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Road Map to 2025

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While the Indian Biotechnology sector is stalled at $4 billion for the last few years, the strategy aims to achieve a target of a whopping $100 billion by 2025 with special major missions in Clean Energy, Education, Food and Nutrition, and Healthcare. All this in just a 10-year period!

The strategy’s key elements vows to build and equip the country’s youth with indispensable needed skills and preparing them for the industry; nurturing innovations and elevating research opportunities; a transparent regulatory system; bolstering international collaborations; building biotechnology tools; reviving the knowledge domain; and redesigning governance model among others.

While the strategy looks great on a piece of paper, how does the industry and all the stakeholders involved in the mission collaboratively make it a reality? According to Mr Manoj Nerurkar, COO, Syngene International, the NBDS is an excellent initiative to promote the Biotechnology industry of India.

‘A notable feature’, he adds, “is that it has opened the doors for the private sector participation. This is an excellent opportunity for the private biotechnology companies to partner with the Government and contribute in its development. While the Government’s focus will be on developing the enabling factors like skilled human capital, research infrastructure and defining regulatory standards, the biotechnology industry should focus on improving R&D productivity and drive innovation. They should also look at scaling up their operations – both quantitatively as well as qualitatively — in order to target a larger share of the global outsourcing business.”

Some industry veterans believe that the current administration has incredibly ambitious goals that are, at their core, focused on promoting significant advancements in the biotechnology arena.

Says Mr Nick Mitchell, MD, Phenomenex India, “While it might be a bit aggressive to target a total sector top line of $100 billion by 2025, it is great to see the Government encouraging the industry to shoot for this mark. It would be even more encouraging to see additional complimentary targets developed, such as number of academic publications accepted in internationally accredited journals, number of Indian institutes and universities with globally accredited programs, number of total companies within the biotechnology sector, and number of plants and factories built
and their measureable commercial output quantified, to name a few.”

He says that it takes more than just monetary goals to measure advancement, and with these additional metrics and tracking toward them, progressive milestones can be celebrated as the entire industry works to accomplish them.

As fossil fuels were fodder for the economic growth in the 20th century, the era of growth in 21st century is expected from Information Technology (IT) and Biotechnology (BT).

India stands at the forefront in the IT sector and the Indian vaccine and generic drug manufacturing industries has pivoted it to be the ‘Pharmacy of the World’.

The country has vast potential for growth in all areas of biotechnology including medicine, agriculture, food (marine & dairy), environment and energy, provided the knowledge, skill, and talent of the younger generation are channeled at this period in time with public and private funding and with favorable regulatory framework.

Among all branches, points Dr Arumugam Muruganandam, MD and CSO of Bangalore-based biotech start-up Affigenix Biosolutions, “agriculture and medicine could be the major contributors in achieving the target of $100 billion by 2025. Among the two, agriculture growth is at the mercy of nature; whereas growth in medicine is purely dependent on the Indian innovation engine in discovering and developing low-volume, high-value blockbuster drugs. Both public and private investors also need to have the appetite for taking risks in such ventures, and bear with the lengthy production and drug development cycle. The agriculture and food sector, instead of being a raw material supplier, should focus their efforts in bringing value addition to their products for export market.”

CEO of enzymes-maker Caprienzymes, Dr Ravindran, quite optimistically states that the set target is definitely achievable when the industry works together. “If the Government makes the rules flexible enough for start-ups, it will boost people to work enthusiastically,” he shares.

India continues to remain a heavy net importer of medical devices and in vitro diagnostics (MDIVD), and various stakeholders are only slowly beginning to realize the importance of having a full-fledged MDIVD R&D and manufacturing ecosystem, which can cater to Indian and export markets with a focus on innovation, quality and affordability.

MDIVD-focused start-up SynThera Biomedical’s founder Dr Nilay Lakhkar feels that the Indian biotechnology industry is a long way off from hitting the $100 billion mark by 2025.

