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Article Title: India Races to Be a Global Vaccines Hub
Slowly, but steadily the Indian pharma and biotech companies are carving a niche for themselves. Not just that, they are now becoming an important destination to source vaccines worldwide too. In the ensuing pages, Ch. Srinivas Rao analyses the Indian Vaccines potential with inputs from Narayan Kulkarni and Nandita Singh ( CyberMedia News Service) At a recent Indo-US symposium on infectious disease research
and development held in Bangalore, NK Ganguly, director general, Indian Council
of Medical Research (ICMR), remarked: "Not many are aware that the US is There is ample proof of reality in the statements. For instance, the Pune-based Serum Institute of the Poonawalla Group has developed the aerosol measles vaccine under a World Health Organisation (WHO) project for the Indian and overseas markets. Ganguly informed that the aerosol vaccine will be released in the market by 2006 after completion of clinical trials and formulation of a new delivery system in order to be cheaper than existing products. Consider another example, the International Vaccine Institute and ICMR have set up special facilities in Mumbai and other cities to undertake cholera vaccine trials. Also there are efforts to develop a new typhoid vaccine for India’s armed forces, DNA rabies vaccines are under development by several companies like Indian Immunologicals and Bharat Biotech. There have been partnerships among several leading institutes and pharmaceutical firms to develop new anti-malaria drugs and recombinant drugs for HIV/AIDS victims. THE REASON: There is every reason for India to become the vaccines hub of the world asserted all the people that BioSpectrum spoke to. Growing demand, shrinking base of vaccine manufacturers in the developed countries, cost pressures, etc. have given India and other developing nations the opportunity to fill the gap. A recent Business Week report pointed out that incentive-stifling price controls, liability fears and greener pastures elsewhere have prompted a massive flight of big drug companies out of vaccines. The number of players have shrunk from 26 in 1967 to eight in 1996 and finally to four big players today. As big pharma companies are pulling out of the low-margin vaccine business, upstart outfits are exploiting new technologies to tap niche markets.
"In view of price rationalisation and low manufacturing costs, many global firms have ceased producing vaccines though the threat of emerging and re-emerging diseases continue to haunt several countries," Ganguly noted. He pointed out that the number of major vaccine producing countries in the world had shrunk from 36 to six due to various factors, including globalization. This decline in the share of vaccine production by developed countries had led to the rapid growth of the Indian vaccine industry over the past decade. The secretary-designate of the Department of Biotechnology(DBT) Dr Maharaj Krishan Bhan too is very optimistic about India’s prospects in the vaccine market place. Dr Bhan himself is a pioneering scientist who is developing vaccines against rotavirus and diarrhea. "It is good for us that we come under the bulk vaccines manufacturing countries. India and China are two leading countries in vaccines development. We hope that we will continue to do well in this area and improve our pace of growth," he asserted. Let’s see another point. Business Week reported that biotech’s babies are doing well by doing good. It referred, "Biotechs like Chiron have greeted the larger player’s disinterest with glee. The California-based biotech garners more than 33 percent of total revenues from vaccines, pulling in about $400 million over the first three quarters of 2003." Clearly, the trend indicates that biotech process vaccines can be brought quickly into the market as well as be more effective. Probably, this could be the reason why Indian players are succeeding too. Indian companies have successfully developed recombinant hepatitis-B vaccines. That too at affordable prices. This success has paved the way for India to become a major ‘center of excellence’ for clinical trials of new vaccines, drug discovery and production of new medicines. What facilitates all this? "The availability of abundant natural and human resources, ongoing research and development in multi-disciplinary subjects and application of information and communication technologies are leading to the discovery of new vaccines," Ganguly asserted. Productive partnerships Another significant factor for success has been the growing collaboration between academic and research institutes in public and private domains. For example Bharat Biotech partners with some of the leading institutions like Centers for Disease Control, Atlanta, USA, National Institutes of Health, Washington DC, USA, Institute of Genomics and Integrative Biology, New Delhi, and National Institute of Virology, Pune, among others. Similarly others like Shantha Biotechnics, Panacea Biotech, Indian Immunologicals are collaborating with reputed institutes to fasten the pace of product developments. Not just these. The partnerships are also extending to tap niche areas of opportunity. For example under the Indo-US partnership, ICMR has begun to work with the US Army Medical Research and Material Command to exchange information and data on the dengue vaccine being developed by the latter in Thailand. Besides ICMR, the National Institute of Health, Centre for Non-Infectious Disease