India and the Curious Absence of Clear Policy When it Comes to Local Vaccine Production

The vaccine policy announced by Prime Minister Narendra Modi recently lacks in transparent and accountable steps for the enhancement of public and private investment in local production. The policies required for the promotion of technology transfer, technology absorption and indigenous technology development are missing.

The prime minister really should be listening to scientists. They have been asking the government to announce a policy with concrete steps introduced for the promotion of research and development, and technology development activity in the case of vaccines.

The prime minister praising scientists for their contribution is taken as a meaningless platitude. More than 200 eminent scientists, doctors, academics and health activists recently asked the Union government to take concrete steps supporting research and development of vaccines, and their local production.

Expectations belied

In their statement, scientists pointed out that India would effectively need over 3.1 billion doses to cover its entire population of 1.3 billion people.

Their demands included many suggestions to the Centre. They expected the prime minister to commit to revive the existing public sector undertakings and state-owned enterprises to ramp up local production of vaccines.

Also read: Modi Forced to Change Tack But New Vaccine Policy Still Promotes Inequity and Inefficiency

The Centre should hand over the Integrated Vaccine Complex (IVC) facility at Chengalpattu to the state government of Tamil Nadu with clear provisions allowing contractual use of the facility for COVID-19 vaccine manufacturing. The IVC facility, set up by the Centre at Chengalpattu in Tamil Nadu at a cost of Rs 900 crores has been ready for vaccine production since 2017. It is yet to produce a single dose of any vaccine.

Arbitrary and discriminatory provisions restricting the use of facility by state-owned enterprises should be withdrawn from the tender issued on the use of the IVC facility under instructions from the Ministry of Health and Family Welfare. The government of Tamil Nadu has also pleaded with the Centre to allow the state government to run the facility. 

The Centre should also nudge Bharat Biotech and Serum Institute of India to enter into joint ventures with public sector undertakings to expand the local production of vaccines. Specific compulsory licenses provisions for government use, available in the Indian patent legislation, should be deployed to enable interested parties to get started on vaccine production.

The Centre should ensure technology transfer from Bharat Biotech, Serum Institute of India and other private sector companies to PSUs, SOEs and other units to enable them produce vaccines for domestic use.

Research and development capabilities at the national and state level should be expanded for the development of multiple vaccines to increase their efficacy. Research on new vaccine development strategies and development of multiple vaccines must be enabled and encouraged through increased financial support.

Genomic surveillance be increased appreciably and linked to viral efficacy and epidemiological studies, so that vaccines are constantly checked for efficacy against variants of concern enabling collaborative modification across manufacturers, as required, especially in view of emerging variants and for different demographics such as children.

The country would need 2.19 billion doses to cover the 18+ population. This will mean fixing the vexing issues involved in the expansion of capacities available for local production and research on vaccines in India.

Policy path still a mystery  

The Centre’s announcement of free vaccine in the absence of assurance of vaccine supply is a recipe for the country to be put on a “Ram bharose” policy path.

Motives dominating the policy announcement made by the prime minister on the issue of vaccination are unclear and under debate in the media. From the perspective of scientists, the cost of policy announced by Modi without transparently providing for the new strategies required for the expansion of supply of vaccines through self-reliant local production would be very high and unbearable.

Currently, the known numbers do not add up to assure us how the Centre would be able to fulfil in practice the newly accepted obligations and the promised vaccine supplies to the states in a fair manner. 

Source: Compiled by the author based on media reports

Vaccine production will be of the order of about 8 crore doses a month in India by the month of June and approximately 9 crore in the month of July, according to Hindustan Times.

In a submission before the Supreme Court on May 9, the government said that the COVID-19 vaccine manufacturing capacity of India for three vaccines, Covishield, Covaxin and Sputnik V, could cumulatively cross 14 crore doses a month by July 2021 – making 46 lakh doses available a day. This is almost triple the current stage vaccination which is approximately 15 lakh a day.

The Serum Institute of India has said that its production would be 6-7 crore doses a month. Bharat Biotech said it was to produce 2 crore doses in April and increase the production to 3 crores doses in May. This means that India’s existing production capacity of the two COVID-19 vaccines would be in the range of about 8.5 crore doses a month.