“The Indian MDIVD sector’s performance essentially mirrors that of the broader biotech or life sciences in terms of chronic underinvestment…But the situation is changing for the better, as more and more life sciences companies begin to focus on basic R&D, and various Government agencies begin to get their act together to promote innovative healthcarerelated businesses. However, the rate at which these changes are occurring suggests that reaching $100
billion by 2025 may be too optimistic a target even with a growth rate of 30 percent as suggested by Government sources, unless all stakeholders immediately begin to work much harder on mitigating all the above mentioned factors.”

“The policy is timely and made in the right direction,” says Dr Raja Mugasimangalam, founder and CEO of Genotypic Technology, a Bangalorebased genomics service provider. “It is bound to succeed and reach fruition with involvement and proactive participation and action of all stakeholders,” he notes.

A similar opinion emerges from another start-up entrepreneur, Ms Smitha Murthy, the founding director of Credora Life Sciences.

She adds, “The target is possible if all the strategies are implemented effectively, else it will end up on the paper alone like the big promises made earlier. Indian biotech industry should emphasize more on R&D. Only providing services or manufacturing products will not help sustain in the longer run. The research has to be product-oriented and facilitate today’s basic needs in the field of healthcare and agriculture sectors.”

Proper execution of plans, awareness of various schemes, transparency, and simplified and faster application processing time are certain concerns in the industry.

Dr Ganesh Jangir, CEO, Newndra Innovations, says, “The National Biotech Development Strategy is good and well thought out. It has touched every aspect of the industry.

The Government is doing an excellent job with good initiatives. Its ‘Startup India’ initiative is the icing on the cake.”

Does the markets and the set ambitious goal go hand-in-hand? ‘Domestic market is the key,’ expresses Mr Sanjay Bhardwaj, CEO & executive director, CromDx, a molecular diagnostics company.

“We are already playing cost arbitrage in the export markets, However, not much has been done to increase the market domestically. We need to develop and suit products for Indian markets. Healthcare is poised to grow. We need to increase the share of biotechnology in the healthcare segments including biosimilars, stem cell therapy, molecular diagnostics and vaccines, to name a few.”

He points that it is important to have Indian population-specific data — clinical and genetic data. “There has been no serious attempt made regarding this either by the Government or commercial establishments. The data is very limited and are available in islands.

“Availability of centralized data will create support industries in the field of healthcare IT, genomics, data analytics, and telemedicine. This data would help innovation and developing new products specifically to Indian markets. This would directly add to$5 to 7 billion by 2025 in the overall biotech kitty.”

The inclusive growth of different Biotech entities is imperative to achieve such a mammoth goal.

“For example, majority of revenue is earned through biotech industry. However, the role of academia still remains negligible in terms of producing tangible assets like products, and non-tangible assets like IPs. There are a few fundamental steps the Government needs to take to reach closer to the proposed target of $100 billion figure,” voices Dr Aman Sharma, founder & director, ExoCan Healthcare, a Pune-based Oncodiagnostics and therapeutics start-up.

Dr Sangeeta Naik, director, Cleanergis Biosciences, opines that equipping the younger generation with much needed soft skills will play a major part in the success story.

“The target is overly ambitious and is going to be a very challenging task…There should be high-level cooperation, trust and respect between fellow Indian biotechnologists. Soft skills are highly necessary for such ambitious and collective target. In India, we have ample young and technically trained manpower. However, they are highly deficient of soft skills,” she remarks.

Ubiquitous Obstacles To 2025
While the NBDS is a strong indication of the intent of the Government to give a strong push to the Indian Biotech industry, which has tremendous growth potential, the road ahead towards implementation will not be devoid of challenges. The Indian biotech industry is already facing stiff competition from other countries like China, Korea and Taiwan.

“These countries continue to place strong enabling policies and ecosystem for the growth of their biotech industries. To the extent the policy is in the right direction, and with a committed and determined action from the Government and supported by the industry, it is possible to meet the goals and objectives of the policy,” stresses Mr Manoj.

Biotechnology is a very risky business and has a unique ecosystem where bottlenecks such as regulatory, patents, ethics, safety, society, culture, market access, consumer affordability, and competition are unavoidable while developing and marketing a product.

