TA I LO R I N G B I O T E C H N O LO G I E S

Vol. 2, Issue 3, Winter 2006/07, pp: 107-130

India's endeavors in biotechnology:

A policy overview

A.S. Ninawe1

Introduction
Biotechnology may be defined as the application of science and engineer-
ing in the direct use of living organism or parts or products of living organisms
in order to produce products, processes or services. Biotechnology may
encompass recombinant DNA technology, used to modify the genetic materi-
al of living cells to produce new substances or perform new functions.
Worldwide, biotechnology is revolutionizing the development of products,
processes and services in healthcare, agriculture, industry and environment.
Large investments are being made in biotechnology mediated enterprises,
biotech products and services are becoming a multibillion dollar industry.
Biotech products and processes enhance value in a range of industries from
leather, detergents, textiles, food and feed, beverages, beer, wine, confec-
tionery, cosmetics, therapeutics, vaccines, diagnostics and neutralceuticals are
available in the market. In agriculture sector, transgenic crop are under culti-
vation increasingly. General awareness on biotech product and process devel-
opment has brought public perception that has greater importance than any
other technology in the global arena. The aim of this article is to present an
overview of India's endeavors in the area of biotechnology.

Biotech Industry Backgrounds

The biotechnology sector is booming across the globe. Biotech companies
are pioneering new technologies, platforms, industry segments and business
models. According to an estimate, the global biotechnology industry has
expanded to the tune of about US$ 250 billion. Global R&D expenditure in the
private and public biotech sectors is around US$ 4.4 billion with over 95% of
the total in the industrial countries.
1 The author is affiliated to the Department of Biotechnology. The views expressed are of author's and not nec-
essarily that of the Department of Biotechnology
 TA I LO R I N G B I O T E C H N O LO G I E S INDIA’S ENDEAVORS IN BIOTECHNOLOGY:A POLICY OVERVÝEW

The developing countries find applications of biotechnology in diverse growth of the current Indian biotechnology market vis-à-vis the Asian and
areas viz. hybrid seeds, tissue culture plants, fermentation derived products global market, India has great potential to become one of the most significant
including antibiotics, bakers' and distillers' yeast and biological cultures. players on the global arena by 2010.
Biotech products are largely composed of therapeutics and diagnostics for
India's biotechnology industry is worth only US$ 1.1 billion which consti-
human healthcare, industrial enzymes and contract research services.
tutes around 2% of the global revenues with a market share of US$ 705 mil-
Considering the global trends on pharmaceuticals, 70% of the products under
lion, investments to the tune of US$ 137 million and exports being 59% of the
clinical testing are rDNA products or gene based products emanating from
revenue with 37% growth over the previous year. Very few companies record-
small and medium size companies. Approximately 25% of R&D is outsourced
ed revenue in excess of US$ 22 million in the sectors like health care, animal
by drug majors. The baseline revenues of Contract Research Organizations
health, agri-biotechnology, drugs and biopharmaceuticals. The current market
(CROs) in 2000 were estimated at US$ 7 billion and are growing at 30% per
size of biotechnology products in India is expected to grow US$ 5 billion by
annum. Outsourced R&D is estimated to account for 40% of R&D expendi-
2010 and improve its share in the global marketplace to about 5%. India ranks
ture by the year 2008. The R&D expenditure of the top 20 pharma majors has
third in Asia after Australia and China and in top ten in the world. US ranks
more than doubled over the years, i.e. from US$ 20 billion in 1995 to US$ 40
number one followed by Germany, Scandinavia, UK and France in Europe.
billion in 2000 and it is expected to increase exponentially to more than US$
Successful initiatives in drug discovery, clinical development, bioprocessing
100 billion by the year 2010. The genomics, proteomics and other informat-
and global marketing have raised to deliver products and solutions to partners
ics-based research is expected to expand further to meet the challenges for new
and customers in over 50 countries.
drugs.
With an estimated growth rate of 55%, India is expected to reach over US$
Asian biotechnology is focusing on strategies to become competitive at the
3 billion by the end of 2006 with the competition mounting between the Asian
global level. Singapore is currently considered the service hub in the South
countries to establish their position as good environments for the industry.
Asian region. The country is building up its biotech sector with a major focus
Biotechnology sector in the Asia-Pacific region exceeded rest of the world,
on gene therapy, agri-sciences, bioinformatics, genomics and proteomics.
with a 46% increase in revenues and significant progress toward profitability.
Malaysia is focusing on the establishment of trade and investments to take
An Australian pharmaceutical company, CSL Ltd., boosted the country's
advantage of the immense market potential of their close neighbors. China and
biotech revenues by over 60%, allowing the Australian biotech sector to reach
India are attracting attention and deals to increase access to large and growing
profitability ahead of the U.S. and Europe, and propelling focus on biotech as
drug markets by lowering the costs of drug development. The number of deals
a strategic priority segments as contract research and manufacturing, vaccines,
in vaccines was energized by concerns around the avian flu, SARS, and bio-
information technology and bioinformatics, traditional medicines, and stem
defense products, while looming patent expirations in the generics segment.
cells.
Asia-Pacific companies are forming partnerships to position themselves in an
environment characterized by vigorous growth, increasing competition and
sweeping regulatory changes.
