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Overview Of indian BiOtech

Market assOciated with

cliMate change

INDEX

Authors: Gautam Khurana, Mg. Partner, Akash Chauhan, Sr. Associate, Abhishek Hans,

Associate, India Law Offices

The report has been compiled based on an in-house research and various sources,

including the Department of Biotechnology (DBT), Ministry of New and Renewable

Energy (MNRE), Ministry of Environment & Forests (MEF), Federation of Indian

Chambers of Commerce & Industry (FICCI), Confederation of Indian Industries (CII),

The Energy and Research Institute (TERI) and many private researches.

S.No. Index Page

1.

2.

3.

4.

5.

6.

Overview of the Indian Biotech Market 2011

Overview of Indian Biotech associated with Climate Change; Strengths and Weaknesses

Opportunities in India

Government Initiative

Intellectual Property Rights

Future Opportunities – New Business Model

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89

114

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www.ebtc.eu EuropEan BusinEss and TEchnology cEnTrE

5ovErviEw of indian BioTEch MarkET associaTEd wiTh cliMaTE changE

Executive Summary Biotechnology sector in India is witnessing exponential growth and plays a pivotal role in the

Indian economy. In the year 2009-2010, the Indian biotech industry breached EUR 2,218.58

Million mark with a staggering growth of 17% over the previous year.

Amongst the various disciplines of Biotechnology, Bio-Agri emerges as the winner recording a

growth rate of 37% followed by Bio-Services at 28% and BioIndustrial at 16%. Exports accounted

for 53% share with 5% growth over FY 2008-09 and Domestic accounted for 47% share with 34%

growth over FY 2008-09.

Government Organisation and Autonomous Bodies

To provide an impetus to the Biotech sector in India the Government established The Department

of Science and Technology (DST), the Department of Biotechnology (DBT), and Health Biotech

Science Cluster (HBSC) under the Ministry of Science and Technology. Apart from these,

autonomous organisations like TERI (The Energy and Research Institute) play a significant role in

the development of Biotech Sector.

Biotechnology and Environment

Indian policies have always had provisions for Climate change. According to the International

Energy Agency, India is set to become the third largest emitter of greenhouse gases by the year

2015. India has set voluntary targets to reduce the intensity of carbon emissions by 20-25% by

2020 and plans to meet these challenges with combined forces of Public and Private Partnerships.

Biotechnology has an enormous potential to offer eco-friendly, efficient, economically viable, and

unique options for in-situ waste treatment and degradation of the potentially hazardous toxic

waste into harmless/ relatively less harmful by-products. Certain technologies developed with the

efforts of the DBT and other bodies are: Industrial Effluent Treatment, Paper and Pulp Mill Effluent

Treatment, Oilzapper Technology, Chemo biochemical process, Biosensor for Detection of Pesticide

Residues, Detection of Pathogens in Drinking Water, Biosurfactants from Wastes, and Bioscrubber

for Removal of Odours from Industrial Emissions.



The National Policy on Biofuels was initiated in 2009 to promote the use of renewable energy

resources as alternate fuels for transportation vehicles with a target of 20% biofuel blending

(Ethanol Blending Programme-EBP) by the year 2017.

National Bio-diesel Mission (NBM), since 2003, has been promoting Jatropha curcas as the ideal

tree-borne oilseed for producing bio-diesel on wastelands. The Planning Commission of India has

targeted covering 11.2-13.4 million hectares of land under Jatropha cultivation by the end of 11th

Five Year Plan (2011-12). According to the industry sources the government is in the process to

devise an ethanol purchase price for the EBP.

The Ministry of New and Renewable Energy is implementing a biomass power programme with the

objective of harnessing grid quality power from biomass resources through various conversion

technologies along with optimising power generation from bagasse produced in sugar mills.

New Legislation and Regulation

The GoI has drafted the Seed Bill 2010 that seeks to repeal and replace existing Seeds Act, 1966

but is presently pending for an approval of Parliament. The Bill seeks to regulate the production,

quality of seeds for sale, import and export, distribution and sale of seeds, and addressing other

seed-related matters.

Most recently, the National Green Tribunal Act, 2010 has evolved establishing a National Green

Tribunal which shall have the jurisdiction over all substantial questions relating to environment and

power to provide relief and compensation to the victims of pollution and other environmental

hazards.

Public-Private Partnership

The public-private partnerships are increasing with several business houses acquiring approval for

projects to bolster R&D efforts and focus on innovative and eco-friendly products. The initiatives

taken by Bill & Melinda Gates Foundation and DBT Small Business Innovation Research Initiative

(SBIRI) are examples of collaborations between the industry and the government.

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8 ovErviEw of indian BioTEch MarkET associaTEd wiTh cliMaTE changE

Recently in March 2011, SG Biofuels, a US based bioenergy crop Company using breeding and

biotechnology to develop elite hybrid seeds of Jatropha, has extended operations in India.

Advantage in India

India offers a lot of advantages in the field of Biotechnology, including investments, Outsourcing

Opportunity, Low Manufacturing Cost, High Quality and Technical Capability, Quality Manpower,

Climate Condition, and Innovative Product Market.

Carbon Credit

India is actively promoting ‘Clean Development Mechanism’ (CDM) to achieve the targets as per

the Kyoto Protocol and save Carbon Credits. The country has entered into CDM projects with

companies investing in Windmill, Bio-gas, Bio-diesel, and Co-generation and these companies are

are generating Carbon Credits to be sold later to developed nations. The GoI has further

constituted the National Clean Development Mechanism Authority for the purpose of protecting and

improving the quality of environment in terms of the Kyoto Protocol.

Government Initiative

The Indian Government announced the Jawahar Lal Nehru National Solar Mission (JLNNSM) in

2010 to generate 20,000 MW of grid connected solar energy by 2022. Recently, Cleantech

Switzerland entered into an agreement with the Confederation of Indian Industry (CII) to explore

business opportunities in the clean energy sector for both Indian and Swiss entities.

The Government has also proposed the establishment of the National Biotechnology Regulatory

Authority (NBRA) for regulatory approval. In July 2008, the DBT introduced the National

Biotechnology Regulatory Act, which would establish the NBRA as an empowered body to approve

genetically modified crops, food, recombinant biologics, like DNA, vaccines, recombinant gene

therapy products, and recombinant and transgenic plasma-derived products, such as clotting

factors, veterinary biologics and industrial products.



The Eleventh Five Year Plan has allocated EUR 1015.62 Million for Department of Biotechnology. In

February 2009, DBT implemented a new scheme “BIPP” for enhancing the scope of public-private

partnership.

The Small Business Innovation Research Initiative (SBIRI) is the new scheme launched by the

department to boost public-private-partnership effort in the country. The scheme brings together

users and producers of technology creating direct focus and a sense of urgency for producing

defined results that can only be produced by the private sector engagements.

A National Mission called “Green India” has been launched to enhance ecosystem services. An

initial corpus of over EURO 1 Billion has been earmarked for the programme through the

Compensatory Afforestaion Management and Planning Authority (CAMPA) to commence the work.

The programme will be scaled up to cover all remaining degraded forest land.

Government of India has designed a National Mission on Enhanced Energy Efficiency (NMEEE),

which is one out of eight missions planned under the National Action Plan on Climate Change.

International Collaboration

The Department of Biotechnology has been introducing joint proposals and maintaining

international collaborations with countries like EU, Australia, Canada, USA, and Japan. Some are as

follows:

NEW INDIGO, the Initiative for the Development and Integration of Indian and European Research

aims at strengthening the multilateral science and technology cooperation between EU and India.

Department of Biotechnology has also partnered with UK based Wellcome Trust (WT) to a three-

tier fellowship programme on biomedical research at postdoctoral level.

Namaste is a collaborative small or medium-scale focused research project between European

Commission and Department of Biotechnology, India. The project Namaste EU was launched on 1

February, 2010 while Namaste India was launched on 26 March, 2010 for 3 years duration.



An MoU for cooperation in the area of Biotechnology and Biological Sciences between DBT and

BBSRC, UK has been signed. Areas identified are Food Biotechnology, Vaccines for communicable

and non communicable diseases, Diagnostics for infectious and non-infectious diseases, Bioprocess

engineering and down stream processing, and Exchange of information on technology transfer.

Taxation Benefit

1. As per Section 10AA – Special Economic Zone, Income Tax Act 1961, the profit and gain

derived from export of goods and services shall be exempted.

2. Any expenditure on scientific research (except cost of land and building), on in-house

research, and development facility as approved by the prescribed authority shall be allowed a

deduction of a 200%.

3. Full exemption from basic custom duty is being provided to bio-polymer/bio-plastics (HS Code

39139090) used for manufacture of bio-degradable agro mulching films, nursery plantation &

flower pots.

4. As per Notification No. 4/2007-Central Excise, excise duty on Bio-Diesel (Alkyl esters of long

chain fatty acids obtained from vegetable oils) is exempted.

5. Full exemption from excise duty on all items of machinery, required for initial setting up of a

project for the generation of power using non-conventional materials, namely, agricultural,

forestry, agro-industrial, industrial, municipal and urban waste, bio waste or poultry litter.

Intellectual Property

World Intellectual Properties Organization (WIPO) was formed in 1967 which ensures IPR

protection amongst its member countries worldwide. Trade Related Aspects of Intellectual Property

Rights (TRIPS) is an international agreement administered by the World Trade Organization (WTO)

that sets down minimum standards for many forms of intellectual property (IP) regulation as

applied to nationals of other WTO Members.

Intellectual property being an intangible property includes 'patents', 'trade secrets', 'copyrights'

and 'trademarks'. Under biotechnology, processes and products are most important examples of

intellectual property. In 1967, WIPO was formed to centralise the world’s patent and copyright

information. The Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement



introduced intellectual property law into the international trading system for the first time in 1994.

Biotechnology Patent Facilitating Cell (BPFC) was set up in 1999 to create awareness and

understanding about Intellectual Property Rights (IPRs) among scientists and researchers.

New Business Model

Collaborative R&D: Indian companies can partner with foreign players to enter into collaborative

R&D efforts as an initial step towards developing an R&D focus.

New revenue streams: Revenues from patent licensing and litigation can re-define existing

business models completely, and shift them to a higher value-generation plane.

Emerging business Opportunities: India will become a highly lucrative option for contract

research once strong IP protection legislation is introduced.

Capturing the Indian Market: Indian companies can introduce entry barriers for foreign players

in the Indian market by using IP to protect their own innovations.



1: Overview of the Indian Biotech Market 2011

1.1. Introduction BIOTECHNOLOGY is a wide term covering a broad range of scientific applications being used for

various sectors. The term is inter-related with other disciplines and technologies like systems

biology, synthetic biology, bioinformatics and nanotechnology, whose convergence will lead to

improved future products and technologies.

Indian Government is embracing biotechnology as the next driver of innovation and economic

growth. Biotechnology is already beginning to usher in complex, rapidly emerging and far-reaching

novel changes in several areas, particularly food and nutrition security, healthcare and

environmental sustainability.

The private sector with several home-grown companies has performed well. This has strongly

impacted the promotion of low cost vaccines and other useful healthcare products and forced a

price reduction on various bioproducts of MNCs.

The Year 2010 - 2011 was considered the ‘Year of Recovery for Indian Economy’ after the global

downturn in 2009 and a slow recovery in the Q1 2010. Unlike the biotech sectors worldwide, the

global recession has left the Indian biotech industry untouched due to its less reliance on investors’

capital. India’s biotech industry has blossomed in recent years as domestic companies have grown

aggressively in a liberalized intellectual property (IP) regime and as companies worldwide have

sought to seize opportunities from India’s large, skilled workforce, lower manufacturing and

research costs.

1.2. India Biotechnology Sector – Emerging India’s biotechnology sector has flourished in the recent years with a steady pace. The domestic

companies have shown a marked growth due to the liberalized regime in terms of intellectual

property (IP). Also, both the domestic and global companies have made use of the advantages



offered and have benefited from the large and skilled Indian workforce in addition to the low

manufacturing costs.

Currently, India holds a two percent share in the global market. In the year 2010 – 2011, the

revenue for Indian biotechnology industry touched an astounding figure of EUR 2,343.75 Million.

This figure is estimated to reach EUR 10.2 billion by the year 2015, indicating a robust growth for

the Indian biotech industry. This, however, implies that the industry would have to grow at about

30% year-on- year with increased government initiatives.

A consistent double digit growth has been recorded for the industry over the last decade with the

average revenue growth figures being greater than 20%. The Indian Economy has witnessed a

sharp growth in deals involving outsourcing, technology transfer and entry of foreign players to tap

the burgeoning Indian biotechnology market.

The Government of India has introduced a number of important legislations in order to support and

promote the growth of biotechnology industry in the country. However, several organisations are

involved in regulating the development of biotechnology in the country which has often led to an

overlap of functions. In order to streamline the regulatory process, the Government has proposed

the establishment of the National Biotechnology Regulatory Authority (NBRA) to provide a

consistent mechanism for regulatory approval.

1.3. Evolution of Indian Biotech Sector



1.4. Market Overview

Amount in EUR Million

Particular / Year 02 -03 03-04 04-05 05-06 06-07 07-08 08-09 09-10

€ € € € € € € €

BioPharma 279.68 430 557.81 735.62 933.28 1077.96 1231.71 1379.53

BioServices 21.09 42.96

20.31

66.40 112.50 172.18 245.62 322.18 412.34

BioAgri 18.3 51.56 93.43 144.68 187.65 233.43 302.5

BioIndustrial 36.71 37.18 50 58.59 61.71 64.06 74.68 88.12

BioInformatics 11.71 12.5 15.62 18.75 22.65 29.68 34.37 36.09

Total 366.37 542.95 741.39 1018.89 1334.5 1604.97 1896.37 2218.58

Particular / Year 10-11 11-12

€ €

Expected Market (Biotech) 2343.75 2765.62



Market Overview

The Indian BioPharma market in 2009-2010, primarily comprising of vaccines, therapeutic drugs,

insulin, animal biologicals, statins and diagnostics continued to grab the largest share of the total

biotech industry revenue of over EUR 2218.58 Million. It contributed EUR 1379.53 Million

accounting for 62% revenue share.