Mr Arumugam adds, “The bottlenecks become obstacles when it limits access to much-needed risk capital. Investors (VCs) especially in India perceive the unique bottlenecks would delay their return on investment (RoI) even though they have good understanding of risk-reward trade-off in biotechnology.”

The Government’s public funding to academic institutions until recently was putting value only on training of students, publications and patents. Now there has been a paradigm shift in public funding towards monetizing scientific knowledge and technical abilities through solution driven R&D and product commercialization.

“Venture philanthropy and access to corporate social responsibility (CSR) fund that is not linked to return on investment in the short period can help draw the needed smart capital to overcome the inherent obstacles,” he explains. “The pros and cons of genetically modified organisms (GMO) debate is not helping in alleviating the fear of public and investors. The situation should not have gone to the level of Judiciary’s intervention in clinical trials, and the legislative process should have sorted out and come up with proper revised regulatory framework much faster to build the confidence of service industries, investors and consumers.”

Mr Nick terms one of the major obstacles as ‘The Brain Drain’ happening in the country. India is losing some of the youngest and brightest minds, many of them going off for international education, and finding jobs abroad and never returning.

“We must reverse this trend, perhaps one idea is to begin to develop educational scholarships and grants that could be offered to foreign students that would like to come to India to pursue and advanced degree or perhaps to do some post-degree research on exciting research topics.

“Another idea is to recruit Non Resident Indians (NRIs) that are professors in the West, to come home to India. If not permanently, then perhaps on sabbatical leaves from their present educational institutions (for a semester, or for a year) and work closely with domestic faculty to ensure world-class education in the best universities in the country. Lastly, we must build stronger bridges from academia to industry, so that students have a much better understanding of how to transition from their academic career into their professional one,” he urges.

He also opines that India shouldn’t be relying on the help of organizations like The Gates Foundation or WHO grants.

“We have to solicit the funding from our own countrymen and women. We must find a way to educate our wealthiest citizens about the longterm benefits of a strong biotechnology contribution to our nation’s overall output,” he suggests.

Many of the industry captains believe that dealing with multiple regulatory bodies result in serious delays thus raising production costs.

Dr Ravindran comments, “There are funding constraints as the investor community shy away from investing in early-stage ventures, and the bank funding would not always suffice the expenses involved. Also, costs involved in rising a biotechnology company is always high and it is directly proportional to the potential risks. Policies for the biotech industries are not flexible enough for the industry, which usually curtail business relationships abroad.”

He emphasizes that Biotech professionals in the country need to be enlightened on the importance of quality practices established based on the ICH guidelines (International Conference on Harmonization) and Indian regulations, in order to deliver safer products to patients.

“Students whose passion is to become quality scientists,” he continues, “have to look elsewhere, mostly abroad, to sustain their interests and passion because the industry is unable to keep up with the platforms provided by companies abroad. Cutting-edge in scientific breakthroughs cannot come unless more research is funded by the Government. It should promote upcoming companies having innovative or environmental friendly ideas which will ultimately lead to better discoveries and better products to sustain the needs.”

According to Dr Nilay, the Indian MDIVD manufacturing sector today is probably at the same stage as it was in the US’ MDIVD sector during the 1960s and 70’s, except with some crucial differences.

“The American innovation paradigm has always relied on two major catalysts for start-up growth — a culture of close contact between academia and industry whereby innovative ideas born out of basic research in university R&D labs were intelligently transformed by businesses into viable commercial products and services; and constant support from the US Government and particularly the US’ military for nurturing and commercializing innovative ideas. Both catalysts are almost completely absent in the Indian innovation paradigm, mainly because the various stakeholders (academia, industry, Government, military) have never come together on the same scale to solve Indian problems through products and services. This lack of connect between various stakeholders needs urgent change if India is to realize its potential as an MDIVD manufacturing powerhouse,” he explains.