Emerging Segments for India
China is the leading investor in R&D on crop biotechnology in developing
India is among the first few countries in the developing world to have
countries, followed by India. China has an estimated 400 biotech companies,
declared the importance of biotechnology as a tool for advancing growth in the
as against India's 200. China's biotech industry could be the fastest growing
agriculture and health sectors. The Government of India established the
industry in the next 15 years and the China has already invested US$ 1.8 bil-
National Biotechnology Board (NBTB) in 1982 as the apex body to identify
lion in it. There are 200 government-funded laboratories conducting biotech
priority areas and evolve a long-term plan for the development of biotechnol-
research in China. Their scientists have decoded the rice genome and they've
ogy. Later, the potential and benefits of this industry were realized at an early
commercialized bio-engineered crops and plans to increase funding of agri-bio
stage and the Department of Biotechnology (DBT) was formed in 1986 that
research to US$ 500 million and more annually. In context of the size and
has now become the central agency, responsible for policy, promotion of R&D
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and for international cooperation and manufacturing activities. India is already accounted for 6.74% of the total market. Bioinformatics sector registered 25%
in a pivotal position to secure a significant share in important segments such growth and accounted for 2.11% of the market. The total biotech exports from
as vaccines, diagnostics and clinical trials. It is considered that that India India stood close to US$ 455 million and contributed to 42.17% of the total
already has the largest vaccine production capacity in the world. By 2010, biotech business. Table 2 summarizes the turn over of sales of major biotech
India could open new frontiers by developing the globally fast growing seg- products (current and forecast until 2010).
ments facilitated by the capabilities developed indigenously.
Table 2: World Biotech Product Sales Forecast
Table 1: Sectoral Break up of Biotech Market:
Year
Secto
1% Bioremediation 200 200 201
24%
12% Biopesticides
Biodiagnostics Human Therapeutics 24 40 72
Enzymes
3% Human Health Human Diagnostics 5 7 11
4% Vaccienes
4% Bioinstrumentation Agriculture 2 4 8
6% Veterinary Specialty Products 1 2 5
9% Contract Research
5% Bioengineering
6% Total 32 53 96
18% (Source: Confederation of Indian Industries)
Biotech Tools 3 5 8
It is estimated that vaccines, contract research, agriculture and human
health sectors comprise as much as two thirds of the total market. It is further Biotech tools have a wide range of products ranging from special enzymes
estimated that health care products would dominate the Indian biotech market, (restriction enzymes, DNA modifying enzymes etc) used in recombinant DNA
roughly 40% of the total market by the year 2010 followed by agriculture of technology to ultra centrifuges which help purify DNA or fermentors to grow
about 30%. Contract research and bioinformatics would pick up and account bacteria or automated sequences (and their reagents) which help sequence
for as much as 25% of the biotech market. An estimation by CII shows that DNA so on. This industry supplies products and services as support for
the agri-biotech would see growth rates of as much as 60%, diagnostic and biotech industry. Increasing number of pharmaceutical companies finding it
therapeutics of about 25% and Vaccines of about 15%. These figures clearly difficult to conduct entire drug discovery process-in-house and they are look-
indicate good prospects for biotech industry in India. ing for the ways to minimize costs. India has become a very attractive base as
the cost of infrastructure is relatively lower compared to other nations. Foreign
companies also benefit from cheaper qualified workforce available in India.
Bio-Service Sector India produces enough qualified graduates each year thus companies looking
to expand their operations can easily do so without facing a shortage in labor.
On the threshold of the new biotech revolution, numerous companies have
sprung up to take a piece of the exponentially growing market worldwide for
products and services. India's population has a very interesting demography
Healthcare and Pharmaceutical Sector
that creates almost a perfect environment for biotech companies to shift bases
here. The biotech industry has also seen substantial growth over the past quar- Biopharmaceutical industry is the single largest contributor to the total
ter century and poised to grow in the years to come. The Bio-services market biotech business. The sector with total sales revenues of US$ 811.4 million
is estimated to grow very fast. Two BT cotton companies, Mahyco-Monsanto accounted for more than 75% of the total business in India and registered about
and Rasi Seeds established in bio-agri sector shown the fastest growth, though 30% growth, primarily driven by the vaccines business. Several large pharma-
it accounted for only 6.95% share of the total market. Bio-industrial sector ceutical and biopharmaceutical companies scattered around the country that
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manufacture and export to global markets, such as Biocon, Intas and Zydus- specialized manpower like MDs and PhDs are in acute short supply to conduct
Cadila to name a few. trans-national research. DBT has initiated a number of links between medical
colleges and research institutes.
The Indian pharmaceutical market is growing very rapidly. According to a
study by Mckinsey, Indian Pharma industry is expected to grow to an innova-
tion-led US $25 billion industry by 2010 with a market capitalization of
Discovering New Medicines from Nature
almost US $150 billion from the current US$ 5 billion generic based drug
industry. The vaccine market is expected to grow by roughly 20%. Nearly 40% of the new drugs approved by the Food and Drugs
Administration, USA were either directly or indirectly derived from natural
India can achieve a global position in clinical trials hub of the world. Even
products. In India, traditional system of medicine is an integral part of the
if 15% of all clinical trials were to be outsourced in the next 3 years, US$ 4
health regime. Research and Development (R&D) is continuing to develop
billion worth of clinical trials will be conducted in developing countries and a
cures for diseases that have affected people for decades and even centuries.
