Developmental Scenario of Small and Medium Indian Biotech Industries

Small and Medium biotech industries shall come up in large numbers through entrepreneurial efforts in the country. Entrepreneurial journey begins with ideas, which may or may not be novel but they have to be stewarded through entrepreneurial innovation.

The ideas that are market driven, that are strategically and economically attractive, that are durable and timely shall produce goods and services, which are valuable to the user and the consumer.

Entrepreneurs are people who can take risks, who are comfortable with ambiguity and who are determined and strongly willed against adversity. Generally, they have a clear vision for moving towards success.

Entrepreneurs plan every step of their venture. The analysis includes competitor spectra, product description, product developmental and improvement plan, marketing plan, access to finance and analysis of critical risks.

Small and Medium entrepreneurs are at heavy risks however. Their success possibilities brighten in an encouraging environment, which includes multilateral support from the government in every critical step including obtaining licensing, land acquisition, waste handling methods and their placement in a cluster of similar industries with sturdy and durable communication and transport infrastructure. Success factor also requires ease of partnering with academics and an environment for strong intellectual property protection.

In most of the above areas, India is trying to extend support to the industries. Several State governments are trying to create a cluster of biotech industries by encouraging entrepreneurs to get together at the Biotech parks. They are also trying to create incubators within the park to provide premises that have strong developmental infrastructure and instrumental support for easing the conversion of ideas into products and services. In States, where the incubators are established, such facilities shall ease the induction of several knowledge-based small and medium biotech industries. As biotech product development is highly capital-intensive and requires strong instrumental support, the States that have planned for incubators and formation of clusters shall do much better than the states that are only providing land.

The Indian Central Government through the Department of Biotechnology is trying to promote skill development at different public funded institutions and universities. Many states are also supplementing such efforts. All these efforts would provide a good number of skilled young people, trained in profound biotech skills for the country. The Central and the State governments are also creating excellent web sites, which are rich in modern biology related information. All these efforts are moving in the right direction.

One of the essences of development is time management. There is fierce competition all around the world to take advantage from biotech research innovation and development. One of the shortcomings which are observed in most of these national endeavours is that they are not moving at the right speed. Too much of time spent in implementation is likely to have its debilitating negative effects. Therefore, all the biotech projects must pick up more speed so that the efforts are more prominently visible.

The money available for the development of small and medium biotech industries from different sources is also adequate. While the basic knowledge development is therefore inadequate, the shaping of the innovations into competitive products and services is also getting affected. There is a need for putting more thoughtful efforts to prioritize areas for basic research and applications at the national level and to allocate adequate funds for making the country more innovative in biotech industry sector in the global context.

JANAKPURI, WEST DELHI (INDIA)

Most of us, the Bengali residents of Janakpuri are the migrants from outside Delhi. We came to this part of State in search of a job and a reasonably cheap residential place, as we had to stay somewhere in Delhi. Delhi provided us with jobs and opportunities for becoming prosperous.

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Even though we have been migrants during the recent time, Delhi had been the seat of attraction for a long time for the migrants from different parts of the world for more than several thousand years! Delhi has therefore, a social face and culture of mixed heritage. The unified but complex fabric of Delhi can be visualized from its history. We can also peep in to the events that evolved over time for the creation of our Janakpuri!

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The present Delhi became the focus of human activities after the British Empire was shifted to this city in 1911 from Kolkata. But another six hundred years earlier, Delhi was important only for parts of the present India; the Turkic and Afghan dynasties ruled from Delhi during 1206-1526, emplacing the Muslim culture. During that period, Delhi was administratively cut off from most parts of our modern India. Sizable parts of the eastern, the southern and the western region of the present India were not then the parts of the land under the rulers of Delhi. The Mughal period (1526-1857) brought in substantial portions of eastern, southern and western India under its control and enlarged the seeds of broader human integration in culture and practices. The British Empire was thereafter responsible for catalyzing total integration of the present day India, where vibrant inter –regional amalgamation stated to be seeded. British India was divided and independent India was created in 1947. This act resulted in huge human migration and increased Delhi's population in a short period. The migrants started to occupy open spaces and the civic services virtually collapsed. This required the creation of a systematic planning and controlling authority to check the haphazard and rapid growth of the city; as a consequence, the Delhi Development (Provisional) Authority was constituted in 1955, which on 30 December 1957 became the Delhi Development Authority (DDA). DDA became the 9th builder of the grand city of Delhi. Our Janakpuri was conceptualized in early sixties; the DDA started allocating built-in flats and developed land thereafter. Brisk growth and expansion of population started from early seventies and it soon became a vibrant residential colony in West Delhi-thanks to the efforts of the DDA. DDA promoted the human intergration process by alloting lands and flats to every Indian from all corners of the country, whoever came to Delhi to stay permanently and had a source of livelihood here.

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The present Janakpuri is one of the best middle class residential colonies in West Delhi. The population is well educated, and comprises of people from different parts and regions of India; the people represent the symbol of integration of varied cultures of the great country. The place is well connected through road and metro transportation. Chartered buses ply from almost all blocks up to the corporate offices in and around the National Capital Territory of Delhi. Good schools like the Central School, the Government Schools, St. Marks, St. Francis de Sales and D.T.E.A Senior Secondary Schools exist. Janakpuri has also a Delhi University College and a technical studies institute. It has a strong network of public health services, which include hospitals, clinics and nursing homes. A super specialty hospital is under construction. Business interest is also vibrant. A state-of-the-art hotel of the Hilton Group is established at the Janakpuri District Centre Complex. A number of Temples such as Paschim Delhi Kali Bari, Sri Rajarajeshwari temple, Kripa Dham, Ganesh Mandir, Shiv Mandir, Hanuman Mandir, Ram Mandir and other temples have been constructed. Gurdwaras, Churches, Masjids and other places of worship are also vibrant. The secular picture of the country that is India is thus truly represented in Janakpuri. The Janakpuri Bengali Association is constructing a community centre, which has been named as the DURGABARI Community Centre. The construction work has made progress at the allotted site of the land.

