How Indian Biotech Is Driving Innovation

INDIAN BIOTECHNOLOGY SPOTLIGHT DHIRAJ SINGH/BLOOMBERG VIA GETTY IMAGES VIA GETTY DHIRAJ SINGH/BLOOMBERG

Crop researchers at an institute near Hyderabad, India, are using biotechnology to boost yields of pigeon-pea plants, a food crop and important protein source. How Indian biotech is driving innovation Bolstered by government support, a wealth of investment and an eager graduate workforce,the country’s biotechnology industry is booming.

BY BIANCA NOGRADY

nu Acharya was in her twenties when Mapmygenome, also in Hyderabad — to By the end of 2016, there were more than the human genome was first mapped bring the personalized-medicine revolution 1,000 biotechnology start-ups in India, and in its entirety. In 2000, the young to India’s diverse population. more than half of these had been established AIndian entrepreneur was just breaking into “Because, ultimately, when you’re making within the previous 5 years. Australia, by con- the biotechnology arena with her first start-up medicine precise, it has to be for specific indi- trast, has 470 biotechnology companies and — the genomics and bioinformatics company viduals and populations rather than based on the United Kingdom 3,835. The biotechnology Ocimum Biosolutions in Hyderabad. She saw one population that has been studied.” industry in India was valued at US$11 billion the Human Genome Project’s achievements Acharya is among India’s rapidly growing in 2016, and is forecast to grow to $100 billion as opening up a new world of possibilities in ranks of biotechnology entrepreneurs and by 2025. personalized medicine, informed by an indi- start-ups that are riding a wave of government More than half of the biotechnology vidual’s genetic profile and predispositions — enthusiasm, free-flowing venture capital and start-ups are in the medical arena — diag- but at the time, the field of genomic medicine growing demand from an increasingly wealthy nostics, drugs and medical devices — but was dominated by Western science. population that wants better treatment options. 14% are in agricultural biotechnology, 3% in “I wanted to make sure that India had its These factors are helping to drive India’s bioindustry, 1% in bioinformatics and 18% in own voice heard in that,” Acharya says. So, a biotechnology industry beyond its historical biotechnology services. decade later, she launched her second biotech focus on unbranded generic drugs and into Biocon in Bangalore is one of them. Now start-up — molecular-diagnostics company the innovation limelight. valued at more than $1 billion, it started

SPOTLIGHT INDIAN BIOTECHNOLOGY

in 1978 as an enzyme manufacturer, but is now making a name for itself in the research and development of biological drugs for treat- ing diabetes, cancer and autoimmune diseases. By March 2018, its revenue had topped $650 million. India has long been a global player in the manufacture of generics (unbranded versions of existing pharmaceutical products), account- ing for 20% of global exports of generics and A banana farm in Jammu, northern India. A earning just over $17 billion from that market research programme used biotechnology to in 2017. So what has prompted the nation to develop trees that would grow in the region. move beyond such a lucrative comfort zone and into the more risky game of biotechnology innovation? to “stimulate, foster and enhance the strategic Washington, on the Grand Challenges India research and innovation capabilities of the initiative to tackle global health and GOVERNMENT SUPPORT Indian biotech industry, particularly start-ups development problems. In 1986, with the encouragement of then- and SMEs”. “I always call my Grand Challenges pro- prime minister Rajiv Gandhi, India became “The idea of forming BIRAC was to sup- gramme ‘in India, for India and beyond’,” says one of the first countries in the world to have port the innovation ecosystem in India, and Mukherjee. “So we will do it in India, we will a government unit dedicated solely to bio- to nurture innovators from academia and validate it in India, we will use it India, our technology. The Department of Biotechnol- industry to work independently or together,” citizens will use it, and then if it goes beyond ogy started with a relatively modest budget says Shirshendu Mukherjee, mission director India we are happy to do that.” of between 40 million and 60 million rupees of the Program Management Unit at BIRAC. ($557,000–835,000), growing exponentially Mukherjee says India has always excelled at CONSUMER DEMAND to 24.1 billion rupees in 2018. In addition basic research but has faced challenges in A similar motivation is driving at least some to establishing 17 Centres of Excellence in translating that into commercial outcomes. of the scientists and entrepreneurs such as Biotechnology at institutes and universities BIRAC’s mission is therefore to “take innova- Acharya, who get into the biotech space

