After announcing the National health Policy which commits Health for all, the Government has approved a Biopharma Mission for production of Indigenous affordable and accessible vaccine, Biotherapeutics and Medical devices. A US$250 m Mission with US$125 m coming as a World Bank funding, the mission I³ is “Innovate in India” for Biopharma. It will create an ecosystem for innovate indigenous product development by researchers Startups and SMEs and make Indian Biotech Industry Globally competitive. India which today occupies only 3% of the Global Market aims to reach 5%

· Innovation is one of the key driving forces behind the sustainable growth of the biopharmaceutical industry and an important determinant of a nation’s potential for economic growth and global competitiveness. The Indian biopharmaceutical industry is around 10-15 years behind their counterparts in the developed countries and faces stiff competition from China, Korea in respect to innovation. According to the Global Innovation Index, India ranks at 81 out of 140 that is way below China (rank 29) and South Korea (rank 14).

Figure 1: Distribution of products across the Global and Indian biopharmaceutical market

· Changing Paradigms - Next Generation Technologies increasing success rates

In recent times for the biotechnological sub-disciplines of biopharmaceuticals, areas such as translational research (including discovery and validation), early development and clinical development, are on the forefront of successful biopharmaceutical innovation programs. The confluence of recent technological advances (e.g. systems biology and immune monitoring), if harnessed effectively, can yield a tremendous opportunity for biopharmaceutical product development (biopharmaceutical value chain outlined in Figure 2) and increase success of product development e.g. High Throughput platform technologies increase a manufacturer’s ability to work with small samples and shorten assay times.

Figure 2: Biopharmaceutical Product development Value Chain

Chemistry, Manufacturing, and Control (CMC) is also an important step in the value chain of biopharmaceutical development that defines the identity, strength, quality, purity and potency, and thus relates to the safety or efficacy of the product. Focused efforts are therefore geared towards increasing productivity and yields by improving upstream (e.g., improving cell-line development and optimizing feed and media formulations to promote better yields) and downstream (e.g., developing platform technologies and decreasing purification steps) processing. There is thus a need for establishing accessible bio-manufacturing or CMC units, which are current Good Manufacturing Practices (cGMP) and current Good Laboratory Practices (cGLP) compliant, are product-agnostic, have varied capabilities for modern enabling technologies, and are modelled to operate in a non-competitive phase.

Innovative medical devices for early screening and diagnosis of disease are also leading to substantial impact, particularly for cancers that have high mortality rate and are diagnosed at an advanced stage, when treatment is less likely to be effective and expensive.

Considering factors like the current market perspective, growing public health needs and the emergence of new technologies for translational research, bio-manufacturing and medical technology and the time is ripe to work towards defining a strategy for preparing India’s technological capabilities to a level that will be globally competitive over the next decades.

To meet this challenge the Government of India has launched a Mission programme for accelerating Discovery Research to Product development in Biopharmaceuticals.

Mission of the Programme is:

“Enable and nurture an ecosystem for preparing India’s technological and product development capabilities in biopharmaceuticals 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

The mission will focus on:

• Development of product leads that are at advanced stages of the product development lifecycle and relevant to the public health need by focusing on managed partnerships

• Upgrade shared infrastructure facilities and establish them as shared Infrastructure for both product discovery/discovery validation and manufacturing

• Develop human capital by providing specific trainings to address the critical skills gap among nascent biotech companies across the product development value chain, including in business plan development, technology transfer, intellectual property registration and market penetration.

• Satisfy surplus demand for startup incubation space and services (through establishing and strengthening biotech clusters, pertinent consortia and clinical trial networks).

This is a US$250 M programme over 5 years to be led by Department of Biotechnology Ministry of Science & Technology, Government of India implemented by Biotechnology Industry Research Assistance Council (BIRAC) a Public Sector Undertaking of DBT

The anticipated social impact of this program could be direct (a. Alleviated disease burden; increase in affordability etc.) and indirect (increase in funding opportunities; increase in innovation; building an entrepreneurship ecosystem; pandemic preparedness; reduction of out of pocket costs; reduced impact due to the disease on output, revenue, and profitability affecting business performance and economic growth etc

The Mission will provide a holistic and integrated approach to strengthen and support the entire product development value chain for accelerating the research leads to product development. This will help not only in immediate product development addressing public health needs, but will also help to create an ecosystem which will facilitate development of a continuous pipeline of products.