The contribution of the Top 20 companies in the total revenue was 52% and these companies

grew at an average growth rate of over 22% while the industry growth rate stood at 17% in FY

2009-10.

Biocon, India’s leading Biotech Company, has record revenue of EUR 184.37 Million.

Firms in India manufacture around 60,000 generic brands across as many as 60 therapeutic

categories. After USA, India is the 2nd country to permit clinical drug trials on humans using

dormant cells in the body with natural regeneration capabilities.

India contributes around 50% in the overall worldwide drug production and is likely to be

counted among one of the top five innovative hubs due to its noteworthy contributions.

Indian Biotech Indusry 2009-10

61%19%

14%4% 2%

BioPharma

BioServices

BioAgri

BioIndustrial

BioInformatics

Indian biotech industry witnessed a

growth of 17% in 2009-10 standing at

a figure of EUR 2,218.58 Million.

With the various government initiatives

in place, the industry is expected to

grow at a robust rate and reach EUR

10.2 billion by 2015.

BioAgri Sector has shown a remarkable

growth of 37% followed by BioServices

at 28%.



1.5. Domestic vs. Export Exports accounted for 53% share with 5% growth over FY 2008-09 and Domestic accounted for

47% share with 34% growth over FY 2008-09.

Biotech Industry Export Vs Domestic 2009 – 2010 EUR in Million

Segment Export Domestic Total % Share

Exports

% Share

Domestic

BioPharma 744.94 634.58 1379.52 54 46

BioServices 391.72 20.61 412.33 95 5

BioAgri 9.075 293.42 302.495 3 97

BioIndustrial 19.38 68.73 88.11 22 78

BioInformatics 11.55 24.54 36.09 32 68

Total 1176.665 1041.88 2218.5 53.04 46.96

Source: BioSpectrum—ABLE Biotech Industry Survey 2010 All figures in EUR Million unless indicated otherwise



1.6. Key Market Segment

Vaccines

Diagnostic

Therapeutic

CRO

CMO

Hybrid Seeds

Biofertilisers

Biopesticides

Industry Enzymes

Biotechnology

BioPharma

BioServices

BioAgri

BioIndustrial

BioInformatics

Database Services

Biotech Software Services

Integrated Research

Application Software



1.6.1. BioPharmaceutical

The key ingredients of the Indian BioPharma market primarily include vaccines, therapeutic drugs,

insulin, animal biologicals, statins, and diagnostics. These are nothing but medical drugs used for

therapeutic or diagnostic purposes using biotechnology.

Majority of the biotech industry’s revenue comes from this segment. It contributed EUR 1,379.53

Million, accounting for 62% market share.

The last year sale figure for Vaccines was EUR 312.5 Million which advanced to an estimated sale

of EUR 340.62 Million; setting a new benchmark. The Total sales from the human vaccine business

stood at EUR 273.43 Million over EUR 242.18 Million for the year 2008- 2009. Animal Vaccines

witnessed a marginal decline with sales dipping down from EUR 70.31 Million to EUR 67.18 Million.

The vaccine market will push the biopharma segment growth by 10-13% in the next 5 years.

The diagnostic market touched EUR 312.5 Million in FY 2009-2010. Its share in the total BioPharma

market stands at 20-22%. On the other hand, the therapeutics market had a 15% market share in

FY 2009-2010.

The market size of Oral Diabetes Drugs and Insulin (including analogs) is estimated to be EUR

242.18 Million and EUR 95.62 Million, respectively. In the near future, Biogenerics segment will

spur quick growth for Indian players, especially with the US ready to establish a biogenerics

(biosimilars) pathway by the year 2013. In India, Erythropoietin (EPO) clocked a sales of EUR

14,960, c-GSF—EUR 7,480, interferon– EUR 14,960 and streptokinase EUR 10,880.

Currently, at least 25 Indian players are functional in the domestic market in this segment with

over 50 products already on sale. Some of the well-known companies that have taken initiatives in

the field include Glenmark, Cipla and Lupin Pharma.



Top 20 BioPharma Companies by Revenue (2009-10)

*bio spectrum estimates All figures in EUR Million unless indicated otherwise

Source : BioSpectrum—ABLE Biotech Industry Survey 2010

1.6.2. BioServices

Clinical research and contract research organisations (CRO) are two main components of

BioServices. However, to some extent it also includes custom manufacturing. Today, BioServices

Revenue Rank 2010

Company 2009-10 2008-09 % Change over 2008-09

1 Biocon 184.37 142.55 29.34

2 Serum Institute of India*

132.81 174.06 -23.7

3 Panacea Biotec 109.87 93.30 17.76

4 Reliance Life Sciences

70.31 - -

5 NovoNordisk 53.43 51.56 3.64

6 Shantha Biotech 52.22 38.59 35.32

7 Indian Immunologicals

42.63 36.16 17.89

8 Bharat Biotech 42.44 37.66 12.7

9 Eli Lilly 29.21 25.62 13.85

10 Bharat Serums 27.34 21.87 25

11 Haffkine Biopharma

26.40 - -

12 Cadila Healthcare 23.04 14.64 57.4

13 GlaxoSmithkline 19.27 13.04 47.75

14 Intervet India 19 - -

15 Intas Biopharma 17.96 13.94 28.82

16 Themis Medicare 17.51 15.23 14.99

17 Concord Biotech 17.45 8.14 114.27

18 Venkateshwara Hatcheries*

14.06 - -

19 Aventis Pharma 10.67 5.62 89.83

20 Dr Reddy's Laboratories

9.76 6.25 56.25



also covers areas like data management, clinical trials, site management, bio equivalence and

toxicology studies apart from catering to the pharma industry for knowledge process outsourcing.

BioServices segment recorded a 28% growth in 2009-10 over the previous year’s total segment

revenue of EUR 322.18 Million. Over 90 percent of the total revenue of this segment comes from

exports.

The Top 10 CROs form 60% of the total segment revenue of EUR 412.34 Million.

Several companies have started contract research and clinical research services in India and

considering the potential for growth the number is expected to grow further.

Indian service industry is, decidedly, set to take the collaboration growth highway.

Top 10 Service Companies by Revenue (2009-10)

Rank 2010


1 Quintiles India * 58.59 - - 2 Syngene

International 39.37 35.09 12.2

3 Jubilant Organosys

38.95 37.81 3.02

4 Sirco Clinpharm 23.43 43.75 -46.43 5 Lambda

Therapeutic Resarch*

22.65 4.68 383.33

6 Veeda Clinpharm 17.18 - - 7 Ecron Acunova 15.15 - - 8 Vimla Labs 13.81 12.75 8.36 9 Anthem

Biosciences 8.28 5.05 63.88

10 Max Neeman International

6.25 2.34 166.67

*Bio Spectrum Estimates All figures in EUR Million unless indicated

otherwise

Source: BioSpectrum—ABLE Biotech Industry Survey 2010



1.6.3. BioAgri

Agri-biotech includes hybrid seeds and transgenic crops, biopesticides and biofertilisers. In the FY

2009-2010, Agri biotech was the third largest contributor to the Indian biotech industry with a

turnover of EUR 302.5 Million. It accounted for around 14% of the total biotech revenue. BioAgri

registered a 37% growth over last year and emerged as the fastest growing segment of biotech

industry.

The Bt cotton cultivation in India covers almost 8.4 million hectares of land. In India, there has

been a dramatic increase in the number of companies selling Bt cotton seeds over the last eight

years after the first commercialization in 2002. At present, there are more than 30 companies in

the country marketing Bt cotton seeds.

Nuziveedu Seeds is acclaimed as the largest Bt cotton seeds seller which sold 70 lakh packets

generating a revenue of EUR 74.50 Million followed by the second largest seller - Rasi Seeds with a

sale value of EUR 56.05 Million. Nuziveedu holds a leading market share of 25% while Rasi Seeds

stands second holding a market share of 19%. Some of the other prominent players include Ajeet

Seeds and Ankur Seeds selling 1.2-2 Million packets each in FY 2009-10.

In 2009 alone, a total of 28 Million seed packets, containing 450 grams were sold. Out of the total

seeds sold, around 87% were Bollgard II and 13% were Bollgard I. In addition to this, an

estimated figure of at least 2 Million packets of spurious seeds was sold illegally to the farmers

particularly in the state of Gujarat. The pricing of Bollgard I and Bollgard II cotton seeds was kept

as EUR 10.15 and EUR 11.71 respectively in most of the regions, however, the pricing in North

(especially Punjab, Haryana and, Rajasthan) was kept as EUR 11.85 for Bollgard I and EUR 14.45

for Bollgard II.

Nine states were involved in the sale of the “Bollgard” Bt cotton seeds - Andhra Pradesh, Tamil

Nadu, Karnataka, Gujarat, Madhya Pradesh, Maharashtra, Haryana, Punjab, and Rajasthan. From

the nine aforesaid states, Maharashtra leads the sale charts selling almost 9 Million packets in the

region followed by the South (7.5 million packets) and North (4.5 million packets). The northern

market is primarily ruled by Shriram Bioseeds.



A region wise split reveals Northern India as the producer of the highest yield of Bt cotton. The

approval of MLS 9124 was an important breakthrough in the year 2009. The type was developed

indigenously by Metahelix Life Sciences. It comprises a synthetic cry 1C gene. Another significant

development was the release of two cotton hybrids namely MH 5124 and MH 5174 expressing the

synthetic cry 1C gene (MLS 9124).

Region Production

North 600 kg per hectare

West 516 kg per hectare

Central 472 kg per hectare

South 595 kg per hectare

Top 10 BioAgri Companies by Revenue (2009-10) Rank 2010


1 Nuziveedu Seeds

74.50 70.15 6.07

2 Rasi Seeds 56.05 58.68 -4.48 3 Mahyco 48.75 32.98 47.78 4 Monsanto* 39.84 53.90 -26.09 5 Krishidhan

Seeds 20.81 9.88 110.64

6 Ankur Seeds 17.10 12.55 36.28 7 Ajeet Seeds* 16.09 - - 8 Nath Seeds 13.28 7.57 75.26 9 J K

Agrigenetics* 5.46 4.06 34.62

10 Bayer CropScience*

3.51 - -

*BioSpectrum

Estimates All figures in EUR Million unless

indicated otherwise

Source: BioSpectrum—ABLE Biotech Industry Survey 2010



1.6.4. BioIndustrial

The BioIndustry primarily comprises enzyme manufacturing and marketing companies. In India,

enzymes are still used on a limited scale but India surely holds a considerable growth potential.

The industrial enzyme consumption in India is principally in the detergents market (40%), followed

by the starch market (25%). Lately, enzymes have found wide applications in food,

pharmaceutical, diagnostic, and chemical processing industries.

Novozymes is a leading player in this segment holding over 50% market share followed by

Advanced Enzyme Technologies holding 25-30% market share.

The Indian companies are experiencing a substantial growth, and are thus focusing more on R&D

due to which new applications are being discovered. However, the global enzyme industry in India

still has a long road to be covered.

Top 10 BioIndustrial Companies by Revenue (2009-10) Rank 2010


1 Novozymes South Asia*

41.87 39.06 7.2

2 Advanced Enzymes

18.90 13.84 36.57

*BioSpectrum

Estimates All figures in EUR Million unless

indicated otherwise


1.6.5. BioInformatics

BioInformatics entails the creation and advancement of databases, algorithms, computational and

statistical techniques, and theory to solve formal and practical problems arising from the

management and analysis of biological data. Basically, it involves construction of databases on

genomes, protein sequences, and modeling complex biological processes, including systems

biology.



BioInformatics accounts for the smallest segment of the biotech Industry, holding a mere 2%

share in the overall industry. In the year 2009-2010, it recorded a sluggish 5% growth over 2008-

09 as compared to the 16% growth in FY 2008-09.

The pure-play BioInformatics companies in India include Strand Genomics, Ocimum Biosolutions,

SysArris, CytoGenomics and Molecular Connections. Majority of these companies are small- to-

medium enterprises based in Bangalore, Hyderabad, Pune, etc.

Rank 2010

Company 2009-10 2008-09 % change over 2008-09

1 Ocimum Biosolutions

6.46 7.43 -12.97

2 Strand Life Sciences

5.46 5.46 0

*BioSpectrum Estimates

All figures in EUR Million unless indicated otherwise


1.7. Top Biotech Cluster and Cities

Particular Amount Percentage

Maharashtra Mumbai 480.625 35.04

Pune 186.25

Karnataka Bangalore 446.40 20.12

Andhra Pradesh Hyderabad 348.43 15.71

NCR NCR 317.18 14.30

Gujarat Ahmedabad 160.15 7.92

Others Others 270.46 6.91


All figures in EUR Million unless indicated otherwise



This increased the share of the Western region in the overall revenue by 3% over FY 2008-09

giving it a lead of 6% over the Southern cluster.

Southern region is counted as India’s largest Biotech cluster with the highest number of biotech

companies - 172 in number (West has 137 companies) which made a revenue of EUR 865.26

Million in the FY 2009-10 accounting for 39% of the total revenue. Further, Karnataka state

government has plans to set up around five new biotech parks involving an investment of EUR

171.87 Million. Andhra Pradesh is also launching a MedTech Valley at Shameerpet in Hyderabad

stretching across 1,200 acres of land.

The Kerala State Industrial Development Corp (KSIDC) has announced setting up state-of-the-art

life science park worth EUR 46.87 Million at Thonnakkal in Thiruvananthapuram spanning across

260 acres.

