Industry experts outline how Prime Minister Narendra Modi’s dream of ‘Make in India’ for the biomanufacturing sector can be fulfilled in the stipulated time frame By Akanki Sharma
As the year 2020 began, Prime Minister Narendra Modi came up with good news for the biotechnology sector. Speaking at the inauguration of the 107th session of the Indian Science Congress at University of Agricultural Sciences in Bengaluru last month, Modi said, “We aim to develop India as a world-class $100-billion biomanufacturing hub by 2024.”
“The growth story of India depends on its achievements in the science and technology sector. There is a need to revolutionise the landscape of Indian science, technology and innovation. My motto for the young scientists burgeoning in this country has been -innovate, patent, produce and prosper. These four steps will lead our country towards faster development. If we innovate, we will patent and that, in turn, will make our production smoother and when we take these products to the people of our country, they will prosper. Innovation for the people and by the people is the direction of our ‘New India’,” he added.
While the biotechnology sector is one of the key drivers for contributing to India’s $5 -trillion economy target by 2024, the Indian biotechnology sector is poised to grow exponentially over the next decade. Further, the country is among the top-12 destinations for biotechnology in the world, with approximately three per cent share in the global biotechnology industry.
The biotech sector can be broadly divided into five major segments — biopharma (which accounts for around 55 per cent of the revenue of the total sector), bio-agri (22 per cent of market share), bioservices, bioindustrial and bioinformatics. According to Invest India, the National Investment Promotion and Facilitation Agency, the Indian biotechnology industry was valued at $51-billion in 2018 and is growing at almost 15 per cent year-on-year.
Potential that the biotechnology sector holds
Our country is currently ranked at 52nd on the Global Innovation Index (GII) 2019, with a jump of five places since last year, and 29 places in the past five years, informed Dr Renu Swarup, Secretary, Department of Biotechnology (DBT), Government of India (GoI). She also said that India has an immense potential to emerge as a global key player. “It is an important and exciting time for the industry. The challenges are as great as the opportunities. As we are moving forward, we are on the cusp of breakthroughs in medical innovations that will benefit patients as well as the societies for decades to come. The advancements through various innovations not only have vast implications for people and society, but these also help reshape the different sectors of the world economy. Innovations have come a long way in addressing challenges across varied sectors like agriculture, healthcare, pharmaceuticals energy, etc. The vibrant ecosystem offered to the innovators has been very helpful in addressing major societal problems and it also gives us the confidence that our innovators will be noticed globally,” she said.
According to her, policy initiatives of the GoI such as Make in India, Skill India, Start-up India programmes are aimed to develop India as a world-class biotechnology and bio-manufacturing hub. She highlighted, “It is because of all these contributing factors that India today is a favoured partner for all global biotechnology collaborations. The government’s aspirational goal of developing the country into a $100-billion biomanufacturing hub by 2024 is certainly going to give a fillip to the biotechnology sector as well. For this, we have set up an ambitious target of $150 billion, and the current growth rate and the enabling ecosystem has given us the confidence to achieve this.”
Biotechnology is a multi-faceted domain encompassing applications in agriculture, pharmaceuticals, scientific discoveries, etc. It has the potential to create innovative solutions to current challenges and healthcare problems. In this regard, Dr Swarup mentioned, “We at DBT are committed to creating an ecosystem for innovative and indigenous product development, which is globally competitive and involves participation from researchers, academia, start-ups, small and medium-sized enterprises and industry. Each of our schemes at DBT and its public sector unit Biotechnology Industry Research and Assistance Council (BIRAC) is uniquely designed and caters to a specific need-based application to support innovation and product development. These schemes, along with our partnerships like Grand Challenges India and national programmes like the National Biopharma Mission and ‘Make in India’ would be instrumental in achieving this goal. We have already been proactively working in this direction of achieving this goal,” she further said.
Echoing the same sentiments as that of Dr Swarup, Dr Rajesh Jain, Managing Director, Panacea Biotec and Chairman, CII National Committee on Biotechnology, said that biotech has been recognised as the sunrise sector among 14 champion sectors under ‘Make in India’ programme which has the potential to contribute to the $5-trillion economy goal of India. He emphasised, “Biotechnology occupies a strategic position in the socio-economic advancement and development of the nation and the world at large. Biotech is an answer to various current and future challenges not only for India but the entire world. It has an impact on health and food security, along with environmental sustainability. Its socio-economic impact extends across demographics and the entire spectrum accrues its benefits. Our former Prime Minister Atal Bihari Vajpayee used to say that while information technology stands for ‘India Today,’ biotechnology stands for ‘Bharat Tomorrow’.”
