UPSC IAS exam preparation - Technology and environmental issues in India - Lecture 16

Excellent study material for all civil services aspirants - begin learning - Kar ke dikhayenge!

Biotechnology: boon or bane?

[हिंदी में पढ़ें ]

---

1.0 INTRODUCTION

Biotechnology is the process of harnessing cellular and biomolecular processes to develop technologies and products that help improve our lives and the health of our planet. Mankind has used the biological processes of microorganisms for more than 6,000 years to make useful food products, such as bread and cheese, and to preserve dairy products. Some of these were accidentally discovered.

Modern biotechnology provides breakthrough products and technologies to combat rare and deadly diseases, reduce our environmental footprint (carbon emissions), feed the hungry, use less and cleaner energy, and have safer, cleaner and more efficient industrial manufacturing processes.

Currently, there are more than 250 biotechnology health care products and vaccines available to patients, many for previously untreatable diseases. More than 13.3 million farmers around the world use agricultural biotechnology to increase yields, prevent damage from insects and pests and reduce farming's impact on the environment. And more than 50 biorefineries are being built across North America to test and refine technologies to produce biofuels and chemicals from renewable biomass, which can help reduce greenhouse gas emissions.

The Indian biotechnology sector is one of the fastest growing knowledge-based sectors in India and is expected to play a key role in shaping India's rapidly developing economy. With numerous comparative advantages in terms of research and development (R&D) facilities, knowledge, skills, and cost effectiveness, the biotechnology industry in India has immense potential to emerge as a global key player.

In fact, India has been ranked among the top 12 biotech destinations worldwide and third largest in the Asia-Pacific region.

The sector can be divided into the segments of bio-pharmaceuticals, bio-services, bio-agriculture, bio-industrial and bio-informatics. Nearly 64 per cent of the biotech companies operate in the bio-pharma sector, followed by the bio-services (18 per cent), bio-agri (14 per cent), bio-industrial (3 per cent) and lastly the bio-informatics sector (1 per cent).

However the initial optimism regarding the bio technology sector in India has slackened with serious challenges emerging on the investment and infrastructure front. Also, legal issues in India have, in their own way, slowed down the growth process.

2.0 BENEFITS AND RISKS OF BIOTECHNOLOGY 

Benefits and risks of biotechnology are a matter of great discussion and debate, especially when it comes to the safety of genetically modified foods (GM foods). Benefits for human health, as well as risks, can be divided into four categories:

2.1 Benefits

1. Increased food safety
2. Enhanced nutritional composition of foods
3. Food with even more health benefits
4. Reduction of certain chronic diseases related to diet

By the application of genetic engineering, organoleptic properties and expiration date of certain grains were able to improve. Delaying the rotting process of fruit and vegetables provides better quality, taste, color and texture. With the help of genetic engineering it is possible to create foods with greater amount of minerals, vitamins and antioxidants. Also, by increasing crop yields deforestation is prevented, and, the most important for the developing countries, economic development is accelerated.

For developing countries, particularly useful is growing beans resistant to pathogens, virus-resistant papaya, cotton, and rice enriched with vitamin A. The production of certain vaccines for oral use is also important, which would be cheaper, easier to store and less stressful to use than the previous ones, and would be used for prevention of diarrhoea, cholera and hepatitis B.

On the other hand, for many researchers and the public, production of so-called Frankenstein food is an unacceptable tampering with nature.

2.2 Risks

1. Allergies
2. Toxicity
3. Nutrient imbalance
4. Decrease of food diversity

There are concerns that the use of genetic engineering in the food industry can increase sensitivity to certain allergens. In fact, the transfer of allergenic properties of donor can be transferred to recipient. Foreign genes can disrupt the balance of nutrients. The question is how the changes will affect

1. Interaction of nutrients
2. Interaction between nutrients and genes
3. Bioavailability of nutrients
4. Metabolism and
5. "Strength" of nutrients.

By the production of genetically modified foods, different genes from different genetically modified organisms are transmitted in different ways. So far, this food is present in the market, because it is approved in many studies. So it is a little likely to endanger the life of man.

In order to determine the attitude to genetically modified products, we need to have in mind many facts, such as the rapid growth in world population, the available farmland, environment and the characteristics of genetically modified food and its impact on human health. At the same time it takes extensive knowledge and a multi-disciplinary approach to this issue in order to take advantage of this technology, and to avoid negative consequences.

2.3 Ethical issues in biotechnology

There is a rich public debate about how the potential risks associated with biotechnology methods and bio-industry products should be assessed, and about whether and how bioethics should influence public policy. A general structure for guiding public policy discourse is emerging but is not yet fully developed. Groups perceive risks differently depending on their culture, scientific background, perception of government, and other factors. Expert opinion supports a range of positions.

In May 1995, a large coalition of religious leaders Catholic bishops, Protestant and Jewish leaders and groups of Muslims, Hindus and Buddhists announced its opposition to patents on human and animal life. The coalition did not oppose genetic engineering or biotechnology, but rather patenting human genes or organisms. It contends that such patents violate the sanctity of human life and reduce the "blueprint of evolution" to a marketable commodity. The group argues that life is a gift from God that should be cherished and nurtured. To reduce life to a commodity is to turn it into a product that can be owned and manipulated for profit alone, according to the group. Other issues of debate are: organ transplants and embryological tissue, field testing and growing genetically engineered crops, and human trials of products and the legal framework for the same. The following issues need to be kept in mind during conflict resolution.

1. We need to understand what might be called the nature of genes and their origins, evolution, and their role in the shaping of different organisms.
2. Until we understand well the size and role of genetic exchange between different types of materials we should not experiment with transgenic organisms.
3. We must bear in mind that the largest number of phenotype properties of humans by which people differ, result from the large number of genes and environmental factors.
4. Information related to the genetics should exclusively be used to allow each person to make a personal decision about lifestyle.
5. The creation of biological weapons should be completely banned.
6. Genetic diversity of species on Earth is one of the main resource of our planet and it is of the greatest interest to preserve that diversity.

The development of biotechnology has enabled access to genetic information stored in chromosomes and opened the way for a new development. Products obtained by using biotechnology have the potential to positively affect the environment and to change human society. On the other hand, there is much still unknown and the possibility of misuse of scientific discoveries and unpredictable consequences of scientific research are reality. It is impossible to rule out the occurrence of bioterrorism. Therefore, the development of biotechnology brings up many unresolved issues, the questions of intellectual property and legal issues.

Many predict that, over the next decade, thanks to genome sequencing operations in the developed countries, scientific development will direct towards biotechnology, while investments in the Internet and IT in general may be secondary!

Making diagrams of the human genome is considered by many to be the greatest scientific achievement of the twentieth century. Reading of the genome will open new areas in the field of science and medicine, but will also lead to major changes in the sphere of industry, economy and other sciences as well as in the way of thinking about the world and nature. Directed manipulation with genetic material has become a reality, and studies have begun to direct to the developing of more sophisticated instruments and methods.

3.0 KEY DEVELOPMENTS AND CURRENT STATE OF THE INDIAN BIOTECHNOLOGY SECTOR

The Indian government's increased focus on the country's biotechnology industry has enabled it to grow at a compounded annual growth rate (CAGR) of approximately 20 per cent over the past decade. The biotechnology sector in India has reached an estimated size of Rs 20,441 crore (US$ 3.8 billion) in value over FY 2012, and is forecasted to reach Rs 55,300 crore (US$ 10.4 billion) by 2015. However, given the availability of skilled manpower, improved infrastructure, and the presence of strong regional markets, analysts project that attaining an ambitious growth rate of approximately 30 per cent, taking the industry to a value of Rs 5,50,000 crore (US$ 103.7 billion) by 2025, is a possibility.

