Vaccines, biosimilars, biologicals which covers mAbs(monoclonal antibodies) and stem cell products are seen as future growth drivers of the biotechnology sector. While vaccines have proven to be the single most cost - effective means of controlling the spread of infectious diseases, biotech drugs like biosimilars and biologicals have also shown comparable quality, safety and efficacy to the original product but which are also cost effective. Stem cells have the potential to treat Parkinson’s disease, rheumatoid arthritis, multiple sclerosis, hepatitis, dermatomyositis, psoriasis, muscular dystrophy and even autism.
Indian companies are fast gearing up to tap the potential international market of biosimilar MAbs & other biologics estimated at $ 34 billion
Biopharma, which constitutes nearly two-thirds of the Indian biotech sector, invests in innovative product development. A lot of companies see more value in ramping up their service offerings even as they try to face the technological, financial and regulatory challenges, before they are able to offer cutting edge drugs in the market place, according to the Federation of Indian Chamber of Commerce report.
“Indian biotech has come of age and it is gratifying that it is now a $7.5 billion sector. The sector is set to touch $100 billion by 2025. Specifically with reference to bio-pharma, we see the growth contributors would be vaccines . One third of the global children are inoculated with vaccines from India. Biosimilars and biologicals are proving to be the hub of manufacture from the emerging markets and India will take a lead in the same, said Vision Group on Biotechnology, government of Karnataka and as the CMD Biocon Ltd, Kiran Mazumdar-Shaw.
The Department of Biotechnology (DBT), under its advanced technology scheme, Biotechnology Industry Partnership Programme (BIPP) and the Biotechnology Industry Research Assistance Council (BIRAC) has invited fresh proposals from biotech companies for providing support on a cost- sharing basis targeted at development of novel and high risk futuristic technologies mainly for viability gap funding and enhancing existing R&D capacities and manufacture of drugs.
The broad areas of research include biotechnological interventions for large scale production of high value products such as fine and speciality chemicals, antibiotics, vitamins, etc; improved enzymatic systems for new and more efficient bioprocesses that show increased yield, quality and purity through bioprocess design, process optimisation and downstream processing; and production of new and functionalized biopolymers.
The area of research also includes conversion of renewable raw materials into sustainable and cost-effective bio-products; bioremediation (using novel products or methods) and bioenergy (new biological sources and efficient production processes); and innovative down-stream processing (economic separation and purification processes for complex biochemical mixtures).
BIPP & BIRAP schemes
DBT is operating this BIPP scheme through BIRAC, a not-for-profit company set up by the DBT to promote and nurture innovation research in biotech enterprises specially start-ups and SMEs. BIPP is a government partnership programme with industry for support on a cost sharing basis targeted at development of novel and high risk futuristic technologies mainly for viability gap funding and enhancing existing R&D capacities of start-ups and SMEs in key areas of national importance and public good.
There is also a National Biotechnology Regulatory Authority Bill (NBRA Bill) which is expected to be cleared by the government soon, said Prof K Vijay Raghavan, secretary, DBT.
The bill seeks to regulate research, import, transport, use of organisms and product produced from modern biotechnology. It will be an independent, autonomous, statutory agency to safeguard the health and safety of the people of India and to protect the environment by identifying risks posed by, or as a result of, modern biotechnology.
There are several other bills like the ART Bill, HIV/AIDS Bill, Ethical Guidelines for Biomedical Research on Human Subjects Bill, Medical Devices Bill, which are awaiting for the final nod. Of the Parliament. The Biotech strategy 2013 which was expected to be approved during the recent Parliament session also got postponed.
The DBT is expected to unveil the Biotech strategy 2013 in April. “India is at the threshold of global developments and assumes significant role with its technical manpower but what is needed is valuable expertise. The strategy document would look at a four - pronged strategy to bring in the government, industry, research institute and global organizations to help the sector achieve its targeted revenues of $100 billion by 2025 from the current $7.5 billion. Developments in biotechnology so far is especially significant for an emerging economy like India that must balance its economic growth in the backdrop of diverse socio-economic challenges,” said Prof K Vijay Raghavan.
In this regard, DBT would continue to support in basic research and bring in the linkages . The strategy of 2013 would be to increase collaborations and this was the only way to support the basic research being carried out in the country. In fact DBT will support all partnerships for high quality standards in science and technology. Although our investment is small , we can be the rudder ensuring the direction and provide the connection with our teams in the department, said Prof. Vijay Raghavan
“ BIRAC and other funding options coming out of our department will encourage affordable product development and provide the base of the Biotechnology Strategy 2013. Increased interactions with the industry is the way forward because life sciences research is a dynamic world. The world is changing and therefore only those who are agile can succeed. We cannot afford to be myopic. The reality is that engines of modern science and technology are still far from India. Indian biotechnology cannot afford to be isolated and it now needs to grasp every opportunity coming its way.
We need to be aware of this and this is where an interactive situation will provide a steady flow of outcomes that will help the sector generate the revenues and the growth. The Biotechnology Strategy 2013 documents will provide much of these and be an enabler of inclusive and sustainable growth", added Prof. Vijay Raghavan.
Biocon, Intas, Anthem Biosciences, Serum Institute, Reliance Lifesciences, Panacea Biotec , Novo Nordisk, Shanta Biotech a Sanofi, Strides Arcolab, Indian Immunologicals Limited (IIL) and Bharat Biotech are the major biotech players in India.
Biocon, India’s largest biotech conglomerate has clocked Rs. 1194 crore in 2012-13. The company is building the India business and expertise in biologics. It is working to reduce therapy costs of chronic diseases like diabetes, cancer and autoimmune diseases by leveraging India's cost advantage to deliver affordable healthcare solutions to patients, partners and healthcare systems across the globe. The core expertise of the company is small molecules, biosimilars, branded formulations, research services and novel molecule development. In the area of novel molecules it has entered into an option agreement with BMS for our novel asset, a prandial oral insulin: IN- 105 and its Itolizumab has received marketing approval received from Drugs Control General of India for Psoriasis in India.
In the area of biosimilars, it has expanded its partnership with Mylan to include the insulin analogs. For its biosimilar insulin, it completed the part II of the EU Phase III trial with Insulin Glargine successfully completed global Phase I trial . Further it is also completed the patient recruitment for the global phase III trial initiated for Biosimilar Trastuzumab.
Companies like Intas, Anthem Biosciences, Serum Institute, Reliance Lifesciences, Panacea Biotec, Novo Nordisk, Shanta Biotech have also a research and manufacturing pipeline.
According to Shaw, the Indian bio-pharma industry is witnessing major challenges due to ongoing regulatory uncertainties and policy making based on knee jerk reactions.