Control and National Science Foundation are joining hands to expand Indo-US cooperation in medical research. Recently, US Congressman Frank Pallone, the co-founder of the Congressional Caucus on India, and Indian MP Kapil Sibal, co-chairperson of the Indo-US Parliamentary Forum, announced a joint initiative to build support for increased funding for HIV/AIDS and the development of legislations and policies. The initiative would support the International AIDS Vaccine Initiative (IAVI). Such alliances between biotechs and the big pharmaceuticals are now fairly common in vaccines, a trend that is likely to continue for some time. Big Pharma is increasingly willing to look outside its own R&D departments for new vaccine products and technology, but that hasn’t always been the case. India’s share "Many developed countries are no longer interested in producing vaccines for various infectious and communicable diseases as their production has become uneconomical due to drastic reduction in prices and less access to markets in the developing countries. India along with other developing countries such as Indonesia, Cuba, Brazil supplies 60 per cent of UNICEF’s global requirement for EPI vaccines. This is a remarkable achievement. We (India) are now self-sufficient for DTP group of vaccines (DTP, DT, TT)," informed Dr Krishna Ella, CMD, Bharat Biotech, Hyderabad.
Dr S D Ravetkar, senior director, Serum Institute of India added, "We have to consider two factors, one is value and another one the volume. In Europe and the US, the value for vaccines will be more because of the currency variations. But as India exports over 60 percent of its vaccines to developing countries, the value will be less but in terms of volume it will more. India is presently exporting vaccines for newborn babies across the globe. But Indian companies are developing vaccines for other sector too i.e., for teenagers and elderly persons. I feel to enter European market Indian companies have to go through exhaustive clinical trials under stringent norms and international standards. The companies are working towards that. Indian companies can achieve a milestone in three-four years and enhance the value from the vaccines they produce."
Staying on top Prof. Phillip K Russellin in his paper on "Development of Vaccines to Meet Public Health Needs: Incentives and Obstacles", observed that the vaccine industry is changing drastically. The vaccine technology too is changing, creating a push from the bottom up to produce new products. The companies are working rapidly with new combinations where they can. Technological changes and market changes are driving the companies into larger and larger aggregates, and there are predictions of maybe one or two very large vaccine companies emerging in the future. The above fact is probably setting the precedent for this happening.
"The innovations brought about by these changes are setting the trend for vaccine manufacturing in developing countries such as India. Today, countries such as Brazil, China, Indonesia and Vietnam largely produce their own DTP. The immediate concern is to standardize our manufacturing capabilities. The international issues of the management of intellectual property rights and technology transfer assume greater importance in this context," advised Dr Ella. The earlier outside view was that India is capable of making only conventional vaccines using older technologies unencumbered by intellectual property and that it has no capability to develop new products and are dependent on technology transfers from large MNCs. So coming to vaccine manufacturing in India, innovation is the key. Companies like Serum, Bharat, Wockhardt, and Shantha are already demonstrating their capabilities. "The only way for India to emerge as a vaccine hub is by developing a strong R&D to produce newer vaccines under GMP/GLP standards," Dr S D Ravetkar. Of course, there are other concerns too. "The first and the foremost step is to initiate regulatory reforms. The need of the hour is to have a multidisciplinary expert panel to evaluate and approve the manufacture of vaccines. What we need is a focussed approach and speedy approval under a single window," said Dr Ella. "The important concern is trained manpower. For getting approval for a new vaccine we have to go through many committees. It is taking valuable and precious time." "Government controlled agencies should become more competitive. They have to enhance their skills and strengthen their trained manpower. Companies in the western world are not only looking at the facilities at the manufacturing companies but also the monitoring agencies. Hence I feel the monitoring agencies should strengthen their competitiveness to meet the global standards," Dr Ella suggested. Combination Vaccines There is a growing demand for combination vaccines. R&D efforts are also on for developing "effective" vaccine for tuberculosis. In India, efforts are on to develop Meningococcal and Neurococcal vaccines. There are focussed efforts to develop vaccines for Japanese Encephalitis, Rotavirus and Malaria too. Globally, the new areas would be development of Helicobactar vaccines (vaccines for stomach ulcers) and Dengue viruses. Combinational vaccines like DPT, DT, MMR, Hepatitis B, and BCG too are growing globally. "The Indian companies are already working on these vaccines. They will take time to come out with vaccines," added Varaprasad Reddy, MD, Shantha Biotechnics. Elaborating further S Swaminathan, VP, finance, Biological E, said "There is a great