The Northern biocluster – National Capital Region (NCR) houses the Top 3 biotech companies that

contribute around 15% of the total industry revenue. The Northern cluster is famous for its

research institutes and government bodies. A 200 acre Health Biotech Science Cluster (HBSC) is

being developed at Faridabad and would include Translational Health Science & Technology

Institute (THSTI), Regional Center for Biotechnology (RCB), Center for Vaccinology, Molecular

Medicine Center, Center for Diagnostics, Biotech Park, Center for Health Science Technology,

Maharashtra35%

Karnataka20%

Andhra Pradesh16%

NCR14%

Gujarat8%

Other7%

Among the biotech clusters in India, the

Western cluster continues to dominate

the industry with a 46 percent share in

the overall revenue of EUR 2218.58

Million. The companies in the Western

region, 137 in number, churned out a

whopping amount of EUR 1036.09

Million in the FY 2009-10.



Center for Platform Technologies, UNESCO Center, Incubator and a Center for Animal Model for

Clinical Advances. The first initiative in this regard came with the recent inauguration of a

temporary THSTI lab at Gurgaon, which will later be shifted to Faridabad once the infrastructure is

ready.

In addition to the above, Lucknow also has a biotech park. Rajasthan State industrial Development

& Investment Corporation (RIICO) has also taken an initiative to set up three Biotech Parks at

Sitapura-Jaipur and Chopanki, Bhiwadi (Alwar), and Borandi. A biocluster at Mohali (Punjab), a

biotech park at Chandigarh (Punjab), and at Nalagarh in Himachal Pradesh are also proposed.

1.8. Major Deals • Four Deals have been completed in 2010

• In June 2010, Piramal Healthcare Ltd. acquired Canadian biotechnology company

Biosyntech, Inc for EUR 2.85 Million.

M&A (Period: January 1, 2010 to October 31, 2010)

Deal Type Number of Deals Deal Value (EUR Million)

Inbound 2 16.49

Outbound 1 2.85

Domestic 1 -

Foreign Direct Investment (Period: November 2000 to August 2010)

Sector Amount of FDI Inflow (EUR Million) Drugs and pharmaceuticals 1,239.36

Deal Summary

Deal Type Acquirer Acquirer’s Country

Target Name Target Country

Completion Date



Inbound Sequoia

Capital India Invest

Mauritius

Celon Laboratories Ltd

India 5th October 2010

Inbound Telematic& Biomedica

Italy

MNE Technologies Pvt Ltd

India 31st March 2010

Outbound Piramal Healthcare Ltd

India

Bio Syntech, Inc

Canada 21st June 2010

Domestic Anu's Laboratories Ltd.

India

Stilbene Chemicals Ltd

India 16th April 2010

1.9. Government / Organisation

Government of

India

Ministry of Science

& Technology

Ministry Of Health

Ministry of

Environment & Forest

Ministry of New &

Renewable

Ministry of Agriculture

Ministry of Human

Resource and Development

Departments of Biotechnology

Departments of

Environment, Forest & Wildlife

Indian Council of Medical Research

Indian Council of

Agricultural Research

Recombinant DNA Advisory

Committee (RDAC)

Regulatory Committee on

Genetic Manipulation

(RCGM)

Institutional Biosafety

Committee (IBSC)

Genetic Engineering Approval Committee

(GEAC)

Department of Science & Technology

Department

of Atomic Energy

DSIR



1.9.1. Government of India In 1986, the Department of Biotechnology (DBT) was set up by the Government of India under the

Ministry of Science and Technology. The DBT has established ‘Centres of Excellence’ which

generate skilled manpower and support the R&D efforts within the country. Before DBT, the

National Biotechnology Board (NBTB) was established in 1982 to promote biotechnology products

and processes.

1.9.2. Department of Biotechnology The Biotechnology department was established with the vision to create innovative technologies

and tools that can address the existing issues in food production, agriculture productivity,

environmental sustainability, nutrition security, and health care by launching new products and

services at affordable prices and generating employment opportunities that eventually give India a

global competence in the emerging bio-economy.

The functions of the department of Biotechnology are as follows:

1. Human Resource Development, biotech product development and value chain processing.

2. Establishing the required facilities and infrastructure for biotechnology for research purpose.

3. Orienting the sectoral R&D programmes towards the emerging and development areas of

agriculture, vaccines and diagnostics, biofuels and bioenergy, stem cell biology, etc.

4. Establishing centres of excellence and encouraging innovative thinking.

5. Launching Grand Challenge Programmes on breeding crops.

6. Encouraging young Indian scientists/ scientists from abroad to take up research in Indian

universities and institutions.

7. Establishing new institutions for critical areas holding national importance.

8. Promoting interaction between academia and industry and the development of both

products and processes.

9. Introducing major public-private partnership programmes for research on futuristic

technologies and also providing assistance to SMEs and other big industries.

10. Establishing superior mechanisms and institutional framework for facilitating stakeholder

communication.



Objective Action

Ensure availability of adequate human

resource at all levels

Different fellowships and HRD & R&D

schemes

Engage public-private partnerships Launching healthcare & agricultural

projects at the right time: public-private

partnerships.

Promote basic and translational research Undertaking genomic crop research

Establish new centres of excellence and

technology platforms

Increasing the biodesign capacity to

produce improved medical devices

1.9.3. Department of Science & Technology (DST) May 1971 was the year of establishment of Department of Science & Technology (DST). It was

founded with the purpose of promoting new areas of Science & Technology and also to act in the

capacity of a nodal department for coordinating, organising and promoting S&T activities in India.

The department has responsibilities for particular projects and programmes towards:

1. Policy formulation for Science and Technology.

2. Promoting new avenues in the field of Science and Technology with increased emphasis on

upcoming trends and areas.

3. Futurology.

4. Approving the Grants-in-aid for the Scientific Associations, Scientific Bodies and Scientific

Research Institutions and also supporting their cause.

5. Matters related to domestic technology; especially promoting ventures for commercialization of

a technology that does not fall under Department of Scientific and Industrial Research.

6. Matters related to capacity building for institutional Science and Technology.

7. Promoting Science and Technology at a grass-root level.

8. Applying Science and Technology for the benefit of weaker and disadvantaged sections of the

society.



1.9.4. National Biotechnology Regulatory Authority The Department of Biotechnology (DBT) has been assigned the responsibility of establishing the

National Biotechnology Regulatory Authority (NBRA) as per the directives of the Indian

Government. The NBRA will function as a self-directed, independent, and professionally led body

offering a single-window mechanism for obtaining a biosafety clearance for the genetically modified

processes and products.

The National Biotechnology Regulatory Bill, 2008 seeks to safeguard the health and safety of the

people and to regulate the safe development and deployment of biotechnology products and

processes.

The new legislation is expected to provide an opportunity to consolidate and enhance the efficiency

and effectiveness of biotechnology regulation, increase collaboration with state governments in this

area, promote public confidence in the regulatory system, and facilitate international trade.

The Indian Government has also given a green signal to the National Biotechnology Development

Strategy. The strategy, besides using the available opportunities in manufacturing and services

also lays a strong platform for innovation using technology for sustainable industrial growth and

long-term benefits.

1.9.5. Council of Scientific and Industrial Research (CSIR) The Council of Scientific and Industrial Research undertakes research in different fields of science

and technology through a network of national institutes and laboratories in different parts of the

country. It gives special importance to applied research with an equal emphasis on utilising the

results thereof.

Currently, there are 38 research institutes, including five research laboratories at regional level.

Some institutes have established survey field stations for experimental purpose in order to

enhance their research activities. At present, 39 such survey field stations are operating and are

attached to 16 laboratories. The CSIR laboratories are set up for the advancement of Indian

science and industry and for catering to the societal needs for food, fuel, roads, etc. However,



some laboratories look after specific problems which are of interest for particular industries, for

example, biotechnology, drugs & pharmaceuticals, marine chemicals, scientific instruments, etc.

There are yet other laboratories concerned with research in aerospace science and engineering,

mechanical engineering, metrology, oceanography, electrochemistry, geophysics, experimental

medicine, and toxicology.

Having completed more than 63 years of existence, CSIR today is the country’s largest holder of

intellectual property rights (IPR) on patents.

1.9.6. Indian Council of Medical Research (ICMR) The Indian Council of Medical Research (ICMR), New Delhi, is undoubtedly one of the oldest bodies

in the world for medical research. It formulates, coordinates, and promotes biomedical research in

India.

Formerly known as the Indian Research Fund Association (IRFA), it was founded in 1911 by the

Indian Government specifically for coordinating/ sponsoring medical research in the country. Post

independence, IRFA saw major changes in the organisation, activities and a wider functional

expansion. In 1949 IRFA was renamed as the Indian Council of Medical Research (ICMR).

The research priorities of the Council coincide with the priorities of National health. All its efforts

are directed at reducing the disease rate and promoting the population’s well-being and health.

The Union Health Minister presides over the Governing Body of the Council. Scientific Advisory

Board provides scientific/ technical assistance to the Governing Body of the Council and includes

eminent experts with a varied background in biomedical disciplines. The Board is further assisted

by a series of Scientific Advisory Committees, Scientific Advisory Groups, Task Forces, Steering

Committees, Expert Groups, etc., these monitor and assess the Council’s research activities.



The ICMR is not merely involved in research activities, it also promotes the manpower

development in biomedical research through (i) Research Fellowships (ii) Short-Term Visiting

Fellowships (iii) Short-Term Research Studentships and (iv) Various Workshops and Training

Programmes organised by ICMR Institutes and Headquarters.

The Council also gives an opportunity to the retired medical teachers and scientists by offering the

position of Emeritus Scientist to take up/ continue with the biomedical research on specific topics.

The Council also confers prizes and awards on the Indian scientists. Currently, there are 38 awards

that the Council gives away for significant contribution. Out of these 38 awards, 11 awards are

exclusively meant for young scientists who are below 40 years of age.

The burgeoning population and the increasing count of infectious diseases have become a priority

to be dealt with using medical research for several decades. Apart from dealing with these issues

the current trends have increasingly intensified the research on emerging health problems. This

has also sparked and revived the research on Herbal Remedies or Traditional Medicine adopting a

disease-oriented approach. The Council is keeping a watch on new diseases and also looking into

the new aspects of existing diseases; the growing network of Surveillance Centres for AIDS in the

different Indian States in 1986 is a good example.

1.9.7. Indian Council of Agricultural Research (ICAR) An autonomous organisation, the Indian Council of Agricultural Research (ICAR) falls under the

ambit of Department of Agricultural Research and Education (DARE), Ministry of Agriculture,

Government of India. Originally addressed as Imperial Council of Agricultural Research, the

organisation came into existence on 16 July, 1929 as a registered society under the Societies

Registration Act, 1860 in accordance with the report of the Royal Commission on Agriculture. ICAR

is headquartered at New Delhi.

An apex body, the Council is responsible for guiding, co-coordinating, and managing education and

research in different fields of agriculture throughout the country, including fisheries, horticulture,

and animal sciences. The Council has a widespread network of 97 ICAR institutes and 47



agricultural universities across the length and breadth of the country and is hailed as one of the

largest national agricultural systems in the world.

A pioneer of the Green Revolution in agriculture, the ICAR has played a crucial role in the

subsequent agricultural developments in the country by promoting research and technology that

has enabled India to increase its food grain production by 4 times, production of

horticultural crops by 6 times, production of milk by 6 times, production of eggs by 27

times, and production of fish by 9 times (inland 17 times and marine 5 times), since 1950-

51.

1.9.8. University Grant Commission (UGC) UGC has a broader spectrum of responsibilities and duties towards universities. It has the onus of

providing leadership in professions, politics, administration, industry, and commerce. The UGC has

been entrusted the responsibility of meeting the growing demands of higher education, technical

and professional knowledge and literacy and scientific fields. It also inspires the country to achieve

the freedom from disease, want, and ignorance in a short span of time by applying and developing

scientific and technical knowledge.

UGC has a unique identity of being India’s one and only grant-giving agency which shoulders two

major responsibilities of providing funds and determining, coordinating, and maintaining higher

standards in higher educational institutes.

1.9.9. Department of Scientific and Industrial Research (DSIR) The Department of Scientific and Industrial Research (DSIR) is an undertaking of the Ministry of

Science and Technology. It was announced through a Presidential Notification, dated January 4,

1985 (74/2/1/8 Cab.) contained in the 164th Amendment of the Government of India (Allocation of

Business) Rules, 1961. The Department of Scientific and Industrial Research (DSIR) takes care of

the activities related to technology promotion, development, utilisation and technology transfer at

an indigenous level.



The primary purpose of DSIR is to promote industrial R&D, support small and medium industrial

units in developing state-of-the art international level technologies of high commercial potential,

facilitate commercialization of lab-scale R&D at a rapid pace, increase the percentage of technology

intensive exports out of the overall exports, enhance capabilities related to industrial consultancy &

technology management and introduce a user-friendly information network to assist industrial and

scientific research in India. It also plays a key role in linking the industrial establishments and

scientific laboratories for transferring technologies through National Research Development

Corporation (NRDC) and encourages investment in R&D through Central Electronics Limited (CEL).

1.9.10. UNESCO and other similar organisations The United Nations Educational, Scientific and Cultural Organization (UNESCO) is a

specialized United Nations agency that contributes to and promotes international collaboration

through education, science, and culture.

UNESCO achieves its objectives through education, natural sciences, social and human sciences,

culture, communication, and information. It also sponsors programs on literacy, technical, and

teacher-training; international science; promotion of independent media, freedom of press;

regional and cultural history projects; promotion of cultural diversity; international cooperation

agreements to preserve the (World Heritage Sites), and the human rights. UNESCO also strives to

bridge the global digital divide.

The Government of India and UNESCO jointly established the Regional Centre for research, training

and education in biotechnology sponsored by UNESCO. Also, by next year a UNESCO Regional

Centre for Biotechnology will be set up in Faridabad, Haryana.

