In order to create a globally competitive biopharmaceutical industry and to spur growth, the Union government is pulling out all stops to foster industry- academia partnerships. The sector which is expected to reach US$11.6 billion in 2017 from US$ 7 billion in 2015, is required to garner a 30 per cent Compound Annual Growth Rate (CAGR) to touch US$ 100 billion by 2025.
In June this year, the Union government had unveiled the Innovate in India (I3) programme. The US$250 million programme of the Department of Biotechnology (DBT), is a first-of-its-kind that brings together industry and academia to promote entrepreneurship and indigenous manufacturing in the biopharmaceutical sector.
This flagship program of the GOI in collaboration with the World Bank will be implemented by the Biotechnology Industry Research Assistance Council (BIRAC), said Dr. K. VijayRaghavan, Secretary, Department of Biotechnology.
According to the Minister of Science & Technology, Dr. Harsh Vardhan, the ‘I3’ is anticipated to be a game-changer for the Indian biopharmaceutical industry. It will create an enabling ecosystem to promote entrepreneurship and indigenous manufacturing in the sector. The programme will specifically focus on the development of new vaccines, bio-therapeutics, diagnostics and medical devices to better address the rising burden of diseases in the country. It will also bring isolated centres of excellence together, enhance regional capabilities and strengthen the current bio-clusters network in terms of capacities as well as quantity and quality of output.
“This endeavour will help nurture next- generation technical skills; promote entrepreneurship and support institutions in adoption of global innovations, technologies and licensing models. It will provide young entrepreneurs the confidence as well as the systemic support to pursue their aspirations in biotechnological innovation and transform India into a global hub for cutting-edge biotechnology research and development,” said Dr. VijayRaghavan.
The programme would be monitored by the Inter-Ministerial Steering Committee comprising members from various Ministries. This would be supported by Program Technical Advisory Group comprising global and national leaders from industry and academia. The programme is positioned to become a cradle to innovate, co-create and co-facilitate scientific discoveries and offers young entrepreneurs an avenue to engage with the best in the industry.
“We undertook an extensive study to identify critical gaps impeding growth and innovation in the biopharma sector. Taking cognizance of these gaps, i3 is focused on targeted measures to develop platform technologies for product validation, link disparate institutions to strengthen clinical trial networks, promote partial de-risking for novel products and build capacities in emerging areas like translational bioinformatics, bioethics among others. With an aim to provide a level playing field for new entrants, the program would call or research proposals beginning August and roll-out in October this year, said Dr. Renu Swarup, Senior Adviser DBT & MD, BIRAC.
The programme will boost the growth curve for domestic biopharma in India by accelerating the translation of research concepts into viable products, enabling sustainable networks for collaboration between industry and academia and supporting entrepreneurial ecosystem amongst many others, said Dr. Swarup.
Creation of trained workforce
Early this month, DBT under its 'Star College' Scheme, invited applications from colleges of all the states and Union territories in the country offering undergraduate (UG) education in sciences to brand and nurture excellence in UG science education.
The 'Star College' programme emphasizes holistic improvement of science education at undergraduate level with special emphasis on practical training to students. The initiative provides support to improve knowledge and skills of teachers in basic sciences and specialized techniques. It would enable access to specialized infrastructure to students ensure assurance of consumables, reagents and chemicals It would create a platform for substantial hands-on experience in designing and conducting practical training to ensure critical thinking. In addition there will also be easy access to books and journals including e-journal facilities.
Though, the programme does not initiate new UG courses in biotechnology, its objective is to enhance the practical training in existing science courses like botany, zoology, chemistry, physics, microbiology, biochemistry, biotechnology, bioinformatics, mathematics, electronics, computer science etc. Subjects like mass communication, geography, economics, management and statistics can be included, provided these departments are able to weave their proposal with other science departments and suitably justify their collaboration for benefit of undergraduate science education, according to DBT.
The major purpose of the scheme is to strengthen the academic and physical infrastructure to achieve excellence in teaching and training. The focus will also be to improve the quality of the learning and teaching process to stimulate original thinking through ‘hands–on’ exposure to experimental work and participation in summer schools.
Further the programme would give added focus to networking to strengthen ties with neighbouring institutions and other laboratories. There will be several specialised training programmes for faculty improvement to optimise technical capabilities.
The department of biotechnology foresees the capabilities of core instrumentation resources to come to the fore. This would be by procuring new equipment and upgrading of existing facilities. There would be easy access and exposure to students to research laboratories and industries in the country. The department eventually sees that it would help in devising standard curricula and Standard Operating Procedures (SOP’s)/kits for practical training.
