PREPARING FOR MODERN BIOTECH PRODUCTS IN INDIA
Part I
Introduction
Although recession has reduced the enthusiasm for investment in new ventures all over the world, some sectors of the industry like the biotech business have not yet been pushed to the walls. Hopes prevail in the opportunities emanating from new discoveries in the management of chronic and life threatening diseases; raising the productivities in agriculture; the use of green technologies in industry to reduce pollution; the utilization of degraded and waste lands by using modified stress resistant plants or treating solid and liquid waste using rugged natural or recombinant microbes and modified plants. Biotechnology applies a set of techniques developed though basic and applied research, using biological materials to produce, identify or design substances or to modify living organisms including human cells. Biotech products meet diverse human needs.
Government contribution to biotech development
Modern biotechnology applied through the use of recombinant DNA technology, is rather new to India. The whole sector, conventional and modern, has been promoted mainly through government departments like the Department of Biotechnology (DBT), Department of Science &Technology (DST), Department of Scientific & Industrial Research (DSIR), Ministry of Agriculture, Ministry of Health and a few other departments. The public money deployed through these sources, has been utilized to promote all aspects of biotechnology including manpower development, setting up of a basic and application oriented research institutions, funding for research, promoting the development of the technology and technology transfer, providing assistance to small & medium entrepreneurs, intellectual property protection, setting rules and procedures for fostering the growth of biotech industries and the like. Public institutions of the DBT, DST, Council of Scientific and Industrial Research, Indian Council for Agricultural Research, Indian Council for Medical Research, the University Grants Commission and the All India Council for Technical Education had carried out research and development in different aspects of biotechnology. The combined expenditure for promoting biotechnology in the country, starting from February 1986 up to December 2009 is estimated to be over rupees 5700 crores from the Government alone.
Investment by the modern biotech industry in India
During the last 2 decades several industries have made investment in modern biotechnology although earlier there had been sizeable investment in conventional biotechnology. Conventional biotechnology industries in India are more than 100 years old; the products raised through fermentation techniques include ethanol, acetic acid, antibiotics, certain vitamins, steroids, industrial enzymes, fermented foods and the like. Sera & vaccines have been produces by use of immunological techniques. The investment in modern biotechnology started from early 90’s and the first unit went into production on August 18, 1997 with the starting of basic production of recombinant hepatitis B vaccine in genetically modified Pichia pastoris. Thereafter, several units have come up. The modern biotech products include recombinant hepatitis B surface antigen based vaccines; granulocyte colony stimulating factor; erythropoietin; interferon alpha 2B and the pegylated product; epidermal growth factor; streptokinase; human insulin; and two monoclonal antibodies (MABs). One of MABs blocks certain receptors of epidermal growth factor and therefore, prevents the proliferation of certain cancer cells in breast tumor, and the other blocks the CD20 protein and thereby prevents proliferation and differentiation of cancerous B-cells into plasma cells in diseses like non-Hodgkin’s lymaphoma and rheumatoid arthritis. Several companies are also producing multivalent vaccines, combining hepatitis- B surface antigen in to them. The total investment in modern biotech industrial sector including those in modern vaccines is estimated to be of the order of rupees 1200 crores up to December 2009.
Indian Modern Biotech Industry in Global Context
The Indian Biotech Industry in the global context is yet small. The Indian contribution in the manufacture of modern biotech products was about 0.2% in 2005, which is expected to rise to 1.3% by 2010, compared to the global production. This situation is not surprising, considering the slow development of R&D in basic biology in the country and the weaker affordability of the high-cost medicines.
However, the reduction in costs followed by considerable use of some of these products during the last one and a half decade or so, clearly established the superiority of modern biotech products to prevent or treat certain dreaded diseases in India: vaccination with recombinant HBsAg particles to prevent infection from viral hepatitis B have reduced the incidence of the disease; use of insulin for treating diabetes has increased longevity and quality of life; use of streptokinase and t PA to dissolve the thrombus clot in myocardial infarction has saved many lives; treatment with erythropoietin to enhance the production of hemoglobulin in kidney failures has provided better quality of life with increased longevity ; treating cancer by using erythropoietin and G-CSF to induce concurrently the production of red and white blood cells has prolonged the life of the patients ; the use of in-vitro cultured mononuclear and endothelial progenitor cells from human bone marrow, osteoblast cell culture, messenchymal stem culture, melanocyte & keratinocyte cell culture and the likes followed by their use for conducting autologous transplants have benefited several patients for a wide range of ailments. These benefits had brought in societal demand for more availability of biotech medicines at affordable prices.
