The government is planning to frame a national vaccine policy to streamline production of vaccines and to ensure self-sufficiency in the sector. Establishment of a regulatory authority and boosting research and development in vaccines would also form part of this initiative.

In the run up to this goal, the government has already held a brainstorming session to deliberate on a draft policy with the help of Indian Council for Medical Research and experts in the field and the participants have endorsed the call for a comprehensive policy in this regard. The aim of the policy is to prevent mortality and morbidity due to diseases that afflict large populations, especially children through the development and/or use of safe, effective and affordable vaccines, chosen rationally and produced sustainably and cost-effectively.

"The purpose is to achieve national self-sufficiency in vaccine production and 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. It also aims restore the pre-eminence of indigenous public sector capabilities in all aspects of vaccine development, production and immunization for national health security and biosecurity," the draft said.

The policy also seeks to promote ethical conduct in the development, trials, adoption and administration of vaccines, especially aimed at children and pregnant women, besides harmonising all other relevant policies.

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 universal immunisation programme (TT, DT, DTP, BCG, Polio, Measles) must be exclusively reserved for the public sector for their indigenous production. Further, the presence of at least two functional PSUs per vaccine (as a backup for each other) must be developed, it says.

The suspended vaccine PSUs under the ministry of health must be urgently revived and modernized to fill the demand-supply gaps in all essential vaccines, including the UIP vaccines. Various vaccine PSUs are currently under different managerial regimes - state and central governments, and even within the central govt., under health ministry, DBT and NDDB. In order to enhance functional coordination between them to meet the national vaccine needs, their governing bodies should be expanded to include public health experts, epidemiologists, microbiologists immunologists, vaccine policy experts, pharmacologists, economists, sociologists and other interdisciplinary experts and NGOs, according to the draft.

The current set-up should be restructured into a central vaccine regulatory authority that allows wider representation to indigenous scientists, policy experts and indigenous public sector and civil society. Apart from invited membership, provision should also be made for voluntary participation of representatives from any non-commercial organization. This authority would be empowered to take all major decisions such as monitoring disease burden, vaccine development, adoption, production, procurement, distribution, immunization and follow-up, the draft says.