India To Be A Biotech Hot Spot

The last 70 years have been transformational for the Indian biotech industry, mirroring the nation’s own rapidly advancing economy and rising global status. We have successfully leveraged recombinant DNA technology to deliver biopharmaceuticals, vaccines, genetically engineered crops and enzymes. In doing so, we have created a notable bio-economy valued at $35 billion. 

We have embraced cutting-edge technologies, built global scale manufacturing capacities, and benchmarked our systems and strategies to global best practices. Currently, India is among the top 12 biotechnology destinations in the world and ranks third in the Asia-Pacific region. While our immediate goal is to build a $100 billion bio-economy in India by 2025, in the next 30 years, India aspires to become a biotechnology hot spot reputed for its high-value, low-cost innovations in bio-therapeutics including personalised and precision medicine, advanced enzyme technologies, GM crops and bioinformatics.  

The success of India’s biotechnology industry can be traced to the pioneering spirit of entrepreneurs who leveraged a nascent technology and India’s cost-effective scientific talent pool to bring affordable innovations to the market. Its evolution over the decades mirrored the country’s growing confidence in life sciences. While the 1980s were the decade of enzymes, the next decade saw vaccines gaining prominence as a business segment. The emergence of genomics research companies in the 2000s was followed by Novel biologics and biosimilars making an impact from 2010 onwards.

I started Biocon as India’s first biotech enterprise in 1978 in a garage in Bengaluru to manufacture industrial enzymes for food and textile industries around the world. The initial years were tough as I encountered market scepticism, funding challenges, infrastructural hurdles, manpower issues and government apathy. I persevered because I believed biotechnology was the technology of the future with the potential to deliver transformational change.

By the mid-1980s, Biocon had evolved as the largest enzymes company of India pursuing an R&D-led biotech business. As few more biotechnology-based companies started coming up, it caught the attention of the government and, in 1986, the Department of Biotechnology (DBT) was established. I was privileged to be invited to be a part of the DBT’s Task Force, which helped articulate the regulatory framework for the industry. Recombinant technologies were at the fulcrum of regulations covering vaccines, genetically modified crops and biopharmaceuticals. 

Biocon’s stock market debut in 2004, as the first biotech company in India to go public, commanded a premium valuation. It led to the development of a biocluster in Bengaluru, attracting a number of large and small biotech companies. These included Strand Genomics, a bioinformatics company; Gangagen, a phage-based antibiotic company; Reametrix, a whole blood-based diagnostics instrumentation company; Syngene, which spearheaded research services; and Bio-IT companies like Genotypic Technology, BigTec and Molecular Connections. The cluster also spurred the growth of ancillary biotech companies. 

The disruptive power of Indian biotechnology innovation grabbed the attention of the world in the late 1990s when companies like Shantha Biotechnics, Bharat Biotech, and Serum Institute started producing and supplying vaccines at a fraction of the cost of western drug makers. Today, ‘1 in 3’ children globally are immunised with a ‘Made in India’ vaccine. 

Having built a strong base of indigenous R&D capabilities and excellent clinical trials and manufacturing infrastructure, the industry started developing biotech-based drugs or biologics. Taking the lead, Biocon introduced India’s indigenously developed recombinant human insulin using a proprietary fermentation technology in 2004 and, along with Wockhardt, was able to break the monopoly of innovators in insulins by offering indigenously manufactured affordable alternatives, thus enhancing access to this life-saving therapy. 

Over the years, Biocon has successfully launched two novel biologics and five biosimilar products aimed at cancer, diabetes and autoimmune diseases, making these advanced therapies available to a large patient population. Today, there are a select few companies such as Dr. Reddy’s Labs, Zydus Cadila, Intas Pharma, Reliance Life Sciences, Lupin, etc., which are active in the area of complex biologics/biosimilars. The biotechnology sector is evolving fast and it promises to transform healthcare, agriculture and environmental management, leading to the dawn of the ‘Biotechnology Age’. 

By 2030, the Indian bio-economy sector is expected to attain a size of $200 billion. I foresee the intelligent use of data to transform global health. India’s highly developed software skills offer a unique Bio-IT opportunity to mine, analyse and interpret data and create algorithms that can match therapies with the diagnosis. There is also considerable excitement over the promise of targeted genome editing technologies like CRISPR CAS9, which can potentially prevent several diseases, including some cancers, and prevent specific genetic anomalies from being passed on to future generations. 

I believe, by 2050, cancer will become manageable through advances in the field of immuno-oncology, which works by stimulating an immune response against malignant tumours, thus replacing the need for chemotherapy and radiotherapy. 

Biotechnology in agriculture and farming has the potential to address numerous challenges associated with food security in India. Just as the commercial cultivation of genetically modified cotton in India, starting 2002, helped convert the country from a net importer to a net exporter of cotton, selective propagation of genes that improve yields and are resistant to pests, flooding and drought, could make food cheaper, more nutritious and abundant. 

Bioremediation techniques, which offer a cheaper alternative to conventional cleaning technologies, can be used to address the impending global crisis in the area of water and energy. Application of technologies like the ones being developed by Sea6 Energy, will help harness the potential of the oceans to provide solutions in energy, agriculture and feed, thus helping restore the ecological balance.

This article originally appeared in September 2, 2017 issue of Business World Magazine.

Science and Technology Shape Economic Future

The new government will have to act swiftly in course correcting the stalled Indian economy. To begin with, they will have to focus on a number of regulatory reforms that will address the ease of doing business, reduce transaction costs and expedite approval timelines. The lack of rules and guidelines in taxation and business matters have deterred investment and introduced delays in project approvals. These measures alone can add a per cent or two to GDP growth through increased FDI and project implementation.
The new government will also have to bring greater investment into healthcare and education.  Private sector must have a role in these sectors. Other areas include power and natural resources, especially water. We are in urgent need of management of perennial sources of water where there is a staggering loss.

 A sector of strategic importance is science & technology.  We must step up investment in this area. Innovation is key to value-added growth. We have barely leveraged technology to address a number of grand challenges the country faces starting with e-governance. Aadhar has been sub-optimal in its application. This is a powerful platform that should have served as the basis for e-governance and e-healthcare, but unfortunately this has not happened. The next government has the opportunity to build on the 600 million Aadhar cards and create a unique e-delivery model. Science & technology have a crucial role to play in shaping economic future and the new government must enable innovation through scientific research and development. We must identify key areas in which to build world class scientific and technological excellence eg. genomics, nanoscience, synthetic biology, IT, space technology etc. The ban on clinical trials and GM crops must be lifted. To quote Narendra Modi, “I am all for technology.  We should not discard technology that helps farmers; we must have faith in science. We must put technology and science to use with regulations and add value to produce.”

Finally, it is time we put in place rules and regulations that are unambiguous and transparent and prevent any impediments that often arise due to ambiguity and opaque norms. We must now rely more on deemed and automatic approvals and not inordinately lengthy approval timelines that have denied us infrastructure project implementation which has perhaps knocked off 1-2% off GDP growth.

The Congress manifesto has made a plethora of promises to deliver 8% GDP growth most of which relate to regulatory and fiscal reforms. Let us hope the new government is effective in acting and not be wrapped up in mere rhetoric.

After all, the underlying economy is still strong and capable of delivering robust growth.

The original article appeared in The New Indian Express on the 30^th of March, 2014 and can be viewed here