around the country, the department has sup- tion from the bench to the bedside, from the because they feel that Western biotechnol- VIA ZUMA WIRE/SHUTTERSTOCK PRESS THAKUR/PACIFIC SHILPA ported the creation of 8 biotechnology parks, lab to the field, from the desk to the market”, ogy isn’t necessarily addressing the needs or incubators, in cities such as Lucknow, Ban- he says. of the Indian population. One example is galore, Hyderabad, Chennai and Kerala. In just six years of existence, BIRAC has Vivek Wadhwa, a technology entrepreneur at The aim of these parks is to provide facili- Harvard Law School in Cambridge, Massachu- ties for scientists and small to medium-sized setts, and at Carnegie Mellon University’s Col- enterprises (SMEs), where they can develop “A LOT OF lege of Engineering at Silicon Valley, California, and demonstrate their technologies and even who has invested in Indian medical-diagnostics build pilot plants. The hope is that this will EARLY-STAGE START- company HealthCube in New Delhi. speed up the commercialization process. The “I did a big study on the pharmaceutical park staff also provide mentorship and guid- UPS ARE GETTING industry in India, and I concluded that West- ance on issues such as intellectual property, ern companies were not addressing Indian business plans, proposals for clinical develop- FUNDED disease because it wasn’t profitable enough for ment and exit strategies. BUT I THINK THE them,” Wadhwa says. This support is helping to address some of But as the cost of technologies such as the logistical challenges that have hampered CHALLENGE genome sequencing and medical sensors industry in the past, says Tej Singh, a bio- comes down, Wadhwa says, it has now become physicist at the All India Institute of Medical IS STILL THE LATE viable for Indian biotechnologists to harness Sciences in New Delhi and president of the STAGE.” these advances for the Indian market. Biotech Research Society, India. And what a market India is for these inno- “They created some sort of industrial vations. The country’s population is 1.36 bil- regions in many areas, but there were issues supported 316 start-ups, which have gener- lion and rising, and health care is one of India’s like electricity, water [supply]; all these small ated $125 million through 122 products and fastest-growing sectors, driven by higher things used to take time,” Singh says. “But technologies, including a cattle-feed supple- incomes and an increasing prevalence of life- the government has addressed these things ment, a new process to manufacture human style diseases, such as heart disease and stroke. nowadays; this current government particu- albumin and immunoglobulin, microfluidics- By 2022, the health-care market in India is larly is very proactive.” based diagnostics and a rapid test for malaria. expected to be worth $372 billion. The Department of Biotechnology has also Its initiatives include ‘biotechnology igni- “People are finally realizing that the supported biotechnology research infrastruc- tion grants’ of up to 5 million rupees for consumer, or the patient, actually has control ture, including a high-resolution mass spec- start-ups and entrepreneurs to take a proof- over their own health,” says Acharya. The trometry facility in Mumbai, flow-cytometry, of-concept through to the first major step on rising middle class wants better health and imaging and microarray facilities in Delhi, and the path to commercialization. Another is a medical choices, and she says that’s one of the animal-house facilities in five other regions. ‘glue grants’ scheme, which connects clinical- main drivers for investment in biotechnology The jewel in the departmental crown, and science departments with those for basic sci- research and development. the scheme that attracts the most attention, is ence in institutes and universities in the hope For example, Biocon has developed the first the Biotechnology Industry Research Assis- that this will encourage partnerships and col- recombinant insulin to be produced in India, tance Council (BIRAC). This is a not-for- laborations. and an antibody-based treatment for head and profit, public-sector enterprise that was set up BIRAC has also joined forces with the neck cancer. In 2017, Indian vaccine manu- by the Department of Biotechnology in 2012 Bill & Melinda Gates Foundation in Seattle, facturer Bharat Biotech in Hyderabad began

