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Bharat Biotech set to upgrade plants post WHO suspension

Recently, WHO inspected Bharat Biotech plant and identified GMP (good manufacturing practice) deficiencies following which the global health body alerted the country to take appropriate action in this regard. (REUTERS)Premium
Recently, WHO inspected Bharat Biotech plant and identified GMP (good manufacturing practice) deficiencies following which the global health body alerted the country to take appropriate action in this regard. (REUTERS)

  • WHO has observed deficiencies company’s existing manufacturing facilities which are not 100% perfect for manufacturing of covid vaccines and hence upgradation work is proposed

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HYDERABAD : Hyderabad-based pharma firm Bharat Biotech has moved swiftly to upgrade its manufacturing facilities, specifically for Covaxin, after WHO suspended the supply of the vaccine through UN procurement agencies, a person aware of the matter said on Monday.  

The person from Bharat Biotech said that WHO has observed deficiencies company’s existing manufacturing facilities which are not 100% perfect for manufacturing of covid vaccines and hence upgradation work is proposed. 

Recently, WHO inspected Bharat Biotech plant and identified GMP (good manufacturing practice) deficiencies following which the global health body alerted the country to take appropriate action in this regard.  

It may be noted that for the last one and half year, Bharat Biotech has been manufacturing covid vaccine in its existing facilities which they have-repurposed for production of covaxin.  

 “After the company got India license, we applied for EUL (emergency use listing) with the WHO, which was given to us. The intent for EUL was to supply vaccine to UN agencies like UNICEF, PAHO and GAVI Covax facility. The company has not received any orders till date from any of the UN agencies. So, no supplies have been mare so far. The Pharma company has only supplied vaccine to Government of India and to quite a few other countries, but all these supplies were based on Emergency Use Authorization (EUA) received from those countries," said the person from Bharat Biotech quoted above. 

Questions sent to Bharat Biotech on the issue, however, remained unanswered . 

Last year in November, WHO issued an emergency use listing (EUL) for COVAXIN adding to a growing portfolio of vaccines validated by WHO for the prevention of COVID-19 caused by SARS-CoV-2. 

 “We are in the process of doing facility upgradation and maintenance. That will take some time. And once we do that, we are good to go again," the person said adding that the company will be ready for global requirements in case there is another pandemic in future. 

Talking about GMP, another person aware of the development said that several of Bharat Biotech’s facilities that are being used for manufacturing covaxin are not designed facilities for Covid vaccines. 

“So, these are repurposed facilities. Some were designed for production of IPV, Rabies, Japanese Encephalitis. These facility designs are not 100% perfect for manufacturing of covid vaccines. We have given a commitment to WHO that whichever are those facilities in the future where we will manufacture covid vaccine will be perfectly designed for manufacturing Covaxin. Those are facilities upgrades that we are coming up," the person from BB told Mint.

 “Nobody knew covid was going to be big problem. Nobody had SoPs (standard operating procedure) for covid. Most of these facilities will revert to the products that they were designed for in a few months depending upon the facility and each product," said the person adding that WHO announcement will not impact the company’s operations. 

“WHO has given just global advisory; countries get to decide what they need to do. The amount of procurement of covid vaccines in general has come down internationally," he said. 

For the last 15 months, the company was not able to shut down its facilities for maintenance or upgradation work because of the production pressure. 

“During the peak of the pandemic there were lot of technical constraints. For example- When you order some equipment, it takes 12-15 months. These are not equipment which you can buy off the shelf. And then, if you want to make a facility modification or upgrade the facility then you need to shut down the facility. Right now, we have the time, and we need to do that," the person from Bharat Biotech said.

As of now, the pharma giant has shut down the facilities at Ankleshwar, Indian Immunologicals etc. 

 “We had two facilities in Ankleshwar and we have slowly closed them down. We had been manufacturing at Indian Immuologicals and that has also been closed. Here at campus, there is only one facility right now that is making coxavin. The rest have been closed. We do have enough drug substances (bulk available) and we have built up an antigen bank. If the country needs it, we can convert it within 30-45 days' timeline and we can supply the products. We have covered all the basis from our perspective. As of now we have 150-200 million doses available in bulk," said the person. 

Since February, Bharat Biotech started to slowly turn down our manufacturing to commence maintenance work. The company has completed its supply commitments. 

 “Our manufacturing takes about 120 days from start to finish. We need to do planning in the month of November and December for what's going to happen in March and April. We had decided that we will be turning down sometime in the month of January or February based on what orders we have received," he said. 

The pharma company believes that the cost of escalation will be in tens of crores but there will be no impact in terms of supply.

 

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