing Covaxin. These had been re-purposed amenities: some had been polio virus vaccine amenities; and others had been for rabies and Japanese encephalitis vaccine. When we began manufacturing Covaxin in these amenities, we undertook a threat evaluation and manufactured it in a fashion the place the vaccine is secure,” sources mentioned.
Sources mentioned that primarily based on the inspection, WHO has directed the corporate to improve the amenities, together with gear. “We have promised WHO that the GMP standards will be met at the facility that will manufacture Covaxin,” sources mentioned.
Sources mentioned the corporate has not but taken a choice on which facility can be upgraded for manufacturing Covaxin.
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With inputs from TheIndianEXPRESS