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Our DURGA BARI is our worshiping place. We have also a project to complete. Our project is moderate with many noble objectives. We would construct a library, promote literacy, train young people in songs, promote learning of dances, and accelerate acquiring the wisdom of computer-operations, set up an internet service and the like. All these can be started after our Community Building DURGA BARI is fully constructed. In the meantime, we extend availing of parts of our space for various social and cultural practices. Anyone around can contact us for their needs.

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Janakpuri in Delhi is becoming an abode for people of all religions who have migrated to his place from different parts of India.

PREPARING FOR MODERN BIOTECH PRODUCTS IN INDIA

Part II

Priority and choice in the Biotech sector

Around the world, of all the sectors of biotechnology, health care is presently receiving highest attention for technology development and product use. The major product groups are r-DNA based therapeutic substances, vaccines, diagnostic devices and humanized monoclonal antibodies. Stem cell research is also progressing with rapt attention. Tissues specific deliveries through nano technology are other areas of considerable interest.

In the development of r-DNA products it is important to develop expertise in the cloning of certain cell types. Most of the presently used products deploy Eschricia coli, Saccharomyces cerevisae. , Pichia pastoris, Hansenula polymorpha and Chinese Hamster Ovary (CHO) cell lines as their workhorses. In a few cases, BHK and VERO cell lines have been used. Baculovirus mediated insect cell lines are also gaining acceptance. Indian industry has narrowed down its choice to E.coli, P.pastoris , and CHO cell line based products; only one company has preferred to choose insect cell lines. More than 60% of the modern biotech products, which are mainly highly glycosylated therapeutic proteins, are presently made in CHO cell lines. Therefore, Indian expertise in the handling and use of CHO cell lines must enlarge and increase.

Biotech operations are another important area where right choice of processes must be made. Since the volumes are small, the use of glass reactors or the SS reactors for cell multiplication can be alternate choice options. If CHO cell lines are the main workhorses, it is beneficial to look for disposable plastic bioreactors to cut down the cost of sterilization, which is sizable.

Chromatography is a down stream processing operation of choice where standardization is required to minimize the use of columns; rugged columns with efficient resin matrices must be used that can be resorted to cleaning in place (CIP). Membrane adsorption techniques can be coupled with multi-tier chromatography to enhance through puts. India is not yet an efficient producer neither for resin matrices nor for separating membranes.

Formulation development is another area where success would depend upon simplification and the use of simple, easily sterilizable substances. In all these areas, Indian development is expected to be significant in coming years.

Stem cell research has picked speed and products are on the horizon. Autologous transplants using in-vitro cell culturing are on the rise. One aspect of the activities comprises isolation and preservation of the embryonic stem cells. This work had made considerable progress with the hope that methods shall soon be in place to multiply them in the desired direction for differentiation to meet the tissue specific deficiency needs. Such manipulative generic procedures have not evolved yet. Therefore, embryonic stem cells preservation has slowed down. Another technology is under development; efforts are being made to develop the re-programming techniques to induce pluripotency in aged genomes to reverse the aged DNA in to their youthful forms. Such work requires advances in retro and non-retroviral means of over expression of certain oncogenes into engineered cell types. Non-retroviral means would be preferred as the retroviral means change the chromosomes considerably through the insertion of viral DNA, which is not preferred. Research in these directions is very expensive; success is not assured. Therefore, Indian focus of research in these areas may be diminutive.

Tissue target specific deliveries requiring use of biodegradable polymers and nano particles are other areas where high technologies can be developed and Indian industries can be set up.

In agriculture, production of transgenic plants has made considerable progress around the world. The application areas are based on nuclear integration of a wide range of transgenes. Therefore, the traits are expressed in both pollens and angiosperms. Transgenic DNA insertion only into the chloroplasts is being experimented upon to impart and preserve transgenic characters only in the maternal part of the plant. Commercial plants are not yet released. This technology, when matured and made to commercial use shall put to rest several environmental risk issues. Transgenic animals are yet at the developmental stage for application; some transgenic fishes containing multiple copies of growth hormone genes have been released, which have increased feed conversion ratio.

In Indian context, biotech seeds and planting materials hold great potential. The Bt-cotton story is revealing; extensive deployment of transgenic Bt –cotton has not only been responsible for increased production of better quality of cotton lint, the technology has also reduced the usage of chemical pesticides in the environment. The technology is deployed from multiple sources, resulting in severe competition and reduction in the selling price of GM seeds. In order to sustain Bt-technology over the years, multiple Bt-genes inserted plants need to be developed and deployed to delay the emergence of inset-resistance in the field. Bt-technology means insertion of the toxin producing genes of Bacillus thuringiensis, mostly known as Cry genes of the bacterium; Bt-Cotton contains Bt-Cry1Ac genes covalently inserted into the genome of the cotton plant.

The apparent success of Bt-cotton technology in India has not been able to promote usage of genetically modified planting materials for other crops. The main impediments are: a) Environmental safety issues, b) Human and animal food safety issues and c) the issue of dominance of private seed companies thereby transferring control of agriculture and especially food to them.

The environmental concerns hover around the threat of contaminating the closely related natural germplasms, cultivated or wild, by transgenic nucleotide sequences, spreading residual toxins secreted by insect-toxin-producing genetically modified (GM) plants, in to the soil, and resistance development in the target insects in situations where GM plants code for toxic proteins. Besides, some GM plants may carry antibiotic resistant genes; their free access to agriculture may hasten the development of pathogenic microbes in to antibiotic resistant substances. On food safety issues, different models of animal feeding trials have been designed and data generated.

