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DBT steps on gas to spruce up bio-manufacturing

Our Bureaus, Mumbai & BengaluruThursday, March 13, 2014, 08:00 Hrs  [IST]

The National Biotechnology Development Strategy-2014 (Biotech Strategy II), issued by the Department of Biotechnology (DBT) recently, aims to accelerate the Biotechnology Vision-2020 for a new understanding of life processes and utilizing the knowledge and tools to the advantage of humanity.

It also aims to launch a major, well-directed effort backed by significant investment for generation of biotech products, processes and technologies to enhance efficiency, productivity, safety and cost-effectiveness of agriculture, food and nutritional security; affordable health and wellness; environmental safety; and bio-manufacturing.

Realizing that biotechnology has the potential to be a globally transformative intellectual enterprise of humankind, the strategy aims to empower, scientifically and technologically, India’s incomparable human resource and also to create a strong infrastructure for research, development and commercialization for a strong bioeconomy.

The 10 guiding principles that will drive the Strategy-II are build top-notch competence in technologies directly relevant to the growing bioeconomy; continue to provide strong support to basic, disciplinary and inter-disciplinary sciences; encourage use-inspired discovery research; increased investment in R&D directed in such a manner as to improve economic and social impact; promote connectivity in R&D through national or regional alliances; build world class translational capacity; strengthen regulation, accreditation, validation and standards; investing in world class human capital - nurture an outstanding workforce as well as leadership for R&D in both public sector and industry; strengthen institutional capacity with redesigned governance models; and create a matrix of measurement of process as well as outcome.

Earlier in September 2007, the DBT had announced the National Biotechnology Development Strategy -I. Through the strategy, biotechnology was recognized as a sunrise sector that needed focused attention. The cornerstone of the strategy was to focus on     building coherence and connectivity between disciplines and bring together variegated skills across sectors to enhance synergy.

The Strategy-II is the direct result of formal and informal consultations over the past two years with over 300 stakeholders including scientists, educators, policy makers, leaders of industry and civil society, voluntary and non-government organizations, regulators, and international experts. The consultations offered an opportunity to discuss and evaluate technological, societal and policy aspirations, critical success factors as well as barriers that will impede growth and put them in newer and broader perspective and action plan. The consultations have resulted not only in identifying guiding principles that will drive Strategy-II but also in detailing the instruments through which these principles will be implemented.

Consultations with stakeholders have identified the 10 guiding principles that shall drive the renewed mission through Strategy-II and these can be applied to R&D, innovation and solution finding for scientific excellence in education, agriculture, health, energy, environment and bio-manufacturing.

University Innovation Cluster Programme
At the same time the Biotechnology Industry Research Assistance Council’s (BIRAC) Rs.500 crore funding has attracted Rs.700 crore industry commitment for research and development over the last three to five years. Now in order to give an impetus to funding the young entrepreneurs, the Council has unveiled the University Innovation Cluster Programme (UICP) and Cluster Innovation Centre (CIC), a model conceived by Dr Sam Pitroda, chairman, National Innovation Council.

When BIRAC made the fund offering, it saw a Rs.700 investment coming in from the biotech industry. Since much of the investments have been made by small and medium enterprises and start-ups, we have looked future nurturing the new age young entrepreneurs. This has also led the Council to identify five universities in the country to identify the prospective entrepreneurs. The objective was to nurture a culture of applied research and innovation among students to catch them early to provide professional mentoring, said Dr Renu Swarup, advisor, Ministry of Science and Technology, department of Biotechnology and managing director, BIRAC.

One of the main engines of innovations in the country is biotechnology and it is now imperative to focus on fostering local ecosystems within Anna University, Chennai, Punjab University, Chandigarh, Tamil Nadu Agricultural University, Coimbatore, University of Rajasthan, Jaipur and University of Agricultural Sciences, Dharwad. There is also a fellowship grant of Rs.35,000 to Rs.50,000 to students, Swarup told .

