The Union Health Ministry has finalised a national vaccine policy to strengthen the institutional framework, processes, evidence base and framework required for decision making for strengthening the universal immunisation programme.
The policy, based on the recommendations of the National Technical Advisory Group on Immunisation (NTAGI), also seeks to streamline the decision-making process on new and underutilised vaccine introduction, besides addressing issues of vaccine security, management, regulatory guidelines, vaccine research and development, and product development, it is learnt.
The policy document has specifically called for taking into consideration various factors like disease burden, safety and efficacy, affordability and financial sustainability, cold chain capacity, domestic and external production capacity, cost effectiveness of the programme and the alternatives other than vaccination while introducing new vaccines in the Universal Immunisation Programme.
“A National Vaccine Policy with specific relevance to local vaccine needs is required to guide decision-making and develop a long-term plan to strengthen the whole vaccine programme and not just a component. It intends to provide broader policy guidelines and framework to guide the creation of evidence base to justify need for Research and Development (R&D), production, procurement, quality assessment of vaccines for UIP,” according to the policy document.
It also suggests creation of a fund for challenges in vaccine research aimed at disease burden specific vaccines, flexible governance and granting systems to ensure that additional science funding, cooperate granting system, rapid decision-making to allow building alliances and partnerships, both national and global, and for support to agencies for diffusion of the technologies into the social systems, and workable mechanisms.
“There is a need to develop mechanisms, where speedy regulatory clearances are possible including flexibilities in the import of biological materials needed for such development. The mechanisms need to be evolved where the risk of the manufacturers is cushioned by appropriate assistance from the Government. It should be mandatory for the Government to support such developments with Advance Market Commitments and honour the commitments,” the policy says.
“The current regulatory guidelines followed by the NRA for vaccines are dated and essentially designed for the drugs. There is an urgent need to develop vaccine specific guidelines. Laboratory testing for vaccine consistency is a critical component of vaccine quality. A system of accreditation of laboratories through a set of internationally accepted parameters should be in place. The institutions like the National Institute of Biologicals (NIB) need to be adequately strengthened to take on the laboratory testing of new generation of vaccines. India should develop pre qualification standards that are in alignment with WHO-UNICEF standards. Single window system should be in place to prevent any unnecessary delays in regulatory clearances,” it says.
“Since vaccines are administered to healthy people, especially children, it is pivotal to ascertain they are safe and cost effective. Consequently vaccine development has become time and resource intensive, with more stringent regulatory pathways to ensure safety and efficacy of vaccines. In a situation where there is abundance of new and expensive vaccines on one hand and limitations of resources on the other, it becomes imperative that use of vaccines through induction in the Universal Immunization Programme (UIP) as well as in the free market is done through a framework of decision-making that confers positive health and economic benefits to the society,” according to the policy document.