The microeconomic scenario is changing towards betterment significantly faster. This shall lead to greater purchasing power and affordability. The current per capita health expenditure of about USD 53 and allopathic drug consumption of USD 12, catering to and out-reaching the needs of only 40% of the population are indicators of potential untapped market. As the infrastructure gets better to cater to the increased need of more people living in the villages and as the microeconomic scenario improves, the demand for better biotech drugs shall obviously rise.
The commitment of government to make rapid stride for development in this area has consequently been strong and vigorous.
Modern Biotech is skill intensive
There are certain skills and instruments which have contributed greatly to the development of biotechnology around the world. This include Microscopy & Imaging; Air handling, decontamination & sterilization (space,equipment,materials and air) ; Recombinant DNA technology, recombinant products and monoclonal antibodies including the humanized ones; PCR technology; Proteins & Nucleotide Sequencing techniques and machines; Chromatography & Electrophoresis; LC-MS & MALDI-TOF for molecular weight determinations; Protein & DNA Chips and Micro arrays; Flow-cytometry & cell sorting techniques; in-vitro cell culturing including stem cell culture of various lineages ; and Bio-Informatics. Indian scientists, academia and industry use these skills in different aspects of biotech product development and management. All these skills were invented and initially developed outside India. Use of these skills is linked with the use of highly precise instruments, which India had to procure at expensive prices. Nevertheless, a large number of professionals have emerged within the country that can use these skills. Such skillful people and the instruments are the strengths on which Indian biotech industry has to be developed and expanded. Utilizing a combination of these skills the Indian industry produces the conventional vaccines, diagnostic devices, fermentation-based therapeutics including antibiotics, enzymes, vitamins, steroids and antilipidemics. As mentioned earlier, certain generic modern drugs are also being produced, utilizing recombination DNA technology. Additional production capacities shall be established on off-patent bio-similar products.
Industrial environment
There is an acute shortage of skilled leaders to run the modern biotech industry and to meet the company’s specific needs. The industrial environment is yet not strong to maintain robust levels of confidentiality and the issues of IPR are more public friendly. R&D institutions are not adequately linked with the industry and therefore, the knowledge flow is slow. The statutory requirements are often more demanding and the conformation criteria for the approval process under the statute are some times hazy for new products and techniques, which are to be first time introduced. The opinion makers are frequently biased . These situations need to be examined and better solutions need to emerge to benefit the industry.
Part I
Introduction
Although recession has reduced the enthusiasm for investment in new ventures all over the world, some sectors of the industry like the biotech business have not yet been pushed to the walls. Hopes prevail in the opportunities emanating from new discoveries in the management of chronic and life threatening diseases; raising the productivities in agriculture; the use of green technologies in industry to reduce pollution; the utilization of degraded and waste lands by using modified stress resistant plants or treating solid and liquid waste using rugged natural or recombinant microbes and modified plants. Biotechnology applies a set of techniques developed though basic and applied research, using biological materials to produce, identify or design substances or to modify living organisms including human cells. Biotech products meet diverse human needs.
Government contribution to biotech development
Modern biotechnology applied through the use of recombinant DNA technology, is rather new to India. The whole sector, conventional and modern, has been promoted mainly through government departments like the Department of Biotechnology (DBT), Department of Science &Technology (DST), Department of Scientific & Industrial Research (DSIR), Ministry of Agriculture, Ministry of Health and a few other departments. The public money deployed through these sources, has been utilized to promote all aspects of biotechnology including manpower development, setting up of a basic and application oriented research institutions, funding for research, promoting the development of the technology and technology transfer, providing assistance to small & medium entrepreneurs, intellectual property protection, setting rules and procedures for fostering the growth of biotech industries and the like. Public institutions of the DBT, DST, Council of Scientific and Industrial Research, Indian Council for Agricultural Research, Indian Council for Medical Research, the University Grants Commission and the All India Council for Technical Education had carried out research and development in different aspects of biotechnology. The combined expenditure for promoting biotechnology in the country, starting from February 1986 up to December 2009 is estimated to be over rupees 5700 crores from the Government alone.
