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Panel asks govt to revive existing vaccine units & examine possibility of technology transfer of Covaxin
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Gireesh Babu, New Delhi
September 17 , 2022
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Lamenting that the public sector vaccine units were not reckoned to service in times of crisis during the Covid-19 pandemic and the negligible contribution of these institutions to the vaccine production, the Department-Related Parliamentary Standing Committee for ministry of health and family welfare has recommended to the Ministry to revive the existing units and examine possibility of technology transfer of Covaxin to public sector units.
The Committee, in its 137th report on ‘Vaccine Development, Distribution Management and Mitigation of Pandemic Covid-19’, also urged the Government to continue making efforts for waiver of IP Protection for Covid vaccines and other Covid-19 diagnostics and therapeutics so that the vaccines are produced on a large scale and 100% vaccination of the world population is achieved.
The Committee lamented that the public sector vaccine units were not reckoned to service in times of crisis and their contribution to the Covid-19 vaccine production remained negligible in the fight against the pandemic Covid-19.
The Committee observed that in 2008, the vaccine production in Central Research Institute, Pasteur Institute of India and the BCG Vaccine Laboratory (BCGVL), Chennai were halted for non-compliance with Good Manufacturing Practices (GMP). Although the licenses were restored in 2010; however these vaccine units continued to remain under utilised.
“The Committee strongly believes that revival of these units is imperative to bridge the gap between vaccine demand and supply and to make vaccines more affordable and accessible,” it said. It further noted that the Madras High Court in May 2021 had asked the Central Government as to what steps were being taken to revive the existing Vaccine Institutes owned by the Government. The Supreme Court in December, 2021 had also sought the response of the Central Government on its policy to revamp public sector vaccine manufacturing units.
“The Committee, accordingly, strongly recommends the ministry of health and family welfare to revive the existing vaccine manufacturing units and issue production licences to the GMP compliant vaccine manufacturing units,” it added.
It demanded that the Committee would like to be apprised of the total number of Public Sector Vaccines Units that are owned by the Central Government and the State Governments. It must also be informed about the financial status and the annual budget that has been allocated to these public sector manufacturing units over the past four years.
The Committee recommended the Ministry to monitor the revival of these units and henceforth, furnish quarterly Reports to the Committee. The Committee desires that the ministry of health and family welfare must forward the revival plan along with financial requirement to the ministry of finance for approval at the earliest, added the report.
While India has been advocating the waiver of intellectual property rights of Covid vaccines at the global level, “however, the Committee is perplexed to note that the government has taken no major initiative to waive the intellectual property rights for the indigenous vaccine Covaxin which was developed in collaboration with ICMR. The Committee strongly recommends to examine the possibility of technology transfer of Covaxin to the public sector units and start its production in these Units,” it averred.
It further observed that had the Ministry implemented the comprehensive guidelines for undertaking biosafety and biosecurity measures under the National Disaster Management Guidelines, Management of Biological Disasters and addressed the gap that was highlighted in the Report, the country would have been better prepared to tackle the pandemic. If the government would have implemented the National Vaccine Policy, 2011 in letter and spirit, it would have helped to deal the issues of vaccine-security, management, regulatory guidelines, vaccine research & development and product development in a better manner.
It recommended the Ministry to assess the functional status of National Disaster Management Guidelines, 2008 and National Vaccine Policy, 2011 and apprise the Committee of the initiatives being taken for implementation of these policies at the ground level to achieve the set objectives in these guidelines/policy.
Observing the importance of vaccination in fighting the Covid-19 pandemic, it strongly recommended the Government to continue with National Covid-19 control Plan through massive vaccination drive so as to mitigate the causation factor of mutating variants of Covid-19.
The Committee recommended the Ministry to focus not only on the vaccine supply side barrier but also on the demand side barriers so that vaccination targets are achieved. The Committee also recommends the Ministry to take necessary measures to increase the uptake of precautionary doses so that the mortality rate is lowered given the rise in fresh infections. It also cautioned the Government against mutating variants of Covid-19 and strongly recommends to have the vigil for total elimination of virus through resilient mitigation policy and effective mass vaccination Programme.
It also suggested back log entry option or off line mode of entry to be permitted in data entry of vaccination, considering the geographical challenges, so that the extent of actual vaccination coverage can be observed and any possible gap for vaccination is abridged.
Considering that there is a looming fear of future resurgence and more virulent viruses persists and global eradication of the Covid is crucial for halting this pandemic, the Committee suggested that transfer of technology and waiver will significantly bridge the large demand supply gap as the vaccines will be produced without authorization from the patent holder. This could also help in ensuring vaccine equity. However, it opined that the move to waive Intellectual Property Protections (IPP) must not disincentivise the pharmaceutical companies to invest on vaccine research rather the industry and the countries across the world must unite and work together to expand the global vaccine manufacturing capacity.
“The Committee accordingly urges the Government to continue making efforts for waiver of IP Protection for Covid vaccines and other Covid-19 diagnostics and therapeutics so that the vaccines are produced on a large scale and 100% vaccination of the world population is achieved,” it added.
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