What the experts say...

BioSpectrum posed queries to industry experts regarding the availability and prospects for wider coverage of Hepatitis B vaccine in the immunization program. And this is what they had to say:

Dr SV Kapre, executive director, Serum Institute of India.
At what best price can companies offer the combo vaccine to the government for its NIP initiative for a win-win situation?
I must first of all tell you that although India is the largest manufacturer of Hep B vaccine, the government does not buy any vaccine for the National Program. Generally if the government desires to buy any new vaccine, it would normally float a tender where it gets a chance to have competitive bids. Declaring any price without the tender would not be appropriate. It suffices to say that the Indian industry has always given a competitive price to all such efforts.

Are the Indian companies equipped to supply the government order for its NIP activities? And what will be the supply and demand scenario as far as the combo vaccine is considered?
For any company to be geared up, there are three issues; First one is setting up of an adequate capacity. This is only possible if one knows the quantity of take; Second is solid epidemiological data, which gives some indication of disease pattern that also guides a manufacturer to take a calculated risk; Third is the national indicator of any move to include any product in the National Immunization Program. In the absence of the above, it is almost impossible to go ahead.

If in your interaction with various agencies, you find that such thoughts are percolating then giving some forecast may be possible. As you are aware, for a vaccine unit to be functional, it takes anywhere from five to seven years. Hence, when you say a win-win situation, it would only be possible if some forward signals are given by the government. A lot depends on the priorities and the product, as in today's world we have to also deal with IPR issues. I would therefore feel the appropriate way would be having some kind of an advance purchase indication that should be a program that would get executed at the appropriate time. If the industry sees that this budgeting and forecast comes into actual practice, it will act as an incentive for it to take up the challenge and be able to really give the best.

The cost outlay for universal immunization with hepatitis B vaccine in India is Rs 500 crore each year. What are your views on this?
I am a little concerned to see a figure of Rs 500 crore. One shot of hepatitis vaccine today costs Rs 15 a dose. The vaccine is being advocated in a combination regimen, which for a birth cohort will cost only Rs 150 crore due to a combination with DPT that is already being used.

The disease once contracted is not mitigated by the vaccine. The vaccine is helpful only in the cases not infected at the time of injection or at the time of birth. The point is, in the numerous child births, it is difficult to wean out only those susceptible and hence a mass immunization becomes a necessity as otherwise on an ethical basis one would be responsible for a pre-ordained punishment to susceptible young one to save money. Even if the cancer percentage is low, it only tells us the numbers that would arise if a population were not immunized. But it cannot tell us which of the subjects would suffer this tragedy. Due to this unknown factor, there is a need to look at the entire population. In other cases this being a sure remedy in case of transfusions, an elected immunization could be done.

Varaprasad Reddy, managing director, Shantha Biotechnics.
When do you think the government of India will implement Hep B vaccination in the National Immunization Program?
It is a well-known fact that it is more than 20 years now since OPV has been implemented in the NIP but still 100 percent immunization has not yet been achieved, This is in spite of regular awareness through media and constant educational programs across the country. Therefore, when Hep B is included in the NIP, it will take at least 40-45 percent more time than that of OPV. This is the assumption of a few state government authorities who implement the immunization programs in the state.

What steps should be taken to ensure proper and timely implementation of Hep B in the National Immunization Program?
As you are aware that at present the Hep B progam is implemented as a pilot project in 33 districts and 15 metropolitan cities. These vaccinations are done at public health centres (PHCs) of selected districts and metros, either on demand or as and when children come for other treatments at the PHCs. We feel that if the government can build awareness through the same media as that for OPV, then there will be a proper implementation to ensure timely completion of the Hep B immunization. However, we cannot expect 100 percent implementation can be achieved, looking at the OPV immunization program.

Nitin Deshmukh, head, private equity, Kotak Mahindra Bank.
At present it is mainly the public sector firms supplying vaccines for six vaccine preventable diseases to the government for the National Immunization Program. The companies in private sector are more active in exports. Are the Indian private vaccine players able to offer the Hep B vaccine or combo vaccine at an affordable price for the National Immunization Program? And how optimistic are you about the success of inclusion of Hep B vaccine in the National Immunization Program?
At present the Indian companies are offering the Hepatitis B and combo vaccine at a reasonably lower price. And these are available like any other commodity. I feel price won't become a hindrance. There are players in this business. They have set up good infrastructure that helps to meet the requirement. The only concern I have is about the willingness of the private players to supply at smaller margin in the bids when the government invites tenders. However, we see that they are already supplying other vaccines to UNICEF/WHO.

Utkarsh Palnitkar, director, life sciences, Ernst & Young.

Why is the industry keen on adding more to list of vaccines?
Whilst the Hepatitis B vaccine is a useful addition to the National Immunization Program, a detailed analysis of validating the stance of the disease is necessary.