Aside from the lack of an integrated culture of innovation, the MDIVD manufacturing sector is majorly hamstrung by a lack of Government regulation, which raises the risk profile for investors and companies looking to enter this market.

Recent reports suggest the Government is looking to improve the situation at a broader level by delinking medical devices from pharmaceutical drugs in its regulatory apparatus.

Dr Raja on the other hand points that the current import and export regulations are cumbersome. “It needs to be made into a single-window with exemption of customs duty on certain critical analytical reagents and equipment. Disconnect between education and readiness for industrial and academic research is another bottleneck,” he mentions.

Ms Smitha also stresses that, in the strategy, there is no mention of any industry-academia relations.

“Students are the backbone for this target to be realized. It is noticed that not all established biotech companies encourage students to intern at their organizations owing to IPs getting leaked. But there can be a mention in the policy which ensures industry faculty training budding students, and provide hands-on training on equipment which colleges or institutions cannot afford,” she remarks.

Dr Shama Bhat, CMD, Bhat Biotech, says that in India there is absolutely no attempt between stakeholders to work together to build technologies and processes.

“There is very little equipment manufacturing happening in the country… Lack of manufacturing is the greatest hurdle we face today. In many ways we are still in the 1920’s where cotton was grown in India, sent to Manchester and then us buying their finished clothes. Another major bottleneck are salaries. The Government salaries are much higher than that of industry.”

“There must be a way where salaries can be supplemented with personal grants. Greater flexibility of moving from academia to industry and vice versa is needed. The best brains are heading into other areas. Increasing salaries in the Government sector does not induce migration to the industry. It is possible that in case where ideas and innovations
are funded through equity, a part of the problem with salaries may be solved,” he comments.

Dr Arun Chandrashekar, R&D president, Bhat Biotech, feels that in India there is more talk happening than taking necessary actions.

“Though talk is necessary, a good vibrant culture of writings reflecting Indian works should appear in popular press and papers. There should be more science in the news. Governmental intervention through the DBT has been pushing things forward and setting up incubators. But it is not enough to help spawn new ideas. They need to grow and multiply,” he says.

“The major obstacle are funds and investments. Government funds are not easily available and private investors are hard to find. Besides, biotech products take longer time for development, and small industries find it hard to sustain for such long periods,” Dr Sangeeta highlights.

Similar to Dr Bhat’s opinion, Dr Aman says that India terribly lacks Biotech manufacturing infrastructure in most states.

“Absence of bio-entrepreneurial mindset, minimal understanding of mutual needs between industry and academia, lack of start-up culture, and lack of entrepreneurship among Government funded scientists can serve as obstacles,” he reasons.

Transformation Towards 2025
Indian Biotechnology companies can provide a distinctive cost-advantage. However, this should not undermine the focus on quality. The industry should focus on continuous improvement in the quality of their offering to meet global quality standards.

Mr Manoj opines, “Currently, the biopharmaceutical sector is the major contributor of the Indian biotech industry. However, there is ample scope for growth in other areas like agriculture biotech and bioinformatics. The industry should also focus on developing innovative products. Amongst other things, the NBDS aims to create a pool of highly-skilled and trained human capital especially for the biotech industry. This opens up huge opportunities for the industry-academia partnership which will help give this pool the right exposure and opportunity to work closely with
the industry.”

The country can look to other nations like Singapore, Australia, and New Zealand that seem to be fostering the right ecosystems for a thriving Biotechnology economy, and consider collaborating with them, or at minimum, studying their best practices.

Mr Nick suggests, “The US-based industry association, Biotechnology Innovation Organization (BIO), and India’s ABLE (Association of Biotechnology-Led Enterprises) must work together to synergize their efforts. Within India I would submit that each of the states has to understand how to work for the nation’s best interest once in a while, this
means putting the pan-India agenda objectives above their state’s interests. If biotech-focused institutes and universities are already advanced in some states, it may be good to fund their further expansion and development, building on the base that has already been established by some of the nation’s leading biotechnologists.”

