With the present Indian population of over 130 crore people, the number of vaccines required would be about 310 crore doses (3.1 billion doses). This is the number of doses required with provisions of about 15% process losses, which is inevitable in any vaccination strategy. While it is not an easy task to gather such huge doses in a short time, India should not give up.
Today, ordinary citizens are seeking answers to the question of why India, a pioneer in vaccine production before the current pandemic and a big exporter of vaccines, has to rely on just two private domestic manufacturers – Serum Institute of India (SII) and Bharat Biotech – to produce COVID-19 vaccines. With the vaccine shortage developing rapidly, there have been calls for imports. There is huge demand for equipping public sector units to develop COVID-19 vaccines, including from 13 political parties and four chief ministers.
Unfortunately, much time has been lost. Does India have a way forward? In how much time can India realistically be expected to expand the scale of vaccine production to the required level?
Path to expansion
Presently, India has almost two dozen vaccine production units. Both the public and private sector have units that can contribute to the expansion of local vaccine production. At the moment, two vaccines – Covishield of the Serum Research Institute (SII), Pune and Covaxin of Bharat Biotech, Hyderabad – are available for supply in India.
Covaxin is a home-grown vaccine; Bharat Biotech developed it in collaboration with the National Institute of Virology (NIV), which is a public sector R&D institute affiliated to the Indian Council of Medical Research (ICMR), an agency under the control of Ministry of Health and Family Welfare. Presumably, NIV and Bharat Biotech jointly own the intellectual property (IP) in the case of Covaxin. The Central government is entitled to make use of the march-in rights available to government entities. Since ICMR is a co-owner of IP related to Covaxin, the government can nudge Bharat Biotech to handhold the interested public and private sector units who want to produce the vaccine.
It was in 2012 that the United Progressive Alliance government gave a nod for the Integrated Vaccine Complex on 100 acres of land in Chengelpet, to allow the public sector to contribute to vaccine production after much deliberation in the government and the parliament. The facility was meant to be the nodal centre for public sector manufacturing and research. The aim of establishing this facility was to ensure the supply of vaccines at affordable prices to the nation. Currently, the facility has the capacity to supply 585 million doses per year. If required, its capacities can also be further augmented.
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Though construction and installation of labs was done in 2017, so far no vaccine production has taken place in vaccine complex. Recently, the labs were instead used for the production of sanitisers. The Central government’s plans for COVID-19 vaccine production have not included the use of public sector facilities.
The need for joint ventures
The three PSUs – Central Research Institute (CRI) in Kasauli, Himachal Pradesh, BCG Vaccine Laboratory (BCGVL) in Guindy, Tamil Nadu and Pasteur Institute of India (PII) in Coonoor, Tamil Nadu – have been involved in the manufacture of vaccines in a cost-effective way for India’s universal immunisation programme against tetanus, diphtheria, pertussis, measles, polio and tuberculosis.
In the beginning of 2000s, 80% of India’s vaccines for the Universal Immunisation Programme were sourced from the public sector. Today, 90% are sourced from the private sector at a higher cost. Brazil, Cuba and China are using public sector companies and institutes to undertake integrated R&D and production operations to vaccinate their populations and export to developing countries to meet their requirements.
India has neglected public sector facilities even after they have been upgraded to the level of GMP-compliant facilities. India has a large number of decades-old facilities as well as some new facilities equipped with the most appropriate modern infrastructure almost ready for use if the country wants to expand vaccine production in the timeframe of a year or so. Presently, India has 11 public sector units. Some are almost ready to go into production. The government has taken some initial steps in the direction of using a few selected units.
The IVC needs only Rs 100 crore and some handholding by consultants to start the local production of COVID-19 vaccines, conversations with sources at the unit have shown. Joint ventures can be tried out. Some of the public sector units can also be made to step in to produce vaccines for the Universal Immunisation Programme, for which SII has had to stop production to expand COVID-19 vaccine production.
The Central and state governments need to mobilise only a small amount of resources to provide funds for the required balancing investments to these units. The Central government will have to direct Bharat Biotech and SII to do the handholding for the COVID-19 vaccines. Bharati Biotech and SII can help these units by signing know-how transfer agreements. Joint ventures (JVs) with SII and Bharati Biotech are the way forward for the use of public sector facilities for the expansion of vaccine production.
Infrastructure at IVC, Chennai
In 14 blocks, It has 5 bulk vaccine antigen production units and 4 formulation units. It also has 4 filling lines with 200 vials / min speed. Only commissioning and validation is pending.
Analysts suggests that the first three blocks can be easily converted for COVID-19 vaccine production as the capabilities needed are similar, using the same technology or process. Rs 100 crore is only needed initially to get started with COVID-19 vaccine production.