large part of this opportunity can be secured by the Indian biotech industry. It
Medical tourism is high thriving activity in India with huge employment
is estimated that India can secure around US$ 250-300 million of the global
potential. Biodiversity treasure and rich traditional herbs provides an ideal
clinical trials market by 2010. Clinical trial is a large opportunity given the
combination for discovery and patenting of new drugs would be encouraged
number of patents but simply does not have the required number in terms of
for screening, combinatorial synthesis, structure elucidation and profiling of
investigators and Clinical Research Associates (CRAs). A large number of
bio-molecules for drug development. Neutraceuticals, functional foods that
focused training programmes are being conducted to address this gap. To
are used in preventive health care such as weight regulation, stress manage-
reduce drug development cost through cost reduction in clinical trials, oppor-
ment, antioxidants, are another class of health care products having rich poten-
tunities lies for the countries like India to provide low cost clinical trials.
tial and will be the focus. Leading Ayurveda companies have large number of
Opportunities for biotech business are vast through IPR and commercializa-
formulations, Ayur-clinics and health resorts. Out of the marketed classic for-
tion.
mulations, a large number is of patented drugs. Herbal plantations are coming
Indian R&D establishments like Central Drug Research Institute (CDRI) up in various states and coastal areas to meet the companies' requirements for
have produced a drug to treat cerebral malaria. Themis, and Indian pharma potential Ayurvedic medicines and medical tourism. Creation of an advanced
company sells it under the brand name E-Mal to 48 countries, many of them multi purpose analytical testing and standardization laboratory approved by
in Sub-Saharan Africa, at affordable prices. India's Shantha Biotech firm has the National Accreditation Board for Testing and Calibration of Laboratories
come out with a recombinant DNA vaccine (Shanvac) on Hepatitis B. This will cater to the needs of the Ayurvedic and Pharmaceutical industry for meet-
vaccine was being sold for US$ 15 per dose. The prices of the vaccine kept on ing international standards.
tumbling till they came to less than a dollar per dose. Shanvac today supplies
With the advent of GATT in 2005, many multinational companies have set
this vaccine to UNICEF for 50 cents. This is a spectacular reduction in price
up their operations in India and investing in research and development of new
by a factor of thirty. India's unique S&T capacity as well as low-cost manufac-
products to compete in this market. Large career opportunities lie in biophar-
turing capacity can benefit India and the whole world. Opportunities are set on
maceutical sector due to increased awareness of healthcare and availability of
fermentation technology and innovative research skills in drug synthesis to
newer medicines. It creates opportunities in entrepreneurship development,
focus on biopharmaceutical from small molecules to biologicals to develop,
rural marketing, contract research outsourcing, medical insurance, quality
manufacture and market leading-edge drugs for human healthcare. Challenges
control and logistics etc. This is a very vibrant and dynamic sector and offers
may lead to good vaccine development for malaria and HIV/AIDS. New drug
immense scope for research and development activities.
discovery research can take about 15 years and investment up to US$ 1.5 bil-
lion to move a molecule to the market. India has distinct comparative advan-
tage to sustain biopharma sector and can be a major partner in the process of
discovery, development and delivery of such healthcare products. For this,
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Agriculture, Non-food Crops and Biodiversity Focus on fast-growing herbicides segment is currently on. Cultivation of
transgenic crops has been spectacular over the last 5 years. The estimated
India has one of the largest agriculture sectors in the world and varied cli-
global area of transgenic crops has increased from 1.7 million hectares in 1996
matic zones, favorable for research and development products applicable
to US$ 44.2 million in 2000. Herbicide tolerant soybeans and cotton and insect
worldwide. India has an excellent scientific infrastructure in agriculture, rich
resistant corn and cotton account for most of the transgenic crop acreage.
bio-diversity and skilled and low cost human-power. In a report by Ernst &
Other commercial transgenic crops include herbicide tolerant canola and corn.
Young, it is expected that the neutraceutical market is roughly US$ 532-638
Most of the transgenic crops are grown in the USA, Argentina, Canada, and
million presently. The green revolution technologies with the productivity
China. In Europe, commercial cultivation of GM crops is very limited, prima-
gains have brought about a major impact on increased crop production in the
rily due to concerns expressed by environmental and consumer groups.
last five decades. However, the benefits of these technologies have leveled off.
For example, the yield growth has slowed down from an average of 2.9% per
year for cereals in 1967-82 to 1.8% in 1982-94. This may be due to depressed
Marine Resources
crop prices, increased input demands and resultant increase in fertilizer and
pesticide prices and increasing water scarcities. In agriculture, the major Sea food export is one of the highest revenue earners, as it provides direct
emphasis is given on crop improvement through development of transgenics, and indirect employment to hundreds of thousands of people. With its 8000
genetic transformation, refinement of protocols for tissue culture and demon- kilometer of coastline including Andaman & Nicobar and Lakshwadeep
stration of horticulture, forest and woody species, bioprospecting and molec- islands, India has a rich aqua culture and its Marine resource development
ular taxonomy, biopesticides, biofertilizers etc. The focus is also on salinity, holds great potential. Environmentally sustainable harvesting of fisheries
drought resistance, pest resistance and nutritional enhancement among others. wealth in the Indian EEZ as well as monitoring environmental health in the
Realizing the importance of bioresource conservation, the major emphasis is coastal ecosystems is the priorities. Upgrading of facilities and creation of new
on inventorization of microbial, marine, animal and plant resources, silkworm, ones for testing and certification for microbial and viral loads and antibiotic,
medicinal plants and studies on functional genomics. Unlike the west, which hormone and chemical pesticide residues are being attempted. Other commer-
depends on relatively few plants and animals for food, India has an impressive cial aspects on hatchery production protocols are also being attempted for
variety of plants and animals in agricultural production, the majority of which variety of sea foods as well as marine ornamental fishes establishment of
are not the subject of research projects in Western nations. This in itself sug- onshore and sea farms for shrimps, crabs, fin fish, shell fish, seaweeds, micro
gests scope for rapid improvement. algae and other related marine products viz. agar-agar, aligns, anti-oxidants,
neutraceuticals, seafood waste utilization towards development of byproducts.
