In order to stimulate, foster and enhance the strategic research and innovation capabilities of the Indian biotech industry, the Department of Biotechnology (DBT) has embarked upon a slew of initiatives.
Recently it has started the process of setting up the 'Biotechnology Industry Research Assistance Council' (BIRAC) which is being established particularly to give a boost to the small and medium enterprises. The setting up of an innovation support organisation like BIRAC will address the need in the government system for providing a comprehensive enabling environment and technology related service package to promote, nurture and support medium and high level innovation in biotech research. This would be particularly useful for small and medium size companies, and also support and facilitate creation of new start-ups.
It is under stood that after getting the cabinet nod, the department is currently engaged in the process of company incorporation for setting up the BIRAC by which the government aims to make India globally competitive in biotech innovation and entrepreneurship and to create affordable products and services.
BIRAC is being established as a separate body for supporting product innovation and providing required infrastructure and services at different stages of the value chain for promoting innovation and product development. It will provide funding and investment for early and late stage, including Small Business Innovation Research Initiative (SBIRI), Biotechnology Industry Partnership Programme (BIPP) and Ignition grant; technology transfer and acquisition in national priority areas; and technology development – incubators, parks, etc.
It will also provide support services such as IP facilitation, legal and contracts, regulatory and clinical trial facilitation; mentoring and capacity building.
The council would function as the government’s, inter-phase agency for supporting industry –academia interaction, which will service as a single window for the emerging biotech industry through which they can acquire knowledge, access world class R&D infrastructure, access rate limiting serious technologies and seek technical problem solving help regulatory advice.
Similarly in its endeavour to extend support to academia in the form of grant-in aid for validation of the proof of concept (PoC) by an industrial partner, DBT will soon begin a programme called contract research and services scheme (CRS).
The CRS scheme is being launched under the Biotechnology Industry Research Assistance Programme (BIRAP) which was earlier launched by the DBT with an objective to facilitate innovative research in the country in the field of biotechnology.
The scheme would support the academia-industry interaction between research institutes, universities, public funded research laboratories, governmental organizations, research foundations and companies/industries under the Public-Private Partnership (PPP) mode.
Under this scheme, public sector research institutes, universities who have already generated or have pre-existing scientifically established proof of concept/leads could seek support for specific research and validation process to be performed by a company partners within a defined time frame. The industry partner in turn would complete the validation phase in a contract research mode. In addition, if the Academic group requires some specific services from the industry such as toxicology, sequencing, use of specific equipment etc. these could also be supported under this scheme.
Public and/or private universities and research institutions can apply under the scheme with pre-determined company partners having DSIR recognized R&D/service units. For contract research, available leads should be at a level which provides sufficient data for scale up/validation and may fall under the categories but not limited to exploratory validation of technology; small scale contract research resulting in generating several batches of process or multiple prototypes; and large scale validation of prototype to commercial design.
Aiming to accelerate research initiatives in the field of fungi or invasive fungal infections prevalent in India, DBT will soon begin research in the domain of medically important fungi with focus on the aspects of molecular epidemiology, pathogenesis and mechanism of fungal diseases, diagnosis of invasive fungal infection and drug development.
The fungi or invasive fungal infections prevalent in India include Candida tropicalis and other Candida spp. that cause blood stream infections; Aspergillus flavus and other Aspergillus spp. involved in fungal rhinosinuisitis, ABPA and endophthalmitis; Zygomycetes; and Cryptococcus neoformans.
The focus aspects of molecular epidemiology for the programme included molecular genotyping of clinical and environmental isolates of Indian patients, and comparative genomics: phylogenetic analysis of Indian isolates and comparison with world-wide data.
The focus area under Pathogenesis and mechanism of fungal diseases included immune surveillance of specific genes for vaccine preparation, virulence factors, and development of in-vitro model systems for understanding host-pathogen interactions.
Under the diagnosis of invasive fungal infection, the focus will be on development of point of care immunoassays, DNA based diagnostics, and validation of diagnostic techniques.
And under the drug development category, the focus will be on Identification of enzymes and other targets for antifungal development Structure based design of compounds; QSAR studies; Susceptibility studies against different pathogens; Mode of action, in vitro enzyme assays, cytotoxicity; transport, resistance and mechanistic studies; and other routes for anti-fungal development – antimicrobial peptides, natural products, microbial secondary metabolites.