demand for DPT and TT in the global market and with pharma majors moving on to the more lucrative areas of drugs and drug delivery mechanism the opportunity in the basic vaccines lies wide open too. But the entry barrier is strong." However, that should not be the issue for companies like BE. "We have been in existence since 1953, long before the word biotechnology came to acquire the connotations of its present potential. The company has been associated with the National Immunization Programme for the last 30 years supplying DPT and TT. So taking this strength to the world market is not so difficult for someone already supplying quality product in vaccines in the domestic market," reasoned S Swaminathan. Given the shortfall of DPT and TT one need not worry about the demand at all—it will be there." There are, however, no clear-cut numbers available on the market size. Said Dr Ravetkar, "The local vaccine market is estimated at Rs 400 crore. It is very difficult to estimate the size of export market. This is mainly because of currency variations in different countries. However, I feel that Indian companies are exporting vaccines to the tune of Rs 2,000 crore. Reddy feels "The vaccine market in India is valued at approximately $150 million." The BioSpectrum-ABLE survey in September 2003 study shows that the vaccines market in 2002-03 accounted for 57 percent of the total biopharma segment, with total sales of Rs 725 crore. According to the projected sales of the companies, this segment is expected to register 27 percent growth in the current year. Interestingly, exports have been a major contributor. The reason was several vaccines were procured by WHO. The initial costs of vaccine manufacturing are still high. But indigenous manufacturing holds the key. "When Bharat said it would manufacture Hepatitis - B vaccine in 1995 for less than a dollar nobody believed us. But we have gone on to prove that this could be done. So long term planning is really the key," observed Dr Ella. And the estimated cost, investment on development of Vaccines? For developing a vaccine from concept to commercialization stage it requires at least Rs 40-50 crore is what the experts feel. In view of price rationalization and low manufacturing costs, many global firms have ceased producing vaccines though the threat of emerging and re-emerging diseases continue to haunt several countries the world over. The reduction in the share of vaccine production by developed countries had spurred the growth of Indian vaccine industry. Manufacturers here understand that affordability is a major concern. This has led to production of cheaper vaccines. Yet, accessibility to vaccine is still a huge concern in India. Unless, the capabilities are enhanced to address this concern, vaccine for every human being would remain a dream. Added Reddy, "Shantha’s entry into market with its Hepatitis B vaccine (SHANVAC-B) brought down the prices of imported vaccine from Rs 780 to Rs 50 in 1997 and to Rs 25 in 2003. The pharmaceutical industry as a whole has focused on outsourcing manufacturing during the past decade. There is a financial imperative to reduce capital infrastructure costs and focus on core competencies. However, despite this macro industry trend, key vaccine players have not yet shown such a dramatic shift towards outsourcing. According to Datamonitor analysts, the US felt the effects of a shortfall in vaccine production capacity and manufacturing difficulties experienced by industry players. Shortfalls in pediatric vaccine supplies arose, in part, because of the limited number of companies with the manufacturing capability to produce essential components of childhood vaccination programs. Increased scrutiny regarding good manufacturing practice (GMP) has also led to regulatory problems and further shortfalls in supply while lack of spare capacity has prevented unforeseen demand being met. But companies like Wyeth Lederle are beginning to outsource. Bharat Biotech has a contract to manufacture a vaccine, HibTITER for Wyeth Lederle. This trend could also open up new opportunities for the Indian companies. Further with UNICEF aiming to ensure global vaccine and vitamin A supplies. "We are extraordinarily concerned about the future of vaccine supply. UNICEF meets around 40 per cent of the global demand for children’s vaccines. We have already had several temporary vaccine shortages and it seems to be becoming a global problem," said UNICEF deputy director, supply division, Stephen Jarrett. In fact it is the biggest procurer vaccines. In 2002, UNICEF procured over two billion doses of vaccine for nearly 100 developing countries to protect children against a handful of killer diseases, including polio, measles, tetanus, diphtheria, pertussis (whooping cough) and tuberculosis. UNICEF is a major supplier of vaccines for the campaigns to eradicate polio, eliminate maternal and neonatal tetanus and to control measles. UNICEF is taking several steps to ensure the reliability of vaccine supply. It is trying to enter into more guaranteed procurement with major suppliers so they can plan ahead, confident that UNICEF will buy their vaccines. All these mean India has every reason to capture a significant place in the global vaccines market. "Once clinical trials and certification processes are completed, vaccines for diphtheria, pertussis or whooping cough and tetanus will be shipped out of India to several countries," Ganguly asserted. And if all things go well, India after 3-4 years will be a major global hub for vaccines.
