India: World’s Biggest Producer Fails to Vaccinate its People

Our first concept of self-reliance came out of our struggle for independence. It meant developing the indigenous capacity of our people, institutions and industry against the colonial control of the economy. The second self-reliance—Modi's slogan of atmanirbhar Bharat—means only local manufacturing. Without the other elements of self-reliance, it has failed to deliver even the vaccines that we need so urgently today. The first self-reliance broke the monopoly of multinational companies—Big Pharma—and gave us the generic pharmaceutical industry that made India the global pharmacy of the poor. Backed by the 1970 Indian Patent Act, the CSIR laboratories reverse engineered the drugs. This is how the Indian public sector and other indigenous manufacturers developed the world's biggest generic drug and vaccine manufacturing capacity.

The Modi version of atmanirbharata and has squandered all of that. Given India's Covid-19 crisis, Serum Institute of India, the largest vaccine manufacturer in the world, is unlikely to resume its vaccine supply before the end of the year to WHO's Covax platform. According to UNICEF, Serum Institute is going to have a shortfall in its commitments by 190 million doses up to June and  by our calculations, another 200 million till December. This is a disaster for all the countries who had banked on the Covax platform for their vaccines. Instead of boosting Indian vaccine manufacture, Modi's atmanirbharata has signalled that India is not a good place to set up global manufacturing.

All the scientific inputs—barring those from sycophants—would have indicated a second wave. The need for rapid ramping up of vaccine production capacity should have been obvious to all and sundry. Instead, the Modi government declared victory over Covid-19 and went into battle to defeat the opposition in the state elections.

What should India have then done differently?  It should have used the period of about 5 months in which the numbers were low to build up hospitals, oxygen, other medical support systems and accelerated vaccine production. We have about 50 companies that can produce vaccines. With planning and government support, India could have ramped up its vaccine production to not only provide vaccine its people but also be a major supplier to other countries for Covid-19 vaccines.

Let us start with the two technologies for vaccine production that are already proven and for which we have ample indigenous capacity. The inactivated virus vaccines have been there for more than a hundred years. They still work. The ICMR-Bharat Biotech's Covaxin, Sinovac's Coronavac, Sinopharm's BBIBP-CorV, are all examples of such inactivated virus vaccines. The second technology platform is using a benign virus—usually an adenovirus vector—to carry a small part of the SARS-CoV-2, the virus that causes Covid-19. The well-known Covid-19 adenovirus vector vaccines are Oxford-AstraZeneca's, manufactured in India by Serum Institute as Covishield, Gamaleya Institute's Sputnik V and Cansino's Convidicea.

We are not discussing the mRNA technology here or other DNA or sub-unit protein technologies, as these are relatively new technologies and therefore have a greater degree of uncertainty. If we are looking to ramp up production rapidly, the inactivated virus or the adenovirus vector vaccines are preferable. These technologies are known and we have the capacity to quickly ramp up their production in the country.

The inactivated virus technologies started in India in Haffkine Institute, Mumbai and has a history of almost 100 years in India. In 1893 Waldemar Haffkine, a student of Louis Pasteur came to India and went on to found the Haffkine Institute in Mumbai. In 1932, Sahib Singh Sokhey became its first Indian Director and developed the Institute as a centre for advanced biotechnology, as well as a centre for production of vaccines. The Haffkine Bio Pharmaceutical Corporation, a Maharashtra Government undertaking, was spun out of the Haffkine Institute, and is one of the largest suppliers of vaccines globally. It is this vaccine base that Serum Institute used, stealing scientific personnel from the Haffkine Institute, three of whom even ending up on its board.

The tragedy of Indian vaccine manufacturing has been that while it was built on the back of the public sector, once the private sector came up, it was systematically gutted. This is why even though there are seven public sector units in India, the procurement of vaccines for our public health program is almost exclusively from the private sector.

It is because of its history of vaccine manufacturing, that India has a large vaccine production base. It produced 60% of all vaccines that was sold in the world before the current Covid-19 pandemic. According to Central Drugs Standard Control Organisation (CDSCO), India has 21 vaccine manufacturers and the combined licensed production capacity is around 8 billion doses per annum.

