INDIA’S HIGH QUALITY VACCINES ARE BUILDING ITS ROBUST NEXUS GLOBALLY
India’s vaccine production is scaling new heights as the country has emerged as one of the prominent players in this sector. The recent WHO report suggests that this sector is likely to hit US $871 million mark by the end of 2017, which is more than double of 2011’s figures (US $350 million). As per the Global Business Intelligence (GBI) Research, the Indian vaccine sector will grow at a rate of 20 per cent annually for the next four years. New research into cancer vaccines and fears of bioterrorism and severe acute respiratory syndrome (SARS) are sparking the rise in production.
The current vaccine market in India is not only self-sufficient but due to its high niche vaccine producing quality it has outrun number of prominent international players globally. This industry began as a network of state owned manufacturers, supplying basic childhood vaccines to the national immunisation programme. The current scenario states that India is emerging as a lifeline for various regions where vaccines are not funded by the United Nations or charitable organisations. Currently, Indian vaccines exports have scaled 65 per cent as compared to last year.
India’s vaccine market experienced a growth spurt from 2005 to 2011 as big pharma companies posted massive profits. Glaxo Smith Kline ($GSK), Merck ($MRK), Sanofi ($SNY) and Pfizer ($PFE) all have skin in the game when it comes to investing in the second most populous country in the world. But GBI expects more growth opportunities for the production and sale of vaccines from emerging economies such as China.
Government of India has kept a close watch on this sector over the years and this has acted like a catalyst to raise the bars among the vaccine manufacturers. From 2005-2011, government put all the vaccine manufacturers under a strict scanner and their each and every move was closely monitored. As a result, three vaccine-producing units Central Research Institute, the Bacillus Calmette-Guerin Vaccine Laboratory and the Pasteur Institute of India were sealed since these firms were found non-compliance with Good Manufacturing Practices (GMP). Apart from that, in April 2011, India’s Ministry of Health and Family Welfare (MOHFW) launched a National Vaccine Policy (NVP) that focused on the future significance of the vaccine industry.
“In the coming four years, the Indian vaccine market is expected to grow significantly, doubling from approximately €500 million to €1 billion by 2020. Immunisation provides one of the most powerful, simple, and cost effective health interventions. Millions of lives are saved thanks to vaccination. The Indian government has taken tremendous efforts in the area of immunisation in the last few years. The government is committed to continue with its efforts with the introduction of four new vaccines in the Universal immunisation programme of India by 2019. At the same time, the government has given a boost to ‘Make in India’, allowing new vaccines to be developed and produced in the country. Lastly, the regulatory process, for the approval of innovative vaccines in India, has improved and allows a faster reach of these innovations to the population. These three factors will generate important growth in the coming years,” quoted Pierre Baylet, Country Head, Sanofi Pasteur India, Sri Lanka and Nepal.
These supporting steps by the government have allured many private players to step into this sector. Involvement of private players in the vaccine business has changed the entire landscape of this business. Their
biggest success factor is similar to the approach that has been followed by Indian generic pharmaceutical manufacturers. This model involved concerted efforts to develop vaccines for not only tropical neglected diseases, but also cheaper alternatives of vaccines that are already available in the West.
Elaborating on India’s current vaccine market, Dr Kishore Kumar, Chairman and Neonatologist, Cloudnine Group of Hospitals said, “Being one the leading players in pharmaceutical sector, India’s vaccine market is one of the most important epitomes of public health not just in India but globally. One of the most successful health interventions i.e. production of vaccines, India has experienced impressive improvements in its economic status and population health during the past two decades.”
“India undeniably remains the vaccine epicenter of the world, being home to highly successful vaccine giants who have not only helped India attain domestic self-sufficiency in vaccines for the public market, but also helped the country emerge as a global vaccine manufacturing hub,” he added.
According to the recent report ‘Global Human Vaccine Market 2016-2020’ by Technavio research company, headquartered in London, the global human vaccines market is expected to grow at a CAGR of 11.69 per cent during 2016-2020. It is interesting to note that vaccine manufacturers from all over the world have been involved with governments regarding supply and demand of vaccines in India, and developing nations are increasingly demanding vaccines and regulatory approvals, Dr Kumar said.
Shedding some light on the tough competition with China, Pierre Baylet opined, “There is indeed a threat from China to the Indian export industry. I believe that Indian producers still have an edge at least for the next five years or so. To continue to sustain the position, Indian manufacturers will need to expand their portfolio of vaccines, innovate, bring new generation of vaccines to the table, and maintain the highest quality standards.”
“I also believe that the adolescent and adult immunisation in India is not at the level where it should be. When talking about vaccination in India, most people think about children. There is an urgent need to boost adult immunisation in India. We saw the need last year during the outbreak of influenza. Often vaccine preventable diseases are transmitted to children through parents, family or caretakers. A good example is pertussis. Getting the adults, closer to children, vaccinated is crucial. The industry, the media and the government need to further boost their efforts in this direction,” Baylet elaborates
Echoing the same voice, Dr. Kumar opined, “India has the potential to make varieties of vaccines, but research is at its very nascent stage and the quality of the vaccines we produce is very good – getting approval from Bill & Melinda Gates Foundation and various other reputable organisations. We have to ‘invest’ more in research to keep the pace going. China is catching up and they are producing vaccines similar to the global vaccines but the world currently is skeptical of Chinese vaccines to a certain extent as it is something you administer to your body, people are not entirely satisfied with Chinese vaccines at this stage.”
Dr. Akshay Kapoor, Consultant Paediatric Gastroenterologist, Hepatologist and Liver Transplant Physician, Indraprastha Apollo Hospital feels that underestimating China can turn the table around, he said, “China has been growing rapidly in the vaccine space, especially after getting WHO approval for its vaccines in 2010. It is emerging as a major vaccine powerhouse. Coupled
with its low cost of production it is emerging as a major player challenging India. China has a better penetration of its national vaccination policy as compared to India. Majority of the vaccines being manufactured by local players means that the cost of production is low. India suffers from a poor vaccination coverage policy. Moreover, Indian manufacturers can’t sell vaccines in the Chinese market, while the reverse is true.”
Despite its recent growth, however, the Indian vaccine industry still has a number of challenges to address. The market remains small (currently accounts for less than 2 per cent of the global market) and underpenetrated compared to the developed countries. The country also lags behind its global peers in terms of vaccine coverage with a significant number of lives lost due to vaccine preventable deaths.
India lacks a robust system to track vaccine-preventable diseases. Vaccination coverage varies considerably from state to state, with the lowest rates in India’s large central states. Differences in uptake are geographical, regional, rural-urban, poor-rich and gender-related. On average, girls receive fewer immunisations than boys and higher birth order infants have lower vaccination coverage. Huge population with relatively high growth rate, geographical diversity and hard to reach population, lack of awareness regarding vaccination, inadequate supervision and monitoring, lack of micro-planning and general lack of inter-sectoral coordination are largely responsible.
“India has experienced impressive improvements in its economic status and population health during the past two decades. However, it lags other countries of similar per capita gross domestic product in child survival. The mortality rate for children age five and younger currently stands at sixty-six per thousand live births, compared to thirty-four per thousand live births in the Philippines, a country with roughly the same per capita gross domestic product. Between 1990 and 2001, the probability of dying before age five fell more than twice as rapidly in Bangladesh and Indonesia as it did in India.”
Although child survival rates have improved since 2001, India failed to achieve its own goal of reducing the number of infant deaths by half before 2012. And at the current rate of decline, it will not meet the goal that was set in the United Nations’ Millennium Declaration of cutting the mortality rate for children under age five by two-thirds between 1990 and 2017.
As per the WHO report, there are twenty-seven million new births in India each year, the largest birth cohort in the world. However, fewer than 44 per cent of these children receive the full schedule of immunisations. This level is only slightly better than it was in 1998, when the proportion was 42 per cent. In contrast, in Bangladesh, on the northeast border of India, 82 per cent of children are fully immunised by age two. In adjacent Nepal, 80 per cent of children are fully immunised by age one. The 9.6 million unimmunised children in India today account for more than one-third of the 27 million unimmunised children around the world.
Although the current immunisation programme targets twenty-seven million infants and pregnant women every year and is one of the largest immunisation programmes in the world, immunisation rates through the national programme are uneven across twenty-eight states in India. The proportion of children under age five who are vaccinated exceeds 70 per cent in only eleven states; it drops below 53 per cent in eight states that are also the most populous.
Clearing the air about the mortality rate due to lack of availability of vaccine, Baylet commented, “There is misunderstanding among the people that high mortality is due to lack of availability of vaccine but because of lack of effective immunisation. In order to reduce morbidity and mortality, there is a need to have more vaccines that have already been proven to be safe and efficacious in many other countries, to be approved for use in In- dia. Take Sanofi Pasteur’s dengue vaccine for instance, a culmination of over two decades of scientific innovation and collaboration, as well as 25 clinical studies in 15 countries, involving 40,000 volunteers, around the world. The vaccine, which is recommended by the WHO in highly dengue-endemic countries as part of comprehensive dengue management and prevention efforts, is proven to be effective against all four serotypes of the disease. Since its launch, based on its safety and efficacy results, the dengue vaccine has been approved for use in 13 countries across the world. The need for dengue prevention in India is urgent, and the Indian population at risk for this debilitating disease, for which there is no cure or treatment, deserves to have a choice to be protected against the disease with a well-tested vaccine proven effective against dengue.”
She further quoted, “Thus, there is a need to simplify the regulatory approval process and the import rules. Secondly, we need to find a sustainable model so as to guarantee that vaccines are accessible to everyone, but at the same time we need to ensure some returns for the manufacturers to be able to (a) re-invest in R&D (b) provide more volumes of vaccines (c) offer new vaccines against current or emerging threats.”
Indian Immunologicals Ltd. representative said, “Immunisation is one of the most cost-effective public health interventions and largely responsible for reduction of under-5 mortality rate. However, vaccine preventable diseases (VPDs) are still responsible for over five lakh deaths annually in India. This underlines the need of further improvement. Today, India is a leading producer and exporter of vaccines, still the country is home to one-third of the world’s unimmunised children.”
India is emerging as prominent vaccine manufacturer globally and this target has been achieved because of the joint efforts of the government and the private vaccine manufacturers. In the coming years, Indian vaccine market will further spread its wings to penetrate deeper into the global market. Though it is facing a tough competition with China, but the experts feel that still India has the upper hand. Now, the main challenge for the country is to further overhaul its domestic immunisation process as there is a big scope of improvement there. If the country manages to tighten up these loose screws then it is on the verge of becoming the ‘World Vaccine Manufacturing Hub’.