Sharing his views on Prime Minister’s goal of making India a $100-billion biomanufacturing hub by 2024, Dr Jain said, “Considering that manufacturing in biopharma sector is capital intensive, such investments have been suboptimal in India due to limited access of capital, inadequate infrastructure and complex and ever-evolving regulatory framework. Biomanufacturing hubs under the flagship initiative of ‘Make in India’ are an answer to many of the challenges, and will enable world-class facilities to boost development and manufacturing of innovative products in various streams of biopharmaceuticals including vaccines, medical devices, biosimilars, etc.”
Dr Jain further opined that biotechnology is a high-people and high-value industry. “A higher percentage of people employed in the biotech sector will have a ripple effect that increases per-capita incomes and gives a sustainable boost to the entire Indian economy. Integrated hubs will also facilitate Foreign Direct Investments (FDIs), build the confidence of investors, enable technology maturation at a faster pace, enhance Indian export potential for quality products, boost in-house capacity towards import substitution, and nurture and support innovations to generate more IP for India,” he stressed.
To help chart a robust and favourable policy framework for encouraging improved research, innovations, manufacturing and regulatory ecosystem so as to promote and position India as the hub for innovation and manufacturing in biotechnology, CII National Committee on Biotechnology has been very active.
In this context, Dr Jain said, “Higher innovation will mean increased costs and we need a more predictable system of governance and managing stakeholder returns while keeping affordability in mind. As a society, we have to find newer ways to address these systems. We acknowledge the government’s need for lower costs but we also have to emphasise quality, reduce risk of reliance on a single supplier, reward innovation and enter into long-term supply agreements which ensure that companies can plan ahead while being assured of some market share – to keep the lights on.”
According to him, some of the opportunities to enhance growth and innovation within the biotechnology sector in India are: government policies to attract global talent; government investment in new areas, eg. new vaccines for human and veterinary use, biosimilars, new medical device manufacturing in India; enforcement of IP; faster regulatory approvals; transparent and consistent drug approval process; expert committees to have global expertise; infrastructure for conducting clinical trials in India; adequate reward for innovation; private sector investment to substitute imports; and monitoring demand and capacity building, amid others.
Gaurav Kaushik, Managing Director and CEO, Meteoric Biopharmaceuticals, said that $100-billion biomanufacturing hub by 2024, beyond bringing the benefits to the nation, in terms of employment and income, will be doing the world a great service as biotech products are garnered from completely natural and biological sources – namely plants, animals and microbes, and tend to deliver higher efficacy, with almost no side effects. When asked about his company’s plans to contribute towards this goal, Kaushik responded, “In the past 14 years of our existence, we have offered a bouquet of over 100 products, and have a strong and innovative presence in the specialised biological, biopharmaceutical and biotechnology products segments. We are exploring many healthcare and nutritional fronts through our enzymes and probiotics portfolio. We are currently exporting our products to over 28 countries across the globe — the USA, Japan, Brazil, the UK, Germany, South Korea, Japan and Canada, to name a few, and look forward to expanding our footprint in other parts of the world too.”
Encouraging factors for the making
The growth story of India depends a lot on its achievements in the field of science and technology and there is no dearth of talent. Biotechnology serves mankind in helping to move towards a biotechnology-led economy, transforming as many lives as possible, creating opportunities and promising development for all. “One of the major encouraging factors is the growth of the biotech sector and the number of new production and technology which instil in us the confidence of developing India as a world-class $100-billion biomanufacturing hub by 2024,” stated Dr Swarup. She, in addition, said, “Support from the government in terms of funding, policies and various schemes and programmes have fuelled the innovation drive and is helping in creating a conducive environment to solve some of the biggest challenges faced by India. The high demand for biotech products across the world has opened up scope for the foreign companies to set up their base in India. In fact, several foreign companies are joining hands with Indian counterparts due to the tremendous potential they see in the biotech sector. The biopharma and the MedTech sector have seen a strong growth which should now be scaled.”
With startups being one of the major contributors to the growth of almost every industry today, the biopharma sector is also not untouched of these. “Today, we are one of the fastest-growing startup innovation hubs in the world. Our innovators and startups are our strength and it is their growth trajectory that encourages us, even more, to be confident about realising our dream of a $100 billion bio-economy. With over 2,500 startups in the country, a sizeable contribution is expected from them in achieving our goals as a nation. A lot of young innovators and entrepreneurs in the biotech space are inclined towards nation building by providing innovative solutions to unmet needs in the public health sector. We continue to facilitate and encourage innovations that leave an imprint on the international biotech space. I also urge the innovators/startups to assume greater responsibility in nation-building and carve the success stories for us as a nation by achieving the goal of 2024.”
