Indian biotech sector is valued at over Rs. 20,000 crore and is registering a growth of around 20 percent. It is one of the fastest growing knowledge-based sectors in the country and is expected to play a key role in shaping the rapidly developing economy.
Ranked among the top 12 biotech destinations in the world, the Indian biotech sector is the third largest in the Asian region. The sector is at the forefront of the scientific research and the country is a key location for the developments of biotechnology in Asia because of its expertise.
There are around 325 biotechnology companies in India, employing around 20,000 scientists. The industry can be divided into five sectors which cover bio-pharmaceuticals, bio-services, bio-agriculture, bio-industrial and bio-informatics.
The global biotechnology industry, currently estimated at US$ 125 billion has shown robust growth over the past five years. Scientific advances and changes in market conditions have produced a rapidly maturing industry, with pharma biotech being one of the largest sectors. Frost & Sullivan estimates the global biotech industry to reach US$ 433 billion and the global biosimilar industry to reach US$ 19.6 billion by 2015.
In the last five years , Asia and particularly India have seen high growth in biotechnology. The regions have witnessed significant investments from global majors because of the adherence to Intellectual Property Rights and presence of a vast pool of skilled expertise.
National Biotechnology Regulatory Authority of India Bill
A major development from the government stand point was the National Biotechnology Regulatory Authority of India Bill (NBRA Bill), which was introduced on December 21, 2011. The much awaited Bill has sought to make the National Biotechnology Regulatory Authority of India as an independent, autonomous, statutory agency to protect the health and safety of the people and maintain an environment by identifying risks posed by modern biotechnology. The Bill seeks to manage risks through regulating the safe development and deployment of biotechnology products and processes. It will now streamline the process of regulatory approval for biotech products through a single window agency. As biotech products are more complex than the chemical drug molecules, more specialized information needs to be considered during the approval process to decide whether they are safe, efficacious and suitable for human use.
Further, the Bill will regulate research, import, transport, use of organism and product produced through biotech processes. Further, the National Biotechnology Regulatory Authority of India will have powers on matters related to the development and deployment of biotechnology products and processes in the country.
The Bill which was drafted by the Department of Biotechnology (DBT) has taken the views of all stakeholders across the country. In fact the DBT had organized deliberations with the experts in major cities like Delhi, Bangalore, Hyderabad, Chennai, Mumbai and Kolkata.
DBT initiatives
In April 2011, the Department of Biotechnology (DBT) stepped up its focus on bio-pharma by setting up centres of excellence, support basic and applied R&D in universities and institutions. Over the last five years, it received Rs.7, 000 crore funding to increase its biotech research and manpower training efforts. Of this Rs.400 crore has already been invested in its varied activities.
Initiatives like the Biotechnology Industry Partnership Programme(BIRAP) to provide industry the support by cost sharing on high risk discovery and innovation projects are giving fillip to the bio-pharma sector as there are already 100 applicants of which 80 are in the bio-pharma space and the remaining 20 percent in the agri biotech segment.
Further, DBT will also encourage universities and colleges to seek grants to organize training programmes for technicians in lab methods and related techniques. It will also help to establish affiliation with recognized universities and institutions of higher learning for the purpose of enabling research scholars to register for postgraduate degrees. In addition, it will also promote effective linkages on a continuing basis between various scientific and research agencies/laboratories and other organizations working in the country in the field of immunology, vaccine development and related areas.
“Today, more than 200 laboratories and 1,000 researchers in public and private sectors are engaged in biology; research and development; molecular marker assisted diagnostics; genome sequencing and functional genomics. Technology platforms, research resources, facilities and services coupled with training skilled human resources, networks and public-private partnerships are supported in the pathway from discovery to market for desired level of development”, said Dr S.R. Rao, advisor, DBT.
There is a massive effort to enhance infrastructure which includes setting up modern labs and training institutes for which funds are set aside. Vaccine development, genomics and proteomics are some of the future areas that will be addressed by DBT. There are funding options for research, capacity building and human resource development, he added.
In order to capitalize the best from the global majors, the DBT in 2010, pursuant to the memorandum of understanding of October 25, 2004, with the Danish Ministry of Science, Technology & Innovation decided to further develop and strengthen the Danish-Indian research collaboration within the biotechnological area.
India and Denmark commenced a strategic research collaboration in biotechnology covering aspects of nano-science, nanotechnology, bioengineering and bioinformatics in bio-resources, biological manufacturing and biological products. The main objective to collaborate was to intensify the research effort within these areas and to integrate the specific competencies of the Indo-Danish research groups involved. Under the project, researchers from universities, research institutions and private companies in India and Denmark conducting research within the biotechnology area and also sought for funding of joint Indo-Danish strategic research collaborations.
