The government has drafted a comprehensive national vaccine policy seeking to bring all kinds of vaccines under the Drugs Price Control Order (DPCO) and aims to enable rational and evidence-based decisions for the development, entry, production, stable supply, pricing, promotion and use of appropriate vaccines on scientific grounds.
The policy also bats for the public sector as the sole producer of key vaccines. "In order to ensure stable and affordable supply of vaccines to the national immunization programme and also to address national health security and biosecurity concerns, all essential vaccines covered under UIP (TT, DT, DTP, BCG, polio, measles) must continue to be produced by the public sector. Further, the presence of at least two functional PSUs per vaccine (as a backup for each other) must be ensured as a protection against market uncertainties," the draft says.
"Pricing of all vaccines should be brought under the Drug Price Control Order (DPCO) and subjected to regulation in accordance with the objectives of this policy. Pricing of vaccines should be done on a transparent basis and agreed principles of reasonable returns on investment, rates of royalty and costing of R&D efforts. There should be no overhead taxes imposed on vaccines such as excise duty, value added tax (VAT), customs duty etc. The difference between maximum retail price (MRP) and the price at which vaccines are supplied to wholesalers, retailers, hospitals or even to doctors will also be minimized to deter monetary incentives for unethical vaccine promotions," according to the final draft.
The policy aims to ensure to everyone in need and to achieve national self-reliance in vaccine R&D as well as to maximize the national benefits of international sharing of indigenous biological diversity of pathogens, hosts and knowledge, to the Indian end-users of vaccines on terms that are fair and just.
"Vaccination should be need-based and all vaccines are deemed non-universal, unless specified otherwise based on scientific evidence. The mere availability of a safe and efficacious or even affordable vaccine cannot be a good enough justification for its widespread use. Vaccines are not consumer goods and should not be given or taken, unless their necessity is proven based on the scientific principles of public health," says the draft, prepared by a host of institutes, bodies associated with vaccines under the aegis of the Indian Council for Medical Research.
Vaccines outside the UIP should not be unethically promoted through direct or surrogate advertising, advocacy by individuals, groups or aid agencies, on their own or funded directly or indirectly by the vaccine industry, it says.
"Publicly funded R&D on vaccine technologies should be made available widely on a non-exclusive basis to promote manufacture of quality vaccines at competitive prices. Research papers emerging out of publicly funded R&D should also be made available freely through an open access policy,'' says the draft.