Investment by the modern biotech industry in India
During the last 2 decades several industries have made investment in modern biotechnology although earlier there had been sizeable investment in conventional biotechnology. Conventional biotechnology industries in India are more than 100 years old; the products raised through fermentation techniques include ethanol, acetic acid, antibiotics, certain vitamins, steroids, industrial enzymes, fermented foods and the like. Sera & vaccines have been produces by use of immunological techniques. The investment in modern biotechnology started from early 90’s and the first unit went into production on August 18, 1997 with the starting of basic production of recombinant hepatitis B vaccine in genetically modified Pichia pastoris. Thereafter, several units have come up. The modern biotech products include recombinant hepatitis B surface antigen based vaccines; granulocyte colony stimulating factor; erythropoietin; interferon alpha 2B and the pegylated product; epidermal growth factor; streptokinase; human insulin; and two monoclonal antibodies (MABs). One of MABs blocks certain receptors of epidermal growth factor and therefore, prevents the proliferation of certain cancer cells in breast tumor, and the other blocks the CD20 protein and thereby prevents proliferation and differentiation of cancerous B-cells into plasma cells in diseses like non-Hodgkin’s lymaphoma and rheumatoid arthritis. Several companies are also producing multivalent vaccines, combining hepatitis- B surface antigen in to them. The total investment in modern biotech industrial sector including those in modern vaccines is estimated to be of the order of rupees 1200 crores up to December 2009.
Indian Modern Biotech Industry in Global Context
The Indian Biotech Industry in the global context is yet small. The Indian contribution in the manufacture of modern biotech products was about 0.2% in 2005, which is expected to rise to 1.3% by 2010, compared to the global production. This situation is not surprising, considering the slow development of R&D in basic biology in the country and the weaker affordability of the high-cost medicines.
However, the reduction in costs followed by considerable use of some of these products during the last one and a half decade or so, clearly established the superiority of modern biotech products to prevent or treat certain dreaded diseases in India: vaccination with recombinant HBsAg particles to prevent infection from viral hepatitis B have reduced the incidence of the disease; use of insulin for treating diabetes has increased longevity and quality of life; use of streptokinase and t PA to dissolve the thrombus clot in myocardial infarction has saved many lives; treatment with erythropoietin to enhance the production of hemoglobulin in kidney failures has provided better quality of life with increased longevity ; treating cancer by using erythropoietin and G-CSF to induce concurrently the production of red and white blood cells has prolonged the life of the patients ; the use of in-vitro cultured mononuclear and endothelial progenitor cells from human bone marrow, osteoblast cell culture, messenchymal stem culture, melanocyte & keratinocyte cell culture and the likes followed by their use for conducting autologous transplants have benefited several patients for a wide range of ailments. These benefits had brought in societal demand for more availability of biotech medicines at affordable prices.
The microeconomic scenario is changing towards betterment significantly faster. This shall lead to greater purchasing power and affordability. The current per capita health expenditure of about USD 53 and allopathic drug consumption of USD 12, catering to and out-reaching the needs of only 40% of the population are indicators of potential untapped market. As the infrastructure gets better to cater to the increased need of more people living in the villages and as the microeconomic scenario improves, the demand for better biotech drugs shall obviously rise.
The commitment of government to make rapid stride for development in this area has consequently been strong and vigorous.
Modern Biotech is skill intensive
There are certain skills and instruments which have contributed greatly to the development of biotechnology around the world. This include Microscopy & Imaging; Air handling, decontamination & sterilization (space,equipment,materials and air) ; Recombinant DNA technology, recombinant products and monoclonal antibodies including the humanized ones; PCR technology; Proteins & Nucleotide Sequencing techniques and machines; Chromatography & Electrophoresis; LC-MS & MALDI-TOF for molecular weight determinations; Protein & DNA Chips and Micro arrays; Flow-cytometry & cell sorting techniques; in-vitro cell culturing including stem cell culture of various lineages ; and Bio-Informatics. Indian scientists, academia and industry use these skills in different aspects of biotech product development and management. All these skills were invented and initially developed outside India. Use of these skills is linked with the use of highly precise instruments, which India had to procure at expensive prices. Nevertheless, a large number of professionals have emerged within the country that can use these skills. Such skillful people and the instruments are the strengths on which Indian biotech industry has to be developed and expanded. Utilizing a combination of these skills the Indian industry produces the conventional vaccines, diagnostic devices, fermentation-based therapeutics including antibiotics, enzymes, vitamins, steroids and antilipidemics. As mentioned earlier, certain generic modern drugs are also being produced, utilizing recombination DNA technology. Additional production capacities shall be established on off-patent bio-similar products.
Industrial environment
There is an acute shortage of skilled leaders to run the modern biotech industry and to meet the company’s specific needs. The industrial environment is yet not strong to maintain robust levels of confidentiality and the issues of IPR are more public friendly. R&D institutions are not adequately linked with the industry and therefore, the knowledge flow is slow. The statutory requirements are often more demanding and the conformation criteria for the approval process under the statute are some times hazy for new products and techniques, which are to be first time introduced. The opinion makers are frequently biased . These situations need to be examined and better solutions need to emerge to benefit the industry.
To be Continued...
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