The UNESCO Regional Centre for Biotechnology is a unique platform for interdisciplinary research,

training, and education to furnish human resources required at the biotech interface of medicine,

chemistry, physics, and engineering. Its objective also includes empowerment of human resources

for the varied biotech needs and seeking innovative and context-specific biotechnology solutions.



1.9.12. Health Biotech Science Cluster (HBSC) Even though the life sciences industry in India has progressed with the upcoming research centers,

academic institutes, and development of healthcare industry, the growth is still confined.

Faridabad, Bangalore, and Mohali have decided to host biotech science clusters where all such

ideas can bear fruits. These clusters include an exclusive Health Biotech Science Cluster (HBSC)

being developed by the Department of Biotechnology. The HBSC will be built on a 200 acre stretch.

It will foster ground-breaking conceptual research for biotech-related sciences, initially focusing on

health biotechnology. The Translational Health Science Technology Institute (THSTI) and UNESCO

Regional Center for Biotechnology (URCB) will be housed as the founding institutes in this cluster.

To begin with, they will operate from Udyog Vihar, Gurgaon. Faridabad is where the first phase of

work will begin on the 40-acre land. The permanent laboratories will be set up in the coming three

years.

The second phase of the cluster will see the presence of a number of related centers which are still

at a conceptual stage. Center for Vaccinology, Center for Diagnostics, Center for Health Science

Technology, Center for Platform Technologies, Center for Animal Model for Clinical Advances,

Biotech Park, Incubator, Molecular Medicine Center, and National center for Biodesign are likely to

be a part of the cluster in the second phase.

1.9.13. All India Biotech Association (AIBA) All India Biotech Association (AIBA) was founded in 1994 as a non- profit Society to serve as the

top-most Forum at national level for representing the interests of the people engaged in different

areas of Biotechnology. The primary purpose of AIBA is to promote and protect the overall

interests of Biotechnology as a science, industry, profession & trade. The Southern Chapter of AIBA

started functioning at Hyderabad in August, 1999. The core objectives of AIBA are as

follows:-

• Promoting and protecting the overall interests of Biotechnology.

• Collecting all the relevant information to safeguard the interests of the constituent members for

activities related to Biotechnology.



• Subscribing and promoting the goals and objectives of an Association/ society that shares the

same objectives as those of the Association and encouraging a Government Policy or any

Association for improving the laws related to Biotechnology.

• Coordinating and assisting its constituent members for research, manufacturing, and

professional and export promotion activities.

• Sponsoring business and study teams, undertaking research, and market surveys.

• Settling the disputes arising within the Association objectives.

• Advising/ representing the local public bodies and Central and State Governments for all the

matters related to biotechnology.

• Awarding individual persons and institutions for their exceptional contributions to meet the

objectives of the society.

1.9.14. Ministry of New and Renewable Energy (MNRE) The Ministry of New and Renewable Energy (MNRE) is allocated the following subjects or business:

1. Research/ promotion of Biogas and related programmes;

2. Commission for Additional Sources of Energy (CASE);

3. Application, development and production of Solar Energy, including Solar Photovoltaic devices;

4. Programmes for research and promotion of improved chulhas;

5. Indian Renewable Energy Development Agency (IREDA);

6. All aspects related to hydel projects which are small, mini or micro-level and have a capacity lower than 25 MW;

7. Research and promotion of fresh sources of renewable or non-conventional energy and related programmes;

8. Tidal energy;

9. Integrated Rural Energy Programme (IREP);

10. Geothermal Energy;

11. Bio-fuels: (i) Establishing National Bio- fuels Development Board and fortifying the current mechanism of the institutes; (ii) National Policy; (ii) Promotion, demonstration and research on transport, stationary and other applications; and (iv) overall coordination.



2. Overview of Indian Biotech associated with Climate Change; Strengths and Weaknesses

2.1. Indian Biotech Sector - Climate Change Climate change is a hot topic for discussion and a key government agenda on a global scale. India

too cannot escape the damaging effects of global warming. With majority of India’s population

residing in the rural areas, the poor cannot afford to fend for themselves against the devastating

effects of global warming. The National Action Plan commented on the Climate Change stating that

India’s population is closely knitted and economically dependent on the natural resources and

climate dependent sectors like agriculture, water and forestry and thus needs an honest adaptive

approach and capacity to combat the climatic changes. According to the International Energy

Agency, India is set to become the third largest emitter of greenhouse gases by the year 2015.

India is still at a developing stage and so it can not really afford to face the dangers arising out of

climate change. Also, more than a quarter of the country’s population lives below the poverty line,

which makes it essential to reduce the vulnerability of the masses to the severe impacts of climate

change. Knowing this, and the fact that by the year 2030 the primary energy demand will be

doubled implies that the Indian government has already initiated significant mitigation measures

by framing new laws and introducing green business codes: incentives for promoting renewable

energy/ energy efficiency, and adaptation techniques making agriculture more resistant against

the impact of climatic changes have been suggested. In an effort to cut down the intensity of

carbon emissions by 20-25%, India has also set voluntary targets for itself with a deadline of

2020. Despite of all the measures and the public acknowledgement about recognising climate

change as a pressing problem for India, policymakers still struggle to locate the required resources

and the necessary expertise to be able to address the climate-related issues and find workable

resolutions.

To overcome the menacing challenges of climate change it has become necessary for the private

sector to step in and play a critical role.



A recent study indicates that by the year 2017, the green spending in India may touch a figure of

EUR 102 Billion. This in turn will usher huge business opportunities. India stands a fair enough

chance to be the world leader in the “Go-Green” drive harnessing the resources as well as the

expertise of private investors and enterprises. The country already has a large market for green

and low-carbon goods and is still at an expansion stage.

Similarly, investments look promising with an increased number of Indian enterprises and their top

management taking pains to control their percentage of carbon emission. This is a deciding factor

for most of the financial institutions for investing their capital. Currently, investors are well-versed

with the available opportunities in the market and the Indian private sector has executed low-

carbon projects utilising different sources for investment, for example, self-financing, venture

capital, private equity investment and carbon finance, if available.

There is still a lot to be done to speed-up the process. Financial incentives can play a critical role in

bringing individuals and institutions on board. To mitigate the climate change impact, a regulatory

environment which is crystal clear and reliable is the need of the hour. Investors have a never-

ending appetite to fund green and clean technologies like renewable energy, but this is possible

only if they are assured about their investment decisions being safe with a secure legal framework

in place. It is essential to analyse and inspect how the financial market expertise can be utilised to

develop unique financing techniques. For that matter, London can enter a partnership with India

where India’s green drive and entrepreneurial talent can be linked with London’s expertise

regarding financial innovations and its image as the main hub for carbon financing.

Climate change brings its own set of challenges for each and every individual and there is surely no

easy way out, however, if the government along with the private investors work in a coordinated

manner and take prompt actions the same challenges can actually be transformed into big-time

opportunities for the Indian businesses building a new path that leads to a sustainable and cleaner

planet.



2.2. Role of Various Ministries and Autonomous Institutions

Department of Biotechnology: Environmental Biotechnology – Programmes

Biotechnology has an enormous potential to offer eco-friendly, efficient, economically viable and

unique options for in-situ waste treatment and degradation of the potentially hazardous toxic

waste into harmless/ relatively less harmful byproducts. The Department of Biotechnology has

given a significant thrust to programmes on treatment of industrial effluents, mining spoil dumps,

development of biosensors for detection of pollutants, ecorestoration of degraded ecosystems, and

use of molecular markers to characterise biodiversity. All such programmes have been pushed and

conceived by eminent scientists who have headed the task force on Environmental Biotechnology

and Biodiversity Conservation over the last few years.

Achievements

Around 65 projects were sanctioned during the review period. As many as 45 projects have been

finished while 50 are still under process. The projects cover some prime areas like treatment of

industrial effluents especially paper and pulp industry, electroplating, distillery, oil refineries, dye

industry, tannery, etc., use of isozymes/ molecular markers like RFLP, RAPD for characterisation of

biodiversity, ecorestoration of degraded lands and mine spoil dumps. Developing programmes

based on the needs of the users has also reflected in the Department’s efforts.

Efforts are being made to change the research leads obtained from completed/ ongoing projects

into technologies and then demonstrating them at the site of user industries. A lot of emphasis is

laid on involving the user industry right from the start to validate the process on site for a smooth

technology transfer. The standard technologies developed in the labs are being upgraded and

transferred to industries for large scale exploitation. Several attempts were made to spot out the

priority areas and many brainstorming sessions were also held for gap areas to create integrated

R&D proposals. The brainstorming session details are as below:

• Degradation of pesticides held in May, 1999 at ITRC, Lucknow

• Biodiversity Conservation held on Sept, 16, 2000 at NEHU, Shillong

• Biodegradation of Textile and Dye Industry wastewater treatment on 19th July, 2001 at

Sardar Patel University, Anand



• Conservation and Genetic Enhancement of Cryptogamic Plants for Pollution abatement on

28-29th December, 2001 at NBRI, Lucknow

• Metabolic Engineering for Environmental amelioration at Thapar Institute, Patiala on 8-

9th April, 2002

Some of the important achievements are as follows:

1) Establishing a laboratory for conservation of endangered animal species CCMB, Hyderabad

2) Pesticide degradation network programmes

3) Programme to conserve the biodiversity of North-Eastern Region

4) Conservation programmes and programmes to make use of lower plants as pollution

indicators

5) Molecular biology programmes for environmental amelioration

6) Ecorestoration of degraded ecosystems, including mine dumps

7) Afforestation of Mangroves by applying biotechnological and classical tools

Environmental Biotechnology – Technology / Treatment

The standard technologies developed at laboratory scale due to the efforts of the Department have

been upgraded to pilot level, demonstrated on the industry site, and transferred. Some of the

noteworthy technologies are as below:

1) Industrial Effluent Treatment: Microbial Treatment of Cassava Starch Factory Waste Water;

Central Tuber Crops Research Institute (CTCRI), Thiruvananthapuram has introduced a

standard technology for degradation of waste water from starch factory.

2) Paper and Pulp Mill Effluent Treatment: GB Pant University of Agriculture and Technology

has invented a pilot scale technology for treating the effluent of paper and pulp mills. The

technology was demonstrated at Shyam dyeing company, Sanganer. For treating the waste

of 3 units, a common effluent treatment plant has been established having a capacity of

treating textile wastewater up to 35,000 litre/ day. Sardar Patel University, Anand has

developed bench scale sequential anaerobic-aerobic treatment system comprising anaerobic

up flow film bioreactor and fluidized bed bioreactor for treating reactive dye industry

effluent.



3) Oilzapper Technology has been developed for Treatment of Oily Sludge and Bioremediation

of Crude Oil Spills. The technology has been developed by TERI, New Delhi and has been

demonstrated in several refineries viz., Bharat Petroleum Corporation Ltd., Guwahati

Refinery, Assam; Digboi Refinery, Assam; Kandla Terminal, Gujarat; Barauni Refinery,

Bihar; Bharat Petroleum Corporation Ltd., Maharashtra; and Hindustan Petroleum

Corporation Ltd.

4) A chemo biochemical process has been developed by Microbial Desulphurisation of Fossil

Fuels and Biogas NEERI, Nagpur for desulphurisation of gaseous stream which contains

hydrogen sulphide. The process has been successfully demonstrated at Vam Organic

Chemicals Ltd., Gajraula on a pilot scale with a capacity of 100 Nm3 / hr to check the

techno-economic feasibility of the process for large scale application. The same process has

also been demonstrated at Mathura Refinery.

Biosensor / Biosurfactant / Bioscrubber

1) Biosensor for Detection of Pesticide Residues: A biosenser has been developed by the Visva

Bharti University, Shantiniketan for detecting and estimating organophosphates like

carbamate residues and Metacid in the environment. The sensor is constructed and

designed as per the ability of these two pesticides to inhibit the activity of

acetylcholinesterase (AchE); an indispensable enzyme responsible for normal neural

transmission. The biosensor is portable, simple, and capable of providing quick data in the

field for measuring the trace concentration residues of these pesticides. The biosensor is

similar to a pH paper which changes colour depending on the contamination level. Lower

contamination level is indicated by a greater intensity of the yellow colour while a higher

contamination level is indicated by a decreasing intensity of the same.

2) Detection of Pathogens in Drinking Water: A user-friendly colour based detection system

has been developed by NEERI, Nagpur for the presence of E.coli (up to 500 cells) in

drinking water. Attempts are being made to enhance the sensitivity of the test by

decreasing the pathogen load and extending the test to Vibrio and Salmonella.



3) Biosurfactants from Wastes: Two microorganisms have been isolated from oil-contaminated

soils by NEERI, Nagpur, which produce biosurfactants. It has also introduced a standard

and cost-effective technology for production of biosurfactants from low-cost substrates like

distillery and whey waste without any additional carbon source. It is an extremely

ecofriendly substitute for synthetic surfactants.

4) Bioscrubber for Removal of Odours from Industrial Emissions: Microbial cultures that can

degrade different odourants in industrial emissions have been isolated and characterised by

NEERI, Nagpur which biotransform odourants into secondary products or change them to

water and carbon dioxide. A pilot plant is being set up in Bhartiagram at M/s Jubilant

Organosys Ltd. (JOL). Details of patents filed or granted:

A total of 12 patents have been filed for the Department of Biotechnology supported

projects, their details are as follows:

o Four patents on biocatalyst preparation process in order to eliminate DDT residues

from soil and contaminated sites, industrial effluent, an increased DDT degradation,

and degradation of HCH by microbial formulation by CFTRI, Mysore.

o One Indian Patent filed by Centre for Biochemical Technology, Delhi (presently

known as IGBD) to improve the process for simultaneous biogas production mainly

containing methane and biofertiliser using high rate biomethanation of Palm Oil Mill

Effluent.

o Two Indian patents filed by IIT, Kharagpur on pollution-free gaseous fuel production

and developing a hydrogen production process with high rate and yield.

o One Indian patent filed by TERI, New Delhi on oil refinery waste biodegradation.

o Two Indian patents filed by NEERI, Nagpur on biosurfactant preparation process for

oil recovery and biosurfactant from distillery waste.

o One Indian patent by NEERI, Nagpur on a novel odour monitoring unit.

o One Indian patent filed by Visva Bharati University, Shantiniketan on biosensor for

detecting pesticide residues.