“Now funding in biotech companies is critical for growth. If there is no access to finance, innovation would be stalled . This is where we have gone to increase the entrepreneur zeal in an environment where there is an increased level of innovation,” she said.

This ecosystem will need to include stakeholders in the entire value chain from idea to discovery to proof.

“Under the initiative, a Cluster Innovation Centre in Biotechnology (CIC-B), established within the University, will be the nerve centre to manage the UICP. It would facilitate the creation of networks, partnerships between stakeholders to strengthen the innovation ecosystem. The cluster concept is seen to provide the impetus for pre-incubation support to innovative concepts that would merit converting into viable products. The assistance will include technical trainings, IP management, technology business management and access to risk finance.

Export potential of biopharma sector
Understanding the huge potential of the growing biopharma sector in the country, the Pharmaceuticals Export Promotion Council of India (Pharmexcil) is keen to tap its export potential by encouraging more companies to invest in research and development activities. The Council foresees that in the near future, almost the entire healthcare spectrum will undergo a huge transition from being a small molecules to biologics based sector, considered to be safer and more efficacious alternative with fewer side effects.

According to Pharmexcil, right now India exports over Rs.600 crore worth of biopharma products to countries across the globe. And the Council feels that with increased focus on the biopharma sector, the export is expected to double in the coming five years. However, the council stressed that to achieve the target, the country needs to address a lot of gray areas that are blocking its growth prospects.

With a view to addressing this and to spur more R&D initiative in this area, the council had recently invited experts from the bio therapeutics and personalised medicines from UK, US, and Italy along with Nobel laureate from Germany to share their expertise and technical know-how with Indian counterparts. According to Pharmexcil director general, Dr P V Appaji, the main thrust behind this initiative was to boost the importance of biopharma among Indian companies and project the latest technologies identified and accepted globally among the Indian researchers.

“There is a lot of untapped potential in the biopharmaceutical segment as they are considered to be free of toxicity, and have proven to be far more effective for the treatment of complex diseases including cancers and severe metabolic disorders than the chemical entities. However, all said and done, there is an urgent need to foster and develop interest on personalised and genomic medicine in the country, so that we can meet with the global expectations. Understanding the changing market dynamics, we had for the first time provided a technology promotion platform to the interested parties to spruce up their export activities, by encouraging investment and research opportunities in biopharma sector,” Dr Appaji added.

He further stressed that in the coming years personalised medicine and genomic medicine will play a major role in the healthcare requirements, making it imperative for the Indian pharma manufacturers and researchers to get better understanding of the subject matter.

Investment prospects
According to an analyst with research and consulting firm GlobalData, the Asia-Pacific (APAC) region is experiencing a significant boom in the volume of private equity (PE) and venture capital (VC) investments in biotechnology, with investors looking to cash in on the remarkable potential of the region’s healthcare sector.

Adefemi Adenuga, GlobalData’s Senior Analyst covering industry dynamics, says that the APAC countries are being targeted by large pharmaceutical companies seeking to recover their loss of market exclusivity in Western Europe and the US, due to patent expirations and slow growth.

In fact, GlobalData states that the volume of healthcare PE investment in the APAC region increased massively between 2011 and 2013, growing by 125.8 per cent during that period. On the other hand, deal activities in Europe and North America decreased by 30.5 per cent and 2.5 per cent between 2012 and 2013, respectively.

Adenuga says: “Within the past five years, the APAC region has witnessed various pharma deals, including Sanofi’s takeover of India-based Shantha Biotechnics, GlaxoSmithKline’s purchase of a stake in South Korea-based Dong-A Socio Holdings, and Novartis’ acquisition of a stake in China-based Zhejiang Tianyuan Bio-Pharmaceutical.

“It is therefore not surprising that PE and VC firms have also caught on to this trend, increasing their focus on the region in the hope that future returns will justify their investments and opportunity costs.”

 
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