Expressing slightly different views from Dr Swarup, Dr Jain said that being a high-risk business having a long gestation period, biopharma sector requires scale-up fund and marketing support from the government for generating success stories in the sector to build confidence amongst investors on India. “The industry has proposed needed reforms in current biodiversity and IP Act to boost the culture of innovations in the country through collaborative research. Such reforms will be encouraging for the industry to contribute to the $5 trillion target on a fast track mode,” he said.
There are several factors that can come together to achieve the Prime Minister’s goal. Kaushik said, “The government has already undertaken various initiatives to encourage innovative research, human resource development and an entrepreneurial ecosystem within the biotech space. Beyond announcing some facilitating policy initiatives under the ‘Make in India’ mission and various broader campaigns in the infrastructure and agriculture sector which will impact the biotech sector favourably, India is also one of the first countries to have a department dedicated to biotechnology. The DBT has also set up BIRAC that has been conceived to strengthen and empower emerging biotechnology enterprises to undertake strategic research and innovation. At the same time, the industry is striving to innovate and make a mark in this field too.”
For any industrial hub, choosing a location is a mandatory and daunting task. On this point, Dr Swarup’s say was, “We are committed to cover all parts of the country in terms of establishing clusters and regional centres, so that the target audience in the adjoining areas can reach out and avail the facilities at these centres. We currently have about 45 bioincubators pan-India that function either as a stand-alone entity or as a part of the academia in order to connect and enable interactions for efficient exchange of knowledge as well as facilitate technical and business mentorship. The location of the hubs will depend on critical factors like research and technology development competence, market, industry policies, infrastructure, investments, etc.”
While Dr Swarup put emphasis on covering all parts of the country, Dr Jain felt that selection of locations will consider establishing new hubs in locations like Karnataka, Telangana, Maharashtra, Punjab and Himachal Pradesh, where various stakeholders like academia, research, industry, entrepreneurs, investors and regulators are already present, while also not ignoring those locations where few of these stakeholders are missing and require such facilitation to build on existing capabilities.
Kaushik also suggested the names of some states. “A number of states like Gujarat, Andhra Pradesh, Himachal Pradesh, Assam, Telangana and Rajasthan are actively attracting investments into the biotech sector through various initiatives like setting up pharma and biotech parks and offering other incentives. A hub could be created within these states or in others that evince fresh interest and offer a facilitating environment for biotech companies,” he mentioned.
Interpreting the achievability of the goal
As the Prime Minister aims to achieve the making of this biomanufacturing hub in the next four years, the industry people seem to be prepared to put in all their efforts and make this possible. “We are committed to achieving this target and are confident about achieving the same in the stipulated time frame. The government’s will and policy framework have helped create an environment of trust and mutual understanding for all stakeholders to move ahead with one unanimous goal of achieving this target. We have moved from working in silos to working as a team to achieve this goal which is practically the only way ahead to build new partnerships, establish long-term collaborations and identify investment opportunities as well. DBT and BIRAC have, over the last few years, demonstrated the ability to achieve this. We have today a strong and vibrant industry-academia partnership, a translational ecosystem and a start-up and entrepreneurial base of over 2,500,” notified Dr Swarup.
Sharing that Indians are known to give their best when they work in an emergency situation, which is definitely challenging but not impossible, Dr Jain informed, “Indian biosimilar industry carries the most approved number of biosimilars in the world. This sector represents a vibrant ecosystem comprising innovative products and innovation pipeline with over 2,700 start-ups, 600 plus core companies, 200 plus biotech and research training institutions.” He
further said, “Present government policies have strengthened the institutional mechanisms for empowering innovation and ensuring scale up and sustainability. India understood the value of this sector long back and is the only one that established a dedicated department nearly three decades back to develop an ecosystem supporting innovation, investments, scientific and quality manufacturing skills. Following several years of strategic planning and actions, the Indian biotechnology sector has achieved a unique position.”
According to research by Global Market Insights Inc., the global biotechnology market is set to cross $775 billion by 2024. This indicates the immense potential of the segment. India is the third largest biotech destination in the Asia Pacific Region and among the top 12 destinations for biotechnology in the world. Although it’s approximate share in the global biotechnology industry was just around three to five per cent at $51-billion in 2018, it is growing at almost 15 per cent year-on-year. If it continues to grow at this rate, it can expect to cross the $100 billion mark by 2024.