India is at the forefront of developing vaccines that are affordable and of high quality. It has the expertise and the infrastructure that provide a promising future for growth and also for the manufacture and sale of vaccines. Several Indian vaccine manufacturers hold the coveted seal of quality manufacturing: the 'WHO pre-qualified' tag.
The main reason behind the country's vaccine success story is innovation and entrepreneurship.Other than manufacturing, India has indigenously researched and developed novel vaccines for various diseases. The government investment and support has also been a major driver in the growth of the Indian vaccine market.
Vaccines are one of the most successful health interventions that bring about significant reductions in infectious diseases and adverse health consequences and improve the quality of life. The maximum number of vaccines are expected to come from emerging economies such as India and China, states the GBI Report.
“It is the sound biopharma capability which has helped India to be recognized as a global destination for vaccines, says Kiran Mazumdar-Shaw, chairperson, Vision Group on Biotechnology and chairman& managing director, Biocon Ltd.
The GBI report points out that by 2016, India will register a turnover of $871 million from vaccines. Around 70 per cent of the total volume produced in India is exported and supplied to transnational organizations such as WHO and UNICEF which in turn distributes over 50 per cent the total vaccine demand for childhood vaccination in over 100 countries.
“India can become a vaccine leader as its already known for its indigenous research and manufacturing capability. When the pharmaceutical sector worldwide does not consider vaccine production as an economically viable project, India is proving to the global market that vaccines will be its next forte,” says Prof. G Padmanabhan, scientist emeritus and former director, Indian Institute of Science, Bengaluru.
“Vaccines will constitute the largest component of the Indian biopharma segment and it will take the country to the next level as a hub for global vaccine development and manufacturing. But the country urgently needs a national vaccine policy that is driven by a inter-ministerial healthcare team to take care of not just funding of vaccine research projects but sets an implementable policy on procurement, based on robust forecasting, says Dr. Satya Dash, former Chief Operating Officer, Association of Biotechnology Led Entrepreneurs (ABLE) in his report on Indian Biotechnology: The Roadmap to the Next Decade and Beyond.
The major vaccine manufacturers globally include Sanofi Aventis, Glaxo SmithKline (GSK), Merck, Novartis, Pfizer, Inovio Pharmaceuticals and Immunovaccine Inc, a clinical stage vaccine company. In India, the big names are Serum Institute, Shanta Biotechnics, a Sanofi company, Bharat Biotech, Haffkine Bio-Pharma Corpn. Ltd. Biological Evans, Indian Institute of Immunologicals, Daichi-Ranbaxy and Cadila Pharmaceuticals.
There are also several government - owned vaccine manufacturers like the Central Research Institute, the Bacillus Calmette-Guerin Vaccine Laboratory and the Pasteur Institute of India. But in 2008, the Union government cancelled the licenses for not adhering to the good manufacturing practices.
Some of the key vaccines developed in India are the rabies, Tetanus Toxoid, Diphtheria, Measles, Mumps, Rubella(MMR), BCG, polio, anthrax, Hepatitis, Typhoid, Meningococcal vaccine and cancer.
It was in April 2011, the government introduced the National Vaccine Policy (NVP), focusing on the future of the vaccine industry. Under this initiative, the government is looking at research and development (R&D) giving priority to manufacturing of vaccines for locally prevalent diseases in India . These include vaccines for major killer diseases like pneumonia and diarrhea, diseases with potential to cause outbreaks like Japanese Encephalitis, dengue, cholera, typhoid and diseases like leishmaniasis etc.
Last month, the World Health Organization (WHO) had endorsed the Central Drugs Standard Control Organization (CDSCO)'s regulatory works and cleared the functional vaccine regulatory system in the country, after a thorough inspection involving experts from eight other countries.
Recently, the governments of India and Australia under the Indo-Australian Biotechnology Fund (IABF), came together to look at the joint research possibilities in vaccines.
Though the pediatric vaccines like the polio, BCG, MMR, were dominating the vaccine market , now there is high demand for adult vaccines. This has lead to a sharp increase in sales in areas of influenza and hepatitis vaccines. The vaccines for cancer are expected to have a phenomenal growth due to increased disease incidence, says Dr. Banu Priya C, former head, clinical research, G7 Synergon Pvt. Ltd.
There are two cervical cancer vaccines from GSK’s and MSD. GSK’s , Cervarix, is known to protect against HPV 16 & 18, which accounts for 70 per cent of the cervical cancers. India's 74,000 patients who succumb to cervical cancer indicates the need to introduce a national cervical cancer vaccination drive, observes, Peter L Stern head, Cancer Research UK Immunology Group, Paterson Institute for Cancer Research, Christie Hospital NHS Trust, Manchester.
MSD India, the combined entity of Merck-Schering Plough has ‘Gardasil’ and the company is in dialogue with the government of India to include cervical cancer vaccine under the universal immunization programme (UIP), informs K G Ananthakrishnan, managing director, MSD India.
Another notable development was the launch of Vaxi-Flu-S, the first Indian indigenous H1N1 swine flu vaccine developed by Cadila Healthcare in 2010. Subsequently, companies like Serum Institute of India and Bharat Biotech also launched their versions of the swine flu vaccine, which helped India emerge as a strong global competitor in the vaccines sector, said Dr. Dash.
Vaccines also play a significant role in reducing infant mortality. The mandatory immunization programmes to prevent diseases are proving to be cost-effective methods to ensure good health on a long- term basis and savings on healthcare expenses, informs Dr. Dash.
Global initiatives through international non-profit organization such as the ‘Decade of Vaccines’ and the collaborative efforts of the Global Vaccine Action Plan (GVAP) by the Bill and Melinda Gates Foundation in 2010, PATH Malaria Vaccine Initiative, International AIDS Vaccine Initiative, Novartis Foundation for Sustainable Development among others are efforts to ensure major growth and development for this sector in the next few years.
With the increase in disposable incomes and the launch of new affordable vaccines by both domestic and international companies, the vaccine market is predicted to grow at a rate of 10-13 per cent in the next five years, said Dr. Dash.