This exceptional growth has been facilitated by the robust performance of all the sub-sectors of the Indian biotechnology industry, namely, bio-pharmaceuticals, bio-services, agri-biotech, bio-industrial, and bio-informatics. Bio-pharmaceuticals is the largest sub-sector of the industry, whereas agri-biotech is the fastest growing. Out of the top 10 biotech companies in India (by revenue), six specialise in bio-pharmaceuticals and four specialise in agri-biotech. therapeutics, novel products and contract services. It is a dominant segment of the biotechnology sector because India is one of the world's leading manufacturers of vaccines, with over fifteen companies manufacturing for more than 50 brands. Further, India is rapidly becoming the preferred destination for contract research, and manufacturing services (CRAMS) due to its skilled manpower, low costs, a large number of patients and strong government support. Consequently, the CRAMS market grew at a CAGR of more than 50 per cent over 2007-10, and reached a market size of US$ 7.6 billion by the end of 2012. Though reliable estimates are unavailable, experts forecast the market to grow at a CAGR of 30 to 35 per cent in the near future. Due to this explosive growth in the CRAMS market, India's contribution in global clinical trials (which including pre-clinical trials constitute approximately 80 per cent of the domestic contract research market) is expected to rise from 3 to 5 per cent by the end of 2014.

India's most significant achievement in agri-biotech over the past decade has been the successful cultivation of genetically modified Bt Cotton. This achievement has provided several socioeconomic benefits to the country. The cultivation of Bt Cotton in India exceeds 10 million hectares, and has significantly increased yield, while simultaneously decreasing the use of pesticides by approximately 50 per cent. These advantages benefited over seven million small scale farmers living below the poverty line in 2011.

The biotechnology industry needs to assess the factors contributing to its growth for ensuring sustainable development. With the biotechnology boom in India and the advent of global biotechnology players, numerous initiatives have been taken by both the government and the private sector to propagate rapid growth. The government funding for the Department of Biotechnology (DBT) has increased nearly four-fold during 8th to 12th five year plans.

The increased government funding, along with additional funds from the private sector led to the formation of numerous biotechnology parks and Special Economic Zones (SEZ) across the country, targeted specifically at incubating biotech companies, and propagating research.

By the end of 2011, India had 26 operational biotechnology parks, with key clusters emerging in Andhra Pradesh, Karnataka, Tamil Nadu, National Capital Region (NCR), Maharashtra, Gujarat, and some parts of Rajasthan. Out of the clusters in Western, Northern, and Southern India, the Western cluster had a value share of about A6 per cent, and exhibited a strong compounded growth of approximately 12.5 per cent over FY 07-12. 

3.1 Key factors influencing industry growth

Though India's biotechnology industry has traditionally been export driven, the domestic industry is rapidly gaining prominence as a consequence of rising income levels and an increasing rate of consumption of biotechnology products.

Regulatory environment and government initiatives: The Indian government has started providing grants and forming investment friendly policies to accelerate the biotechnology industry's growth. It allowed 100 per cent foreign direct investment (FDI) through the automatic route to produce drugs and pharmaceuticals and set up the Department of Biotechnology (DBT). The department is a part of the Department of Science and Technology (DST), and is responsible for making policies related to the biotechnology industry. The DBT has been instrumental in the growth of the Indian biotechnology industry, with special focus on human resource and infrastructure development.

The government also proposed the formulation of the Biotechnology Regulatory Authority of India, an independent legal body to manage the production, research, transport, import, and usage of organisms and other modern biotechnology products. It also set up the Biotechnology Industry Research Assistance Council to aid high end innovation in the industry, by providing adequate infrastructure and other essential services.

Among other initiatives, the government established a venture fund of Rs 12,100 crore (US$ 2.3 billion) to finance the new drug discovery projects. It has also provided monetary initiatives such as relaxed price control, subsidies on capital expenses and tax holidays for R&D activities. 

4.0 STORY OF BT COTTON IN INDIA

The story of Bt cotton in India is full of twists and turns, successes and heartburns.The Monsanto camp and those opposing it are struggling with each other since 2002, when Bt Cotton was launched via Mahyco in India. Bt cotton is the only genetically-modified crop, presently being cultivated in India which has incorporated cry1Ac gene from the soil bacteria (Bacillus thuringiensis). Major issues with Bt cotton now include damages caused by pink boll worm (PBW) and whitefly (Bemisia tabaci) to BG II and the possibility of getting substitute of Bt hybrid seeds, the high cost of which is a matter of concern.

4.1 History

The first two years of Bt cottonseed were not encouraging. It didn't take off as the initial hybrids that used the Bollgard-I (or BGI) technology were old. Once deployed in a variety of hybrids in subsequent years, it spread like wildfire and every cotton growing area quickly adopted the BGI seed. Adoption reached its peak in 2007-08, and from a net importer of cotton in 2002, the country emerged as an exporter of the fibre by 2008-09. 

4.2 Acreage grew a lot

Cotton cultivation increased from 45,000 hectares in 2002-03 to an estimated 80 lakh hectares in 2008, owing to the adoption of Bt cotton. While a section of scientists embraced the technology, some others launched an attack on Monsanto and Mahyco Monsanto (which sub-licensed the seed to Indian firms), blaming the technology for the acute agrarian crisis in cotton-growing states such as Maharashtra and Telangana. Key allegation was that "Bt cotton was all false claims and lack of liabilities. Cattle death in Warangal, pink bollworm resistance in several States and contamination of genetic diversity all showed how science fails us when driven by greedy business interests." 

4.3 Return of the worm

Sadly, almost all of the Bt cotton area went without refugia (cultivation of non-cotton or non-Bt crops around the main crop), which led to the worm developing resistance to the technology, resulting in huge losses to farmers. Monsanto quickly launched BG-II to win back the confidence of farmers. However, no lessons were learnt from the bitter experience, and farmers lacked awareness about the importance of sowing refugia crops. So, BG-II, too, fell prey to the virulent pink bollworm, leaving farmers with virtually no defence.

India is the only Bt cotton-growing country in the world facing the problem of resistance of pink bollworm infestation to the toxins produced by Bollgard II. Interestingly, none of the other 14 Bt cotton-growing countries have seen this resistance. China still successfully controls pink bollworm with first-generation Bt cotton. The U.S. and Australia are moving on to third-generation BG-3 without having faced this problem. Why does India suffer this unique misfortune? Bt hybrids are long-duration hybrids.  Cotton researchers broadly agree on the fact that pink bollworm grew resistant because India restricted itself to cultivating long-duration hybrids since the introduction of Bt cotton in 2002. All other Bt cotton-growing countries mainly grow open pollinated cotton varieties rather than hybrids.

The Intellectual property laws in India also played a role. India is the only country whose intellectual property laws have never prevented its farmers from either saving or selling seeds. Other countries restrict saving and selling of seeds in various degrees. Over 70 countries that are members of the "International Union for the Protection of New Varieties of Plants", allow farmers to reuse seeds from a protected plant variety, but not to sell them. In the U.S., where plant varieties are patented, the patented seeds cannot even be reused. Without such protections, several seed companies in India prefer hybrids, because unlike open-pollinated varieties, hybrids lose their genetic stability when their seeds are replanted. This compels farmers to repurchase seeds each year, protecting corporate revenues.