All the above issues are always taken in to consideration by the regulatory authorities and decisions are made based on scientifically generated data on a precautionary principle. However, having regard to the limitations in the scientific tools as developed presently, certain issues cannot be fully resolved. Different countries have therefore taken different stand on GM plants. Fortunately, whichever countries used the technology in their soil, they stood to gain. Several countries have adapted to production of GM crops. Up to 2009, 25 countries all over the world had planted 134 million hectares to produce maize, cotton, soybean, canola, squash, papaya, tomato, potato, beet and alfalfa as major crops. All countries including USA, Canada, Mexico, South American countries, Australia, China and India have benefited from GM crops. In Europe, Spain, Portugal and certain East European countries like Czech Republic, Poland, Slovakia and Romania have adopted GM technology. Europe, Russia, Ukraine and Kazakhstan, Japan, Arabian countries and African countries (except South Africa) have not yet used this technology; their reluctance to this technology is not well understood.

The argument about creating dominance of private seed companies for GM crops/seeds can be addressed by conducting more research in public funded institutions. Concomitantly, a strong environment of competition has to be created by enabling multiple players to enter in to the market place. Multinational dominance can then be minimized and prices of GM plants/seeds can be rationalized. This has happened to a great extent in Indian Bt-Cotton technology application; there are several players in the market place, and as a result market forces have considerably rationalized the prices of GM-seeds of Bt-Cotton.

India has not yet created its strong presence in research in GM crops in its public funded institutions. If this is done, the benefits would accrue. GM plants have great possibilities of contributing to agricultural productivity, other inputs being same.

GM fishes are also other areas where the world community is strongly pursuing research. The feed conversion ratios are being improved by incorporating multiple copies of growth hormone genes into economically important fish. Such experiments can also be carried out in birds and animals. Indian developments or success stories in these areas are meager.

India must prioritize

Human health and agriculture are the two main sectors in modern biotechnology which are expected to impart considerable gains to the country.

Health of the people decides how the economy of a country shall be. Good community health determines the social development; it is the indicator of the earning power or the poverty- status of people. Medicines from modern biotechnology shall ensure prevention and recovery much quicker. But they must be available for use. The disease burden must therefore be addressed in the national context. Several neglected diseases of the poor including tuberculosis, malaria, diarrhea, trypanosomiasis, dengue, leishmaniasis and lymphatic filariasis are responsible for many man-day losses in productivity. HIV is also becoming a major threat. Indian biotech has to address these problems and come out with robust solutions. In other major areas that contribute to significant loss of man-days such as diabetes, cardiovascular diseases, cancer and mental health disorders, efforts have to be made to have access to current biotech drugs to treat these disorders. The innovation platform can be drawn up professionally on a national drawing board. The plan needs to be piloted by the government, which has to generously shell out the resources through a mechanism involving the industry, the specialists who would invent and discover, the money providers and the vocal public. Private money for basic research may be available after public institutional research starts bearing fruits.

With the rise of the growing middle class and with microeconomic growth percolating to the rural areas, there will be the creation of demand for the latest biotech drugs. It is anticipated that the basic production of many of these would not be possible locally due to strong protection of existing technologies and their non-availability to others even though there are compelling reasons. To meet the needs of the poor people in India is different from meeting those in the developed countries. Poor men in India run a much more handicapped race for survival than their counterparts in rich countries. To bring in equity to Indian poor people, government may have to step in and create an enabling environment. Provisions in the existing Indian Patent Law may be inadequate for instituting compulsory licensing authorization. Newer approaches for registration/authorization for the sale in India for the expensive imported products, required for masses in life-threatening situations may emerge in the country in public interest. The provisions of Essential Commodities Act of the country may become handy to tackle such situations.

One of the elements of success in the long term lies in the conduct of basic research. But India has to prioritize its need-based areas, where basic research has to be intensified. It would not be beneficial to pursue the same areas of basic research that the skilled scientists learn elsewhere, which has less relevance to Indian needs. The question is how some of the basic needs can be addressed through basic research and how can this be made attractive to the young scientists.

There is a great need to develop innovative processes for biogenerics and bio-similar products. These can be low pick fruits. A large number of these have become off patent and many others are going out of IPR. Innovations for developing biogenerics scarcely attract the best talent. This is because such work often does not lead to high-class publications. There is a need to develop strategies to attract young talented scientists in this area.

Mass production of multivalent vaccines and diagnostic agents at affordable prices shall enable the improvement of health of Indian children as well as the aged. This will make a great impact to the country. Products can also be exported. India has developed great skills in these areas. More can be done to meet the global needs of the poor.

Novel drug delivery and nano technology require relatively less investment. Industry can concentrate to develop products in these areas for diverse applications.

In all the above areas, innovative processes and products cannot generate extraordinary revenues. There shall be the presence of several companies to explore the opportunities and therefore severe competition will compel reduction of prices, thereby affecting profitability. Some successful companies shall make gain through these activities; however, the revenues shall not be able to generate enough surpluses to plough back for conducting basic research. There is no escape from entering into basic research if the aim is to develop jackpot products. Novel products can only generate enough surpluses, part of which can be ploughed back for more basic research.