India: Home to highest vaccine manufacturers
Vaccine is one of the leading biotech produced via the fermentation route. The country is home to the third highest number of manufacturers and is known for the largest production of vaccines. Some of the companies are the Pune - based Serum Institute, New Delhi’s Panacea Biotech, besides two of Hyderabad-based manufacturers: Shanta Biotech, the Indian vaccine arm for Sanofi Pasteur which introduced the country’s first genetically engineered the recombinant Hepatitis B vaccine ‘ Shanvac-B,’ and Bharat Biotech.
Biotech: Driver of innovation and economic growth
The national and international biotechnology industry is now at the beginning of a technology curve whose upside potential appears limitless. The Indian government is considering biotechnology as the next driver of innovation and economic growth. Biotechnology has made phenomenal success in India in almost all the sectors primarily in healthcare according to Rajashree Sharma, Partner, Corporate Law Group, New Delhi.
A huge support for the onset of biotechnology in India via entrepreneurs has been through private equity and venture capitalists. As the biotech industry in India catapults to grab a share of the global pie of business, international companies have evinced considerable interest in India through foreign direct investments or via the mergers and acquisitions route.
Between January 2010 and October 2011, some of the mergers and acquisitions were Abbot buyout of Piramal domestic formulation business, Reckitt Benckiser’s purchase of Paras Pharmaceuticals and the acquisition of the nutrition business of Wockhardt by Danone. Prior to that it was Daichi’s acquisition of Ranbaxy, Sanofi and Shanta Biotechnics, Hospira and Orchid, Mylan and Matrix Labs.
The alliances that helped to achieve productive collaborations from India are Bayer and Zydus, Eli Lilly and Lupin, Novartis and USV, Sanofi and Glenmark, Merck and Sun Pharma, Endo Pharma and Jubilant, GSK an DRL, Pfizer and Aurobindo and Astra Zeneca with Torrent.
Some of the investments that have come in between 2010 and 2011 include Biocon’s subsidiary Clinigene International and Pacific Biomarkers Inc (PBI), a Seattle, Washington-based limited liability company, inking a collaborative agreement to address the specialty biomarker and high-end clinical trial laboratory needs of the global pharmaceutical and biotechnology industry which took place in December last year.
Kemwell Biopharma Pvt Ltd and Avesthagen signed a Memorandum of Understanding (MoU) to enable the latter to leverage the former’s biopharmaceutical manufacturing expertise for large-scale manufacture of biosimilars. Avesthagen has a portfolio of eight biosimilars under various phases of development in the areas of autoimmune diseases, cancers, anaemia, and cardiovascular disorders.
India, an emerging bio economy
For over a decade, the Bangalore India Bio event has helped catapult the industry from a manufacturer to a service provider which has given a boost to the capabilities of the sector, said Dr. MK Bhan, Secretary, DBT.
This year’s event theme, ‘India- the emerging bio economy’ will focus on creation of job opportunities and encourage investments in start-ups.
According to Dr. Satya Dash, Chief Operating Officer, Association of Biotechnology Led Entrepreneurs, India (ABLE), “The biotechnology & healthcare sector in India will significantly contribute to the nation's GDP in the future and offer innovative solutions to challenges that are both national and global. This year's agenda of the conference therefore reflects a wide gamut of subjects and issues that will influence India's rise as an bio-economy from its strengths in biopharma, manufacturing in bio-similars, contract & clinical services, stem cells, next generation sequencing and its impact on healthcare to nascent segments such as synthetic biology.”
Biotech industry needs to create an experimental culture, foster an entrepreneurial environment, and incentivize business differentiation, said Kiran Mazumdar Shaw, CMD, Biocon Ltd and the Chairperson of Karnataka vision group on Biotechnology.
The recession of 2008 has created a siege mentality across businesses. Innovation-led companies have become bankrupt. R&D is going through an economic wringer. Corporates have crimped R&D spend and the West has seen largescale retrenchment of scientists . In fact, biotechnology companies could scare up much lesser in the last decade. In this scenario India is looked upon as a beacon of hope to bail out the West from this crisis and also seen as a global enabler of affordable drug development, she added.
Innovation is becoming increasingly unaffordable in the West. New drug development is becoming more expensive. As a result, generic drug manufacturing has shifted from the West to India and China. The West is also not able to get sufficient patients to carry out clinical trials. In a way it is good because it shows the general health of the public is improving. However , that is only in the West. In developing and underdeveloped nations, there is no dearth of patients, which is a pointer to the scope of conducting clinic trials in these regions said Shaw.