4.4 Legal issues

On the issue of royalty payable, many cases are pending in different High Courts, with Monsanto and Mahyco Monsanto on one side and farmers' unions and State governments on the other. The recent one was Mahyco Monsanto's plea in the Delhi High Court challenging the Centre's Cottonseed Price Control Order.

The Delhi High Court on 10/03/2018 said Monsanto NSE -0.23 % Technologies' patents on Bt cotton seed varieties Bollgard and Bollgard II were not valid and dismissed its claims against Nuziveedu Seeds on this count, a finding that will likely have far-reaching consequences for the agriculture sector.

The regulator GEAC (Genetic Engineering Approval Committee under the Union Ministry of Environment and Forests) has also been at the receiving end of criticism from GM technology detractors. They allege that permissions are shrouded in secrecy, denying the public the right to know what is happening on the GM front. While several State governments and farmers' unions have waged pitched battles against Monsanto on the quantum of royalty, the BG-II licencee firms want a higher share from the profits as their hybrids were at the heart of the Bt success.

4.5 NSAI argument

The National Seed Association of India (NSAI) has argued that the government must have a pipeline of technologies in place to avert such situations. Monsanto restricts seed licencees from using other technologies. "The seed firms were forced not to try other alternative technologies, leading to monopoly. It also led to the faster development of resistance by the worm. The government should encourage alternative technologies," says NSAI.

4.6 Today's situation

As of date, more than 2000 Bt hybrids have been approved by GEAC for commercial cultivation in the states of Punjab, Haryana and Rajasthan in the North zone; Madhya Pradesh, Maharashtra and Gujarat  in the Central zone and Telangana, Andhra Pradesh, Karnataka and Tamil Nadu in the South zone. More than 30 private seed companies are producing and marketing Bt hybrids to fulfill the requirements. The area under Bt cotton cultivation, which was hardly 0.29 lakh ha (0.38 %) out of 76.70 lakh in 2002-03, increased to 119.40 lakh ha out of 128.19 lakh hectares in 2014-15 showing more than 93.14 % adoption within a span of 13 year. Damages caused by PBW and Whitefly during recent years created a situation that the share of Bt crop in total cotton area sown during 2016-17 (108.26 lakh ha) declined to about 82-83%. The remaining area was sown under desI varieties and a very small area is under other hybrids.

5.0 Bt Brinjal - India's first vegetable biotech crop (first GM food crop)

The Bt brinjal variety was developed using a transformation process similar to the one used in the development of Bt cotton, a widely used biotech crop in India. 

Developed by the Maharashtra-based seed company, Mahyco, Bt brinjal was the first food crop made to contain an insecticidal protein, called cry1 ac, sourced from the genes of the soil bacterium, Bacillus thuringienesis. 

The Genetic Engineering Approval Committee (GEAC), in its 97th meeting held on 14th Oct 2009, recommended the commercial release of Bt Brinjal Event EE-1 developed indigenously by Mahyco in collaboration with the University of Agricultural Sciences (UAS), Dharwad and the Tamil Nadu Agricultural University (TNAU), Coimbatore. This was a penultimate step to commercialize Bt brinjal hybrids and varieties in the country (MOEF, 2009).

Though this was cleared for commercial cultivation it was put in deep-freeze, by former Union Environment Minister Jairam Ramesh in 2010 on the grounds that there was scientific and public disagreement on its safety. It remained banned.

5.1 How it works

Bt brinjal incorporates the cry1Ac gene expressing insecticidal protein to confer resistance against FSB. The cry1Ac gene is sourced from the soil bacterium Bacillus thuringiensis (Bt). 

When ingested by the FSB larvae, the Bt protein is activated in the insect's alkaline gut and binds to the gut wall, which breaks down, allowing the Bt spores to invade the insect's body cavity. The FSB larvae die a few days later.

5.2 Who developed

Bt Brinjal was developed by the Maharashtra Hybrid Seeds Company (Mahyco). It used a DNA construct containing the cry1Ac gene, a CaMV 35S promoter and the selectable marker genes nptII and aad, to transform young cotyledons of brinjal plants. A single copy elite event, named EE-1, was selected and introduced into hybrid brinjal in Mahyco's breeding program. 

Mahyco also donated the Bt brinjal technology to the Tamil Nadu Agricultural University (TNAU), Coimbatore and University of Agricultural Sciences (UAS), Dharwad. The event EE-1 was backcrossed into open-pollinated brinjal varieties. Mahyco also donated the technology to public research institutions in the Philippines and Bangladesh.

The National Center on Plant Biotechnology (NRCPB) developed Bt brinjal varieties expressing the cryFa1 gene. The technology was subsequently transferred to firms like Bejo Sheetal, Vibha Seeds, Nath Seeds and Krishidhan Seeds. The Indian Institute of Horticultural Research (IIHR) also developed Bt brinjal using the cry1Ab gene. Scientists are also looking for ways to develop Bt brinjal in conjunction with other multiple and beneficial traits. 

5.3 Regulatory approval 

Bt brinjal is the first food crop under evaluation for commercial release in India. Since its development in 2000, the crop has undergone rigorous scientific evaluation to assess its food safety, environmental safety, human and animal health safety and biodiversity. Given below is the regulatory process followed -

 

Rigorous scientific tests, including toxicity and allergenicity evaluation as well as nutritional studies on rabbits, rats, carps, goats, broiler chickens and dairy cows, confirmed that Bt brinjal is as safe as its non-Bt counterparts. The safety of Bt brinjal was further validated by the results of the studies on pollen escape, effects on soil microflora and non-target organisms, agronomy, invasiveness and Bt protein degradation. Results of the studies demonstrated that Bt brinjal does not affect beneficial insects such as aphids, leafhoppers, spiders and lady beetles.

5.4 Benefits of Bt Brinjal

Bt brinjal was found to be effective against FSB, with 98% insect mortality in Bt brinjal shoots and 100% in fruits compared to less than 30% mortality in non-Bt counterparts. It needs 77% less insecticides than non-Bt counterparts for control of FSB, and 42% less for the control of all insect pests of brinjal. The benefits of Bt brinjal, translate to an average increase of 116% in marketable fruits over conventional hybrids, and 166% increase over popular open-pollinated varieties (OPVs). Furthermore, the significant decrease in insecticide usage reduced the farmers' exposure to insecticides and results in a substantial decline in pesticide residues in brinjal fruits.

5.5 Potential

It was assumed that Bt brinjal would have enormous potential to benefit both farmers and consumers. The remarkable success of Bt cotton in India, which now occupies more than 80% of the planted cotton, shows that biotechnology can be harnessed to contribute to alleviation of poverty and hunger. But it did not quite work out as envisaged.

Prashant Bhushan notice to Centre, 2019 : In May 2019, Senior advocate Prashant Bhushan sent a legal notice to Central government asking for a freeze on all genetically modified organisms, including field trials. Though growing Bt brinjal is illegal in India, activist groups have given evidence of Bt Brinjal, a GM crop, being grown in a farmer's field in Haryana! Mr. Bhushan's letter demanded that the Environment Ministry "…uproot and destroy planted Bt brinjal in farms and seedlings in nurseries, undertake a scaled-up exercise of testing of seeds and plantings (for the presence of Bt genes) and, ascertain the supply chain - from seed developers to intermediaries."  