2.3. Bio Energy (R & D) – 11th Five Year Plan It is proposed to take up focused R&D projects in the area of bio-energy resource identification and

biomass conversion to energy through combustion, pyrolysation, atmospheric and high pressure

gasification, plasma, bio-methanation and Biogas.

1. Bio-energy Resource

Resource Atlas for Bio-energy covering crop residues, forest residues, MSW, industrial wastes etc.

2. Biomass Conversion

a. Development of MW-scale fluidized bed biomass gasifiers, hot gas clean up system,

and optimum integration of the system.

b. Development of poly-generation facilities, gasifier systems based on charcoal /

pyrolysed biomass, and establishing the concept of a Bio-refinery.

c. Raising efficiency of atmospheric gasification to 25-30% along with cooling systems,

complete tar decomposition, and safe disposal of wastes in commercial production.

d. Raising system efficiency of small (upto 1 MW) combustion and turbine technologies

to 20% plus and laying down standards for various bio-energy components,

products, and systems.

e. Design and Development of high rate anaerobic co-digestion systems for biogas/

synthetic gas production, and of systems to couple with Stirling engine and turbines.

3. Bio-energy Utilisation

a. Design and development of equipment for waste segregation; engines, Stirling

engine and micro-turbine for biogas/ producer gas/ bio-syngas; direct gas-fired

absorptive chillers, driers, stoves, etc.; and improvement in biomass furnaces,

boilers etc. Development of driers for MSW and industrial wastes.

b. Improved design and development of processes/ de-watering device for drying of

digested slurry, and Pelletisation/ Briquetting technology for RDF.

c. Improving/ upgrading biogas and syngas quality.



4. Bio-Fuels

a. Develop technology for production of ethanol from sweet sorghum and sugar beet.

b. Developed technology for production of ethanol from ligno-cellulosic materials (rice

straw, etc.) and other agricultural and forestry residues.

c. Study petrol engine performance (using more than 10% blend of ethanol & petrol),

physico-chemical properties of potential non-edible oils for production of bio-diesel,

and undertaking engine modifications.

d. Developing bio/heterogeneous catalyst and chemical/catalyst conversion processes.

e. Alternate use of bio products, data generation & production of bio-diesel from all

possible feed-stocks.

f. Response of different available additives and their dosages on the bio-diesel.

g. Effect of bio-diesel on corrosion, stability, and engine modifications for using more

than 20% bio-diesel as blend with diesel.

h. Engine performance/ emissions based on different feed-stock based bio-diesels.

i. Toxicological studies and test to check adulteration and design and develop bio-liquid

fuel engines.

j. Development of second-generation bio-liquid fuels and related applications.

5. Bio-Gas

a. Studies in the field of micro-biology, bio-chemistry and engineering for increasing

the biogas yield by at least a factor of two, especially at low and high temperatures;

b. Reduction in the capital cost of biogas plants; development of materials and

techniques amenable for local level fabrication to reduce the time of installation;

c. Diversification of feed stocks to use alternate biomass wastes and cattle dung for

household biogas plants and sustained biogas production methods for winters.

d. Value added products using biogas slurry manure, development of biogas micro

turbines and engines, and cleaning and bottling of biogas;

e. Local power grids compatible with dual fuel engines and gas engines/turbines;

f. Corrosion-resistant paints and sealants for biogas plant components;

g. Portable biogas lantern and advanced bio-reactor techniques in institutional biogas

plants based on cattle dung for improving efficiency;



h. Removal of hydrogen sulphide from biogas produced in Night-soil based biogas

plants, other treatment methods for effluent from Night-soil based biogas plants;

i. Field trials, demonstration of new models/ products, set design and appliances

standards/ specifications and on-site waste water treatment for small & medium

communities (500-5000 people).

2.4. Policy and programme: ‘India’s Biofuel Policy The National Policy on Biofuels was approved by the Government of India (GOI) on December 24,

2009. The biofuel policy promotes an increased use of renewable energy resources as alternate

fuels for transport fuels supplementation (diesel and gasoline for vehicles). It also suggests a

target of 20% biofuel blending (bio-ethanol and bio-diesel) by the year 2017.

At present, the government is finding it hard to implement the compulsory blending of 5% ethanol

in petrol (gasoline) due to the inadequate supply of sugar molasses in the year 2009/10 and

2008/09 due to the overall low production of sugarcane crop in India. As a consequence, India had

to import around 280 million liters of ethanol in CY 2009 to cope up with the increasing demand for

potable and industrial liquor production. With the estimated bumper sugar production for the year

2011, the government may, in all probability, renew its focus to make the 5% ethanol blending in

petrol mandatory. According to the industry sources the government may decide on the ethanol

purchase price for the Ethanol Blending Program (EBP).

India practices commercial bio-diesel production on a very small scale while its utilisation is also

primarily restricted to the unorganised sector. The ambitious plans of the Indian government to

produce plenty of bio-diesel by the year 2011/12 for meeting its mandate of 20% diesel blending

has not quite worked out due to the limited supply of Jatropha seeds for producing bio-diesel.

In India, advanced biofuels are still under research stage and it will take a long time to make the

commercial production of biofuels economically viable. Biomass has been frequently used for

power and heat generation in paper mills, textiles, sugar mills, and small and medium enterprises

(SME).



The National Policy on Biofuels approved by the Indian Government on December 24, 2009,

includes:

1. Establishing a National Biofuel Coordination Committee for a wider policy perspective under

the Prime Minister and setting up a National Biofuel Steering Committee (NBSC) to make

guidelines for the policy.

2. Reinforcing the energy security of India by promoting use of renewable energy resources to

contribute to transport fuels. A proposal of 20% target for blending of biofuel for both bio-

ethanol and bio-diesel to be implemented by the year 2017.

3. Meeting the demands of the vast rural population for the growing energy needs and also

stimulating the rural development and creating opportunities for employment.

4. Addressing the worldwide concerns of limiting carbon emissions by using environmental-

friendly biofuels.

5. Obtaining bio-fuels from non-feed stock being raised on wastelands/ degraded lands that

are not fit for agricultural use, thus avoiding the possible conflict of food vs. fuel.

6. Assist in bringing an optimal development and utilising indigenous biomass feedstock for

producing biofuels. The policy also predicts developing next-generation biofuel conversion

technologies that are more efficient and based on new feed stocks.

7. Minimum Support Price (MSP) mechanism to ascertain a fair price for the oilseed growers

for producing bio-diesel. The proposal would be implemented only after a proper

consultation with central and state governments, stake holders, and the Biofuel Steering

Committee. The National Biofuel Coordination Committee would have the final say on it.



8. A proposal to purchase bio-ethanol at a Minimum Purchase Price (MPP) has been made by

the Oil Marketing Companies based on the actual production and import cost of bio-ethanol.

Similarly, for bio-diesel the MPP should be based on the prevailing retail diesel price.

9. As necessary, the GOI also proposes a National Biofuel Fund to provide financial incentives,

including grants and subsidies, for advanced technologies and conversion processes, new

and second generation feed stocks, and production units based on new and second

generation feed stocks.

10. No central duties and taxes have been proposed on bio-ethanol and bio-diesel except for a

concessional excise duty on bio-ethanol.

11. More emphasis has to be laid on innovation, (indigenous, multi-institutional and time

bound), research and promotion of bio-fuel feedstock production, including second

generation biofuels.

12. In order to attract Foreign Direct Investment (FDI), biofuel projects and technologies will be

permitted a 100% foreign equity through automatic approval routes, given the condition

that biofuel is to be used foe domestic purpose only and not for export. Non-edible oil

bearing plantations will not be permitted for FDI participation.

2.5. Biomass for Heat and Power The Ministry of New and Renewable Energy is implementing a biomass power programme with the

objective of harnessing grid quality power from biomass resources through various conversion

technologies and optimising power generation from bagasse produced in sugar mills. The benefits

include its renewable nature, wide adaptability, carbon neutrality, and the potential to provide

large productive employment in rural areas.

The current potential for power generation from surplus agriculture and forestry residues is

estimated at 16,000 Mega Watts (MW) equivalent.



With modernisation of new and existing sugar mills, the surplus power generation through bagasse

cogeneration in sugar mills is estimated at 5000 MW.

Thus, the total estimated biomass power potential is about 21,000 MW. The availability of biomass

in India is estimated at about 540 million tons per year, including residues from agriculture, agro-

industrial, forestry and plantations. Around 120-150 million tons of agro-industrial and agricultural

residues per year can be made available for power generation. Biomass available in the country

can and has been playing an important role as fuel for sugar mills, textiles, paper mills, and small

and medium enterprises (SME). In particular, there is a significant potential in breweries, textile

mills, fertilizer plants, paper and pulp industry, solvent extraction units, rice mills, petrochemical

plants, etc.

2.6. New legislations and regulations

2.6.1. Draft Seed Bill The Seeds Bill, 2010 was first drafted in the year 2004. The Bill seeks to repeal and replace

existing Seeds Act, 1966. The Bill seeks to regulate the production, quality of seeds for sale,

import and export, distribution and sale of seeds and addressing other matters related to seeds.

The Seeds Bill, 2010 is presently pending for consideration in the Upper House of Parliament.

Clause 1 of the Bill clearly sates that ‘ nothing contained in this act shall restrict the right of the

farmers to grow, sow, resow, save, use exchange, share or sell his farm seeds and planting

material except when he sells such seed or planting material under a brand name.’

SALIENT FEATURES:

1. Definition of farmer:

The Bill defines farmer as any person who cultivates crops either by cultivating the land himself or

through any other person but does not include any individual, company, trader or dealer who

engages in the procurement and sale of seeds on a commercial basis. Further, it includes any



person who conserves jointly with any person any traditional varieties or adds value to such

traditional varieties.

2. Transgenic Varieties:

The Bill provides that no transgenic variety of seed would be registered unless the applicant has

obtained clearance under the provisions of the Environment (Protection) Act, 1986. Further, the

registered seeds have to conform to specified standards for transgenic events and corresponding

traits for transgenic seeds. The label of a seed container has to indicate the above mentioned

information.

3. Registration of Seeds:

Any type of seed for sale has to be registered with the Registration Sub-Committee. The

registration is valid for 10 years for annual/ biennial crops and 12 years for long duration perennial

crops.

4. Formation of Central Seeds Committee:

The Bill provides for formation of Central Seeds Committee which shall consist of a Chairperson

and 7 ex-officio members and other members nominated by the Central Government. It is clarified

that 3 ex-officio members shall include (a) Director, National Centre for Aromatic and Medicinal

Plants, (b) Chairperson, PPVFRA and (c) Chairperson, National Bio-Diversity Authority.

5. Seed Certification Agencies:

The Bill provides for allowing only those organisations which are owned or controlled by the central

or state government to be accredited. The accreditation can be done only by the state government

with prior approval of the central government.

2.6.2 The Protection and Utilisation of Public Funded Intellectual Property Bill, 2008 Public funded research in Universities, academic and research institutions has often produced

innovations that hold potential for public good. However, a large number of innovations have not



been reaching the industry or the public. Important reasons that have been identified for

inadequate movement of Intellectual Property (IP) from laboratory to market include:

Possession, of the IP generated, remaining with the funding agency;

Vague regulatory legal framework in Universities, academic and research institutions for

commercialization, and limited financial incentives to the researchers;

Procedural complexities in technology transfer, its absorption, and commercialisation.

The Government, therefore, has envisaged creating a legal framework in the form of The

Protection and Utilisation of Public Funded Intellectual Property Bill, 2008. The expected benefits of

the Bill include:

Establishment of uniform legal framework for protection and utilisation of the IP generated

out of public funded R&D;

Encouragement for innovations in private sector as well as in Universities, academic and

research institutions that receive grants from Government;

Promotion of collaboration between Government, nongovernmental organizations, and

private sector;

Commercialisation of IP generated out of Government funded R&D and promotion of

innovation culture within the country;

Minimizing the dependence of Universities, academic & research institutions and other

recipient organisations for funding on the Government as the Bill provides for utilisation of a

portion of royalties or income generated out of the public funded IP for research and

educational purposes;

Generation of employment in niche areas with unique skills required for the IP

management, development, and marketing;

Transfer of technologies from research laboratories to market place (nationally and

internationally).

2.6.3. The National Green Tribunal Act, 2010

The Gazette of India has recently carried the National Green Tribunal Act, 2010 which provides for

“the establishment of a National Green Tribunal” meant towards an effective and expeditious

disposal of cases relating to environmental protection and conservation of forests and other natural



resources, including enforcement of any legal rights relating to environment wherein it is included

within the scope of the tribunal to give relief and compensation for damages to persons and

property.

The Tribunal has the power to provide relief and compensation to the victims of pollution and other

environmental damages, restitution of the environment and property damaged also fall under the

purview of the Tribunal. The application to the Tribunal is required to be made within 6 months.

The Tribunal can provide imprisonment up to 3 years and a fine which may extend to EUR 1.56

Million approx. (INR 10 Crore) in case of individuals and EUR 3.90 Million approx. (INR 25 Crore)

for a company as a non-compliance penalty towards its order.



2.7. Role of the business and industry in this segment

Biocon The top management of Biocon identified four strong and differentiated growth drivers as follows:

Portfolio of Biosimilar Insulin and Insulin Analogs and basket of Biosimilar Monoclonal

Antibodies

Research Services powered by Syngene (Custom Research) and Clinigene (Clinical

Research)

High value R&D Assets

Top 20 companies contributed 52% of the total revenue.

These companies grew at an average growth rate

of over 22% while the industry growth rate stood at 17% in FY 2009-10.