In agriculture, basic research for developing highly productive plants and animals including fishes can be intensified in a planned manner so as to harvest the benefits over a period of time. Agricultural productivity increase is driven by scientific discoveries, innovation, new technology development and their adoption by farmers. Of the various discoveries in agriculture, development of GM plants and animals hold great promise Plants must be selected to develop national programs for productivity increase. Field crop improvement through rapid DNA sequencing followed by selection of better genomic traits, use of marker assisted breeding, deployment of double haploid breeding for crossing species and selected such techniques can be extensively used to improve productivity. Projects can be implemented on selected plants for improving the nutritional quality of cereals by enhancing levels of proteins, carbohydrates (where applicable), oil, anti-oxidants and vitamins. Oil bearing seeds need to be selected to convert them into GM plants that produce specific kinds of oils to meet human health and other needs. Basic research may be intensified for the identification and isolation of drought resistant genes and their insertion in to appropriate cultivars, isolation and insertion genes for protection of plants against rootworm and cutworm and other pests and diseases, development of improved root structures etc. Insect resistant and stress tolerant plants of diverse nature may be developed in a planned manner to address the needs of the specific agro-climatic regions. Transgenic animals with emphasis on high Feed Conversion Ratio need also to be developed. Since all these projects require large amounts of money, they must be initiated at the basic level in the several public-funded agricultural and other national institutes in the country with extensive foreign collaborations, where available.

“Invention” -selective and “Innovation” proneness: the backbone for survival

India has severe resource constraint. Tropical neglected diseases and some other factors are still responsible for sizable man-day losses; many such diseases pull back the country towards ill health, morbidity and even mortality. Malnutrition and iron deficiency are other neglected areas. Cheap and effective medicines are not available in many cases. Companies have considered investments in these areas, as economically unprofitable Investment is selected such areas should be deliberately pushed for conducting basic research and applications. Public funds and innovation-friendly policies can make inroads for more investment in these areas within the country.

Specific programs of basic and application-oriented research should also be initiated in agriculture and animal husbandry practices including fisheries as discussed earlier.

Innovation, which is the backbone for acquiring proficiency and an edge, has to take a quantum jump to enable India, to make significant contributions in the global context. In- house technologies for deployment shall not be many; imported technologies shall be expensive. Cutting edge technologies shall not be available for purchase. India realizes this and of late has started paying considerable attention towards developing its own technologies. Several strategies are being opted for, which include strengthening own R&D capabilities, teaming up with institutions and technology companies, buying / acquiring biotech companies that have core competence and the like. It is necessary to examine if these strategies adequately cover the vulnerability of the Indian biotech companies and the people to receiving abundant supply of modern biotech medicines at affordable prices and increased productivity in agriculture so as to keep up the availability of nutritious food and feed for the country.

Concluding Remarks

The scenario of biotechnology industry in India is going to be complex and multifarious. While there shall be considerable increase in the production of conventional biotech products including sera and vaccines, diagnostic devices and fermentation based therapeutic substances, the modern biotech products deploying recombinant DNA technology shall hover around patent expired therapeutics and diagnostics in the healthcare area. In agriculture, backcrossing by using GM plants containing specific genes borrowed from outside shall be used to develop GM plants of diverse nature. However, their acceptability to the common man will be a grey area till other countries, especially Europe come up to accept those in their commercial agriculture. In this context it is emphasized that one of the ways of raising productivity and reducing production costs is to use GM seeds. This factor cannot be lost sight of. On a priority basis, research on GM seeds in public-funded institutions must be pursued more vigorously; matured transgenic technologies be developed and kept ready for use in commercial agriculture. The present time shall change and soon societies shall look for GM technologies, when the preparedness shall come handy.

Government support especially in the form of providing seed capital shall encourage the expansion of new industries in the small and medium scale sector in several areas of biotechnology, specially in the healthcare area. Societal demand shall encourage the registration of high-tech new products, the technologies of which are developed outside India. Such products shall be expensive and it would not be easy for a common man to afford them. Therefore, cheaper substitutes have to be in place even though they might not be as effective. As the reimbursement of medical treatment costs is not liberal and adequate for a common man, the situation is likely to contribute to societal turbulence. A difference can be made only through appropriate planning, prioritization, action and implementation.

There is much turbulence ahead over a period of another four to five decades. There has to be perception for such turbulence and long-term steps must be taken to minimize its adverse affects to the people.

Concluded

PREPARING FOR MODERN BIOTECH PRODUCTS IN INDIA

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.

To be Continued...

PEOPLE DEAL WITH DIFFERENCES IN ORGANIZATIONS, BUT FOR EFFECTIVENESS IT MATTERS HOW ....

Every human has a way to live, survive and prosper. These ways and means are distinct. Minutely examine, there are ingredients of unique identifiers for each. But we can seldom correctly identify each of the factors that constitute exactness. When we develop understandings with others, we are close to those identifiers, to which we modulate and moderate our adjustments to create closeness. But how do we do the spontaneous adjustments are not understood yet.

The uniqueness in each human arises from four distinct nano-characters. These are the distinctiveness of each mind, exceptionality of intelligence, individuality of every ego and the matchlessness of all memories. For every input that a human receives, the processing takes only a few moments and the reaction emerges. Not all reactions are fully expressed in one go! And therefore, the feedback processing to react can go wrong. Consequently, the output reactions based on the processing can create incompatibility sometimes immediately but often at a much delayed interval.

The processing nano-instruments make the judgments. These instruments are individual ego, independent intelligence and the state of mind at the moment of processing, verifying the final output with earlier experiences, which reside in each as the past memory. Memory is created and preserved every moment, some of which are conserved for a long time while most others considered unimportant by individuals are soon erased. Creation of new memory is again unique and complex; it may draw from factors beyond the above four. For creating a memory, a software creator has to be existing. If we consider him as one independent factor as a new addition, the probability of a new impression being created and processed increases to 3125, of which only one is chosen for use!

When an input is received by the senses, the five nano-parameters can make at least 3125 different solutions! But in almost all situations, individuals come out with only one as the out put to respond. This is strange, but this is real!

The receiver makes a processing of the outcome within its nano-body and also finds 3125 different results, but accepts only one! None can predict if the output of the receiver shall match the output of the transmitter. Our experience shows that in most situations there is closeness in the matching, which creates the formation of fondness, families, communities, societies and the global family.