Bt Mustard : Following brinjal, a genetically modified strain of mustard too is in the regulatory pipeline. While this was cleared in May 2017, a GEAC panel changed track and ruled that more tests were required before the mustard could be made available in farmer fields. Hence, nothing further happened.

Technical details of Cry1Ac : Cry1Ac protoxin is a crystal protein produced by the bacterium Bacillus thuringiensis (Bt) during sporulation. It is one of the delta endotoxins produced by this bacterium which act as insecticides. Because of this, the genes for these have been introduced into commercially important crops by genetic engineering (e.g. cotton and corn) in order to confer pest resistance on those plants. GM products such as Bt cotton, Bt brinjal and genetically modified maize have received attention due to a number of issues, including food controversies, and the Séralini affair. 

[ The Séralini affair was the controversy surrounding the publication, retraction, and republication of a journal article by French molecular biologist Gilles-Éric Séralini. The 2012 article presented a two-year feeding study in rats, and reported an increase in tumors among rats fed genetically modified corn and the herbicide RoundUp. Following widespread criticism by scientists, Food and Chemical Toxicology retracted the paper in November 2013 after the authors refused to withdraw it.The editor-in-chief said that the article was retracted because its data were inconclusive and its conclusions unreliable. ]

Cry1Ac is a mucosal adjuvant (an immune-response enhancer). It has been used in research to develop a vaccine against the amoeba Naegleria fowleri. This amoeba can invade and attack the human nervous system and brain, causing primary amoebic meningoencephalitis, which is nearly always fatal.

6.0 GM Mustard in India

In 2014, three GM mustard trials of Delhi University were taken up-at two sites in Punjab and one in Delhi -during the rabi season. Three states of India-Madhya Pradesh, Rajasthan and Haryana-account for more than 70 per cent of India's mustard production. Madhya Pradesh denied allowing GM field trials within the state. Rajasthan initially allowed, but stopped trials in 2012, ordering to burn the crop immediately. Haryana has refused to issue a "No Objection Certificate" for GM mustard so far. However, it is claimed that gene modification will help increase mustard production

6.1 Introduction

Mustard is one of the many oilseeds crops that are grown in India. Over the years, its productivity and production has been on an upswing. In 2010-11, a record mustard production of 81.8 lakh tonnes was harvested.  From 9.04 quintals per hectare in 1990-91, average mustard yield has increased to 12.62 quintals in 2013-14, with Gujarat recording 16.95 quintals per hectare. Mustard yields can still be increased further if farmers are paid a remunerative price, and an adequate mandi infrastructure is created to procure the harvest every year. Since almost 70 per cent of the mustard crop is cultivated in Rajasthan, Madhya Pradesh and Haryana, the problem farmers face is that of over-production and lack of buyers. 

6.2 Why GM Mustard

GM mustard was developed to increase the productivity of mustard to meet the ever-growing demand for edible oil in the country. This contradicts the government's own policy of opening up the edible oil sector to the import of cheaper oils. The government's policies seem aimed at destroying the gains of the Technology Mission on Oilseeds, launched by late PM Rajiv Gandhi in 1985. The doubling of oilseed production during 1985-1993 enabled the country to avoid its humiliating dependence on oil imports that cost the exchequer between Rs 1,500 crore and Rs 3,000 crore annually. From 11 million tonnes in 1986-87, oilseed production jumped to 22 million tonnes by 1994-95. India moved from being a net importer of oilseed to a net exporter, with only negligible imports.

Then, India deliberately began lowering import duties, enabling cheaper edible oil to flow in. The country now imports, on an average, five million tonnes of edible oil, roughly 50 per cent of its domestic requirement, costing the state exchequer more than Rs 9,000 crore. If India were serious about increasing the production of edible oil, the first step should be to stop unwanted imports. 

6.3 EU not happy with GM foods

With the European Union (EU) still holding on to the moratorium on GM Food, some scientists feel the focus has shifted to countries like India to open up to GM foods and crops and thereby add on to the countless problems that already confront its farmers. The apprehension about adverse impacts emanate from experience gained from other countries. For instance, Canadian scientists have found that a related species of engineered canola (rapeseed) has become an uncontrollable weed. At least three "super weeds" have already sprung up with regard to canola. Considering the small farm size and diversity in India, the probability of such super weeds developing is much greater. Among other impacts, GM mustard with protease inhibitors can affect honeybees directly and indirectly by influencing flowering and pollen production.

It is also known that Mustard DMH 11 is an herbicide-tolerant crop that has been made resistant to Bayer's glufosinate, which is even more toxic than glyphosate (a probable human carcinogen, according to the World Health Organization). Glufosinate is a broad spectrum herbicide that causes nerve damage and birth defects and is toxic to most organisms. It is also a neurotoxin for mammals that doesn't easily break down in the environment.

6.4 Mustard, after Brinjal

This would be the first time India would be considering commercial cultivation approval of any GM food crop after an indefinite moratorium was imposed on Bt Brinjal in February 2010. 

This GM mustard, developed by Delhi University, called Dhara Mustard Hybrid 11 (DMH11) adopted the transgenic technology to facilitate hybridisation on claims of increased yields through such a hybrid. In creating such GM mustard, male sterility has been induced in one of the parental lines, in addition to using herbicide tolerance traits.

Large-scale field trials may only be conducted when a crop has comprehensively cleared all bio-safety protocols in rigorous, independent, long-term testing and appraisal. However, this has not been the case with GM mustard. In reply to a Right to Information (RTI) query on May 15, 2015, the authority stated, "The aforesaid matter is under process and the information cannot be provided at this stage." It should be remembered here that the Supreme Court of India has directed GESE to post the bio-safety data on the website of the Ministry if Environment, Forests and Climate Change or DBT, in its hearing on August 1, 2007.

6.5 Safety data in public domain

It is clear that the authorities have not complied with the order of the Supreme Court in 2007 that bio-safety data be placed in the public domain when petitioners in the GM PIL argued that unless the toxicity and allergenicity data are made known to the public, the applicants and scientists concerned in the country would not be in a position to make effective representations to the authorities concerned.

This would not be the first time that a proposal for commercial cultivation of GM mustard has come up before the government. In 2002, the then Union government had rejected a proposal for commercial planting of private sector seed manufacturer Bayer's transgenic mustard.

7.0 THE BIOTECHNOLOGY REGULATORY AUTHORITY OF INDIA BILL

The Biotechnology Regulatory Authority of India (BRAI) Bill 2013, was introduced in the Lok Sabha on 22nd April 2013. The objective of the Bill was to "promote" the safe use of modern biotechnology.

It seemed that the proposed Biotechnology Regulatory Authority would have just a handful of technocrats taking all the decisions, whereas the current apex regulator, GEAC, is a multi-ministerial body representing various interests. According to the bill, BRAI will have a Chairperson, two full-time members and two part-time members; all will be required to have expertise in life sciences and biotechnology in agriculture, health care, environment and general biology. The BRAI Bill, 2013, provides for the setting up of an inter-ministerial governing board to oversee the performance of the proposed BRAI. It will also provide for setting up the Biotech Advisory Council to render strategic advice to the authority on matters relating to developments in modern biotechnology and their implications in India. The regulatory body will be an autonomous and statutory agency to regulate the research, transport, import, and manufacture biotechnology products and organisms. 