The DBT has already invited research proposals from investigators and scientists actively engaged in the field of Medical Mycology preferably in the form of multi-centric consortium.
Stressing on accelerating HIV/AIDS prevention related research including vaccines and microbicides development, DBT and the Indian Council of Medical Research (ICMR) will soon begin collaborative programme on “HIV/AIDS and Microbicides” to promote HIV/AIDS research in the related areas.
The programme aims to support a wide range of anti-HIV candidates including small chemically defined molecules, indigenous compounds, formulations, nucleotides, peptides and proteins targeting a range of relevant targets using a diverse range of delivery systems. In addition to iterative development of candidates, the programme aims to support studies in order to advance the understanding of HIV immunopathogenesis and host immune responses.
The programme also targets to accelerate research that will generate knowledge and develop state-of-the-art technologies to provide the basis for the development of HIV vaccines and novel therapies against HIV including microbicides.
The new collaborative programme will promote HIV/AIDS research in the areas such as 'HIV pathogenesis and vaccine related research' and 'microbicides related research'.
DBT has recently submitted the draft guidelines of Similar Biologics India September 2011 to the Confederation of Indian Industry (CII) to get their consultation and suggestions on the same. DBT is hopeful that after getting stakeholders view on the draft guidelines they will be able to hasten the process to implement the guidelines at the latest for the benefit of the industry.
The DBT's office submitted the draft guidelines to CII on December 27 after reviewing and approving the draft notes on clinical trials that was submitted by the Drug Controller General of India's (DCGI's) office to the DBT. It is reported that CII has already submitted the copy among its members in the industry to get their inputs on the guidelines.
DBT has been working on this guidelines from some time now so as to provide the industry with a unique set of rules that will help them in their growth. As of now, manufacturing and marketing of similar biologics in India are currently governed by the Environment Protection Act of 1970 and the Drugs and Cosmetic Act (D&C Act). Even though similar biologics is regulated under the provisions of these acts, there is no specific set of rules for this sector in the country today.
The 23 page draft guidelines submitted by the DBT contains introduction, background, objective, scope of the guidelines along with requirements for pre marketing and post marketing data. It states requirements for conducting clinical studies for phase I and phase II trials; extrapolation of efficacy and safety data to other indication etc. It also gives in detail, the applicable regulations, principles of developing similar biologics in the country.
The Department is expecting the inputs from the stakeholders soon so that they can proceed further on this matter. The Government is positive that the guidelines will be well accepted by all the stakeholders and if things go as planned, DBT is hopeful to get ready with the final draft guidelines by end of January. It is believed that the market for similar biologics will change significantly by 2015, as many well known biologic drugs are on the verge of patent expiration.
DBT also recently signed a collaborative agreement with US based National Institutes of Health (NIH) for conducting joint research in the field of bio-pharmaceuticals. Through this collaboration NIH and DBT plans to support research projects by sharing technological know-how between the two countries for the betterment of public health.
In a Memorandum of Understanding (MoU) signed between the Director of NIH and Dr Bhan from DBT recently both the countries agreed to work together to boost research and development (R&D) and conduct clinical trials. The agreement also focuses on taking forward initiatives that will focus on exchange of ideas on latest technological innovations between the countries.
According to Dr K K Tripathi, advisor, DBT, “We are very happy to initiate a strong working relation with NIC as it will help in strengthening the research efforts of both the countries. Most importantly it will aid us in jointly developing innovative research strategies that will help us in our goal of protecting and improving the healthcare in the country.”
He informed that as of now both the DBT and NIH has identified government institutes like Council of Scientific and Industrial Research (CSIR), National Institute of Immunology (NII), Institute of Genomics & Integrative Biology (IGIB) etc. for conducting research activities. However he added that since things at at a very early stage it would be difficult to comment any further on this.
“By signing this MoU, we have initiated a process to work together, however things will start to roll only after both the countries submit a proposal on this matter. It is our estimate that if things go as planned, then we can start our joint operations for the research in the area of biopharmaceuticals by early February next year”,Dr Tripathi said,
The collaboration between the DBT and NIH is in the lines of the Indo-US Vaccine Action Programme (VAP) which was developed earlier in order to expand collaborative vaccine research projects to reduce the burden of infectious diseases in India, US, and other parts of the world.