Apart from the inactivated virus vaccines, India also has a strong biologic base that can be used for  vaccine production as well. There are more than 30 companies that have the necessary knowhow and the capacity for manufacturing the adenovirus based vaccines such as the Oxford-AstraZeneca vaccine or the Gamaleya's Sputnik V vaccine. Apart from Oxford-AstraZeneca's tie-up with Serum Institute, five Indian biologic companies have tied up with Gamaleya for producing 850 million doses of Sputnik V vaccines. Similarly, Biologic E has a tie-up with Johnson & Johnson for producing 400 million does of its single shot vaccine already approved in the US. Serum Institute also has an agreement with Novavax, US for producing of one billion doses in India though the completion of its trials and approvals are still some months away.

With all this large capacity, why is India limping at a production rate of only 60-70 million doses per month? The biggest mistake that the Modi government made was in believing that it had defeated the pandemic and therefore had ample time to vaccinate the people. It believed that Serum Institute manufacturing 70-100 million doses and Bharat Biotech another 12.5 million doses per month was adequate to meet India's needs and also its export commitments. These are the numbers that the Government gave to the Parliamentary Standing Committee on Science and Technology (Report dated 8th March 2021). The actual numbers being supplied currently are even lower and add up to about 60 million doses a month.

A back of the envelope calculation would have shown that at this rate, India would take about two and a half years to to produce the 2 billion doses needed to vaccinate its target population, that too without considering exports. Not only would India be exposed to a third or a fourth wave at this pace, it would be completely out of the global vaccine market as well.

What could India done differently if it wanted to ramp up production rapidly? As for example, China and the US has done. While the US chose the mRNA, route, China chose a different way. China's vaccine capacity was well below India's before the pandemic. China developed two inactivated virus vaccine from its state owned Sinopharm and Sinovac, and an adenovirus vector vaccine from Cansino. To ramp up production rapidly, China focussed primarily on the inactivated virus vaccine route. It scaled up its existing facilities as well as created new ones, and licensed the two vaccines to a number of these units. It has also licensed Sinopharm and Sinovac vaccines to a number of manufacturers across the world.

The Modi government chose to believe that it had defeated the pandemic, and therefore the slow pace of its vaccination program posed no problems. Nothing else explains why it did not take the obvious steps that all countries who have indigenous manufacturing capacity took: a) place advance orders, b) extend bank credit to vaccine manufacturers to help expand capacity c) invest money from the exchequer in the existing public sector units d) share the indigenous Covaxin knowhow with other vaccine manufacturers. Instead, it placed an order for only 11 million doses on Serum Institute in early January. The additional 120 million doses came towards the end of March, when the second wave had started and the numbers were rising rapidly. It is only after strong public criticism of its failures, it has placed advanced orders on Serum Institute and Bharat Biotech, and given them some money to expand their production.

How much of would it have cost the government to expand production rapidly? With an investment of Rs. 3,000 crores, India could have created a capacity of 1 billion additional doses of vaccine capacity; with Rs. 6,000 crore a capacity of 2 billion vaccines; with Rs. 9,000 crore, a capacity of 3 billion doses. We would then have vaccinated all our target population in 12 months and yet been a major global supplier. Instead of being looked upon as those who make promises, take money and then renege on contracts. This is what we have done to 92 countries which were were to supply vaccines under WHO's Covax program.

Were there enough vaccine manufacturers in the country for such a course? The list of companies who are already in collaboration with global manufacturing companies show our indigenous capacity. Almost all these agreements are for the more complex adenovirus vector vaccine route. We also have a number of companies who could easily manufacture the inactivated virus vaccines developed by ICMR-NIV. All that was required was planning and the necessary financial support. Just some quick maths: 2 Rafale aircrafts moneywise equal about one billion doses of vaccine capacity; 4 Rafales equals two billion doses; postponing the Central Vista project by two years would have given us Rs. 10,000 crores or more than three billion doses of vaccine capacity!

Not that we really needed to postpone either the Rafale purchases or postpone the Central Vista Project. In this year's Budget, the Finance Minister had earmarked Rs.35,000 crores for Covid-19 vaccines. A less than a third of this kitty would have given us enough vaccines for our people and justified India's claim of being the vaccine pharmacy of the world. Instead, we have not only failed our people, but are now on the dock for denying 92 countries their vaccines. This is the fruit of Modi's atmanirbhar Bharat: destruction of our indigenous capacity and failing the people in the hour of their need.

(This article was first published by Newsclick)