7.1 Process

The biotechnology bill was referred to a Standing Committee on Science and Technology, which has called for opinions and suggestions. Some said that the bill was tabled even though the Parliament Standing Committee on Agriculture had recommended that India does not need such a bill and instead required a bio-safety protection authority. 

7.2 Highlights

The Bill sets up an independent authority, the Biotechnology Regulatory Authority of India, to regulate organisms and products of modern biotechnology. The BRAI will regulate the research, transport, import, containment, environmental release, manufacture, and use of biotechnology products. Regulatory approval by BRAI will be granted through a multi-level process of assessment undertaken by scientific experts. BRAI will certify that the product developed is safe for its intended use.  All other laws governing the product will continue to apply. A Biotechnology Regulatory Appellate Tribunal will hear civil cases that involve a substantial question relating to modern biotechnology and hear appeals on the decisions and orders of BRAI. Penalties were specified for providing false information to BRAI, conducting unapproved field trials, obstructing or impersonating an officer of BRAI and for contravening any other provisions of the Bill.

7.3 Demerits

A Ministry promoting modern biotechnology (Ministry of Science & Technology) seeks to house the regulatory authority in this Bill - promoters cannot be regulators since there is an inherent conflict of interest. The BRAI Bill was proposed by the DBT, under the Ministry of Science and Technology which has a mandate to promote biotechnology in the country. In this situation the promoter of biotechnology will play a major role in constituting the sector regulator and also in assisting its functioning. With the promotion and regulation of GM crops under the same ministry, there is huge conflict of interest. This regulatory Bill has as its objective, 'promoting the safe use' of the technology. For promoting a technology, a legislation is not needed. The need for regulation comes for only one reason: to protect our health and environment and people's livelihoods from the risks of modern biotechnology. The Bill does not have this as an express mandate.

The Bill has its implications on and impinges upon matters that are monitored by other independent laws, such as Environment Protection Act, 1986, Biological Diversity Act, 2002, Forest Rights Act, 2006, Forest Conservation Act, 1980, Food Safety and Standards Act, 2006, Drugs and Cosmetics Act, 1940, Panchayat Raj Act, 1993, Nagarpalika Act, 1992, Right to Information Act, 2005[xvi], to name but a few and keeps the powers of overriding effect on other laws with it. Such an overarching Bill needs greater debates which have not happened so far.

7.4 Who supports

The greatest support for BRAI came from corporations and a section technocrats and agricultural scientists, US imperialism perhaps had a role in the matter. Some allege that one of the major goals of US interests is to fundamentally change the nature of Indian agriculture, and make it subservient to the interests of multinational corporations, especially US multinational corporations. 

In July 2005, the ex- Prime Minister Dr. Manmohan Singh and the then US president George Bush signed the "US-India Knowledge Initiative on Agricultural Education, Teaching, Research, Services and Commercial linkages" or the KIA agreement. A board was established whose main objective was to implement the different aims of the agreement, and thereby usher in the "second green revolution". The greatest emphasis in KIA was laid upon the massive application of biotechnology in Indian agriculture. In order to fully implement the Indo-US agricultural knowledge treaty, it became necessary to establish the BRAI, which will make the commercialization process of GM crops simple and amenable to the interests of multinational corporations.

7.5 Alternative

India needs a Biosafety Protection Legislation. Any regulatory regime around GMOs should have the primary mandate of protecting health of people and the environment from the risks of modern biotechnology and should also realize that transgenic technology is being actively rejected by citizens and governments all over the world and is not a fait accompli. It should have 

Precautionary Principle as the central guiding principle - Going in for GM option only in case other alternatives are missing and only if proven safe, including in the long-term.

Transparent functioning: information disclosure and public/independent scrutiny - Democratic functioning including public participation.

7.6 Conclusion

The BRAI bill would do no good if it comes into force in its present structure. If it is passed by the government as it is, then Bt Brinjal, Bt Rice and some 40-odd food crops would be at risk. The bill attacks the very constitutional rights of the citizens, including their right to information, their right to choose, even their right to seek redressal under court. The bill envisages a limited role for the state government. The choice of safe food along with the right to ask for it would be crushed underneath the multinational giants, who would then take over the agricultural sector of this country. The farmers would be left at their mercy and very soon out country would witness another advent of mass suicides by farmers if this bill comes into force. The legislation should be made to enhance biosafety and ensure democracy in the country and not otherwise.

8.0 BIOPIRACY: A MAJOR THREAT

Biopiracy refers to the appropriation of the knowledge and genetic resources of farming and indigenous communities by individuals or institutions that seek exclusive monopoly control (patents or intellectual property) over these resources and knowledge. 

Patenting of Neem (Azadirachta indica): Neem has been used by the people of India since time immemorial and the knowledge of the properties of the neem have been shared with the entire world. Pirating this knowledge, the USDA and an American MNC W.R. Grace in the early 90s sought a patent (No. 0426257 B) from the European Patent Office (EPO) on the "method for controlling on plants by the aid of hydrophobic extracted neem oil." The patenting of the fungicidal properties of Neem was an example of biopiracy. In 1995, W R Grace patented neem-based bio-pesticides, including Neemix, for use on food crops. Neemix suppresses insect feeding behaviour and growth in over 200 species of insects. This was revoked in 2000 following an appeal by India. In 2014 India has won a decade-long battle against the granting of a patent to a neem-based crop fungicide by the European Patent Office (EPO), proving that it has been part of the traditional knowledge of Indian farmers and the scientific community for centuries. The EPO reversed its original decision granting a patent to the United States Department of Agriculture and the multinational W R Grace.

Patenting of Basmati: Basmati is a long-grained, aromatic variety of rice indigenous to the Indian subcontinent. In 1997 the US Patent and Trademark Office (USPTO) granted a patent (No. 5663484) to a Texas based American company Rice Tec Inc for "Basmati rice line and grains". The patent application was based on 20 very broad claims on having "invented" the said rice. This led to a brief brief diplomatic crisis between India and United States with India threatening to take the matter to WTO as a violation of TRIPS. The USPO reviewed its decisions and RiceTec lost or withdrew most of the claims of the patent, including, most importantly, the right to call their rice lines "basmati." A more limited varietal patent was granted to RiceTec in 2001 on claims dealing with three strains of the rice developed by the company.

9.0 BIOTECHNOLOGY SECTOR IN INDIA TODAY

India is the largest producer of recombinant Hepatitis B vaccine and is among the top 12 biotech destinations in the world.It has recently overtaken Canada to emerge as the fourth largest country to grow biotech or genetically modified (GM) crops.Bt cotton is planted in about 11 million hectares today. The global acreages under GM crops increased to 175.2 million hectares in 2013, about five million hectares more than the previous year. Out of the top 10 biotech companies in India (by revenue), six focus their expertise in bio-pharmaceuticals and four specialised in agri-biotech. A number of institutions, both government and autonomous, provide the necessary opportunities for the student seeking to obtain a degree in this sector. Also, the Government of India has provided adequate scope to this sector by providing facilities for research and development (R&D) in the field of biotechnology.

9.1 Market size

India's biotech industry is estimated to grow from US$ 4.3 billion in 2011-12 to US$ 11.6 billion  in 2016-17. The high demand for different biotech products has also opened up scope for the foreign companies to set up bases and reap great profits.