Serum Institute of India slipped to No. 2 on

account of loss of some key contracts.

Shantha Biotech is the only Top 20 revenue company to have showcased a growth over 30%.

Total revenues of Top 20 homegrown companies have grown by 25% over FY 2008-09.

Fastest growing 20 companies contributed 20% of

the overall industry revenue of EUR 2218.58 Million. These have grown at an average rate of over 150%.

The pack of fastest growing companies in the

region is led by CROs, which have grown from a very small base of less than EUR 4.68 Million.

The fastest growing 20 companies in the region are all below EUR 23.43 Million with the exception of Shantha Biotech at EUR 52.22 Million.



A strong market development focuses on India and Emerging Markets

Biotech Strategies of some leading Indian Pharma companies

Global Company – Setting up Base in India Lonzais is planning to set up a manufacturing base in India at an investment of US$ 150 million in

Hyderabad. The investment outlay has been planned over two phases:

1. Phase I (from 2011 to 2013) will include the development of R&D labs for more than 100

resources.

2. Phase II (from 2014 to 2015) will include the expansion of manufacturing capabilities and

the provision for increasing R&D lab capacity for biologics with 200 additional resources.

Source: ibef

Indian biopharmaceutical players have developed strong capabilities in the high-potential biosimilar

space and have presence in almost all the biologics coming off patent. Companies such as Reliance

Drug Discoveries

Biogeneries

Nicholas Piramals Licensing of Roche’s

Products Genomics divisions

Ranbaxy No Plans to enter biogeneries

market as a manufacture Plan to develop an internal BT

based drug discovery process

Wockhardt & Dr Reddy’s Comprehensive biogeneries production

and marketing strategy Plan to develop an internal BT based

drug discovery process

USV Comprehensive strategy of production &

marketing of biogeneries. In house competency in molecular

biology



Life Sciences, Biocon, Wockhardt, Shantha Biotech, Panacea Biotech, and Intas Pharmaceuticals

have been developing strong capabilities in this area.

Imac and Indus Expression (US-based biotech companies) floated by non-resident Indians have

planned an investment of EUR 70.72 million to set up their units in India at the SEZ proposed by

the Andhra Pradesh Industrial Infrastructure Corporation (APIIC).

Panacea Biotec Ltd. has bagged a three-year contract worth over EUR 81.05 million from UNICEF

to provide the agency with EasyFive vaccine; a protection against a set of pediatric diseases.

France's largest drug maker, Sanofi-Avenits, has bought Shantha Biotechnics for EUR 526.18

million.

Vibha Seeds Group has invested US$ 42.99 million to set up a multi-crop seed processing facility in

Andhra Pradesh. The company is engaged in private crop genetics and plant breeding researches.

Alexandria Real Estate, the EUR 3.53 billion US-based company which provides solutions to the life

sciences industry, has decided to set up a biotech R&D and incubation facility in Gujarat. It plans

to spend around EUR 73.08 million for the project.

2.7.1. Public-private partnerships

It is important to encourage and support the public-private partnerships in areas that are vital for

national development—economically, scientifically or socially. The need of the hour is to focus on

product development and technology. India has a vast network of universities, specialized

institutes and departments that are promoted by different authorities to provide numerous

specialized science degrees at the Masters’ level.

These institutions have also spun a network of research laboratories. It is necessary to make

efforts that bring in a seamless knowledge transfer; result in better coordination among the people

in these institutes, universities, and corporates; and encourages them to share their research-



based information on an ongoing basis. For such jointly funded ventures, the corporates could

have a preferential access to the intellectual property generated therein.

The public-funded successful R&D institutions can also be encouraged to set up ‘not-for-profit’

companies for facilitating the collaborative work with industry. There needs to be an alliance

between industry and academia wherein the industry could actively participate in planning the

curriculum and evaluation methods. Meanwhile, the Private firms may also step in and share the

responsibility of encouraging academic excellence by creating Chairs in Universities and also by

strengthening the industry–academia relationship. The public institutions can prove critical in the initial days of a newly launched biotech project,

apart from merely serving as a potential entrepreneur pool, by providing a shelter for the newborn

project. This interaction is referred to as incubation and is relatively loosely defined. It generally

comprises the provision of a working space along with the chances for the incubated company to

use some of the equipment from the incubator institution. Avesthagen and Genotypic (Genomics),

Shanta (recombinant therapeutics) and XCyton (Peptide-based Diagnostics) have used this

collaboration model.

The public-private partnerships and collaborations are increasing in the biotech industry. The

initiatives taken by Bill & Melinda Gates Foundation and DBT Small Business Innovation Research

Initiative (SBIRI) are examples of collaborations between the industry and the government. DBT

has also tied up with UK-based Wellcome Trust to augment the cutting-edge biomedical research in

the country. The trust will allocate around EUR 33.9 million for five years to fund R&D research in

India.

Other Examples S.No Private Company Public Partner

1 Avesthagen NCBS

University of Agriculture and Science

ICRISAT

CCMB



2 Wockhardt ICGEB

3 Shanta Osmania Iniversity

CCMB

IISC

Tata Nanoraial Hospital

JNU

4 Murugappa Chettiar &

Orchid Pharma

Nano Functional Materials Centre,

IIT Madras

5 Dr. Reddy's Labs Nano Technology Centre, Univ. of Hyderabad

6 ARCI, Hyderabad &

Textile Industry

Centre for Interactive & Smart Textiles, IIT Delhi

7 Pharma industry Centre for Pharmaceutical Nanotechnology, NIPER,

Chandigarh

8 Apollo Tyres Rubber Nanocomposites, MG University, Kottayam

9 Nanotech Corp., USA Nanophosphor Application Centre, University of

Allahabad

10 Murugappa Chettiar &

Orchid Pharma

Nano Functional Materials Centre,

IIT Madras

2.7.2 Certain recent corporate developments

1. Mission NewEnergy Ltd., a bio-diesel refiner and Jatropha plantation company, recently

announced that the Indian Government (Ministry of Finance) has approved further capital

investment by the Company into its Indian feedstock business and that the company can

continue with the original approved activity of being engaged in the contract farming of Jatropha

and utilisation of the Jatropha oil for domestic or export markets.

This affirmation confirms the Indian government's support for the development of the Jatropha

industry and the leadership role that Mission NewEnergy is playing in the further development of

the industry. The company has the largest Jatropha plantation acreage in the world spanning

more than 200,000 acres, 124,000 farmers and five provinces.



The Company is already in discussions with several oil majors regarding new off-take

agreements similar to its recent contract with U.S. based Valero Energy Corp and has

operational plants in Malaysia. The company stated that oil from its Jatropha farms will

eventually replace crude palm oil as feedstock for its bio-diesel manufacturing plants.

2. Recently in March 2011, SG Biofuels, a US based bioenergy Crop Company using breeding and

biotechnology to develop elite hybrid seeds of Jatropha has extended its operations in India.

2.8. Environmental Biotechnology Several programmes have been defined in the biotechnology sector based on the growing

awareness about the unsustainable practices and ecofriendly approach. Biotechnology is an

effective tool for conserving natural resources and mitigating the environmental issues.

Government and research institutes and the Indian firms are busy assessing and developing new

technologies for eco restoration, environmental monitoring, and use of renewable resources.

Various projects led to the development of technological options that were adopted. The

technology demonstration for restoration of environmental quality, hydrocarbon recovery from oily

sludges, environmental monitoring, and oil-spill remediation were addressed.

Substitution of non-renewable resources with renewable ones, Desulphurization of coal, and

conversion of lignocellulosics into value added products has fortified the ecofriendly approaches

adopted for mitigating different problems. Carbon sequestration studies have proved promising in

reducing the impact of climate change.

2.8.1. Biofuel and Bioenergy Energy security is one of the main priorities or prime focus of any developed or developing nation.

The need for energy security is further supplemented by the growing Indian Economy and the

petroleum imports expected to rise to 166MT by 2019 and 622 MT by 2047.



The Department has initiated an end-to-end mission programme which aims at:

1. Perfecting technologies to set up bioenergy plantations for varying agro-climatic zones by

active involvement of local people,

2. Economically viable production of ethanol using efficient high yielding strains of

microorganisms and different types of raw materials,

3. Bio-diesel production for hydrocarbon and oil(s) using alternate feed stock, particularly the

lignocellulosics wastes and improved transesterification process,

4. Hydrogen production from bacteria and algae. The burgeoning energy demand has made it imperative to find new renewable sources. Biomass

has the required potential to become an important source of renewable energy. Significant growth

and development has been noticed in R&D for technologies converting sugar, starch, and fiber

from woody plants and crops, trees, and food processing residues into useful biofuel products. It

goes without saying that Nations and communities bestowed with renewable biomass resources

have the capability to become economically robust and energy independent.

Traditional practices in biomass contribute significantly in bioenergy production. The latest

research is also being pursued for alternative biofuel production – Bioethanol and Bio-diesel.

Biomass R&D should not be merely limited to enhancing the conversion technologies but it should

also focus on using biotechnology tools for redesigning the feedstock for specific products.

Biotechnology offers an undying potential to overcome the limiting commercialization barriers for

this technology. The tools of biotechnology can be extremely useful in developing an integrated

product design strategy where the bioconversion and feedstock can be so designed that it allows

optimal interaction in the system. Such interdisciplinary and integrated strategy would be

imperative in economical and technical breakthrough in biomass utilisation and will lead to

promotion of a sustainable and renewable energy platform.

Considering the rich bioresources available in India, Department of Biotechnology, Govt. of India is

executing an Energy Bioscience Programme with a broad perspective to make available, the



economically viable alternative fuel from Biomass so as to meet the national targets of biofuel

blending and energy deficit.

The objective and specific targets of this programme are:

1. Producing ethanol from cellulosic biomass by the year 2012 using forestry and agricultural

waste.

2. Producing bio-diesel from different feed stocks.

3. Creating alternative second generation biofuels using synthetic biology.

4. Promoting use of alternative biofuel on a large scale through high end research with second

generation biofuels and improving the cost-effectiveness through optimised cultivation of

dedicated feed stocks.

5. Harnessing the energy potential of all natural resources to an optimum level for converting

them to alternative fuel.

2.8.2. Bioethanol Production The need for Bioethanol @ 5% blending is almost 900 Million Tones by the year 2011. At present,

the production of alcohol is approx. 1900 Million Litres for varied consumption. Sugarcane and

mollases are the main feed stock. The limited or restricted availability of feed stock is a major

hindrance in meeting the increasing demands of bioethanol. In addition to this, the present

production process is also not globally competitive. The only solution left is the “Second Generation

Biofuels”. The R&D sector in the Energy Bioscience Area stresses on using Lignocellulose biomass

as a feed stock (Agriculture and forestry waste) and developing commercially viable production

technologies. According to the estimates, India has over 500 Million tonnes of available biomass

out of which only 170 Million tonnes is being used in an effective manner.

The major thrust areas include:

1. Reengineering feedstock for improved ethanol recovery

2. Reengineering microorganisms to boost productivity

3. Improved process productivity—reduction in enzyme and capital cost and feedstock

4. Enhanced cellulose production

5. Modification of plant architecture



Bioethanol has strongly appeared as an alternative liquid fuel. As bioethanol production largely

relies on corn-starch and cane-sugar, feedstock depending on availability of large tracts of

cultivable land which for most areas of the world, including India, can be only available at the

expense of land used for growing food.

Lignocellulosic ‘waste’ biomass obtained from food crops can be counted as a possible sustainable

source that can be utilised for ethanol production. However, the technological setback for

producing alcohol from lignocellulosic biomass (LBM) does not allow a problem-free

implementation. A careful analysis is required for the diverse problem areas.

The technology to produce bioethanol from LBM has multiple components and each component has

its own complications. One has to keep in mind, especially in the Indian context, that LBM does not

come free-of-cost as Indians have learnt to make some use of everything that is ‘waste’. So, for

using LBM for bioethanol technology India needs a ‘zero-waste’ process. This is where the

‘biorefinery’ concept becomes useful.

An LBM biorefinery would be something like interdependent processes integrated together in a

system to convert a given renewable feedstock into fuel, value-added products and energy with

minimum requirement of external energy and practically no emissions and wastes. An LBM

biorefinery is similar to a petroleum refinery producing multiple products and fuels from crude

petroleum. Extracting bioethanol from LBM starts with LBM fractionation which produces three

process streams of cellulose, hemicellulose, and lignin. Besides deriving value-added products and

plain energy from these streams there are many minor components of LBM that, if separated in a

cost-effective manner, can significantly enhance the economics of bioethanol production.

Another upcoming liquid biofuel is the bio-diesel derived from vegetable oils. Here again, the

biorefinery concept is equally relevant for bio-diesel production especially because vegetable oil as

far more expensive as a feedstock than LBM.



2.8.3. Bio-diesel Production The bio-diesel demand is growing day-by-day due to the excessive use of diesel in various

applications with a requirement of around 10.40 Million Tonnes @ 20% blending by the year 2030.

At present, Jatropha curcas is the main feed stock that is being utilised and the Indian Government

has introduced a mission programme on Bio-diesel which targets large scale Jatropha plantation

covering around 11.2 million hectares of land. Even if Jatropha is an excellent feed stock for large

scale plantation, it is essential to have a quality planting material. This can be handled scientifically

with the prime focus on:

Systematic screening, collection and assessment of the existing germplasm for

maintaining proper cost economics to identify material which is superior in quality.

Setting up clonal seed orchards and promoting mass multiplication techniques to ascertain

an easy supply of elite planting material to the cultivators.

Conducting multi-location trials in different agro-climatic conditions to get authentic data

on production economics and yield estimates.