This translates into a daily production and supply of 27.5-28.5 lakh, depending on whether a month is taken as of 30 days or 31 days. The Department of Biotechnology had recently informed the Parliamentary Standing Committee on Science and Technology, Environment, Forests and Climate Change that the estimated manufacturing capacity of Covishield is 70-100 million doses every month, while Covaxin has a planned production capacity of 12.5 million a month (150 million doses a year). However, neither is producing to full capacity as vaccine makers say they are not earning enough to plough back into capacity enhancement.

Uncertainty of supplies of raw materials and equipment

The commitment of supply from Centre to states is dependent till this date on the fulfilment of promise of supplies coming from vaccines from two now three companies and vaccines to be imported from the sources having rather limited supplies for sharing with India.

They have failed India on many occasions and are lacking in commitment to supply raw materials and equipment required for the expansion of local production. Currently, the strain on manufacturing capacities and capabilities is high, in light of the immediacy and scale of the demand. It can get exacerbated further if boosters are needed due to waning efficacy and need to protect the population from new variants across the world.

It has been apparent that many COVID-19 vaccine input supplies of raw and packaging materials, consumables and equipment are in short supply. This may result in the domestic COVID-19 vaccine manufactures not being able to meet their manufacturing commitments. Such shortages will also impact the ability to manufacture other lifesaving vaccines and biologics.

There is a huge risk in not taking the steps required well in time for getting started with the preparation of plans for technology indigenisation. There are no planned programmes for indigenisation of raw materials and equipment required for the acceleration of local production.

Dependence on raw materials and equipment needed for the expansion of local production of vaccines is going to continue.

Vaccine manufacturing processes (upstream, downstream, fill and finish) are characterised by cutting edge science and technologies. The need for highly-specialised equipment and personnel, difficult and time-consuming technology transfers between partnering organisations, globalised  supply chain, and manufacturing networks, and the need for on-time delivery of more than 1,000 components makes import dependent vaccine manufacturing operations vulnerable to supply disruptions.

Also read: The Blueprint for India’s Vaccination Drive Was Always in Its Industries’ Supply Chains

Manufacturing sub-steps can differ significantly depending on the respective technology platform. Although the biologic-derived vaccine manufacturing process equipment has the possibility of alternate solutions, but to ensure that vaccines manufactured are of the highest quality, manufacturers must assure the quality and control the steps appropriately. 

Policy dependent on private sector firms having know-how monopolies 

Technology import and local production of vaccines cannot continue to depend on the cooperation of private sector firms. Few select firms have been allowed to develop complete monopoly over technological know-how.

From the perspective of self-reliance, the policymakers were expected to clearly announce the plans on how the Central government plans to bring about a change in the strategy to ensure enhanced supply of vaccines through local production.

Progress made on the front of policy changes involving public and private sector is not available in the public domain. In the latest policy announcement made on vaccination, the prime minister has made no commitment to the nation on the changes being made in policy on the production side.

As yet there is no commitment from the Centre to ensure technology transfer to the public and private sector companies interested in partnering with Bharat Biotech and Serum Institute of India. At the moment these two private sector companies have complete know-how monopoly.

The Central government has been dependent on these companies to expand local production of vaccines in India. 

Global demand for COVID-19 vaccines has been estimated to range from 10-14 billion doses in 2021 depending on the final aspired coverage rate, need for revaccination and boosters. Globally this requirement means that vaccine manufacturers would need to increase by three-fold annual vaccine output.

Disparities between supply and demand will continue on future developments, including approval of late-stage candidates, optimisation and ramping up of manufacturing processes in line with plans, input supply challenges (e.g. the supply of bio-bag reactors, cell cultures media, filters and so on), and the impact of variants.

The scale up is going to pose both known and currently unknown challenges in the supply of raw materials, testing reagents for batch release, singe use systems, and equipment required for vaccine manufacturing, filters, gamma irradiators. The capacity limitations are also aggravated by a tendency towards higher stock-keeping to counter uncertainties and trade restrictions.

Vaccine is a public good, and the government should treat it as such not for just distribution but also for investment.

Create certainty; elaborate the policy scope and scale of rewards to encourage producers and researchers to contribute. Any delay in firm purchase orders for vaccines will have a tendency to create uncertainty and knock-on effects on the supply chain and manufacturing network.

This is a virus which will persist and the world has to deal with it as a longer term problem. The road to recovery could be a long one. 

Dinesh Abrol former Chief Scientist, CSIR-NISTADS, professor of Institute for Studies in Industrial Development and currently coordinator SASH&KN, TRCSS, Jawaharlal Nehru University, Delhi.