The biotechnology industry in India, comprising about 400 companies, has grown three-fold in the last five years to reach US$ 4 billion in FY 2012-13. Growing at an average rate of about 20 per cent, India's biotech industry comprising biopharmaceuticals, bioservices, bioagriculture, bioindustry and bioinformatics could reach the US$ 7 billion mark by FY 15.Biopharma is the largest sector contributing about 62 per cent of the total revenue followed by bioservices (18 per cent), bioagri (15 per cent), bioindustry (four per cent), and bioinformatics contributing (one per cent).India has also emerged as the leading place for clinical trials which generates revenues of about US$ 636.73 million.

9.2 Investments

The potential of India's biotechnology sector has led to many global companies invest in India. Some of the recent investments in this sector are as follows:

1. Sanofi Pasteur announced on November 10, 2014 the launch of its paediatric pentavalent vaccine Shan, developed and manufactured by its affiliate Shantha. 
2. In a significant development for Kerala-based Arjuna Natural Extracts Ltd, the company has received a patent in the United States on BCM-95, a turmeric extract formulation that could be used to target Alzheimer's disease. Explaining the application patent, Mr Benny Antony, Joint Managing Director of the company said, the product is a re-blend of two ingredients in turmeric, but in a ratio that is not seen in naturally occurring turmeric. It is a reblend of curcuminoid and an essential oil of turmeric, he said.
3. Bristol-Myers Squibb and Syngene International, the contract research subsidiary of Biocon, have announced a five-year extension of their drug discovery and development collaboration in India.
4. The Bhabha Atomic Research Centre (BARC) through its Centre for Incubation of Technologies (BARCIT) has signed a memorandum of understanding (MoU) with M/s Veena Industries, Nagpur, for incubation of technology for biodegradable and edible films for food and pharmaceuticals packaging.
5. Cancer Genetics Inc (CGI) has acquired Hyderabad-based genomics services provider BioServe India for US$ 1.9 million. This will enable CGI to better position themselves globally in personalised cancer care.
6. The Shanghai Jiading Advanced Technology Innovation and Business Incubator has invited Indian technology innovators and Small and Medium Enterprises (SMEs), especially in renewable energy, biomedical devices and advanced manufacturing to set up their businesses in Jiading.
7. Suven Life Sciences Ltd has obtained two patents, one each from Hong Kong and Canada, for its New Chemical Entities (NCEs) for the treatment of disorders associated with neurodegenerative diseases.

9.3 Government Initiatives

A Network of Technology Centres and promotion of start-ups by SIDBI are among few of the steps taken by the government to promote innovation and entrepreneurship in agro industry proposed by the MSME Ministry in a new scheme. The scheme follows the announcement of a Rs 200 crore (US$ 31.52 million) fund by Finance Minister Mr Arun Jaitley in his Budget speech this year for promoting innovation and entrepreneurship in agro industry. 

The Government of India has taken a lot of initiatives to improve the biotechnology sector in the country as well as offer enough scope for research in this field. The Department of Biotechnology (DBT) along with other government funded institutions such as National Biotechnology Board (NBTB) and many other autonomous bodies representing the biotechnology sector, are actively working together so as to project India as a global hub for biotech research and business excellence. Some of the recent major initiatives are as follows:

1. CSIR-Institute of Himalayan Bioresource Technology (CSIR-IHBT) has signed an MoU with Phyto Biotech to formalise transfer of technology, for production of unique autoclavable super oxide dismutase (SOD) enzyme, used in cosmetic, food and pharmaceutical industries for end applications.
2. DBT has announced the Indo-Australian Career Boosting Gold Fellowships under which it will support the researchers to undertake a collaborative research project at a leading science institute or university in Australia for a period of up to 24 months.
3. DBT has allocated Rs 4.6 crore (US$ 724,997.34) to the University of Agricultural Sciences (UAS) to support a national multi-institutional project titled 'A value chain on jackfruit and its products'.
4. Under the 12th Five Year Plan, the Government of India plans to strengthen regulatory science and infrastructure, which involves setting up of Biotechnology Regulatory Authority of India (BRAI) and a central agency for regulatory testing and certification laboratories.

9.4 Road Ahead

India offers numerous advantages in the biotechnology sector due to research and development (R&D) facilities, knowledge, skills, and cost effectiveness, the biotechnology industry in India has immense potential to emerge as a global key player.

With a growing economy and rising levels of income it is expected that Indians will be able to afford healthcare products, and demand for food commodities and energy will grow too. Presently, many countries are looking forward to invest in the Indian biotechnology sector. With all the support, government initiatives and determination to excel, India can soon attain global leadership in providing affordable healthcare and innovative medicines, quality food and feed for all.

10.0 Challenges for the Biotechnology sector

Despite strong growth and great potential, the Indian biotechnology industry faces certain challenges, such as lack of adequate resources for R&D, molecular and chemical screening libraries and level 3 biosafety facilities for research on infectious diseases. The Department of Biotechnology and the ABLE address these challenges by making effective schemes and policies. DBT's major focus currently lies in increasing the investment in the biotechnology industry through public funding and PPP initiatives. Although the Union Budget of 2012-13 has not offered anything special for the biotechnology sector, the major focus has been on R&D in the agriculture and the vaccines domains. Both of the domains are expected to have a positive impact on the industry. The government's core focus areas over the past, current and future five year plans have been the following:

Increasing the influx of funds: This will help the Indian companies to innovate within the various segments of the industry. Innovations have driven the agri-biotech segment by developing crops (Bt Cotton), which have increased yield and lowered wastage and use of pesticides. The government's focus on PPPs has encouraged the private sector to invest in the biotechnology industry and promote the commercialisation of biotech products.

Strong focus on educational infrastructure: The government has laid a strong focus on educational infrastructure  through grants and funds for agri universities and research work.

Impending shift of focus from international to domestic markets: Though exports have accounted for a larger share of the biotechnology market by value in past years, a rise in income levels and the growth of the Indian middle class is expected to drive the domestic market in future years.

Though India has a large pool of educational institutions offering biotechnology degrees, there is a shortage of skilled manpower in research areas, such as oncology, medicinal chemistry, drug delivery, and in-vivo pharmacology. For this reason, the government plans to set up 50 research centres focussing on priority areas in biotechnology such as the ones listed above, in addition to establishing biotechnology parks with high tech facilities. A combination of these factors has poised the Indian biotechnology industry for strong growth in the future.

According to the Indian draft National Biotechnology Regulatory Bill 2008, modern biotechnology is "the application of invitro nucleic acid techniques, including recombinant deoxyribonucleic acid (DNA) and direct injection of nucleic acid into cells; or organelles, or fusion of cells beyond the taxonomic family that overcome natural physiological, reproductive or recombination barriers and that are not techniques used in traditional breeding and selection. It excludes: in vitro fertilisation; natural processes such as conjugation, transduction, transformation; polyploidy induction; and accelerated mutagenesis".

The debate over biotechnology policy is at heart a debate over information policy. At one level the debate covers how to provide intellectual property protection to the tools of biotechnology and the valuable information they produce, such as gene sequences and chromosome maps. At a different and less comfortable level, the debate shifts to questions of how best to distribute information, to empower others to use it, and to prevent its misuse and loss of privacy. Aided by the new tools of the computer age, biotechnology is developing faster than any previous technology and, in the process, creating a wider gap between practice and policy.

Information and the process of opinion formation: Development cooperation can help to improve this situation by promoting public debates on GM crops. This can be done by supporting decision-making processes, while at the same time respecting the sovereignty of developing countries. The aim is to place developing countries in a position to make their own informed choices based on public discussion.