Attempts are being made on development of transgenic wheat with more
Apart from application of biotechnology especially in quality enhancement,
protein content and higher lysine content. Transgenics of rice, brassica, mung-
establishment of gene banks and fish bio-reserves, R&D is required for genet-
bean, pigeon pea and some vegetables like potato, tomato, cabbage and cauli-
ic improvement of disease-resistant fish, productivity enhancement in fish,
flower and cotton are under development. Marker assisted breeding pro-
development of promoters for upgrading eco friendly, aqua-farming systems,
gramme is expected to be introduced in farmers' field for better quality yield.
biotech support for the large scale production of monosex species of endemic
Laboratory research and field trials are being conducted on various genetical-
or exotic high yielding fish varieties, technology standardization for fixing
ly modified crops that include rice, tobacco, potato, tomato, brasssica, mus-
systemic feeding and seeding schedules, and the application of standard units,
tard/rapeseed and cotton. The major emphasis is either on pest resistance or
legal regimes and control measures on the usage of probiotics and antibiotics.
abiotic stress. However, so far serious attention is yet to be given on enhance-
Marine bio-prospecting will be a major theme for novel anti tumour and
ment of nutritive qualities in the GM crops. Recently, genetically modified
immuno-modulatory agents from marine organisms such as sponges and blue
seeds for the cotton industry launched by India based company, Mahyco,
green algae, e.g., Lyngbya Majasculata; marine microbes and saline fermenta-
which attempts to increase the yield manifold and decrease the use of pesti-
tion for therapeutic and industrial applications; biologically active substances
cides. The results for the new genetically modified cotton are encouraging.
from amphibians and arthropods; combinatorial genomic which allows inte-
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gration of DNA from non-culturable microbes into genomes of easily cultur- eral focus areas for catering to domestic and international clients for contract
able host microbe organisms. sequence services (synthesis and mapping (seeds, leaves, blood/organ tissue,
purified DNA)) and molecular marker services (DNA fingerprinting, molecu-
lar markers and ESTs (Expressed Sequence Tags). Awareness courses on Bio
Biomining informatics, genomic, DNA fingerprinting apart from specialized higher
courses on physical mapping, YAC libraries, chip technologies and hardware
The indiscriminate use of chemical pesticides and fertilizers are polluting
and software support services (web hosting services for clients/institutions
the environment and sustainability of agriculture apart from destroying fauna
Data storage and documentation services). There is a network of 64 bioinfor-
and flora and aquatic species. Encroachment, siltation and eutrophication are
matics centers spread all over the country.
destroying wetlands. Oil spills toxic effluents and sewage, blasting and dredg-
ing, collection of ornamental and undersized fish, trawler fishing, nylon nets,
destruction of coral reefs and hot water from nuclear plants are destroying
Interaction with Scientific Community and Researchers
marine life. Chemical pesticides, sewage and other organic wastes and sand
mining are destroying rivers. Forests are cut for timber and urban use. DBT has been interacting with more than 5,000 scientists per year in order
Underground mining of minerals and blasting of rocks goes on unchecked. to utilize the existing expertise of the universities and other national laborato-
There is no natural resource that is not under threat. Bio fouling of backwaters ries. It has developed a very strong peer reviewing and monitoring mecha-
and rivers has assumed alarming levels in coastal areas. Similarly, pollution nism. DBT has a close interaction with the State Governments particularly
due to chemical and industrial effluents is a major environmental hazard. through State S&T Councils for developing biotechnology application proj-
Although, prevention of this pollution is better than cure, biotechnological ects, demonstration of proven technologies, and training of human resource in
tools such as consortia of microbes and viruses as well as enzymes can be used states and union territories. Since it inception, DBT has pursued programs to
for bioremediation. For instance, microbe and enzyme mediated solutions are generate required specialized/trained human resource at postgraduate level in
feasible in the degradation of phonemics and tannins released in coir rotting as multi-disciplinary and application oriented field of biotechnology. As on date,
well as in biodegradation and by-product development from coffee pulp waste. about 61 post graduate teaching courses are being supported on a regular basis
Coir pith, a waste product in the coir industry, is already fast replacing peat and DBT is giving a major push to provide an enabling policy framework for
moss as a multi million dollar industry. GMOs are now developed for bio-min- development of biotechnology industry in the country. This includes establish-
ing, or the inexpensive extraction of precious metals from low-grade ores ing a science based on professional regulatory system, promoting of industry-
using microbes. Plants are also developed to mine precious metals (e.g. academia partnership in R&D, building competence in technology transfer and
Brassica, which is being developed to concentrate gold from the soil in their commercialization, building infrastructure-repositories, biotech parks, regula-
leaves). tory toxicology, safety assessment etc. On the international front, DBT has
been instrumental in promoting biotech collaborations and enters into agree-
ments with various countries through bilateral tie-ups. DBT has been deeply
Bioinformatics involvement with the scientific community through a number of technical task
forces, advisory committees and individual experts in identification, formula-
Bioinformatics and information technology are much needed strategic ini-
tion, implementation and monitoring of various programs and activities.
tiatives for creation and access to the database on unique biodiversity and the
Specialized manpower is certainly a scare resource and the DBT and other
related traditional knowledge in herbal medicines, the genetic traits, agronom-
agencies alike are trying to address this through several initiatives to develop
ic features and disease resistance sensitivity profiles of specialty spices and
ability to build and leverage skills, investing in training and development
commercial crops, marine resources, the clinical/genetic information on dis-
activities for specialized skill building and integrated the network skills.
eases such as cancer, diabetes, cardiovascular-ailments and mental disorders.