Private sector needs to be mobilised
Almost a similar number of private sector units exist which can also contribute to the local production of COVID-19 vaccines. There are quite a few efficient Indian private sector vaccine manufacturing units, such as Biological E. Limited, Hyderabad and Panacea Biotech Malpur, Solan.
Procurement of approved vaccines from abroad by private sector units is also an option. Already, Dr Reddy’s Lab has teamed up with Russia to procure Sputnik V vaccines. More entrepreneurs coming up with such plans would ease the vaccine availability.
The IVC in Chengalpet, Tamil Nadu cost almost Rs 900 crore to set up. Established in 2012, the IVC is yet to produce a single dose of any vaccine. The present government has now initiated moves to make it functional through a public-private partnership. Unfortunately, the private sector has been less than ready to coexist with the functioning public sector.
In an interview to Down to Earth magazine in 2009, Cyrus Poonawalla of SII criticised the suggestion that government funding be used to make public sector vaccine manufacturers GMP-compliant, calling it a “waste of money”. Instead he suggested, “The few hundred staff members [of the PSUs] could be utilised elsewhere for tests or research.” SII was built using the scientists of a state public sector unit, Haffkine Institute (now Haffkine Biopharmaceutical Corporation Ltd) in Mumbai, and by luring doctors and scientists from the Haffkine Institute to produce SII’s first anti-tetanus vaccine. Three former Haffkine employees made it to the SII board.
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Today, the private sector is itself getting subsidies and advance funding from the government. A grant of Rs 65 crore has been made to Bharat Biotech to repurpose one of its production facilities in Hyderabad to produce Covaxin. This is in addition to government advances of Rs 1,500 crore to Bharat Biotech and Rs 3,000 crore to SII to expand their existing facilities. Government grants are also now being made to state-owned companies – Indian Immunologicals Ltd. Hyderabad and Bharat Immunologicals and Biologicals Corporation Ltd. (BIBCOL) Bulandhshahar, UP – to manufacture Covaxin under a licence. Nevertheless, it will take nearly a year for them to produce the first batch of doses.
The Central government has acceded to the Maharashtra chief minister’s demand to involve the Haffkine Institute, a state PSU, which has received a government grant of Rs 81 crore to get started with the manufacturing of COVID-19 vaccines. But Haffkine requires technology transfer – and SII and Bharat Biotech should be made to handhold these units to pay back their own longstanding debt to the public sector. India’s private sector is a child of the Indian public sector units.
There is another complex issue which has surfaced over time from the multiple COVID-19 infections. The original SARS-CoV-2 virus has mutated over the years from December 2019 onwards and the mutated strains are developing capacities to reduce vaccine efficacy. Several other newer vaccine development strategies are getting pursued by the private sector in India. These scientific efforts need to be encouraged in every possible way.
The B.1.617 variant of SARS-CoV2, which is causing tremendous issues in India, needs to be isolated. Newer vaccines in the Bharat Biotech way can be developed and the efficacy tested, so as to ascertain if another new vaccine can be developed.
Although an effective vaccine to neutralise all the mutant strains is not available yet, the vaccines available presently would impart some protection. Availability of multiple choices of vaccines would enable more protection to the population. But the fact remains that the Indian state has not stepped in till this date with a clear-cut policy for the expansion of local vaccine production. India can ill-afford to leave its citizens at the mercy of free market players in public health. We are concerned that inputs from scientists and others are not getting the attention they deserve.
Proposals
Given below are our precise suggestions for the government to bring out a policy within this month:
- Revive public sector undertakings and state-owned enterprises to ramp up vaccine production;
- Reissue the tender for use of the IVC facility with clear provisions allowing state governments, public sector undertakings and state-owned enterprises to plug and play with the facility;
- Issue compulsory licenses to interested parties to allow them to enter into production of COVID-19 vaccines;
- Make use of the conventionally used march-in rights available to ICMR to direct Bharat Biotech to share know-how with PSUs and SOEs to allow them to leverage the joint IP provisions for the acceleration of production of vaccines for domestic use by the Central and state governments;
- Direct and mobilise the SII owners to share the IP and rights to know-how or to initiate joint ventures in collaboration with the interested public and private sector entities for the use in local production of vaccines;
- Ask the state governments to take steps to ensure funding by issuing the advance purchase commitments to the JVs in making to accelerate the production of vaccines.
Dinesh Abrol is Former Chief Scientist, CSIR-NISTADS; Professor, Institute for Studies in Industrial Development; coordinator, South Asia Studies Hub & Knowledge Network, Transdisciplinary Research Network for Sustainability Studies, Jawaharlal Nehru University; and co-convenor of People First. Thomas Francois is Former General Secretary, All India Bank Officers Confederation (AIBOC) and co-convenor, People First.