Road Ahead for Indian Biopharma Sector
Towards strengthening the emerging biotechnology enterprise in India, Department of Biotechnology (DBT), Ministry of Science & Technology has initiated the Mission programme entitled: Industry-Academia Collaborative Mission for Accelerating Discovery Research to Early Development for Biopharmaceuticals – “Innovate in India (i3) Empowering biotech entrepreneurs & accelerating inclusive innovation”. The National Biopharma Mission approved by the Cabinet in May 2017 at a total cost of $250 million for five years with 50 per cent funding through World Bank loan is being implemented by Biotechnology Industry Research Assistance Council (BIRAC) - a Public
Sector Undertaking of DBT. Now with the completion of a year, BioSpectrum looks at the updates about the Mission and its achievements so far.
The National Biopharma Mission was formally launched on June 30, 2017 and the legal agreement with World Bank for flexible financing arrangements for this Mission of Department of Biotechnology (DBT), was executed on April 24, 2018. The Mission aims to make India a hub for design and development of novel, affordable and effective biopharmaceutical products for combating public health concerns.
According to the DBT, this mission would strengthen translational capability of academic researchers; empower bio-entrepreneurs and SMEs by decreasing the cost and risk during early stages of product development and also elevate the innovation quotient of the industry. The global experience of World Bank would be instrumental in building sustained global linkages, technical assistance and knowledge flow between public and private partners for business promotion in biotech sector.
To initiate the Mission activities there have been constitution of the Inter-Ministerial Steering Committee (SC) comprising of members from various Ministries; and the Program Technical Advisory Group (TAG) comprising of global and national leaders from industry and academia, to provide oversight to the National Biopharma Mission. In December 2017, BIRAC issued the first round of Request for Applications (RFAs) under the Mission in alignment to its objectives soliciting proposals from academia and industry focusing on development of (i) Vaccines for Pneumococcus, Dengue, HPV and candidates for other diseases of high burden in India (ii) Biosimilars for cancer, diabetics and rheumatoid arthritis and
(iii) Medical devices and diagnostics (iv) Process Development Laboratory; Chemistry, Manufacturing, Control Units and cGLP validation facility for
Bio therapeutics. Through a three tier screening process potential proposals have been shortlisted for financial support at this stage. In sequel there will be launch of series of RFAs in 2018 under the Mission to strengthen infrastructure, skill development and technology transfer capabilities. Further to train the next generation of clinician-scientists and health professionals involved in clinical research, National Biopharma Mission organized a course on the “Principles and Practice of Clinical Research’, at Hyderabad in April 16-21, jointly with NIH-USA under the aegis of Indo-US Vaccine Action Programme of DBT. DBT envisages that this programme will help deliver 6-10 new products in the next five years, create several dedicated facilities for next-generation skills, and hundreds of jobs in the process.
“The aim of the mission is to accelerate early leads through the product development pipeline to ensure they reach the market in a time-bound manner. This mission is not for new discovery, but for creating infrastructure to move important early leads, which are in different stages, through the pipeline, and come out with products. The mission will follow a consortium-based approach, wherein academia and industry working in an identified area will be encouraged to work together. The government will handhold them through various regulatory processes so that product development can be hastened”, shares
Prof K VijayRaghavan, Principal Scientific Advisor to the government of India says, “The National Biopharma Mission, which is a Rs 1500 crore mission, is supposed to set up a number of platforms such as bioinformatics, genomic sequencing, mass spectrometry, drug discovery and so on. Currently, we lack such platforms for the industry. Also, right now academic areas have intellectual capacity, a certain kind of technical resources but a next level of technicality is required to move into the area of commercialization. Through this mission, we foresee a substantial investment in this context so that it will allow the private sector to use major facilities of a kind that is unthinkable for them to have”.
For the last one year, the thought of the National Biopharma Mission has been creating waves within the biotech industry as well.
“This mission will inject a much needed boost to the Biopharmaceutical Sector with specific reference to the technological and product development capabilities to a level that will be globally competitive over the next decade, and transform the health standards of India’s population through affordable product development. If the biotechnology industry operating landscape becomes more innovation friendly spurred by government’s policies and nudge with increased Academia – Industry – Government interactions and focused business strategies, then the industry could possibly grow at higher CAGR thereby increasing India’s share in the global Pharma market. However, the primary challenge for the expansion of biopharmaceutical industry is the availability of experienced talent pool. Currently there is a wide gap between the quality of human capital available and the needs of the biotech Sector. With a clear 5-10 year vision by the Government, students will be inspired to take up courses which will further feed the ever increasing need for skilled manpower in the Sector. This will equip students with both Theoretical and Practical skills. Extensive training on sophisticated instrumentation with further specialization in the areas of their interest will make these students to be Industry ready and will also slow down the outflow of skilled manpower from the country”,
points out Prashant Tewari, MD, USV India.
But alongside the announcement of the National Biopharma Mission, the industry is also concerned about the addressal of the challenges India is currently facing in the biopharmaceuticals sector.
“The major challenges that lie up ahead for developing biopharmaceuticals in India include long lead times for product development, skilled manpower, rising costs and long gestation times for setting up manufacturing units. Also, longer research and clinical development timelines result in launches closer to patent expiries in an increasingly competitive market. The issue of regulatory scrutiny also comes in to play. Compliance to differing requirements for global markets becomes a challenge for the company’s go-to commercialization strategy. Global MNCs having significant economies of scale for development & manufacturing lead to significantly higher competition”, mentions Dr. Murtaza Khorakiwala, MD, Wockhardt Ltd.
In the long run, it can only be hoped that this program will be able to address the existing challenges to an extent thus enabling sustainable networks for collaboration between industry and academia, and supporting entrepreneurial ecosystem amongst many others.