Albert Einstein defined insanity as doing the same thing over and over again and expecting different results. I would extrapolate a bit: it is also possible to do the same thing differently - we call this innovation.
Richa Dubey
Vaccines are an interesting case study of India's growing experience and role in affordable product innovation. They are also hugely important to the world because we have the means to carry them to every child: rich or poor, rural or urban. They prevent disease - an important consideration - because treatment in remote locations is difficult.
In terms of achievements, the vaccine industry has not lacked for laurels. In fact, right from the basic science required in the initial stage of research up to affordable, bulk manufacture of high-quality products, the Indian vaccine industry has established a firm hold over the entire chain of vaccine development.
Indian vaccines are known for world-class manufacturing and have been stamped with one of the surest seals of quality in any health product: the WHO "pre-qualified" tag for production. India has also emerged as a key bulk vaccine manufacturer in recent times and already produces 60% of the world's vaccines. Viewed another way, one in every 3 doses of vaccines used in the world are produced in India. Indian firms are big suppliers to the UN agencies, accounting for between 60% and 80% of the vaccines it buys every year. Besides mass-manufacture of vaccines, we have also been successful in creating or modifying a whole new range of vaccines indigenously.
Vaccine development is an arduous and lengthy process, however, speedy development has been a hallmark of the new vaccine industry in India, where both: response to a crisis (as in response to Japanese Encephalitis and H1N1 flu - with the latter taking just a couple of years to develop) as well as regular development of vaccines have been speeded up to the extent that a matter of a decade or so has been compressed into a few years. The H1N1 flu vaccine in fact, just took a couple of years to develop.
India's growing capacity in this field also augurs well for the fulfilment of the needs of the developing world. This capacity has been acknowledged by UNICEF through the very fact of India being its major supplier of vaccines. We are today preparing to take on the larger mantle of scientific development to fulfil the health needs of the developing world. In accordance with Gandhiji's commandment to practice science with humanism, we must now learn to deliver vaccines to the 24 million children born every year in India and to millions born in other developing countries. India already produces 60% of the world's vaccines.
This is evident from the rapid development and commercialisation of several influenza vaccines as a response to influenza pandemic, new combination vaccines and development of low cost Meningococcal B Vaccine for Africa, by our researchers and industry. India is a destination for affordable products for the entire developing world now. The key drivers of the emergence of India as a vaccine hub are a large pool of scientific talent, relatively lower costs in manufacturing, research and development capacity, availability of GMP requirements on par with all international standards, lower costs of clinical trials and a high potential for contract services by vaccine manufacturers.
The current Indian vaccine market is estimated to be around $900 million (in 2011). It is poised to grow at the rate of 23% during 2011-2012 and by 10-13% CAGR over the next five years registering revenues and around $2 billion in 2011-2012, $4.6 billion by 2017. With a number of important vaccines in the pipeline, the market is expected to explode globally in future with vaccines expected to grow faster than any other therapy area at around 13% during 2009-12.
India has been building capacity in the area of human resources by investments in science and education - both qualitative and quantitative. The figures speak for themselves. In 1981, more than 95% of Thomson Reuters-indexed papers from India named authors exclusively at India-based institutions. By 2007, however, the percentage of such papers had fallen to 80%, indicating that the nation is gradually participating more in internationally collaborative research. Further, between 1985 and 2007, publications co-authored by scientists in India have more than doubled in volume-and those papers were in general more heavily cited than in previous years. Not only has the volume of India's scientific output risen, so has its quality. In fact, a recent media report indicated that placement of India's top universities on the H-index, which measures citation impact, has gone up significantly in the past two years. Better funding has certainly helped. A recent report indicates that the only significant percentage increase in spending on Science and Engineering Research and development between 1996 and 2007 has come from the Asia Pacific region, led by India, China and other developing countries. The prime driver for this has been increased capacity for research.
Additionally, there have been a number of scientists who have returned to our shores or are in the process of doing so, thanks in no small part to government efforts like the Ramalingaswami Fellowships announced by the Department of Biotechnology which are 5-year fellowships for re-entries.
However, while the base may come from the focus on education and retaining our best brains, it is true that vaccinology is a specialised science and without a focus on infectious diseases, it is not possible to build a robust talent pool or infrastructure. Developed countries which have largely eradicated infectious diseases are understandably less interested in focussing on them, and prefer to focus on chronic diseases. India by virtue of its unique position as an emerging economy with the disease burden of a developing country needs to tackle the problem of infectious diseases internally. We have managed to focus on our own solutions to our problems with a high level of success, particularly in terms of developing the scientific community in this regard. It is no exaggeration to say that some of the best brains in the infectious disease space come from India today.
Brains and talent, crucial as they are, cannot deliver outside of a nurturing and enabling environment. There are several elements this environment, not least of which is funding. Vaccine development is a risky venture, particularly in terms of financing it. We are dealing with the fear of the unknown and the ever-present risk of failure. Few private companies want to take that kind of risk without assured success. This is where the balance between the public and private sector comes into play. The government undertakes the high-risk funding role and guides the private sector, which in turn, builds and utilises capacity for product development. The Indian private companies in the vaccine field have been remarkably open to innovation and it is this combination that has contributed largely to our success in vaccine development.
In the case of vaccines, we require political will and public funding; prioritisation of public health; a robust regulatory system; a strong private sector focus on public goods; public-private partnerships and social venture capital; capacity to innovate and deliver at scale; participation of all stakeholders; and the strengthening of systems through product introduction.
Disclaimer: The writer is a freelance journalist and the views expressed by the author in this feature are entirely her own and do not necessarily reflect the views of PIB or AABC.