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In
1974, the team at Serum Institute of India had to make design
modifications required for blending vessels for Triple Antigen
(Diphtheria –Tetanus –Pertussis) vaccine and fabricated it
indigenously. It faced many challenges and carried out much experimental
work before the production protocol for DPT vaccine. In 1999, it got
recognized as the largest producer of DPT vaccines in the world. The
other leading vaccine suppliers in the world are GlaxoSmithKline and
Pasteur Labs.
At
Biological E (BE), the director in charge of new projects Mahima Datla
hasn’t got a moment to spare. A restructuring is in progress to
transition BE into a vaccine major. It is coming up with a Rs 95 crore
campus on the outskirts of Hyderabad. Spread over 50 acres, the BE campus
will go operational by the end of 2004 when the trial runs will commence.
The company has a clear plan in place for 2005-2007, when three new
vaccines will roll out from its new facility and BE gets counted as one of
the big players in the world vaccine market.
Haffkine
BioPharmaceutical Corporation Ltd, a Government of Maharashtra
undertaking, was the first in the country to successfully develop
indigenous Oral Polio Vaccine (OPV). It has a glorious past. Medha Gadgil,
managing director, Haffkine BioPharmaceutical, "We have a history of
over 100 years. We have been concentrating on our core strength, i.e., the
Oral Polio Vaccine (OPV). Over 75 percent of our revenue is from this
vaccine. We are the key suppliers of OPV to the Indian Government for its
immunization program. Besides, we are manufacturing anti sera for snake
and scorpion venom, injectables, capsules, oral liquid products,
antiseptics and pharmaceutical drugs through our subsidiary called
Haffkine Ajintha Pharmaceuticals. Our success is mainly due to a
combination of factors like strong government support, support from our
dedicated employees and taking the right step/initiative at the right
time."
Shantha
is a pioneer biotech company in the private sector and is believed to be
the first biotechnology company to develop, produce and market the first
recombinant product in India. "In 1992, not many in India knew about
Hepatitis B and its impact on human health. In fact, most of the medical
fraternity also was not aware of this dreaded disease. At that time, only
three companies globally were producing this vaccine, which was very
costly to import and use. I came to know about this in one of the
international seminars, which I attended by chance. There, the impression
was that India and other neighboring countries only look towards
subsidized vaccines and are not able to include Hepatitis B in their
national immunization schedule. We were looked down upon as a country by
the western society for not being able to take any initiatives either for
developing the vaccine or for importing it. I found this very disturbing
and insulting. When I ventured to do something about it and approached a
western company for technology, further insult occurred. The company
spokesperson felt that neither India has the capacity to pay the high
technology fee nor the scientists have the ability to absorb the
technology. It was then that I took up the challenge knowing fully well
that India has a vast pool of talent," informed Varaprasad Reddy, MD,
Shantha Biotechnics Pvt Ltd.
Bharat
crossed its first milestone in October 1998, by developing and
manufacturing REVAC-B, a vaccine for Hepatitis-B using a Recombinant DNA
technology route. The company claims to have pioneered the manufacture of
the world’s first Cesium Chloride free Hepatitis-B vaccine with the
discovery of HIMAX technology, a novel purification matrix. Over 35
million doses of REVAC-B have been sold so far in India, Africa and Latin
America. Further, its facility for Hepatitis-B is the second largest in
the Asia-Pacific, with a capacity of 100 million doses per annum.