Calendar Year 2006 2007 2008 2009 2010 2011

Opening stock 483 747 1,396 1,673 1,243 1,145

Production 1898 2398 2150 1073 1435 1859

Imports 29 15 70 280 300 300

Total supply 2410 3160 3616 3026 2978 3304

Exports 24 14 3 3 3 10

Consumption

Industrial use 619 650 700 700 720 750

Potable Liquor 745 800 850 880 950 1010

Blended Petrol 200 200 280 100 50 200

Other use 75 100 110 100 110 110

Total Consumption 1639 1750 1940 1780 1830 1970

Ending stocks 747 1396 1673 1243 1145 1224

Total Distribution 2410 3160 3616 3026 2978 3304

Production capacity (Conventional Fuel)

Feedback Use(1000MT)

Feedstock A (000’ Tons) 7910 9992 8958 4469 5981 7746

Source: FAS New Delhi Estimates based on information from Trade Sources.



2.8.4. Bio-diesel Downstrean Processing—Transesterification For using vegetable oils as fuels for internal combustion engines, the oils have to undergo

transesterification to meet the strict transportation fuel specifications. Even if there are several

methods of preparing fatty acid methyl esters (Bio-diesel), the one using alkali as the catalyst is

largely used in the industry.

The reasons for this may be rapid reaction, simple operation, cost effectiveness, and less complex

plant operations. For transesterification that is base catalysed, there are some restrictions on the

impurities present in the parent oil, for e.g. moisture and free acids. Several alternate methods are

also being considered, including bio-catalysed, solid acid continuous type and co-processing in

refineries. Although, there are a few pilot scale reports but they are miles away from full scale

commercialisation.

In India, there are many small and medium scale bio-diesel plants that have been set up during

the last 5 years. Out of these, some plants are based upon indigenous knowledge. However, the

bio-diesel produced in these plants meets the ASTM & IS specifications. For such plants, the

required equipment and engineering capabilities are readily available.

2.8.5. Bio-diesel in India In India, bio-diesel production plays a critical role in augmenting the energy security. It is also a

great way to effectively use the available wastelands and creating mass rural employment. A few

states as well as the central government have taken the initiative to harness the potential of bio-

energy crops. Bio-diesel industry in India started evolving some three years back when the

planning commission and the central government started the National Mission on Biofuels. The

industry has taken great leaps since then and has matured and seen the entry of several serious

players.

In the Indian perspective, the bio-diesel industry is basically dependent on the non edible oils. To a

great extent this is the correct strategy socially, economically, and politically as the country is

experiencing high economic growth and depends on imports for edible oils and fuels. Jatropha

curcas is the most suitable of all among the non edible oils. Jatropha curcas is the ideal choice as it

has a relatively shorter gestation period, can adapt well on inferior soil as well as adverse climatic



conditions. Thus, it can be said that Jatropha curcas supports the food chain rather than competing

with the food.

The first phase of bio-diesel industry saw the entry of a number of small local players trying to

leverage their links with the farmers. The main business of these players was to sell planting

material to the farmers based on the hypothesis that such operations will be financed by banks and

Jatropha seeds will be in demand being an energy crop. Although the logic was basically correct it

still missed the aspects of project implementation.

Fundamentally, the bio-diesel industry is actually integrating two separate and distinct knowledge

domains i.e., petroleum and agriculture. The integration of these two unlinked industries, as in the

past, throws several challenges.

The prime challenges include developing an independent integrated model that is free from climatic

risks, government subsidies and at the same time synchronises the good and bad times of both

petroleum and agricultural industry performance. This also implies that the traditional agri-industry

models and process industry demand a thorough review before implementation. However, these

obstacles open up new avenues for opportunities specifically related to byproduct value addition of

Jatropha seed cake and oil on one hand and glycerin and similar value chain opportunities on the

other.



2.8.6. Energy Crises - Microorganisms Microorganisms are nothing but micro-scale factories that can be manipulated for tackling the energy crisis.

The ability to get biodiversity of unique genes, its products capable of performing in extreme environment,

coupled with powerful genetic engineering tools can be used to make efficient biochemical machines that are

tailor-made for the growing biofuel industry. The microorganisms can be used for:

1. Producing "microdiesel", which unlike regular biofuels does not contain toxic chemicals and can be

produced using plant or other types of waste instead of plant oils.

2. Converting waste materials like lignocellulose into substrates for producing biofuel.

3. Detoxification of the waste material in bio-diesel production.

4. Producing energy as electrical current—it should be noticed that bacteria can utilise anything from

decaying animal and plant matter to toxic organic pollutants like benzene to generate electricity.

2.8.7. Algal Biofuels and the Algal Bioenergy Consortium Algae offer a lot of potential strength to be used as renewable energy sources. Unlike the land-

based bioenergy crops, algae do not require large patches of land that are agriculturally productive

or ecologically sensitive. Interestingly, algal culturing facilities can be started on a large-scale on

any land, including industrial/ waste lands. Algae can also be cultured on marine sites. Apart from

this, the algal growth can be directly related to other industrial processes, particularly removal of

nitrates and phosphates from wastewater and the scrubbing of CO2 from flue gas. This not only

has a cost advantage but also reduces the carbon footprint of the traditional industrial processes.

Moreover, algal cultures can also be utilised for producing several high-value products. Some

species of algae are also involved in direct high level production of hydrocarbons.

The Algal Bioenergy Consortium is based at the University of Cambridge, UK and is an

interdisciplinary group with its members in other UK universities and elsewhere. The Consortium

has expertise in algal physiology and molecular biology, electrochemistry, photosynthesis

biochemistry, chemical engineering, engineering, and economics. It covers both prokaryotic

(cyanobacteria) and eukaryotic algae. The Consortium takes special interest in using algae for bio-

diesel and biomass production (which might have links to the sequestration of CO2 from industrial

processes), for the biophotovoltaic hydrogen or electricity production, and for metabolic hydrogen



production. Some hurdles that need to be done away with for optimising the use of algae,

especially for bio-diesel and biomass production include interlinked issues like contamination, light

harvesting efficiency, and design of bioreactor.

2.8.8. Carbon Sequestration and the Challenge of Sustainability and Carbon Sequestration in Biofuel Feedstock Development The global climatic changes with varying temperature and precipitation patterns are likely to

introduce some modifications in the Semiarid tropics in the future. A study was conducted at

Maduari Kamaraj University for measuring continuous CO2 and H2O fluxes and energy fluxes on

Cenchrus ciliaris L. grassland in semi-arid region using Eddy Covariance System with energy

balance components. The results revealed that the soil moisture strongly controlled the Net

Ecosystem Exchange of CO2 (NEE). During the wet periods, high CO2 sequestration was observed

which lasted for 7 months and during the dry periods the grassland ecosystem served as a carbon

source.

A similar pattern was observed during seasonal changes in ecosystem respiration (Reco) with

changes in soil moisture; however, a negative correlation was seen between soil temperature and

Reco. The amplitude and phase of NEE was a strongly regulated rainfall pattern that stimulated

dynamics in soil moisture availability.

An essential research component of any biofuel program should focus on the added benefits of

carbon sequestration and improvement of sustainability. Several research avenues can help in

achieving the potential for a dramatic improvement in sustainability. Sustainability research

includes a need to identify:

1. plant traits and other factors that improve symbiotic and asymbiotic microbial processes;

2. plant traits that enable competent use of the resources and conditions that optimise the

nutrients supplied by the symbiotic and associated microbial communities;

3. the significance of microbial functional diversity & its interdependence on plant diversity;

4. plant and microbial traits that boost carbon sequestration and methods to control age-

related decline in the yield.



An in-depth research is necessary for a deep understanding of genetics and mechanisms

responsible for plant-soil microbial associations and interactions. The research should encompass

varying scales ranging from metagenomics, proteomics of endophytic and soil-derived diazotrophic

bacteria and their habitats to the expression of symbiotic traits phenotypically. The success

achieved can be assessed by identifying the relative contributions of environmental conditions vs.

plant traits for expression of targeted pathways. Such studies need to make use of High-

Throughput (HTP) methods of molecular imaging, molecular biology, and molecular probes

development.

In addition to this, the studies should also integrate the lower-scale findings into measures of

production and growth of biofuel crops, symbiomes of associative endophytic and freeliving

microbes, and feedstock quality.

2.8.9. Biopesticides and Biofertilisers

The biopesticides and biofertilisers are the sub-segments that constitute a humble portion of the

BioAgri segment and have been growing steadily for the last few years.

The Indian Government has introduced several programmes to control pest-diseases and major

weeds for important crops, plants, and vegetables for an increased production through different

biocontrol agents. Several institutes and universities have been working in the area of

biofertilisers. The Indian agricultural sector has got the due support from the public research

programmes in yield improvement, varietal development, and disease management. Many

international companies have established research and development facilities on the Indian soil to

develop hybrid seeds and other activities based on biotechnology.

2.8.10. Bio-Diesel Policy

National Bio-diesel Mission (NBM) was launched by the GOI in April 2003, identifying Jatropha

curcas as the ideal tree-borne oilseed for producing bio-diesel on wastelands. The Planning

Commission of India has targeted covering 11.2-13.4 million hectares of land under Jatropha



cultivation by the end of 11th Five Year Plan (2011/12). The Central government and a few state

governments offer fiscal incentives for cultivating Jatropha and other non-edible oilseeds.

Date Action Comments

April 2003 Demonstration phase 2003 to 2007: Ministry of

Rural Development was appointed as nodal

ministry to cover 400,000 hectares under

Jatropha cultivation. The phase also proposed

establishment of seed procurement and

establishment centres, nursery development,

blending and marketing of bio-diesel, and

installation of transesterification plants.

State government, public &

private sector and Indian and

foreign research institutions

involved in the programme

achieved varying degrees of

success.

October

2005

MoPNG launched bio-diesel purchase policy in

which Oil Marketing Companies (OMC) would

purchase bio-diesel across 20 procurement

centres across India to blend with high speed

diesel w.e.f January 2006. Purchase price fixed at

EUR 0.41 (Rs 26.5 ) per liter.

Bio-diesel production cost

higher (20 to 50%) than

purchase price. No sale of bio-

diesel.

2008 Self-Sustaining Execution phase 2008 to 2012:

Aimed at producing plenty of bio-diesel for 20%

blending by end of 11th (2008-12) five year plan.

Lack of seed collection and

extraction infrastructure, large

scale plantations, capacity and

confidence building measures

among farmers, and buy-back

arrangements impeded the

progress of this phase.

The ambitious plan of GOI for adequate bio-diesel production to meet the mandate of 20%

blending with diesel by 2011/12 is advancing slowly and gradually.

In India, the commercial bio-diesel production is very low. As per the trade and industry records,

Jatropha has been cultivated in wastelands across 500,000 hectares, out of which at least 65-70%



is considered as new plantation that will take around three to four years to mature. Consequently,

there are inadequate Jatropha seeds that can be crushed for producing bio-diesel. Considering the

slow pace of growth for Jatropha plantation and with reports mentioning that most of the Indian

bio-diesel companies are idle/ have a very low capacity, the GOI may fix a higher price of EUR

0.53 per liter (compared to EUR 0.41 /liter last year) for bio-diesel purchase through Oil Marketing

Companies (OMC). Some industrial groups have taken this as a welcome move for attracting more

bio-diesel companies back into business.

Impediments: Lack of drought-tolerant and high-yielding Jatropha seeds, ownership issues with

government or community-owned wastelands, smaller land holdings, little progress made by state

governments for large scale Jatropha plantations, and negligible bio-diesel production for

commercial purposes have hindered the efforts and investments made by the public and private

companies.

2.8.11. Ethanol Policy

Ethanol is produced in India from sugar molasses for blending with petrol. At the start of January

2003, the GOI mandated the use of 5% ethanol blend in petrol through its ambitious Ethanol

Blending Program (EBP).

Date Action Comments January

2003

Ministry of Petroleum and Natural Gas (MoPNG)

made 5% ethanol blending [10] in petrol

(gasoline) mandatory across 9 States and 5

Union Territories

Public & private sector, state

government, and research

institutions (Indian and foreign)

involved in the programme

achieved varying degrees of

success

September

2006

Resurgence in sugarcane production in 2005/06

and 2006/07 led GOI mandate 5% blending of

ethanol in gasoline across 20 states and 8 Union

Territories subject to commercial viability

OMC contracted for 1.4 billion

liters of ethanol for EBP at EUR

0.33 (Rs 21.50) per liter from

Nov. 2006-2009. Only 540

million liters of ethanol supplied

till April 2009 due to short



supply of sugar molasses. GOI

deferred implementation due to

short supply of sugarcane in

2007/08

September

2008

Union Cabinet approved the National Biofuel

Policy: Five percent blending mandatory across

all states in the country, blending ratio to be

raised to 10%. The policy targets 20% blending

by 2017

GOI deferred the plan again due

to short supply of sugarcane

and sugar molasses in 2008/09

Since Indian sugarcane production is cyclical, ethanol and alcohol production in India depends on

the availability of sugar molasses (a byproduct of domestic sugar production). Limited availability

of sugar molasses leading to high-priced molasses has impacted ethanol’s cost of production,

thereby, causing a disruption in the supply of ethanol at pre-negotiated fixed ethanol prices.

Presently, the government is unable to implement the compulsory blending of 5% ethanol in petrol

(gasoline) due to the short supply of sugar molasses in 2009/10 and 2008/09 on low sugarcane

crop production. With a bumper sugarcane and sugar production outlook for 2010/11, the

government is likely to renew its focus and implement the mandatory 5% ethanol blending in

petrol. Industry sources report that the GOI is likely to take a decision on increasing the purchase

price of ethanol for the Ethanol Blending Program (EBP). Augmenting ethanol supply:

Currently, the government does not allow use of imported ethanol for the EBP program as the

focus is on increasing the domestic production capacity. To augment supply, the GOI has permitted

ethanol production directly from sugarcane juice while ensuring that the move does not constrain

production of sugar or ethanol for industrial use. Efforts to produce ethanol from sweet sorghum,

sugar beets, and sweet potatoes, however, are at the experimental stage. The government does

not provide any direct financial assistance or tax incentive for the production or marketing of

ethanol or ethanol blended petrol. The GOI is offering subsidised loans (through sugarcane

development funds) to sugar mills for building ethanol production units; the loan offered would

cover a maximum of 40% of the project cost.



