VACCINE AIPSN

 

Towards an expanded involvement of public and private sector in production and R&D to meet India’s vaccine requirements

All India Peoples’ Science network (AIPSN)

 

Statement calling for Newer Strategies for Vaccine Production and R&D

 

With the present Indian population of over 130 crores, the number of vaccines required to impart vaccines would be about 310 crore doses (3.1 billion doses), 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, but India should not give up. Today therefore the ordinary citizens are seeking answer to this question that 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.

 

Presently India has a number of public and private sector units that can make a contribution to the expansion of local production of vaccines. Presently two vaccines namely COVISHIELD of Serum Research Institute (SII), Pune and COVAXIN of Bharat Biotech, Hyderabad are available for supply in India. COVAXIN technology is a home grown technology. Bharat Biotech developed COVAXIN 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. ICMR has been a public funding source for COVAXIN. In the case of COVAXIN, as ICMR is a co-owner of IP, the government can nudge Bharat Biotech to handhold the interested public and private sector units.

 

In the beginning of 2000s, 80% of India’s vaccines for the Universal Immunization 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 units. India has a large number of a few decade old facilities as well as new facilities equipped with appropriate modern infrastructure. The central and state governments should be making full use of all these facilities to expand local production of COVID vaccines.  Presently India has eleven 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. Integrated Vaccine Complex needs just one hundred crores and some handholding to start the local production of COVID vaccines.

 

Almost a similar number of private sector units exist which can also contribute to the local production of COVID vaccines. There are quite a few efficient Indian Private Sector Vaccine Manufacturing units , such as Biological E. Limited, Hyderabad ; Panacea Biotech Malpur, Solan, Himachal Pradesh ( Head Office in Delhi). Procurement of already approved vaccines from abroad by private sector units is also an option. Already, Dr. Rdddy’s Lab has teamed up with Russia to procure the Sputnik –V Vaccines in the country. More such entrepreneurs coming; this would ease the Vaccines availability. Altogether this way there are close to twenty-two units which can be involved in the production of COVID vaccines. Domestic as well as export requirements can be met to the fullest with the expansion of local production with the involvement of these public sector undertakings and private sector units.

 

While now the private sector is itself getting subsidies and advance funding from the government, the public sector is still not getting the required support. Recently only the government grants became available to state owned companies – Indian Immunologicals Ltd. Hyderabad and Bharat Immunologicals and Biologicals Corporation Ltd. (BIBCOL) Bulandhshahar, UP, to manufacture Covaxin under license. Nevertheless it will take nearly a year for them to produce the first batch of Covaxin. Although the central government has acceded to the Maharashtra Chief Minister’s demand for involving the Haffkine Institute, a state PSU, has received a government grant of 81 crores to get started with the manufacturing of Covid-19 vaccine. Haffkine requires technology transfer. SII and Bharat Biotech should be made to handhold these units to pay back their own long standing debt to public sector. India’s private sector is a child of the Indian public sector units.

 

Here are our specific suggestions for the government to bring out a wholesome policy within this month itself to give a boost to the local production of vaccines. These suggestions are as follows:

 1. Revive public sector undertakings and state owned enterprises to ramp up the vaccine production;

2. Reissue the tender for use of IVC facility with clear provisions allowing the state governments, public sector undertakings and state owned enterprises to plug and play with the facility;

3. Issue compulsory licenses to interested parties to allow them to enter into production of COVID 19 vaccines;

4. Make use of the conventionally used march-in- rights available to ICMR to direct Bharat Biotech to  share know-how with the 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;

5. Direct and mobilize the SII owners to share the IP and rights to know-how or to initiate joint ventures (JVs) in collaboration with the interested public and private sector entities for the use in local production of vaccines; 

6. 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 with the objective of ramping up COVID inoculation for the use of vaccines by the state and centre for the population below 45.

7. Research on new vaccine development strategies and development of multiple
vaccines be enabled and encouraged across research laboratories, public sector
and private sector institutions. These scientific efforts need to be encouraged in every possible way. Newer versions of COVAXIN need to be developed by the BHARAT BIOTECH in collaboration with NIV, ICMR in India to increase the efficacy.

 

We the following scientists and academicians endorse the above statement: