Just a few decades ago, it was quite unimaginable that India could ever produce a vaccine that would be both affordable and globally acceptable at the same time. An indigenous vaccine developed through platforms fully innovated in India was more like a pipe-dream to naysayers.
Proving them wrong, not only did Hyderabad based Bharat Biotech achieve a remarkable feat of US $1 Rotavirus vaccine in 2016, it went on to develop Covaxin, a fully indigenous vaccine against Covid-19 during the the peak of the pandemic in 2021. One of India’s earliest private vaccine manufacturers, Serum Institute of India that steadily expanded its capabilities, started offering a wide range of vaccines post 2001. Be it Shantha Biotech, Biological E, Gennova Biopharma, or Panacea Biotech, all of these names have done their bit in strengthening the sector.
The journey that began from Kasauli in 1904 with the first vaccine research institute to establishment of BCG vaccine factory in 1948, and first indigenous vaccine against polio in 1980, kept getting accelerated with every decade. The development of Hepatitis B vaccine by Bharat Biotech in 1997, indigenous vaccine for JE 2012, Bi-valent oral vaccine for cholera, and Meningitis A vaccine was long before India celebrated its newly found love for the vaccine industry during the Covid-19 pandemic.
It took a lot of incubation and collaboration to create vaccines that are a household name now. At the same time, dedicated national vaccination programs resulted in making India free of smallpox, cholera and polio. Playing a pivotal role has been the Department of Biotechnology (DBT) that has made concerted efforts in the past three decades, towards strengthening vaccine research and development in India. Setting up of both public sector and private sector vaccine manufacturing units, Universal Immunization Program, National Immunization Program, National Vaccine Policy are just a few examples.
“In India, vaccination was adopted by citizens without much resistance compared to several other developing and developed countries. The huge success of the National immunization Program (NIP) created a huge opportunity for Indian vaccine manufacturers. This also got good support from vibrant academic infrastructure, plenty of trained manpower, support from government and global demand for cheap and reliable vaccines, says Dr. Amit Prasad, School of Basic Sciences, IIT Mandi who calls for increased collaboration between industry and academia.
Making strides globally
India has scaled many peaks to carve out a top position in the new vaccine world order. The country now supplies nearly 65% of the world’s demand. As the world’s largest manufacturer of vaccines by volume, Serum Institute of India has now joined the league of globally renowned names such as Pfizer, AstraZeneca, and Moderna. The companies like Bharat Biotech and Zydus Life Sciences are already multiplying their efforts to innovate new vaccines.
The Serum Institute of India partnered with US company Novavax to manufacture their Covid vaccine (NVX-CoV2373) for the US market. India also administered the world’s first DNA vaccine – ZYCOV-D in Patna, which was developed by Ahmedabad-based vaccine manufacturer Zydus Life Sciences. Bharat Biotech has also received permission from the DCGI to start trials of its intranasal booster dose in India.
“During his visit to Zydus Biotech Park in Ahmedabad, Bharat Biotech in Hyderabad and Serum Institute of India in Pune in November, 2020, Prime Minister Narendra Modi underlined that “India considers vaccines as not only vital to good health but also as a global good, and it is India’s duty to assist other countries, including the nations in our neighbourhood, in the collective fight against the virus”.
India has been strongly advocating for the principle of equity in the WHO and has also proposed, along with South Africa, a TRIPS waiver at the WTO for COVID vaccines, diagnostics, and medicines. India is working actively with the Global Alliance for Vaccines and Immunization, World Health Organization and the Access to COVID-19 Tools Accelerator to realize this goal.
The pandemic push
As per the ‘India Bioeconomy Report 2022’, Covid vaccines made in India alone accounted for US$ 8.695 billion of the value of the country’s biotech sector, while other vaccines accounted for $8.672 billion. Vaccine makers Serum Institute of India (SII), Bharat Biotech, Biological E, and Zydus Cadila, among others, have increased their installation capacity by three times since 2020.
The idea of ‘Aatmanirbhar Bharat’ and ‘Made in India’ programs also contributed to motivate and drive the vaccine industry towards vaccine self-sufficiency. During the Covid-19 pandemic, the Indian vaccine industry developed a number of home-grown Covid-19 vaccines and accomplished an incredible task of vaccinating 70% of the population with Indian vaccines.
Most of the industry insiders agree that a lot has changed within the vaccine sector during the Covid-19 pandemic. Compared to the times when approvals would be a tedious task, these were granted at the highest levels . Thanks to its vaccine industry, India’s biotech sector has witnessed a sharp increase in its fortunes. Covid-19 saw a continued growth in research in the biotechnology sector, including development of indigenous vaccines, and continued to attract high investments.
“There has been a marked increase in how much the biotech R&D sector has been innovating in India and the world. Covid-19 saw a continued growth in research in the biotech sector, including development of indigenous vaccines, and continued to attract high investments. The pandemic encouraged a lot of partnerships, be it for developing vaccines, or medical paraphernalia that were needed by everyone during the pandemic,” says Aditya Sharma, Head of Bioprocessing, Merck India.
“The biggest scientific breakthrough in the 21st century would probably have to be the development of the COVID vaccine. COVID-19 was a situation which was not predicted and we as a Leader in the Life Science industry, wanted to support to get through the pandemic. The major challenge we faced was racing against time as these variants were rapidly mutating, were contagious, life threatening and immune evasive,” adds Sharma.
India’s position as a world leader in vaccine manufacturing and development became prominent during the Covid-19 pandemic, when the world witnessed India’s manufacturing capability and capacity. Vaccine development usually is a time consuming multistep process, including regulatory approvals by different government bodies. Due to global emergency, scientific databases, strain sequences and novel research outcomes were made accessible to all, resulting in real time global knowledge sharing never seen before. All the processes were accelerated by unprecedented collaborative efforts among scientists, industry and government bodies.
“Covid provided the opportunity for major expansion of our manufacturing potential and also made us realize our limitations like absence of locally produced raw materials. Hopefully, the lessons learned during the pandemic will shape up a better future ready Indian vaccine industry,” says Dr Amit Prasad.
Maintaining the momentum
Experts feel that maintaining the same kind of momentum in the post-pandemic era will be challenging in the absence of demand for the vaccine. However, the infrastructure created will be useful to manufacture and export vaccines.
“During the pandemic, in a short time the vaccine companies not only came up with vaccine candidates but also enhanced their capabilities to cope up with global demands for vaccines. It was the result of fast tracked approvals by government as well as focused approach by industry and academia. Although it is hard to sustain the same momentum due to obvious reasons, however, now the vaccine industry is primed and ready for any such challenges,” says Prof. Soma Rohatgi, BSBE Dept, IIT Roorkee who is currently working on fungal, viral and bacterial vaccines.
Going forward, promoting and facilitating more industry-academia partnerships with global organizations such as GAVI and Coalition for Epidemic Preparedness Innovations (CEPI) could help in sustaining the momentum. Setting up consortiums between clinical and research institutes will facilitate ease of conducting clinical trials. Expedited regulatory approvals under restricted use in emergency situations concerning public health emergencies would also be beneficial.
The pandemic has pushed the governments across the globe to improve access of healthcare facilities to its citizens. The changes in geopolitical and economic outlook are now driving Indian self-sufficiency agenda and recalibrating the business models of vaccine companies.
While the biggest strength of the Indian vaccine industry remains its quality and affordability, a few challenges include the high cost of storage and transportation, stringent regulations, and drug-development hurdles. It is highly expected from the government to create a centralized mechanism to address the concerns of vaccine players besides special attention to promoting startups in the space.
“Although preventive vaccines are necessary for protection against future pandemics; however in immune-compromised individuals passive transfer of ready-made life-saving antibodies would be helpful. Therefore, more research should be conducted on alternative therapies such as monoclonal antibody-based therapies,” says Prof. Soma Rohatgi who believes that moving towards new vaccine platforms and strengthening the cold chain infrastructure in remote hospitals is the way for the future.
Given the enhanced capabilities across resources, innovative platforms and infrastructure, no doubt India will soon dominate the global vaccine landscape. The focus on neglected tropical diseases like malaria, tuberculosis, and dengue could make our industry much sought after across the globe.