Biocon Academy, a Centre of Excellence for Advanced Biosciences Learning is a CSR initiative of Biocon. It is aimed at developing high-end, industry-ready, talent for the Indian biotech sector to address the skill deficit. The academy has been enhancing the employability of bioscience graduates by providing them advanced experiential learning through practical training. It has been instrumental in shaping careers of aspiring biotech graduates while bridging the industry-academia gap. It has collaborated with Keck Graduate Institute, California, USA and BITS Pilani, India, to offer global quality learning along with scholarships that cover the majority of the cost of these international programs.
Biotech start-ups
Start-up companies are the core to innovation. Around 1,022 start-up companies in the sector has attracted over US$2.8 billion or Rs 18,700 crore investments in five years from 2012 to 2016.
According to the Association of Biotechnology Led Entrepreneurs (ABLE), housing 190 start-ups which have sprung up between 2012-2016, Bengaluru is the biotech start-up capital of India. National Capital Region (NCR) is ranked second with 164 start-ups followed by Mumbai (163) and Hyderabad (160).
The start-up revolution is touching the biotech sector. This demonstrates the interest level to leverage science and engineering capability, said Kiran Mazumdar-Shaw, honorary chairman, ABLE and CMD, Biocon.
“We are also seeing the start-ups moving to inflection point. There are regulatory hurdles. We are requesting the government to ensure that the start-ups are free of any regulatory requirements until they are ready to commercialise the product. The government is also trying to simplify the regulations. We are confident this will happen when the industry works closely with the regulatory authorities and with the policy makers,” she added.
“This is good news and we are aiming to double this number with the ABLE Start-Ups 2020 initiative to take the count to 2020 companies by the year 2020 with US$5 billion of investments,” said Dr PM Murali, President, ABLE and CEO, Evolva India.
The burgeoning biotech companies in India
"Biocon is India’s largest and leading biotechnology in the country. In 2017, the company along with Mylan conducted global clinical studies confirming the safety, efficacy and immunogenicity of its insulin glargine in comparison to the reference product in Type 1 and Type 2 diabetes.
“This is an important milestone in our development of a more affordable insulin glargine and furthers our mission of enabling access by addressing the needs of diabetes patients globally,” stated Arun Chandavarkar, CEO & Joint Managing Director, Biocon.
In January this year, the Ministry of Health (MoH), Malaysia, awarded a three year contract, to its subsidiary, Biocon SDN BHD, Malaysia, to supply recombinant human insulin (rh-Insulin) formulations manufactured at its large scale biopharmaceutical facility in Johor, Malaysia. The company was granted MYR 300 million or Rs 460 crore contract to be serviced over a period of three years for supplying rh-Insulin cartridges and re-usable insulin pens under the Malaysian government’s Off-Take Agreement (OTA) initiative.
The Hyderabad-based Bharat Biotech’s Chikungunya (CHIKV) vaccine is under the Phase 1, first-in- human clinical trials. The company stated that its indigenously developed CHIKV will now evaluate the vaccine’s safety, tolerability and immunogenicity.
The placebo controlled study involving 60 healthy volunteers would test escalating doses of the vaccine in prime-boost regimen.
The company developed the CHIKV vaccine using an isolate of the virus from Indian epidemic. The inactivated virus vaccine was found to be safe and immunogenic in pre-clinical animal testing. After the successful completion of product development and pre-clinical testing, the candidate vaccine was approved by the DCG(I) for Phase 1 clinical trials in 2016.
“We filed a globally pioneering patent in 2007 for CHIKV drawing priority from 2006, and followed up with a second patent in 2011. Patents have been granted in USA, Europe, China, Indonesia, South Africa and is in National Phase in several other countries. If phase 1 clinical testing is successful, we plan to advance the vaccine into Phase II/III clinical development, said Dr. Krishna Ella, Chairman & Managing Director of Bharat Biotech.
Strand Life Sciences, a global genomic profiling company and leader in precision medicine diagnostics, commercialized its Liquid Biopsy test portfolio ‘Strand LB’. The test provides highly sensitive detection of tumour traces from a simple blood draw. It indicates tumour presence, cancer recurrence, and response to therapy compared to any other method used in the medical industry. It costs Rs 20,000 as against the global cost of Rs 2 lakh global with a five-day turnaround for reports.
The Strand LB is an outcome of the collaboration between scientific teams of Strand and Mazumdar Shaw Center for Translational Research (MSCTR). The tests were validated by clinicians at the Mazumdar Shaw Medical Center (MSMC). These Liquid Biopsy tests offer ultra-sensitive detection of mutations which helps early intervention. It is now made available to patients at MSMC and will also test the samples from other cancer hospitals, said Dr Ramesh Hariharan, CEO Strand Life Sciences.