But as the mismatch increases, the destruction begins, first showing its individual differences and disliking, which gradually builds up into Himalayan differences, separating societies, communities and countries tearing apart!

The basic building blocks of the causes of differences are to be understood adequately and clearly. These obviously reside within the nano-structures of each human, wherefrom the differences begin to grow gradually build up and propagate. The remedies can be found only if the causes of the differences are adequately understood. Unfortunately, there is yet no scientific method or instruments that can quantatively analyze and measure the causes of the origin of the differences.

Individually, each one is confronted at one time or the other to deal with differences. To do so one has to understand the causes for the differences. Total withdrawal by way of keeping away from the source, maintaining total silence etc can keep one away from the differences. But these won’t solve the problem. A solution may arise only when the problem is accepted and faced boldy.

In organizations keeping away or avoiding a problem is often not feasible or possible. People have to decide or to act; Organizations comprise people who take action, decide, implement or follow. Managers have to deal with a large number of people. There can be areas where all the actors do not agree. Therefore, there has to be methods for accruing the causes for the differences. Maintenance of suggestion box, periodic people –satisfaction surveys, regular inter-personal meetings etc shall assist in gathering the causes of dissatisfaction. Discussion of problems and complaints can be effective. Therefore, creating procedures in organizations for handling the differences should be in place. The procedures, as far as possible should have the foundations sitting on trust and respect to one another; speaking to people on one-to-one basis can be effective, where one has the chance of coming close to the other in the mental frame work. The complainant usually has a natural tendency to forgive until and unless the complaint or the difference is of malicious nature, requiring legal reprisal; human nature is to have a hustle free environment, an environment where the wishes are to live and let live!

People are born and brought up in social environment that grades activities. Some activities are rated high and some are rated low. Usually, show of power and command, success in showing physical strength, manifestation of extraordinary skills, earning more etc. are rated high. Routine work of production, quality control, keeping up the establishment activities such as maintaining cleanliness, washing, dusting and normal household work carried out by using inexpensive methods are not rated high. All the dirty work are rated low. Moving around to do outdoor work is rated a little bit higher. Making decisions, raising pay, settling payments and releasing money, book-keeping and accounting, taking legal actions and dealing with legal matters, increasing remuneration, elevating status of people etc. are rated high.

Unfortunately, human inherits the impression of high and low profiles of activities from the surrounding and accepts it rigidly from within. The nano-human from within each individual dictates the impression, which is manifested through the visible human in flesh and blood. The visible body expresses conditions of stress and strength from the command, received from the nano-body, which resides inside.

In true world, no job is either good or bad. Jobs are graded by individuals and accepted as good or rejected as bad by them who then group up to form clusters and thus the rating becomes societal.

In an organization, all jobs have to be carried out and completed. It is then that the output shall match the highest standard. Standards are set by experience. Organizations that turn out products and services which have bearing on the health of people must follow the best standards to turn out best products and services.


The people constituting the organization must understand this. Owners and the Executives hasten to ensure compliance of standards so as to turn out the best products. But the imposition of the factors by order for compliance does not always work if people who are to comply do not take the tasks of compliance for implementation from within. The actors who work to comply should have to have unstinted nod from within their nano-human structure that resides inside. If this does not happen but the outward expression of the complier is a positive nod which is read from the body language or from the word of mouth, even then this can be a false nod. False nods are expressed in acts of non-compliance in course of time.

It is the challenge for an organization therefore, how to create conditions so that all the nano-human being in an organization has full compliance to the standards to be maintained. When every individual comes forward to work together to reach the common goal of turning out the best products from their organization, this does not always mean that all the people physically working have consent to a common goal. The situation can be improved by continuously creating one-to-one relationship through talks, discussions and communication in a congenial environment.

RESEARCH STRATEGY IN SMALL BUDGET-AN IDEA

Innovation is a difficult and different work culture. Innovators are different kinds of people who can foresee newer possibilities in arena of their fondness. New products and technologies require lots of persuasion before they can be put to use. Although every human has some part in his life where he starts thinking differently, the innovators are people who spend most of their time thinking differently. A common man is common because he has stopped innovating in thoughts and actions.

In small budget, research is often difficult. This is because research requires lots of measurement, where one requires the inputs from sophisticated equipment. Such equipments are usually costly. Yet if an innovator has his will and has created connections well enough to take the assistance of others who have access to sophisticated equipment and instrument, it is possible to start thinking to innovate even with small budget.


Innovator should build growth strategies to execute innovative research platforms for creating products and production processes that have potentials for putting in to use in a short period of time. Projects have to be identified though their own talents which are to be designed through ideas to accelerate the development of novel products that can enter into the market successfully. All developments are steered around novel ideas that make sense.

Those who have some sense about human body can think about designing drug substances that can be couriered into different parts. Using the oral route, platforms can be conceived using bio-degradable substances which are to courier drugs to the anaerobic portions of the elementary canal like the colon through oral route, using various natural substances that are rich in carbohydrate polymers or the purified polymers themselves that are not digestible by human-borne enzymes but can be degraded by microbes that are micro-aerophilic or anerobic and are abundantly available in the human colon micro flora. The rational for developing innovative projects stems from the idea that colon targeted drug delivery is most useful and effective approach to treat colonic diseases such as colon cancer, ulcerative colitis, irritable bowel syndrome, Crohn’s disease etc. This strategy possesses inherent advantages like avoidance of exposure to gastric environment and enzymes, longer transit time, better bioavailability and low proteolytic enzyme activity. A small budget project can choose a probiotics-dependent approach. The rationale for the development of a polysaccharide based delivery system for colon is the presence of large amounts of bacteria in the human colon, which secrete many enzymes that are not produced by human. The bacterial enzymes of the colon shall degrade the carrier polymer in a well defined way and release the drugs in a definite profile for localized colonic delivery or systemic absorption through colon. Hence, a designed matrix, which is for simultaneous release of drugs and microbes are expected to result in enhanced therapeutic efficacy than individual drug therapy.