INDIAN BIOTECHNOLOGY SPOTLIGHT

need to be connected to the medical practice and they can be solving great problems.” Singh notes that these graduates aren’t waiting for a job to walk up and tap them on the shoulder; they’re taking matters into their own hands. “Graduate students who come out in large numbers from Indian institutes of technol- INTERVIEWS ogy and institutes of management are not look- ing for jobs so much; they create small start-ups and then they grow very fast,” Singh says. RECRUITMENT Working in biotechnology in India does present its own unique set of challenges, says NEWS Acharya. “Some operational things that you never have to think about in the United States the first clinical trials of its vaccine against the you have to plan more in India, because a lot OPINION mosquito-borne virus chikungunya, which of times we are still importing the reagents and re-emerged in India in 2006 after 32 years and things like that.” INTERACT infected more than 1.4 million people. Another major driver of the biotechnology RED TAPE boom in India is the accessibility of funding, Although the government of India is CAREERS from both government and private industry. enthusiastic about supporting the biotech- In one 2016 report on biotechnology, India nology industry, Acharya says the regulatory Q&A ranked only 49th out of 54 countries. But it process for getting products approved could be scored particularly highly on the availability more streamlined. of venture capital compared to countries such In agricultural biotechnology, the govern- ADVICE as the United Kingdom, Australia and Canada ment’s Genetic Engineering Appraisal Com- (see go.nature.com/2rrpuks). mittee has been working to make it easier for COMMENT Acharya says that some of the investors who companies to get approval for genetically mod- have made their fortunes in manufacturing ified crop field trials from state governments. generic pharmaceuticals are now investing The drug approvals process in India has hit UPDATES in biotechnology. She says much of the capi- some rough patches in recent years, and the tal investment in early-stage biotechnology authors of a 2017 World Health Organiza- TIPS is coming from India, whereas investment tion report suggested that innovation there in medical devices is flowing from Japan, could be outpacing regulation (see go.nature. China and the United States. But late-stage com/2pkysow). Even the government’s own blogs.nature.com/naturejobs investment is still an issue. National Biotechnology Development Strat- “A lot of early-stage start-ups are getting egy for 2015–20 acknowledges that timelines funded but I think the challenge is still the late and regulatory steps for biotechnology drug stage,” she says. “It’s not just the first two to approvals are not user-friendly. It has pro- three years; it’s more how do you take it from posed reforms, including the establishment start-up to scale-up? I think that’s the challenge of regulatory departments that are fluent in in terms of getting to where we need to get in good practice in the clinical, manufacturing terms of biotechnology.” and laboratory arenas. There are also concerns about the HUMAN RESOURCES environmental impact of India’s pharmaceu- One thing India has plenty of is people. Recog- tical industry. An investigation in 2016 found nizing that human capital can be a key resource “unprecedented” levels of pharmaceutical for a nation not as well endowed financially pollution in the water system of Hyderabad as Western countries such as the United States (C. Lübbert et al. Infection 45, 479–491; 2017), or United Kingdom, the Department of Bio- which is home to a significant proportion of technology implemented or supported various biotech start-ups and generics manufacturers. training initiatives. These include the Biotech However, as the US Food and Drug Adminis- Industrial Training Programme, set up in 1993 tration reportedly steps up inspections of over- for recent graduates, and 12 Biotech Finish- seas pharmaceutical suppliers, environmental ing Schools in Karnataka state to train Indian standards could be forced to improve. graduates and researchers in biotechnology. Despite the challenges, there is palpable That programme “created a very large excitement about what lies ahead. “Right now, number of institutions or departments of we are seeing the beginnings of a revolution in biotechnology in institutions and also depart- biotechnology in India,” Wadhwa says. ments of bioinformatics”, says Singh. For Acharya is still fired with the same enthu- example, in September, the state of Gujarat siasm that propelled her into biotechnology proposed India’s first university focused nearly two decades ago. “Any innovation in entirely on biotechnology. this space can actually impact lives,” she says. “A decade or so ago, India didn’t have the “That’s why I continue to be in it.” ■ engineers or scientists it does today — it’s been graduating them in droves,” says Wadhwa. “It Bianca Nogrady is a science writer in Sydney, A53746 has millions of technologists who now just Australia.

CORRECTION The Spotlight ‘How Indian biotech is driving innovation’ (Nature 564, S53–S55; 2019) article erred in its description of Biocon as a ‘unicorn’ start-up.