This will be extremely valuable for research and product/process development
in these areas. Bio informatics as a service platform has great potential for sev-
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IPR and Patent Issues Technology Transfer Issues

India's commitment to the product patent regime is now aligned with the During two decades of the existence of DBT, the promotion and accelera-
global IPR system. It can be possible that India should enable biotech innova- tion of development of biotechnology in the country was visible through sev-
tion in areas such as diagnostics, recombinant bio-therapeutics, stem cell biol- eral R&D projects, demonstrations and creation of infrastructural facilities and
ogy, bioinformatics, proteomics and genomics. Considering the growth rate to significant contributions to the growth and application of biotechnology in the
be constant at around 30%, the biopharmaceutical segment has the potential. broad areas of agriculture, healthcare, animal sciences, environment, and
Patents have attracted much of the attention for gap between rich and poor industry, which have been culminating into products and processes. Over the
countries in access to medicine, especially for wide range of drugs to respond last ten years, some 50 technologies covering the areas of agriculture, aquacul-
to most common diseases in developing countries. However, specialized drugs ture, human health, animal productivity, environmental biology etc. have been
like that for HIV/AIDS drug resistant tuberculosis etc. are not accessible to the transferred to the industry or other user agencies. Some of these have already
poor people. There is a major reinterpretation of patenting laws all over the reached the market place. Numerous research publications, quality post-doc-
world on patenting living organisms and their parts and processes, including toral students, several technologies transferred to industries and patents filed
the cells and genes of humans. The ethical and moral issues in the patent sys- including US patents, have been achieved through the efforts of the DBT.
tem play more important role where the patent system should be applied for Research has been funded in genomics, proteomics, molecular basis of dis-
more societal benefits. In India, patent filing in the area of biotechnology is ease, pharmaco-genomics, stem cell biology, nano-biotechnology, and other
based on the applications filed in the Indian Patent Office from 1995 to June, frontier areas. The product development focus is on a new generation vaccines,
2003. A total of 2378 patent applications have been filed in India till June 2003 diagnostic kits and therapeutics. In addition, a bioinformatics network estab-
and these applications are both conventional and PCT. The Council of lished in major research institutions/universities of the country is being used
Scientific and Industrial Research (CSIR) is the largest applicant in filing to address major problems of biology and as an aid to drug design. DBT has
patents in the areas viz. hybrid, tissue culture, embryo, cell line, enhancer, been instrumental in bringing together academia, industry and research insti-
marker, transformation and promoter etc. Many of these applications may be tutions to work coherently for a strong IPR system in the country.
products, drugs/pharmaceuticals, genetically modified micro-organisms, natu-
The Ministry of Science and Technology, Government of India has brought
rally occurring RNA/nucleic acids and genes. The protein, the product of genes
out the guidelines for Technology transfer and intellectual property rights,
has opened a new branch in biotechnology proteomics and about 700 patent
which help in enhancing the motivation of scientists, research institutions and
applications were filed for conventional and PCT applications including appli-
universities in various research and development projects funded by various
cations for enzymes. DBT emphasizes the development of all facets of IPR in
departments of the Ministry of Science and Technology. The institution shall
biotechnology and helps in protection of inventions through patenting or
be encouraged to seek protection of IPR rights and granted ownership of intel-
through other suitable methods by giving importance for innovations and
lectual property in respect of the results of R&D. The ownership of such IPRs
industrial development.
can be retained and institutions, where the research is carried through funding
Till 2005, India only recognized process patents, however, in 2005 India by Central / State Governments, are permitted to take steps to commercially
committed to the product patents regime aligning its IPR system to global exploit patents on exclusive or non-exclusive basis. The owner institutions are
standards. It is a major step to achieve recognition its IPR system globally and permitted to retain the benefits and earnings generated out of the IPR generat-
to attract foreign investments, as there is larger scope at the cutting edge tech- ed. The inventors and other associated persons are allowed to share the royal-
nology and product development, a strong product patent regime and its ty benefits.
implementation. Indian Patents Bill recently passed by the Parliament allow-
Patent Facilitating Fund set with the owner institution(s) and the revenues
ing 20-year patent term, inline with provisions made by WTO and TRIPS.
generated from IPR are utilized to create a patent facilitating fund for updat-
ing the invention(s), filing new patents and protecting the IPR against infringe-
ment and for building competency in the area of IPR and related issues and the
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institution. With the new patent regime in place, collaborations on the research mals, mechanism of implementation of biosafety guidelines, containment
front are likely to rise. India R&D of science and technology has been mostly facilities under three risk groups. The guidelines have been revised matching
government sponsored. India has a huge infrastructure and research network in with the needs of scientific know-how in 1994 as "Revised Guidelines for
place driven by nodal agencies like DBT, Indian Council for Agricultural Safety in Biotechnology". During 1998, to provide special review for geneti-
Research (ICAR), The Council for Scientific and Industrial Research (CSIR) cally engineered plants, "Revised guidelines for Research in Transgenic Plants
and Indian Council for Medical Research (ICMR). The emphasis now has and guidelines for Toxicity and Allergenecity for Evaluation of Transgenic
been increased in the area of private public partnerships and most of the com- Seeds, plants and plant parts" had come into force.
panies are catching up with discovery-led innovations.