It is anticipated that it would be possible to develop a couple of products in the form of matrix granules in sachets, matrix tablets and capsules, where the matrix shall be made up of carbohydrate-rich natural substances or made from polysaccharides extracted from the natural sources. Various active drugs can be entrapped into the matrix; the matrix shall also be enriched with spores of friendly microbes. Such matrix forms of formulations shall have the abilities to deliver maximum quantities of active substances in the colon only; thereby they are expected to mount maximum combat to local lesions more efficiently than substances delivered through injectable routes. Moreover, such formulations shall also manifest minimum toxicity syndrome to the recipients. Several projects of this kind can be thought about which can be easily pursued with a small budget.

Let's intensify strategies for fighting NTDs

For many years, much is known about many tropical diseases and several preventive practices have evolved in poor countries. However, unlike many other life-threatening diseases where the patients would pay for relief or cure, much less attention has been paid to these diseases as those affected are largely poor and have limited capacities to afford expensive treatment costs Diseases such as Ascariasis, Lymphatic Filariasis, Leishmaniasis, Hookworm infection, Leprosy and Tuberculosis are spreading in poor areas of India including the cities and the rural areas. Dengue and Japanese encephalitis spread during the time when mosquito bites increase in specific seasons. In some parts of India Trypanosomiasis and Schistosomiasis infect the rural poor. These diseases and some others (not very rampant in India) have been termed as neglected tropical diseases (NTDs).

The fundamentals of the preventive practices for the control of many of the NTDs are already known. But they are not effectively practiced. Good hygienic practices should be promoted through public media like broadcasting, telecasting etc., more often with scientific illustrations that are easily understandable and appealing to the common folks. This would enable continued recapitulations and adaptation of the good practices on a sustainable basis. People tend to forget or avoid practicing the art. The usefulness of maintaining cost-effective standard operating procedures (SOPs) for maintaining good hygiene are not unknown for most of the NTDs. Practicing them all the time is lacking however. Neglecting good hygienic practices promote infection and re-infection. Continuously educating the target masses is a fundamental component for success. Educating the masses is a social responsibility of the government, which should do this task uninterruptedly through public media. Where the assistance of the rich countries is available, these should be availed of. Cheap but effective medicines are available to treat some of these diseases; these should be distributed to the infected. Feed back information about the effectiveness and cure should be generated. All these efforts shall contribute to minimize the spread of NTDs. The increase in the number of healthy poor people shall contribute to economic gain of the country.

Once infected, the curing of many of these diseases is not easy. There are effective drugs for the treatment for some of the diseases. But they are expensive and administration needs hospitalization (liposomal amphotericin –B for treating leishmaniasis for example), which tells upon the abilities of the resource poor societies, where the infections are more rampant. Death occurs in many such patients. Public infrastructure must be strengthened to deal with the situation.

We have been hearing about the need to prevent and conquer the NTDs for the last fifty years in India. There have been improvements in the situation, driven mostly by the discovery and utilization of appropriate and cost-effective sanitation technologies, hygienic practices, use of safer drinking water and distribution of free or subsidized medicines. But many of these public utility goods and services (clean toilets, urinals especially for women and safe drinking water) are grossly in short supply even in the mega cities. We can construct, maintain and propagate public utility goods and services if there is a burning desire.

Governments have the lion’s share of responsibilities in this struggle. Besides strengthening the existing infrastructure, new avenues for conducting intensive research for developing more effective medicines and preventive practices have to be created. Funds for these have to be deliberately allocated at any cost. Many rich countries are also willing to provide some funds, access to which can be explored. Creative managers who have a flair for such public utilities should be in place. The funding philosophy for allocating resources from the private sectors for these activities do not fit in too well except for some philanthropic NGOs. Together, a judicious balance between preaching and practicing of the existing knowledge along with developing new therapeutics and practices through research, where the government pilots the programs shall have more mileage than taking any one-lane approach.

In the midst of multiple adversities and with severe resource constraints all around, the mankind has to travel many more miles to reach the stage of “concurring” any of these conditions, especially in the poor societies. But efforts can’t stop and must be continued.

GM technology in the context of Food Security in India

GM technology in the context of Food Security in India

Indian population is going to be 1.5 to 1.8 billion by 2050. The land for agriculture, reclaimed from forests is not going to substantially increase in future. With the fast change in the climate scenario due to unplanned human activities, the coming years shall witness reduction in the supply of fresh water, rise in the process of arid land desertification and entry of seawater in larger areas of coastal land used for agriculture .There will be shortage of ground water too fast. The pollution in air and the environment is already on the increase. Under such circumstances, the food adequacy situation shall substantially change. The strong agriculture base of the country is no solace to feed the growing population; the challenge of food security is therefore, going to be severe. Combating such situations would require drawing from the knowledge of diverse sources. New technologies are therefore to be invented and used.

The productivity in agriculture has to substantially go up and therefore, the new technologies must especially address the agricultural productivity increase. Agriculture has to be more sustainable with efficient use of water. The productive loss of crops due to microbial diseases and insects has to be minimized. At the same time, toxins, allergens and anti-nutritional factors must also be reduced in the crops, food, feed and fodder. To do all these, there is no escape from the use of GM technology in agriculture. GM crops are expected to emerge to face adverse situations in agriculture more efficiently if able cultivars are invented that are draught tolerant, salinity resilient and more heat tolerant. Sizable quantities of cultivars would be required, which can utilize sunlight more efficiently under such stress conditions. Research in these directions should be deliberately directed and sharply focused to meet future Indian needs.