Support in setting up guidelines: Ensuring biosafety and preventing arbitrariness and abuse with regard to GM crops requires guidelines and enforcement procedures that are adapted to the relevant national context. This need has been acknowledged by the international community and is recorded in Article 22 of the Cartagena Protocol. By now, numerous projects have been launched in this field. They are funded through international financing mechanisms, such as the Global Environment Facility (GEF), but also by individual states or non-governmental sources. Project activities range from training decision-makers in biosafety to providing support in setting up institutions and in the concrete elaboration of laws, to promoting regional cooperation.

Building capacity for developing and managing biotechnology: This article has highlighted some of the potential risks and benefits of GM crops, the use of DNA for vaccines and diagnostic tests and the therapy of gene. Application of biotechnology to meet the needs of developing countries requires the creation of an infrastructure for the transfer of relevant technologies, development of institutions with the capacity to adopt and develop the know-how required for successful application of biotechnology. This includes building capacity to understand their own ecosystems and to select, acquire, manage and further develop those biotechnologies that are most appropriate to national needs. Clearly, such efforts require investing in science and technology education and research.

Biosafety and bioethics: Biosafety is concerned with the potentially adverse impacts of biotechnology on human, animal and plant health, and the environment. Biotechnology also gives rise to socio-economic and ethical concerns. Physical risk and uncertainty are technical issues, and policies and regulatory regimes intended to manage these risks will depend largely on scientific capacity, including human expertise and well-equipped laboratories. This capacity simply does not exist in many developing countries at present. The types of biotechnologies mentioned here are characterized by a great deal of scientific uncertainty. The Cartagena Protocol on Biosafety, the first international agreement specifically negotiated to deal with products of genetic engineering, is based on applying the precautionary principle to risk assessment of genetically modified organisms. This Principle holds that an absence or lack of scientific proof of risk should not be taken as conclusive evidence of the safety of any given organism and requires risk/benefit analysis. This gives some degree of reassurance to developing countries that are as yet unable to undertake comprehensive risk assessments.

Building awareness of biotechnology: We must invigorate the policy debate to ensure that biotechnology does not just address technological problems in a socio-economic vacuum, but provides redress for hunger and disease universally and democratically. It is not enough to create more wealth; we must create a greater capacity for more to share its benefits. Some of the applications of biotechnology described earlier have potentially serious implications for socio-economic welfare, and ethical and moral well-being. If biotechnology is to be used to provide benefits to a country's population, then political support, as well as public awareness and acceptance of new technologies are essential. There is a wide range of potential applications, and decisions have to be made concerning the choice of technologies, according to national needs. Building public awareness and disseminating qualified and balanced information about biotechnology is a critical issue in most countries.

Need for a differentiated approach: Biotechnology is leading agriculture into new dimensions. Its use is a step that most probably cannot be reversed. The question of whether genetically modified and conventional crops can co-exist side remains controversial. Moreover, biotechnology may further promote the expansion of largescale industrial production systems. Finally, control and safety in the use of GM crops poses great challenges, particularly in developing countries. Development cooperation is faced with the question of how future food security can be achieved in view of population growth and limited natural resources.

About GEAC

• The Genetic Engineering Appraisal Committee (GEAC) functions in the Ministry of Environment, Forest and Climate Change (MoEF&CC). As per Rules, 1989, it is responsible for appraisal of activities involving large scale use of hazardous microorganisms and recombinants in research and industrial production from the environmental angle. 
• The committee is also responsible for appraisal of proposals relating to release of genetically engineered (GE) organisms and products into the enviornment including experimental field trials.
• GEAC is chaired by the Special Secretary/Additional Secretary of MoEF&CC and co-chaired by a representative from the Department of Biotechnology (DBT). Presently, it has 24 members and meets every month to review the applications in the areas indicated above.
• The functions of GEAC as prescribed in the Rules 1989 are : 

1. To appraise activities involving large scale use of hazardous microorganisms and recombinants in research and industrial production from the environmental angle
2. To appraise proposals relating to release of genetically engineered organisms and products into the environment including experimental field trials
3. The committee or any persons authorized by it has powers to take punitive action under the Environment Protection Act

• The composition of the GEAC has been prescribed in Rules 1989 - 

1. Chairman - Special Secretary/Additional Secretary, Ministry of Environment, Forest and Climate Change (MoEF&CC); Co-Chairman - Representative of Department of Biotechnology 
2. Members: Representative of concerned Agencies and Departments, namely, Ministry of Industrial Development, Department of Biotechnology and the Department of Atomic Energy
3. Expert members: Director General of Indian Council of Agricultural Research, Director General of Indian Council of Medical Research, Director General of Council of Scientific and Industrial Research, Director General of Health Services, Plant Protection Adviser, Directorate of Plant Protection, Quarantine and storage, Chairman, Central Pollution Control Board and three outside experts in individual capacity
4. Member Secretary: An official of the Ministry of Environment, Forest and Climate Change (MoEF&CC)

• Biosafety Data of Approved GM crops - Biosafety data including comparative toxicity, allergencity and feeding studies in experimental animals is generated by companies prior to seeking approval from GEAC as per Rules for the manufacture, use, import, export & storage of hazardous micro organisms, genetically engineered organisms or cells, 1989 and Revised Guidelines for Research in Transgenic Plants & Guidelines for Toxicity and Allergenicity Evaluation of Transgenic Seeds, Plants and Plant parts - 1998. As of now five genes/events of Bt cotton and one BN Bt cotton variety and NHH Bt cotton hybrid have been approved by GEAC.
  

Make in India - Biotechnology

SUMMARY

• Third biggest biotech industry in the Asia-Pacific region.
• Second highest number of USFDA-approved plants. 
• USD 3.7 Billion to be spent on biotechnology from 2012-17. 
• No. 1 producer of Hepatitis B vaccine recombinant. 
• USD 100 Billion industry by 2025.

AGENCIES

• Department of Biotechnology, Ministry of Science & Technology, Government of India
• Department of Science and Technology, Ministry of Science and Technology, Government of India
• Biotechnology Industry Research Assistance Council
• Council of Scientific and Industrial Research
• Association of Biotechnology Led Enterprises
• Confederation of Indian Industry
• Federation of Indian Chambers of Commerce and Industry

FOREIGN INVESTORS

• Bill and Melinda Gates Foundation
• Wellcome Trust
• BPI France
• USAID
• World Health Organisation
• Grand Challenges Canada, Tekes, Finland
• Limagrain (France)
• Endo Pharmaceuticals (USA)
• Mylan Inc. (USA)
• Sanofi Aventis (France) 
• Abbot Laboratories (USA) 
• Fresenius (Singapore)
• Hospira (USA

REASONS TO INVEST

• India is amongst the top 12 biotech destinations in the world and ranks third in the Asia-Pacific region. 
• India has the second highest number of USFDA-approved plants, after the USA. 
• India adopted the product patent regime in 2005.
• Increasing government expenditure will augment the growth of the sector - the government aims to spend USD 3.7 Billion on biotechnology between 2012-17.
• India is the largest producer of recombinant Hepatitis B vaccine.
• India has the potential to become a major producer of transgenic rice and several genetically modified (GM) or engineered vegetables.
• Abundance of highly-skilled and trained pool of talent.
• Special purpose organisation such as Biotechnology Industry Research Assistance Council (BIRAC), a Public Sector Undertaking of Department of Biotechnology, to support industry through funding, mentoring,hand-holding and infrastructure support.

