The expert panel on the pentavalent or five-in-one vaccine, which was also given the mandate by the Union Health Ministry to go into the issue of vaccine production potential for new combination vaccines, has recommended to the government to encourage public sector investments in combination vaccines to ensure affordability and vaccine security for the masses in the country.

The panel, headed by professor MK Bhan, secretary, department of biotechnology (DBT), in its recommendation to the Union Health Ministry said, "Encourage public sector investment in combination vaccines (Quadrivalent + Hib separately; or pentavalent) to ensure affordability and vaccine security for the masses. It is necessary to ensure quality of vaccines. Among existing vaccines, for DPT and Hep B, it is relatively easy to monitor good quality, because antibody is a good marker of protection. For other vaccines, government may consider commissioning specific institutes with expertise to standardize given vaccine.

"One way to ensure sufficient quality in public sector is to standardize pilot lot production and transfer to a public sector company. Suitable institutional framework should be developed. The minimum standard for vaccine quality should be WHO pre-qualification and a potentially effective strategy is to develop an approved generic technology and then license it out to different public sector companies," the panel in its report said.

Dr VM Katoch, secretary (DHR) & director general, ICMR had constituted a core committee on vaccines under the chairmanship of professor MK Bhan, to examine the recommendations of expert group meetings on MMR and measles vaccine; Hep B and Hib vaccines; JE vaccine and on vaccine production capacity to address specific questions the secretary (Health) had posed and make recommendations to the union health ministry on these vaccines and vaccine production potential for new vaccines. Two meetings, first on January 27 and second April 26, 2010, were held at ICMR headquarters in this regard.

The panel discussed the issue whether country's laboratories can produce DPT+ Hep B vaccine and JE vaccine as then these vaccines would be available from them at cheaper rate.

The panel noted that as of December 2009, no public sector vaccine manufacturing units were producing (DPT+Hep B) combination vaccine in India. CRI, Kasauli which would have an installed capacity of 40 million doses of DPT, can procure and blend it with Hep B and bottle it for use in India. Pasteur Institute, Coonoor can make upto 40 million dose of DPT, there is a proposal to produce Hep B also in future.

In private sector Biological E (produces individual and Combination DPT - 80m; and Hep.B 20 m); Panacea (produces DPT+Hep.B and is WHO pre-qualified); Bharat Biotech (combo DPT+ Hep B) 20 md/year; and Shanta Biotechnics (comb DPT+Hep.B) produce the DPT + Hep B vaccines

The panel also noted that in the public sector, CRI Kasauli used to produce 5 lakh doses of mouse brain derived JE vaccine (not used any more as given in three doses), Pasteur Institute Coonoor can also produce, training of staff has been completed. BIBCOL can also produce but does not have infrastructure.

In the private sector, Panacea working with Indian strain provided by NII, proposed time line of 18 months, installed capacity of 20 md /yr (in vero cell); Biological E - SA-14-14-w derived JE vaccine, capacity 20md/yr; Bharat Biotech working with Indian strain provided by NIV, awaiting DCGI approval for clinical trials, 50 million doses of vero cell vaccine.

The panel had recently recommended to the government to introduce combination vaccines in the national immunisation programme.