A regulatory framework has been set up for approval of GM crops and
rDNA products. Recently, the Government of India decided to make changes
to the Drugs & Cosmetics Act to make it more globally compatible. In order
Regulatory Issues in Biotechnology
that biosafety guidelines are strictly followed to prevent damage to human
In order to evaluate the risks related to biotechnology, a distinction has health and environment, a three-tier mechanism has been instituted in the
been suggested between technology-inherent risks and technology-transcend- country. DBT provides recognition to Institutional Biosafety Committees
ing risk, as it is associated with threats to human health and the environment. (IBSC's) and also services a Review Committee on Genetic Manipulation
It needs to be addressed by proper risk management covering issues relating to (RCGM) for regulating research and limited field experiments. On the recom-
loss of biodiversity through biosafety policy and laws. Biosafety issues are not mendations of the RCGM, the Genetic Engineering Approval Committee
just related to GMOs alone. Traditionally, there have been regulations on man- (GEAC) of Ministry of Environment and Forests provides clearance from
ufacture, consumption, export and import of chemical pesticides, processed safety angle for commercial purposes. Ministry of Health and Family Welfare
food and food additives, drugs, cosmetics etc. The procedures for assessment provides final licenses for recombinant products of healthcare in accordance
of toxicity, alergenecity, non-target affects have also adequately addressed all with Drugs and Cosmetics Act implemented by office of the Drug Controller
over the world while dealing with the drugs and pharmaceuticals. Therefore, of India. Separate guidelines for clinical trials of recombinant products and
both developed and developing countries have considerable experience in ethics are also published. State level committees have also been set up for
dealing with the food and environmental safety issues related to traditional proper coordination and follow-up. For the first time, guidelines for clinical
technology derived from products and processes. The need for biosafety regu- trials of recombinant roducts / biiologicals, as approved by the Drugs
lations to deal with food and environmental safety of rDNA products was real- Controller General of India have been publicized. Many contained field trials
ized in late 1970s. The products were, however, commercialized in late 1980s. have been conducted under different agro-climatic conditions of the country
Since the regulations of GMOs are of recent origin, they would also require using transgenic plants.
adequate time for achieving stability in terms of procedures, framework and
With the existing regulatory mechanism in force, so far 10 r-DNA drugs
guidelines based on continuous feedback from knowledgeable stakeholders.
have been approved for marketing, 4 industrial units are manufacturing
The Indian Acts, rules and regulations as well as procedures for handling recombinant hepatitis vaccines locally and indigenously produced erythropoi-
of genetically modified organisms (GMOs) and rDNA products have been for- etin and G-csf are also in the market. There are several novel processes to pro-
mulated under the Environment (Protection) Act (EPA) 1986 and Rules 1989. duce r-DNA vaccines and drugs are in advance stages. In commercial plants
The rules in general cover manufacture, use/import/export and storage of haz- viz. cotton with insect resistant BT gene has been given approval for commer-
ardous micro-organisms, genetically engineered organisms or cells and came cial release in March, 2002. About 252 institutions (public and private) are
into force from 1993. India has a sound and widely acknowledged framework working in r-DNA research by constituting Institutional Biosafety Committees
of bio-safety guidelines to deal with evaluation, monitoring and release of (IBSC). Regulatory policies are in general compliance friendly.
genetically engineered organisms and there are more than 106 institutional bio-
safety committees. A set of rDNA guidelines were brought and in 1990 cover-
ing genetically engineered organisms, genetic transformation of plants and ani-
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National Biotechnology Regulatory Authority such incubators in biotech parks and offers a grant up to 30% of the total
cost or up to 49% in the form of equity for such incubators.
To address the concern of both public and private sector, efforts are under
way to establish a single window regulatory mechanism or structure to pro- The industry is spread across the country. Several states have biotech poli-
mote speedy commercialization of recombinant products and processes. A cies and also biotech parks to promote the industry. It is the largest in revenue
competent National Biotechnology Regulatory Authority (NBRA) is proposed generation through bio-industrialization in the country. The industry compris-
to establish for agriculture products/transgenic crops, pharmaceuticals/drugs es over 280 companies that are into biotech business and another 120 that sup-
and industrial products and transgenic food/feed and transgenic animal/aqua- ply technology products to these biotech companies. DBT is promoting estab-
culture. The authority is to be governed by an independent administrative lishment of national facilities and a number of programs regularly and extend-
structure to evolve suitable proposals for consideration by inter-ministerial ing financial/logistical support for establishment of biotechnology parks,
group. A special regulatory cell is likely to be created to build capacity in the biotechnology incubators, training and pilot projects. The DBT has been
country for scientific risk assessment, monitoring and management, to foster extending financial and logistic support for the establishment of biotechnolo-
international linkages, support biosafety research, to obtain and review feed- gy parks, biotechnology incubators, training and pilot projects in various
back from different stakeholders and provide support to industry and R&D states. Besides, it is offering the technical support for identification, imple-
institutions to play promotional and catalytic role. NBRA would also evolve mentation and review of the projects announced by various states. The DBT
new guidelines on transgenic research and product/process development in had a projected a budgetary allocation of US$ 5.5 million towards assistance
animal, aquaculture, food, phyto-pharma and environmental application after for technology incubators, pilot projects, biotechnology parks and biotech
its set up. development fund for the year 2005-06 and presently supporting activities on
development of Biotechnology Park at various states. The department has also
initiated a national wide consultation with stakeholders to create a strategic
Biotechnology Parks and Incubators framework for development of biotechnology in the states.