One mind shift that is critical for all of the scientists, business men and women, and Government officials working to advance the biotechnology sector in India, is to accept that Biotechnology is expensive. If India is to succeed in Biotechnology, there has to be a change in mindset by those investing in the sector’s development.

“If we cut corners in biotechnology investments, the results can be catastrophic. All of those investing and contributing to the biotechnology industry in India must have a strong appetite for risks, and plan to invest for long-term gains. Then, and only then, will India become a leading biotechnology hub, and begin to accomplish the set mark. It’s a bigger upfront investment, but certainly a more fruitful return, not only for investors, but for the entire population of India,” Mr Nick says.

The current mindset in the Biotech industry is investing more in the late stage opportunities (biosimilars) rather than the early stage discoveries (new biological entities). Global biosimilars opportunities are huge and India may get lion’s share of the emerging markets, but may not be able to compete with pharma giants in the lucrative regulated markets.

“To overcome investment obstacles and mitigate the risk involved in biotechnology,” emphasizes Dr Anand, “pharma or other non-biotech sector companies should consider a portfolio that has significant percentage of biotech mix. Merger and acquisition could be one easy option and it should be considered to be more efficient. The industry should find ways to attract and prevent the talent exodus to other countries and IT industry.”

Also, the Strategy cannot be rigid. It should evolve to changing times and be flexible and amenable to demographic and economic challenges. Since all branches of biotechnology does not come under one ministry, it is not clear whether execution of the ambitious strategy can be coordinated by the DBT.

“Academia, industry, the Government and the public need to work together and I hope the ‘Make in India’ and ‘Start-up India’ campaign bring all of them together,” says Dr Anand.

Dr Ravindran recommends modifications in duty structures for biotech products and allowing them to be imported under OGL (Open General License) Scheme.

“Cost and period of clinical trials should be reduced, which would encourage more innovations enabling more products reaching the market in shorter time,” he observes.

There should also be more leasable equipment and processes for shortterm usage and easier ways of obtaining, using, and making equipment, tells Dr Shama Bhat.

“A powerful yet independent regulator is very much needed in the country. The GEAC, a body for approving genetically modified material in India, suffers from very palpable antagonism from politicians and vested interests for the production of GMOs in India. Lack of ideas is an endemic Indian problem. We have become good in rehashing and repeating. There is no recipe for increased creativity,” he continues.

“There should be much better training of students. Less theory and more practical training is what is needed. There should be a change in syllabus so that the scientific method is taught. Encouragement of greater interaction between private and Government bodies for the development of better diagnostic systems is needed,” he added.

Dr Raja recommends that grants and collaborative research, funded by the Government, to be directed towards research that is locally relevant and internationally commercializable.

“We also need,” he elaborates, “representations from entrepreneurs who have succeeded in commercialization of IPs, in the advisory committees, for awarding grants for research. There needs to be increase in capital flow into biotech by various means like increasing start-up funds, easy access to low-cost unsecured debt funds by banks, creation of incubation spaces that not only provides physical infrastructure for start-ups but can also foster mentoring. Industry should move from arbitrage-based services to high-risk but large-returns product development. Another key is ensuring implementation of quality control and GLP, so products meet global standards. Thus we gain the confidence of the global markets which is a necessary step forward.”

As a first-time entrepreneur Dr Aman feels that start-ups should fit into the loop of Industry-Government-funded academia tie-ups for generation of disruptive innovations as he believes start-ups are one of the major powerhouses of IP generation in shorter time.

He explains, “There should a biotech entrepreneurship and skill development training program (BEST) at Master’s or Doctorate degree level to create biotech business-oriented manpower through development of indigenous ideas and risk-oriented projects. We also look forward to more direct investments in manufacturing of biosimilars, consumables, and equipment which are used in routine R&D labs since a lot of money goes in paying duties while importing these materials.”

While, it is not a bad idea to aim for the stars, but an ambitious $100 billion target within a period of 10 years sounds quite like a distant dream and unrealistic, provided all the stakeholders of the industry collaboratively and strongly participate in realizing this dream. Can Indian Biotech achieve this mark? We will have to wait and watch.

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