 INVESTMENT OPPORTUNITIES

• The Department of Biotechnology has established biotech parks in various parts of the country to facilitate product development, research and innovation, and the development of biotechnology industrial clusters.
• Operational biotech parks are located at Lucknow in Uttar Pradesh, Bangalore in Karnataka, Kalamassery and Kochi in Kerala, Guwahati in Assam and Chindwara in Madhya Pradesh.
• The parks offer investors incubator facilities, pilot plant facilities for solvent extraction and laboratory and office spaces.
• India constitutes around 8% of the total global generics market, by volume, indicating a huge untapped opportunity in the sector.
• Outsourcing to India is projected to spike up after the discovery and manufacture of formulations.
• Hybrid seeds, including GM seeds, represent new business opportunities in India based on yield improvement.
• BIRAC has launched an Equity based fund - AcE Fund: An equity fund to address to accelerate the growth of entrepreneurs, in the field of biotechnology, by lending a funding support of up to - USD 150,000 for promising ventures.

STATISTICS

• The Indian biotech industry will grow at an average growth rate of around 30% a year and reach USD 100 Billion by 2025.
• The Indian bio-economy grew to USD 4.3 Billion at the end of 2013, up from USD 530 Million in 2003.
• The Indian biotech industry grew by 15.1% in 2012-13, increasing the market's revenues from USD 3.31 Billion in 2011-12 to USD 3.81 Billion in 2012-13.
• The market size of the sector is expected to rise up to USD 11.6 Billion by 2017 due to a range of factors such as growing demand for healthcare services, intensive R&D activities and strong government initiatives.
• The Indian biotech sector is divided into five major segments - bio-pharma, bio-services, bio-agri, bio-industrial and bio-informatics.
• The bio-pharmaceutical sector accounts for the largest share of the biotech industry with a share of 64% in total revenues in 2013, followed by bio-services (18%), bio-agri (14%), bio-industrial (3%) and bio-informatics (1%).
• Revenue from bio-pharma exports reached USD 2.2 Billion in 2013, accounting for 51% of total revenues of the biotech industry.
• Supported 270 Companies, 360 projects involving 140 Scientists and Entrepreneurs and 113 Incubators with USD 225 million, through BIRAC, a Public Sector Unit of Government of India.
• 24 Intellectual Property field.
• 124,000 sq. ft. of incubation space created.
• 5 University Innovation Clusters created.
• 1 Regional Innovation Centre.
• 3 Bio-Industrial Facilities.

FDI POLICY

• Foreign Direct Investment (FDI) up to 100% is permitted through the automatic route for Greenfield and through the government route for brownfield, for pharmaceuticals.

SECTOR POLICY

NATIONAL GUIDELINES FOR STEM CELL RESEARCH 2O13:

• The guidelines have been laid down to ensure that research with human stem cells is conducted in a responsible and ethical manner and complies with all regulatory requirements pertaining to biomedical research in general and of stem cell research in particular. 
• These guidelines apply to all stakeholders including individual researchers, organisations, sponsors, oversight/regulatory committees and any other associated with both basic and clinical research on all types of human stem cells and their derivatives.

GUIDELINES ON SIMILAR BIOLOGICS-REGULATORY REQUIREMENTS FOR MARKETING AUTHORIZATION IN INDIA 2O12:

• The Guidelines on Similar Biologics prepared by the Central Drugs Standard Control Organization (CDSCO) and the Department of Biotechnology (DBT) lay down the regulatory pathway for a biologic claiming to be similar to an already authorised reference biologic.
• The guidelines address the regulatory pathway regarding the manufacturing process and quality aspects for similar biologics.
• These guidelines also address the pre-market regulatory requirements including a comparability exercise for quality, preclinical and clinical studies and post-market regulatory requirements for similar biologics.

GROWTH DRIVERS

• The sector has seen high growth with a CAGR in excess of 20% and the key drivers for growth in the biotech sector are increasing investments, outsourcing activities, exports and the government's focus on the sector. 
• A strong pool of scientists and engineers.
• Cost-effective manufacturing capabilities.
• The setting up of national research laboratories, centres of academic excellence in biosciences, several medical colleges, educational and training institutes offering degrees and diplomas in biotechnology, bio-informatics and biological sciences.
• For global companies looking to economise, outsourcing to lower cost economies results in a cost arbitrage of more than 50%.
• Fast-developing clinical capabilities with the country becoming a popular destination for clinical trials, contract research and manufacturing activities.
• Establishment of industry oriented organisation - BIRAC to support biotech start-ups and SMEs through funding, mentoring, hand-holding and infrastructure support.
• Setting-up of an Early Translation Accelerator (ETA) by BIRAC, to focus on catalysing transformation of young academic discoveries with possible commercial and societal impact into economically viable ventures and technologies.

SPURRING A START-UP CULTURE - BIRAC INITIATIVES

NESTING GROUNDS FOR BIG TAKE OFFS: BIOINCUBATION

• BIRAC has two 15 incubators (at six Biotech Parks, three IITs, four Academic Institutes, 2 Bio Clusters) providing access to high-tech equipment, mentor networks and hand-holding.
• 124,000 sq. ft. of incubation space created.
• Enabling 199 start-ups/entrepreneurs with incubation support.
• INR 100.00 Crores sanctioned for the Programme.

GERMINATING INNOVATIONS IN UNIVERSITIES : UIC 

(UNIVERSITY INNOVATION CLUSTER)

• UIC is an innovation centre within the university system that is connected to various stakeholders both within & outside the university
• Five UICs set-up at Jaipur, Chandigarh, Dharwad, Coimbatore and Chennai for incubating students to test ideas/discoveries and take them to Proof of Concept.
• An incubation space of 2500-3000 sq. ft. at each UIC
• BIRAC Innovation Fellowships for two post-doctoral and four post M.Sc, Fellows in addition to Innovation Grant.
• Industry Participation for training, mentoring, sponsored research and networking opportunities and IP & Technology Management.

MAPPING & ANALYSIS OF INNOVATION ECOSYSTEM : BIRAC REGIONAL INNOVATION CENTRE (BRIC) AT IKP KNOWLEDGE PARK

• BRIC maps bio-innovation across Southern India in academic & industry.
• Support to start ups for IP & technology transfer.
• Networking opportunities for start-ups, industry & academia.

WATERING THE GRASS ROOT INNOVATION SEEDLINGS: BIRAX-SRISTI GANDHIAN YOUNG TECHNOLOGY INNOVATION AWARDS

• Partnership with SRISTI at IIM Ahmedabad to identify bio-entrepreneurial ideas that are fermenting at institutional level and proving mini seed funds.
• Supporting 100 nascent ideas across the country with micro-funds.

INVIGORATING INDUSTRIAL R&D THROUGH INNOVATION FUNDING

• Taking Start-ups & SMEs to next level of funding support: Small Business Innovation Research Initiative (SBIRI) | India's first biotech focused Public Private Partnership funding scheme that took shape in 2007 | Early stage funding for high risk innovative research by industry | Support extended to 155 companies in diverse fields of frontier biotechnology. 
• Catapulting high-risk innovations through industry partnership: Biotechnology Industry Partnership Programs(BIPP) | Government partnership with industries for support on a cost sharing basis | Support for high risk, highly innovative accelerated technology development | Support extended to 106 companies that are attempting to bring high quality products through cutting edge R&D through 124 projects.

Join PT courses | PT Youtube | PT App | Contribute |  Testimonials