Indian biotechnology sector has, over the last two decades, taken shape
through a number of scattered and sporadic academic and industrial initia-
Bioclusters
tives. DBT is supporting creation of incubators in biotech parks promoted
by a private industry or through public-private partnership. Establishment The government is considering launching special programs like biotech
of Biotechnology Parks plays a pivotal role in contract research, technolo- cluster innovative program, where R&D set up by the industry could be sup-
gy development, incubation, scale-up and commissioning of Biotech pro- ported by providing competitive research grants with specific objectives to
jects. It provides bioresource centre as a hub to provide infrastructure, economic development of the country and alleviates human sufferings. It is
equipment. facilities and services to assist the tenants and clients of the not only the government, but also all individual stakeholders such as suppli-
park and housing Technology Incubator with the capability to develop and ers, venture capitalists, universities, research organizations, service providers
license, in collaboration with R&D institutions, proprietary technologies and networking associations that are also contributing to the development of
to the tenants and clients in the State and elsewhere. It serves as a training bioclusters in India. Clusters in knowledge based sectors like biotechnology,
facility where technology skill packages can be imparted in biotech medical biosciences, life sciences, and information technology play a very
streams, e.g., molecular biology, genetic transformation, immunology, tis- important role in promotion of biotechnology research, use and development.
sue culture, fermentation and down stream processing and instrumenta- Biocluster in terms of development of biotechnology industry have already
tion. Proposals are also being examined to declare special economic zone grown unintentionally as clusters and such clusters are mainly located in the
status (SEZ) to Biotechnology Parks as an integral part of NBDS. These state territories.
SEZ units would be benefited through pilot scale incubator facilities on the
However, the cluster concept in India is still at a nascent stage as an area
lines of software technology parks, already existing in India. The depart-
can evolve as a meaningful cluster over a period of 10-15 years. It is prema-
ment encourages private players and private-public partnerships to create
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ture to say when bioclusters like Research Triangle, Boston, Cambridge and plex and time consuming than that of US and it lack transparency, which
the East England, San Francisco Bay will happen in India. The present affects foreign agencies from collaborating with or investing in India's
biotechnology industry growth in major cities will emerge as a successful bio- biotechnology sector.
cluster provided availability of capital and regular regional networking for free
It is also proposed to set up a central body, Biotechnology Parks Society of
flow of information and fulfillment of gaps in next 5-10 years. The respective
India (BPSI) for the promotion of biotechnology parks in the country on the
government policies and scientific ambiences have been responsible for the
lines of the Software Technology Parks of India (STPI). The BPSI should be
growth of such clusters.
run by professionals having experience in the areas of biotechnology, know-
The state and central governments have been taking many initiatives to ledge in Acts and Rules relevant to biotechnology and management skills. The
support the biotech industry through policy initiatives and announcing incen- existing parks can become members of these new biotech parks. The DBT is
tive packages to the industry and entrepreneurs. In future specific clusters like looking at a scheme to provide incentives to biotech units located in the parks.
proteomics, genomics and drug discovery are likely to come up. The regula- As part of this scheme, biotech companies located in biotech parks are to be
tory and fiscal framework provides incentives that influence company forma- allowed a five year time frame to meet the export obligation norms under the
tion and growth within clusters. The programs initiated by DBT like setting up SEZ scheme. This measure helps to address the long and unpredictable gesta-
of animal facility stem cell centre, incubation facilities and reengineering the tional time lines that are inherent to biotech product development. With these
existing institutions that would help in the development of bioclusters in metro initiatives, the biotechnology industry in India can reach new heights. The
cities. Government of India has been increasing its outlays to provide financial sup-
port to this industry. Government of India is also setting up a venture capital
fund, to support small and medium enterprises. The initiatives taken by both
Networking of Biotech Development Central government and State governments have given a big boost to the
biotech industry in India. Foreign companies looking for new markets and to
The success of many biotechnology products globally, rise of South Asian
expand facilities to much more economical locations can find India ever more
countries like China, Korea and Taiwan etc. is of national concern to Indian
open and responsive to their needs.
industry to compete. In India, organizations like Association of Biotechnology
Led Enterprises (ABLE), Association of Diagnostic Manufacturers of India
(ADMI), Association of Contract Research Organizations (ACRO), Indian
Biotech for Women Empowerment: A Successful Entrepreneurship
Society for Clinical Research (ISCR), All India Crop Biotechnology
Park
Associations (AICBA), Confederation of India Industry (CII) and All India
Biotech Association (AIBA) working for the growth of the biotechnology The country's first biotechnology park for women has been set up near
industry. AIBA closely associated with biotech industry suggesting fundamen- Chennai with the twin objective of harnessing Tamil Nadu's rich bio-wealth
tal restructuring of the regulatory system and emphasis to create resources for and addressing the gender bias that exists in society. The country's first
the private sector. Although about 50 GMOs have been approved for commer- biotechnology park for women, the Golden Jubilee Biotechnology park for
cial production, India is yet to have its first large scale GMO field trial and Women, an autonomous registered society, is part of the Chennai based M.S.