GM technology enables the heritable insertion of species-unrelated heritable materials (genes) in to the genome of living entities. A gene is a nucleotide sequence that has at the minimum a promoter sequence, an open reading frame and a terminator sequence, all of which are made up of DNA. A promoter is a DNA sequence that enables the right and tight binding of RNA polymerase, a complex protein that slides over the promoter to reach to the open reading frame. An open reading frame is a DNA sequence that has the template of a protein which is transcribed in the form of a template called RNA, with the help of RNA polymerase and other cellular materials. A terminator sequence is again a DNA sequence that detaches the RNA polymerase from the open reading frame and restarts the transcription process for producing more quantities of RNA. The RNA in turn gets matured into mRNA and is then translated with the assistance of a complex protein known as ribosome and other cellular components. The DNA, RNA and protein production cycle is the central dogma of what life essentially is in all living forms. However, there is severe restriction of entrance of a gene from one species to the other; even if there is a violation due to abnormal natural process, usually the progeny works in a manner that the transgene is aborted. Human innovation has gone into considerable understanding of how transgenes can be inserted into organisms with species barriers. This is what is done in GM technology where a gene coding for a particular protein and therefore having properties linked with the protein can be inserted into organisms where naturally such genes can never have a place. GM technology enables insertion of genes into translife-forms (unrelated species having the gene) in a heritable manner.

In agriculture, absolute yield/productivity contributions are from a) genetic makeup and optimization of gene technology, b) agronomic practices and agricultural technologies and c) biotic and abiotic stress related factors. The productivity is mainly contributed from the genetic makeup and the optimization of gene technology, which factor can contribute up to 60%, other factors being equal. Biotic stress related losses can contribute to another 20%. Thus, about 80% of productivity increase is somewhat connected with improving the genetic makeup.

Improvements have been made in the genetic makeup and the optimization of genes in the genomes of productive plants mostly through the application of breeding technology. However, there are limitations in the transfer of genes among unrelated species and therefore such technologies cannot contribute to improvement beyond a certain point. As mentioned earlier, GM technology crosses the barrier of transfer of genes among unrelated species and therefore holds the potential of improving and optimizing the genetic makeup in the genome of agricultural plants to provide best outputs under different environmental conditions, where there is considerable variations in the biotic and abiotic stress related factors.

There are 3 main issues which are raised again and again on the use of GM crops. Firstly, they may create environmental damage and change in the ecosystem; secondly, the products may have toxic or allergenic or anti-nutritional property enhancement, thereby making the products unattractive as food and feed to human and animals; thirdly, GM technologies may promote the technology-rich multinational companies and thereby transfer the food security responsibility from the hands of the society at large to a handful of technology-skilled companies. All these issues are relevant and therefore a case-by-case analysis is necessary before authorization for commercial cultivation and use of GM crops is allowed by societies.

Cultivation of GM crops in areas where societal acceptance existed have shown increased optimism among farmers as losses due to biotic stresses have indeed been reduced, thereby reducing the production costs of harvests. There has not yet been an instance to show that the GM crops had severe negative environmental impact. In India for examples, use of Bt Cotton technology has been instrumental to increase productivity of cotton per unit use of agricultural land and that the use of this technology has raised the production of cotton lint substantially high raising the position of India to the place of second largest producer of cotton in the world within a couple of years from 2002 onwards. It is anticipated that India will be the largest producer of cotton within a couple of years as the technology gets diffused further into usage.

The use of Bt cotton technology in India has been responsible for the reduction in the use of chemical pesticides, less by Rs. 600-700 crores compared to the earlier usage of about Rs. 1100 crores annually during early 2000s. Moreover, Bt cotton has contributed to economic benefits of more than Rs. 15000 crores to farmers in terms of delivery of better cotton, more lint and less uses of chemical pesticides.

The technology that enables the horizontal transfer of genes (HGT) stably from one organism to another without reproduction but with human intervention is called GM technology as discussed above. HGT also occurs in nature through certain viruses and mobile genetic elements. However, HGT across plants or across animals is extremely rare. HGT has existed in nature for millions of years. At the present stage of knowledge the HGT occurring in nature has not been considered to be an acceptable human threat. Some scientists have viewed that the probability of HGT can get substantially elevated by the use of GM technology in open environment. HGT is also believed to get increased across prokaryotes by extensive use of GM technology. If HGT is really an issue in prokaryotes that harbor in human and animal gut, then some scientists feel that the modified prokaryotes can be a threat to human and animals. However, such complexities have not yet been found to be real nor there exists evidence that HGT across eukaryotes have become a threat due to the extensive use of GM technology in agriculture during the last fifteen years or so.

As regards food and feed safety issues from the use of GM crops to human and animals, the technology has not produced products that are more unsafe than the natural non-transgenic counterparts. Feeding trials undertaking on different kinds of models have not proven greater risk from the use of GM crops.

GM technology was once considered to be the monopoly of only a few multinationals. This situation is fast changing as this technology has been mastered by different countries. The IPR issues are also getting resolved, firstly because many of the important genetic materials are going out of patents. Moreover, the rights of the sovereign states to exercise authority over its natural genetic resources empower relaxed use of the IPR rights on cultivars that have been picked up from open and unprotected environment of states. In addition, it can be stated from Indian experience that while only one company was authorized to commercialize Bt cotton technology in early 2002, the usefulness of the technology enabled the development and induction of four other technologies. Thus, the monopoly was substantially weakened. I anticipate that this is going to happen in the wide spectra GM technology usage. Moreover, sovereign states have authorities through other societal empowerments to make more public use of any protected technology if such situation as transferring the food security rights from public domain to private domain becomes a threat to the state.

