Amid spiralling Coronavirus cases across the country, Centre announced financial support to three government owned biopharmaceutical institutions to bulk up the production of Covaxin on April 16.
The government also announced that it will provide Rs 65 crore to the only manufacturer of the vaccine currently, Hyderabad-based Bharat Biotech International.
As a deadly second wave continues to grip the country, an acute shortage of vaccines have become evident nationwide. With domestic production remaining stagnant, the government last week announced fast track approval would be provided to all foreign-made vaccines which have already received emergency approval from pharma regulatory bodies in the United States, Japan, European Union, United Kingdom and the World Health Organization.
But as reported by Moneycontrol, the process remains long and the number of steps to vet the vaccines or the requirements for them to be commercially sold has not been reduced. Senior officials say talks with foreign vaccine makers are slowly just beginning and it will be a while for any foreign vaccine to hit the market commercially.
Why did the government suddenly allow public sector enterprises to manufacture Covaxin ?
By providing funds to Bharat Biotech and three other public sector government companies, the Centre hopes to raise Covaxin production from the current level of around a crore doses per month to 6-7 crore doses per month by July-August and hopefully 10 crore doses per month by September.
Also, with the pandemic expanding rapidly, the government did not have much choice. "Given the current circumstances, the latest plan was one of the few options open to the government apart from allowing state governments to directly import vaccines from abroad or radically redistribute vaccine doses, rationing them," a senior official said.
Why can't Bharat Biotech ramp up production with government support ?
The government allocation of Rs 65 crore was provided to Bharat Biotech officially for the purpose of quickly opening and starting the manufacturing vaccine doses at a new repurposed facility in Bangalore. This was, however, less than half of the Rs 150 crore officially sought by the company, Rs 75 crore each for its facilities at Hyderabad and Bengaluru.
Since the beginning of the vaccination exercise, the firm has been under huge pressure from the government to push up production, owing to it's vaccine being fully indigenous. However, the relatively small size of it's manufacturing operations have often prompted the company to try to temper the Centre's expectations.
The company is also suffering from a shortage of a chemical compound , referred to as an adjutant which is crucial to the vaccine manufacturing process. Media reports suggest the compound is imported from a Kansas, United States based company but supplies have run low over the past few months.
Both officials and industry insiders accept that the 10 crore monthly Covaxin production target remains a steep challenge. Under such circumstances, the government believes latest plan offers India a backup to ramp up domestic capabilities while also upgrade existing infrastructure at multiple government biopharmaceutical facilities.
While the Mumbai based Haffkine Institute has informed the government it will take atleast a year to begin production, the government has asked it to begin in next 6-months. One of the oldest biomedical research institutes in the country, Haffkine is a public sector undertaking under the Maharashtra government.
The 122-year old institute had developed a number of critical jabs such as the anti-rabies serum, anti-venom serum, oral polio vaccine but has fallen on hard times due to consistent government apathy. A significant overhaul of infrastructure, including new facilities for a virology laboratory have to be built now.
But the key challenge that the institute faces is the construction of a biosafety level-3 (BSL-3) facility, which is absolutely crucial to contain the virus in the event of an accident. Sandeep Rathod, CEO of Haffkine had recently said a brick-and-mortar BSL-111 facility normally takes three years to get completed. But the institute is looking to create a makeshift one and get requisite permissions within the next 6-months.
Bharat Immunologicals and Biologicals Limited (BIBCOL), Bulandshahr
Operating under the central Department of Biotechnology, BIBCOLs principal mission is to save the lives of millions of children from avoidable disability, through polio vaccination.
While the public sector enterprise remains the pioneer in the field of polio vaccines with a more than 60 percent market share in India, the latest objective entrusted to it requires significant investment to build facilities from scratch, the company has said. The lack of a biosafety level-3 facility compounds the problem.
Officials say BIBCOL is currently engaged in manufacturing of various biological, pharmaceutical and food products. It had been quickly roped in by the centre last year to manufacture formulations of Vitamin C and Zinc tablets as the Covid-19 pandemic was breaking out.
Indian Immunologicals Limited (IIL), Hyderabad
The best placed lab to produce the Covid-19 vaccine quickly, IIL already operates one of the largest vaccine manufacturing plants in the world. But the plant is solely geared towards producing veterinary vaccines for animals, most importantly cows.
Set up under the National Dairy Development Board, IIL is the market leader in veterinary and human biologicals in India, manufacturing over 150 plus products. While the company produces significant number of pediatric and rabies vaccines as well, the government has to pump in enough investments to create a similar size plant for Covid-19 vaccine manufacturing.
However, officials say that given the company is based in Hyderabad, it has access to the private sector vaccine manufacturing ecosystem and can quickly source material from abroad to construct a new plant and biosafety level-3 facility.
So, what does this mean for total vaccine production in India and the pace of vaccination nationwide?
Overall, Covaxin reportedly makes up for only 10 percent of the 12.38 crore vaccine doses administered in India till now. The rest are Covishield, 6-7 crore doses of which can be produced currently by Pune-based Serum Institute of India (SII). As a result, India's vaccination efforts will still remain more dependent on the SII's fortunes in the short to medium term, experts say.
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