only one home grown recombinant product hepatitis-B vaccine has been Swaminathan Research Foundation (MSSRF) and was established in 1996.
approved. Several lacunae are due to steps required to be followed in approval The basic aim of the park is to utilize bioresources of the region and strength
of biotechnology products, as they have to pass through monitoring commit- the women to develop their full potential. Apart from putting in place a sus-
tees at district and state level and then review committees at the government tainable system to make use of the rich bio-wealth of the State, the park
level, depending on the product's end use a process governed by 1986 addresses the problem of gender bias. Women make up half the world's popu-
Environmental Protection Act. Even if a product makes it through the commit- lation and perform two-thirds of all works, but receive a tenth of the income
tees, it needs to be pursued at the Drug Controller General on the basis of the and own less than one-third of all works, but receive a tenth of the income and
Drug and Cosmetics Act. Thus, India's product approval process is more com- own less than one-hundredth of the world's assets. This discrimination needs
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to be addressed and the role of women as innovators and agents of economic Over thirty independent research groups work in a broad range of modern bio-
and social change should be emphasized. The park and the facilities there have logical disciplines. The research interests of the current groups join together in
been developed at a cost of US$ 0.28 million with raised up banking finance. four major areas viz. gene regulation, immunity and infection and molecular
The park offers decentralized services to promote services of biotechnology design and reproduction and development.
based enterprises in medicine, food and agriculture. The societal development
The National Centre for Cell Science (NCCS) performs research and
programme of DBT has received special attention benefiting large number of
development in various areas including cell biology, cancer biology, immunol-
target population viz. women, rural folk and deprived community through
ogy, diabetes, signal transduction and gene regulation. The NCCS also serves
extending the income and employment generation activities through softer
as a national cell repository and supplying cell lines to scientific institutions
options of biotechnology by demonstrations and trainings to have access to
within the country.
new technologies of products promoting its mass use for health care, nutrition-
al security and environment etc. The National Brain Research Centre (NBRC) provides infrastructure facil-
ities and has a coordinated multidisciplinary team to work at the frontiers of
In addition to the state governments approach for creating conducive envi-
neuroscience research and network the existing groups and whenever required,
ronment for early biotech players, the DBT in its Draft National
create satellite units to catalyze the overall growth of this discipline in the
Biotechnology Development Strategy report also noted its intention to pro-
country. Besides research, the NBRC provides a national level nucleus for
mote and support at least 10 biotech parks by 2010. Each park will necessari-
comprehensive training and teaching in diverse fields of neurosciences.
ly meet the qualifying criteria related to the characteristics of the location, a
Various other institutions and universities are part of its network activities. In
viable business plan, management strategy and a clear definition of the part-
addition to this, it is also working on three research areas namely molecular
ners and their roles. The DBT is supporting research through public funding to
and cellular neuroscience, systems neuroscience and theoretical neuroscience.
promote innovations in small and medium enterprises by a new scheme 'Small
Business Innovation Research Initiatives (SBIRI)' to help in developing prod- Council for Scientific and Industrial Research (CSIR) has a network of lab-
ucts and processes that have high societal relevance. oratories and field stations/extension centers/regional centers all over India to
undertake R&D in several disciplines including biotechnology. It currently
employs more than 22,000 highly qualified multidisciplinary professionals.
Institutes of Excellence ICAR promotes science and technology programmes in agricultural research
and education and carries out research directly through ICAR institutes and
Research organizations are gearing up to face the new challenges ahead -
national research centers, project directorates and also in association with the
not only the new regulatory policies but also completion from the emerging
State Agricultural Universities (SAUs) through the all India coordinated
private sector. Over the years, DBT has set up Centers of Excellence viz.
research project systems. This vast network of ICAR has manpower of about
National Institute of Immunology (Delhi), National Centre for Cell Science
30,000 personnel out of which nearly 7000 are engaged in active research and
(Pune), National Brain Research Centre (Gurgaon) and National Centre for
its management. The 30 SAUs employ about 26,000 scientists for teaching,
Plant Genome Research (Delhi) etc. to facilitate focused research in various
research and extension education; of these over 6,000 scientists are employed
fields like immunology, neurology and cell science among others.
in the ICAR supported coordinated projects. The ICMR formulates, coordi-
The National Centre for Plant Genome Research (NCPGR) was estab- nates and promotes biomedical research in India. Its network consists of 21
lished to carry intensive research on various facets of both fundamental as well permanent research institutes/centers (national institutes) located in different
as applied aspects of plant molecular biology. It aims at nutritional, structural parts of India and six regional medical centers. The ICMR national institutes
and functional genomics of various plant systems with the ultimate goal to offer opportunities for research in the area of medical biotechnology.
manipulate plant genes to breed improved varieties of crop plants.
Specialized infrastructure and skilled human research is critical for promo-
The National Institute of Immunology (NII) has the mandate to undertake, tion of innovation in research and product / process development. To achieve
aid, promote, guide and coordinate research in basic and applied immunology. this, DBT has projected to support 50 centres of excellence in focused themat-
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ic areas in existing institutes / universities across the country on improved

crops, vaccines, diagnostics, nano-medicines and nano-agriculture, environ-
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Although India holds a small share of the global biotech market, it has all http://www.ey.com/content.nsf/international/biotechnology_report_2006_beyond_borders
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technology centres and centres of excellence, technology transfer and crucial
academic and industry linkages through public-private partnership.
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