There are several countries where GM technologies have penetrated to a considerable extent. There was major resistance from the European countries to accept the technology. However, of late, there has been a flavor of change in the attitude of people towards the acceptance of GM technology after considerable observation has been made on the environmental effect of GM crops and substances during the last one and a half decade. The BASF’s genetically modified (GM) potato; Amflora is designed for the manufacture of purified amylopectin starch in the tubers. This GM potato was approved for commercial cultivation in Germany by the European Commission (EC) very recently. The EC had also approved the use of GM maize of Pioneer, Syngenta and Monsanto in Europe in food and feed products. There are presently at least 3 European countries like Germany, Spain and Portugal where GM crops are commercially cultivated; more countries are showing interest in such crops. These are clear signaling of consent of approval of the European regulatory authorities for the GM crops. Obviously, the approvals are based on perceptions of potential economic gain after the safety issues are reasonably resolved. The positive signaling of Europe on the use of GM crops should be read as strong indications of acceptance by a large part of the informed global community for these products.

Indian people would certainly embrace GM technology to supplement its food, feed and fodder needs. Unfortunately, Indian mind set in accepting or rejecting new technological changes is inherited substantially from the British culture. Now, as the EU has signaled the acceptance of GM technology in agriculture it is anticipated that the British acceptance of this technology shall also be on the increase. The Indian societal acceptance scenario for the technology shall then change. Time is changing fast. Let us keep a watch!

The Genetic Engineering Approval Committee (GEAC) of the Ministry of Environment and Forests (Govt. of India) decided to approve Bt brinjal, a product of modern agricultural biotechnology, on October 14th, 2009. However, the Indian Government did not uphold this decision; it decided to review the protocol of environmental safety tests and those for reassessing the public health questions. It has not been elaborated about what new information is to be generated further. The environmental safety tests as well as the food safety issues emanating from the use of GM technology are based on good scientific principles. Such principles have been elaborated on the basis of precautionary principles. The application of precautionary principles is not to find ultimate answers to hypothetical elements of risks; nor there exist any such science that can fully address and resolve all the quests of mind in a set time frame. Experiments have been conducted to address environmental safety issues in different ways. These experiments have demonstrated adequate safety to the environment as well as to animal health from the use of Bt technology. The Bt Cry1Ac gene contained in transgenic Bt cotton is already authorized for commercial cultivation in the country. The persistence of very small quantities of Bt proteins in soil, which is used for cultivating Bt crops demonstrated in experiments carried out elsewhere has not been for more than 60 days; such persistence has not caused irreversible change to the micro-flora of the soil. Bt proteins have not been able to stay in tact in artificial intestinal fluid for more than a couple of minutes. Bt toxins have no binding capacity to human intestinal receptors at the pH of the environment. These are therefore, destined to be degraded by the intestinal micro flora and intestinal enzymes. Therefore, Bt products living or dead are anticipated to pose minimum risks to the environment and to human and animals.

Bt toxins per se and Bt incorporated GM technologies of diverse kinds are in applications in several parts of the world. There is no authentic scientifically verified report to show that use of such technologies has created large-scale untoward adverse effects to the environment or to the human and animal health. On the contrary, use of such technologies has been responsible to the reduction of chemical pesticides in agriculture.
Bt incorporated GM technology is only a small part of the full gamut of GM technologies. Many of these technologies address different questions of human needs. While a part of these address development of cultivars that are resistant to insect pests, others are for imparting microbial disease tolerance, herbicide resistance, draught and salinity tolerance and the like. Production of improved composition of oil or starch or proteins is other sets of GM crops. Increased tolerance to drought or salinity or cold or heat is some other sides of the spectra of GM crops.

As with any new technology, there will be unintended risks and many such technologies would become less effective with time because of aggressive rebounds from nature to resist permanent habitation of such man-made substances. Nature works in a different way and we do not yet know in which direction it would move. Nature has millions of years in its store but man has a limited time. Within its time, the mankind and the society everywhere should grow and sustain its healthy habits with comforts and peace. Therefore, with the limited tools available with the mankind all the technologies, old or new must be reasonably assessed with the available tools and best judgment must be exercised, which is generally acceptable. Making standards of safety that cannot be measured with the existing scientific tools and gadgets is certainly not the intention to evaluate a technology. Best scientific knowledge available to mankind should be utilized when the available tools can generate quantifiable scientific data for deriving conclusions. In certain areas of concern where scientific data cannot be generated at the present moment (because of inadequate current global scientific development), there is no escape from adopting a “wait and watch” policy and periodically review the impacts after the GM technologies have been put to commercial use. This will enable reduction of application time. In case of noticed adversities, the GM crops can be withdrawn. In some situations, the world community may have to live with the transgenes dispersed into the wild. Such situation is already real for certain genes and it has not yet been noticed that such events have created any major setback to the environment or to the human community. With this philosophy, advantages and disadvantages from GM technologies must be assessed on a precautionary principle on a case-by-case basis; but once satisfied, they must be put to commercial use without waste of time. Food inadequacy syndrome is approaching very fast. Our precious time should not run out.

KEEGAD"s FIRST DAYS

More than two year's ardent labour of ours is going to bear fruit. We are soon reaching the market place with our clinical chemistry reagents that are affordable and at the same time they provide accurate results of blood parameters of human so as to have a realistic assessment about the health or disease status of people. Health is most important for everyone. In knowing how the main organs of the body are functioning, one must periodically look at the bodily parameters of analytes in blood that manifest the conditions of health.

We consider that the heart, the lungs, the kidneys, the liver, the pancreas and the other organs must perform normally so that we live a healthy life. In order to have a satisfying endeavour one must therefore, keep an update about the status of their functioning by periodically assessing certain vital analytes that considerably reflect the wellness of the organs.

We shall be roaming in the market place with 17 clinical chemistry reagents to begin with but propose to enlarge the list to about 40 within the end of this year. You may like to visit our website at: http://www.keegad.com. We would very much like to have your comments and feedback from time to time. You may also put your request to have our samples for your evaluation.