National Biopharma Mission

The National Biopharma Mission (NBM) is an industry-academia collaboration mission to accelerate the development of biopharmaceuticals in India. The government launched this mission in 2017 with a total cost of USD250 million, out of which 50% is co-funded by the World Bank loan. The Biotechnology Industry Research Assistance Council (BIRAC) implements the NBM. The Department of Biotechnology (DBT) has set up BIRAC, a public sector enterprise.

The National Biopharma Mission was launched to develop indigenous manufacturing capability and promote entrepreneurship in the sector. The government launched this mission to achieve a target of USD100 billion in the biotech industry in India by 2025 and also to capture 5% of the global biopharmaceutical market share.

The NBM intends to bring together government, private sector and academia, leading to spur in development. The initial focus will be on Dengue, vaccines for Human Papillomavirus (HPV), biosimilars for cancer, rheumatoid arthritis and diabetes and medical diagnostics and devices.

Objectives of NBM

• Development of product leads at advanced stages of the product development life cycle.
• Nurture and facilitate a conducive environment to prepare India’s product and technological development capabilities in biopharmaceuticals.
• Strengthening and establishing shared infrastructure facilities for product validation and development.
• Developing human capital by providing training to address the crucial skills gap across the product development value chain.
• Enhancing and creating intellectual property management and technology transfer capabilities and capacities.
• To make India a hub for developing and designing affordable, novel, and effective biopharmaceutical solutions and products.
• Focus on developing biotherapeutics, new vaccines, medical devices and diagnostics to address the increasing burden of diseases in India.

Activities Under NBM

The primary activities under the National Biopharma Mission are as follows:

Specific product development 

The NBM has identified three significant verticals for product development, namely biotherapeutics, vaccines and medical diagnostics and devices relevant to the public health needs of India. The NBM supports researchers, public and private institutions, entrepreneurs, start-ups and companies that have established proof of concept and are on the way to product development.

Building shared infrastructure

The NBM aims to create an enabling environment to aid current product and future pipeline development and enhance outsourcing capabilities by strengthening the existing infrastructure, accelerating translational research, building effective collaborative partnerships for cutting-edge technologies and enhancing clinical expertise. The components of this activity are as follows: 

• Strengthening or establishing shared facilities that are accessible and equipped with the relevant talent and state-of-the-art infrastructure.
• Building a consortium of partners, in-country and global network of research entities for the development of innovative platforms and technologies.
• Clinical trial units are linked to a network of clinical experts and sites to conduct reliable and standardised clinical trials.

Building and strengthening domain-specific knowledge and management skill

The NBM facilitates skill development to build next-generation inter-disciplinary skills for business development capabilities, knowledge of navigating regulatory policies, product innovation, and better management of IPR systems and practices to create an effective workforce and next-generation leaders.

Creating and enhancing technology transfer capabilities in public and private sectors, including intellectual property management

The NBM provides increased opportunities for academia and enhances academia-industry interlinking to translate knowledge into technologies and products through the following activities:

• Setup of technology transfer offices in regions already established or are upcoming bio-clusters.
• Train intellectual property management and technology transfer professionals.
• Assist in the adaption and acquisition of technologies. 
• Create Intellectual Property (IP) awareness.

Implementation of NBM

The BIRAC manages the NBM through a dedicated Programme Management Unit (PMU). The most promising projects received by the BIRAC in response to its open request for applications issued by the PMU are selected. The projects are selected together with national and international experts.

Any applicant can visit the BIRAC website and apply for the current call of proposals stated on the website. To apply for proposals on the website, an applicant should log in to the BIRAC website and click on the ‘Click Here to Register/Submit Proposal’ button.

When the applicant does not have login credentials and is applying for the first time, he/she can click on the ‘Click Here to Register/Submit Proposal’ button on the BIRAC website and follow the login instructions. Next, the applicant must fill in the ‘NBM User Application’ and click on the ‘Register’ button. The applicant will receive the login credentials and can proceed to apply for the proposal.

The proposals will be assessed for eligibility and compliance with the requirements of the Request for Proposal (RFP) by the PMU. Further, the PMU will conduct the in-depth technical assessment and technical requirement of the RFP and send the full proposals to the Scientific Advisory Group (SAG) for final decision-making. The cumulative score from the SAG members will decide the final grantees.

The inter-ministerial steering committee oversees the mission activities chaired by the Secretary-DBT. The Technical Advisory Group (TAG) reviews scientific progress and provides approval of its components. The domain-specific Scientific Advisory Groups (SAG) are responsible for making scientific decisions and knowledge and oversight necessary for TAG for each activity or product development partnership.

Innovate in India (I3) Programme

The government launched the Innovate in India (I3) programme under the NBM. It envisages creating an enabling ecosystem to promote indigenous manufacturing and entrepreneurship in the biopharma sector. It is the first-ever industry-academia mission to accelerate biopharmaceutical development in India. It aims at filling the gaps in the pharmaceutical sector, such as:

• Lower focus on translational research.
• Unconnected centres of excellence.
• Staggered funding.

The I3 programme has a focus on the following verticals:

• Development of product leads for biosimilars, vaccines and medical devices relevant to the public health need by focussing on managed partnerships.
• Upgradation of shared infrastructure facilities and establishing them as discovery validations/product discovery and manufacturing centres.
• Development of human capital by providing specific training.
• Development of technology transfer offices to enhance industry-academia inter-linkages.

The  NBM would aid academic researchers and empower bio-entrepreneurs and SMEs. It will facilitate the enhancement and creation of IP management and technology transfer capabilities.

It will also bring isolated centres of excellence together and strengthen the current bio-clusters network in quantity, capacity and output quality. It would result in creating various dedicated facilities for next-generation skills and creating jobs in the process.