Impediments:

Rules and regulations (excise duty, inter state charges, etc.) applicable to the control of alcohol for

potable industry use are equally applicable for ethanol blending with petrol, thereby constraining

its availability and utilisation for the EBP.

2.8.12. Oilzapper The product "Oilzapper" will prove to be one of the most powerful bio-products in the emerging

scientific scenario providing great significance to bioremediation for tackling oil spill and oily

sludge.

The Oilzapper feeds on hydrocarbon compounds present in crude oil and oily sludge (a hazardous

hydrocarbon waste generated by oil refineries) and converts them into harmless CO2 and water.

The Oilzapper is neatly packed into sterile polythene bags and sealed aseptically for safe transport.

The shelf life of the product is three months at ambient temperature.

More than 5000 hectares of cropland contaminated with crude oil spills has already been reclaimed

in different parts of India and around 26,000 tonnes of oily sludge has been successfully treated

with Oilzapper. Many oil-slick contaminated lakes in the North-Eastern parts of India have also

been cleaned up in two years using Oilzapper technology.

The success of Oilzapper can be determined by the tremendous response received from various oil

refineries. At present, TERI and IOC R&D centre are working on the bioremediation of oil spill sites

and treatment of oily sludge at various oil refineries and oil exploration sites.

2.8.13. Mycorrhiza This microscopic fungus is potent enough to revive a wasteland and turn it into a lush, flowering

garden, a fruit orchard, or even a verdant field. As this fungus fuses life into earth, sick soil turns

fertile and retains the vigor long lost under the influence of generous doses of heavy chemical

fertilisers and pesticides.



Mycorrhizae, on the other hand, use phosphorus from extremely low concentrations and provide a

nature-friendly alternative to chemical fertilisers. TERI’s mycorrhizal consortium is a technological

innovation with multiple organisms as against its earlier version that contained single specie. The

consortium technology offers improved and multifaceted benefits in plant production systems. A

product of this type bypasses the limitations of the conventional method and allows storage at

room temperature for more than five years.

Implementation of TERI’s mycorrhizal technology requires an investment of EUR 0.1 million –

which includes the capital cost, licence fee, consumables, and annual labour costs for production in

the order of 200-tonne capacity in the first year as compared to an investment of EUR 6.90 million

for conventional technological solutions. Recurring costs are greatly reduced in the TERI

technology. Also, energy inputs in the TERI technology are a mere 5% and water requirements a

minute fraction – 0.0003% – of the conventional technology.

Of the annual demand for approximately 48 million tonnes of phosphatic fertilisers for agriculture

in India, only 33.48 million tonnes is procured from domestic chemical fertiliser industries. The

deficit (14.5 million tonnes) is imported from other countries. This situation can be tackled in a

cost-effective and eco-friendly manner with the large-scale adoption of mycorrhizae.

Trial is being conducted in Europe and USA for mycorrhizal coating on seeds and providing such

seeds to the end user who can directly use them for sowing as Indian farmers are not privy to the

most modern technologies.

The mass production of Mycorrhiza Biofertiliser catered to Cadila Pharamceuticals, Ahmedabad,

KCP Sugar and Industries Corporation, India. Besides that the improved technology of mass

production of Mycorrhiza Biofertiliser was supplied to Cadila in May 2001. Mycorrhiza Consortium

Production was done for KCP Sugars and Industries, Andhra Pradesh in 2005; Magestic Biotech,

New Delhi in 2004, Cosme Pharma, Goa in 2005 and for Sarita Ganga Farms, Ahmedabad in 2006.



Also for the reclamation of industry-created wastelands, the beneficiaries of the technologies are

National Thermal Power Corporation, Tata Chemicals, Fly Ash Mission, TIFAC, Madhya Bharat

Papers, Associated Alcohols and Breweries all based in the country.

2.8.14. Blue Green Algae Technology has been developed at IARI, New Delhi for cheap and environment-friendly

biodegradable carrier material and bulk production of inoculums under controlled conditions. The

Technology for production of BGA biofertiliser with simple nutrient medium in polyhouse has been

standardised. A thick mat was found to develop within 5 days.

A suitable carrier material has been developed where survival percentage of BGA strains was 85%

even after two and half years of storage. The carrier material, Mont Morillonite Clay has been

found to be very promising for BGA biofertilisers where it is essential to store the inoculum for a

longer period.

The Technology for large scale production of BGA inoculum biofertilisers in Flexibioreactors is

developed at MKU, Madurai while a technology to biodegrade coir-pith and simultaneously use it as

carrier material for BGA has been developed at Bharathidasan University, Trichi.

2.8.15. Carbon mitigation NTPC has signed an MoU with The Energy and Resources Institute, TERI for collaborative research

in Carbon mitigation through micro algae. As per the deal, the research work includes narrowing

down of efficient algal strains, designing of photo bioreactor for growth of algae, and downstream

processing of algal biomass. Depending on the success of this Research and Development (R & D)

work the process is tipped to scale up into a pilot plant.

2.9. Advantage in India – Indian Biotech Sector India holds a position of manifold advantage in the field of Biotechnology. The country is not just

generating a vast knowledge base and trained manpower but also becoming an ideal location for



conducting high-end biotechnological research apart from manufacturing activities. The

government initiatives have helped Indian Biotechnology to embrace the tremendous growth

waiting for the country just around the corner.

2.9.1. Advantages for investing in Indian Biotech Market India is poised to become a phenomenal hub for the biotechnology industry. The private sector

companies with several Indian companies have performed well propelling their competence in

services and manufacturing segment. The Country presently holds a 2% share in the global market

but crossed EUR 2.04 billion in revenues which would grow 500% by the year 2015, indicating a

robust growth for the Indian biotech industry. With minimal impact of the global recession on the

Indian biotech industry, India actually benefited from the economic meltdown. India is among the

top 12 biotech destinations in the world and the third biggest in the Asia-Pacific region in terms of

the number of biotech companies. Along with the Government there are several organisations

which are involved in regulating the development of biotechnology segment to streamline the

regulatory process. The establishment of the National Biotechnology Regulatory Authority (NBRA)

is to provide a consistent mechanism for regulatory approvals. In July 2008, the DBT introduced

the National Biotechnology Regulatory Act, which would establish the NBRA as an empowered body

to approve every single biotech product.

Advantage for Investment in

Biotech Market

Innovative Product

Market

Climate Condition

Quality Manpower

High Quality &

Technical Capability

Low Manufacturing

Cost

Outsourcing Opportunity

Indian Biotech

Sector



2.9.2. Outsourcing Opportunity

India is a hot favorite destination for custom manufacturing outsourcing (CMO) and custom

research outsourcing (CRO). Bioservice is an upcoming and fast-developing segment in the Indian

biotechnology industry. It mainly comprises clinical research and contract research organisations

(CRO) and may include custom manufacturing (CMO) to an extent.

BioServices earned revenue of EUR 412.34 Million and recorded a 28% growth. In a period of just

3 to 5 years, several companies have established clinical research and contract research services in

India. The reason behind the fast-ticking growth of this segment is the rising cost of R&D on

foreign lands that has shifted the focus of global companies, interested in contract research, on

India; the US and European companies in particular. The changing market forces have also led to

new business models that have forced the domestic companies to outsource different parts of the

drug discovery chain.

Contract research along with advanced IT skills has also raised new hopes for outsourcing

business. A joint study released in August 2009 by Ernst and Young (E&Y) and an industrial body

stated that India recorded a growth of 116% for the clinical trial sites in India for the industry-

sponsored Phase II and Phase III during June 2008 and August 2009 raising its rank from number

18 to 12 across the 60 most active countries.

CMO has witnessed a record growth of 43% which is three times the global market rate.

2.9.3. Low Manufacturing Cost

By and large, the Indian economy has succeeded in shielding itself against the economic slump.

Moreover, the Indian biotechnology sector has taken great leaps during the global recession.

As the global companies struggled to reap profits in the already developed markets during the

economic downturn they looked at emerging markets, like India, offering a low cost profile. The

cost of manufacturing on the Indian soil is approximately 35-40% less than that in USA. Also, the

overall cost of manpower and low installation charges further make India a preferred destination.

Seeing the cost advantage, as many as 200 MNCs are operating from India.



The Indian private sector has done well focusing its strengths on manufacturing and services.

There has been a strong emphasis on producing low cost vaccines, new healthcare products, and a

forced price reduction for the bioproducts manufactured by the MNCs.

2.9.4. High Quality and Technical Capability

In 2009, the count of US Food and Drug Administration (FDA) approved plants in India was

more than 120 and the country had at least 84 plans approved by UK Medicines and

Healthcare products Regulatory Agency (MHRA). These plants have the potential to

manufacture products which are incomparable in quality.

India presents a wide scope for generic manufacturing with world-class facilities, which

comply with internationally acclaimed standards like Good Clinical Practices (GCP), Good

Laboratory Practices (GLP), and current Good Manufacturing Practice (cGMP).

India is hailed worldwide for its generic biologicals and low cost fermentation technology.

2.9.5. Quality Manpower

The world’s 2nd largest English-speaking population resides in India. The country has plenty of

skilled and cheap manpower which is a pre-requisite and an asset for the knowledge-based

industry. Easy availability of competent manpower gives India an edge over the other global firms.

Department of Biotechnology (DBT) has opened several topnotch Centres of Excellence (COE) in

India to generate a higher number of skilled manpower and also to support the corporates in their

R&D efforts. An increased interaction between the industry and the academia is all due to the

efforts of these institutions. There are, at present, eleven such COEs under the execution stage in

the following areas:

Genome sciences and predictive medicine;

System biology and tuberculosis;

Genome-mapping and molecular breeding of Brassicas, Anti-virals, Stem Cell

research, etc.



There are plans to fund around 50 COEs mostly in Universities.

2.9.6. Climate Conditions

India’s topography and physiographic conditions allow the country to experience a range of

climatic conditions, which actually favour the application of biotechnology on a large scale. The

country boasts of owning one of the world’s largest coastlines. India is divided into at least seven

different climatic zones and is blessed with the largest and wide-ranging variety of marine

organisms; this again leaves India with a huge scope for biotech industry to flourish. The prevailing

temperature in most parts of India presents favourable conditions for developing biotechnology

products using living organisms. This is better than practicing biotechnology in the Western World

as it cuts down the cost of heating/ cooling to a large scale (normally mandatory in the West).

These are not the only advantages that India offers—the country has coastlines receiving

uninterrupted sunshine for nearly 340 days per year, which in turn facilitates the growth of marine

organisms in open areas.

2.9.7. Innovative Product Market

India’s burgeoning population, having crossed the billion mark, offers a huge market for the

biotechnology products and services. The domestic pharmaceutical companies are making hay with

the advancements of the Indian biotech industry by indulging in activities like product

development, process innovation, and drug discovery. The growth of the Indian pharmaceutical

industry thus increases the market scope for the Indian biotech industry.

The industry is concentrating on the constant technology upgradation to improve the product

quality. India is apparently to be counted among one of the top five innovative hubs with the

country producing around 50 percent of drugs on a worldwide scale.



2.10. Weakness – Indian Biotech Sector

1 Lack of Financial Support for doing innovation and shortage of the state-of-the-art facility for doing R&D

2 Slow Regulatory Approval Procedure

3 Need for more human competence

4 Lack of awareness and understanding of biotechnology–derived medicines among physicians and public

5 Inconsistency in meeting timeliness and delivering



3. Opportunities in India

3.1 Nanotechnology Nanotechnology is one of the most promising technologies and in recent years there has been a

focus on convergence of nanotechnology and biotechnology. In India, nanotechnology is still at a

nascent stage but given the potential of the sector it is expected to grow at a robust pace in the

coming years.

Nanobiotechnology is a field involving medicine, material science, and engineering apart from

chemistry, physics, and biology. Nanotechnology deals with the production, processes, and

phenomena associated with engineered materials within a specified scale, while biotechnology

deals with using living organisms or substances obtained from them for manufacturing products

and services.

There are certain nanotechnology tools and systems which are used to analyse biological systems;

including cells and sub-cellular entities such as DNA, mitochondria, studying interaction between

engineered nanomaterials and biological entity; and manipulate materials involving biological

systems. These procedures have the potential of engineering novel materials and devices with high

sensitivity, high specificity, and multi-functional capabilities.

Nanobiotechnology shall influence the field of medicine to treat diseases like cancer, diabetes and

cardiovascular, and imaging and diagnostics. A wider scope may cover computer science,

information technology, power and environmental engineering.

It has the potential to revolutionise the Indian agriculture scenario and will have a strong impact in

transforming the entire food industry—changing the way food is produced, processed, packaged,

transported, and consumed. Several Indian Companies, firms, and research institutes are working

on nanotechnology products for drug delivery, water filters, arsenic removal, reducing water and

air pollution, antimicrobial coatings, and river cleaning projects.



The Government on its part is actively promoting various programmes under nanotechnology. A

‘Vision Group’ has been formed with members from academia, industry and research to develop a

national nanotechnology policy. Government of India has announced an investment of EUR 156.25

Million through a mission on nanotechnology from 2006 to 2011. The Government has also

announced a EUR 170 Million programme to build three national institutes for nanoscience.

INDIA’S FIRST NANOTECH PARK

Nanobiosym Inc, a globally recognised nanotechnology firm is setting up India’s first Nanotech

Park, “The Nanobiosym Technology Park (NTP)”, in Ahmedabad spanning 500 acres under public-

private partnership involving the state Government.

The NTP will bring together brightest talent from around the globe for cutting edge research,

learning and incubation, and commercialisation of new nano-enabled technologies and products. It

will bring the latest medical developments, including the GeneRADAR.

Nanobiosym is also forming a global consortium comprising best of breed partners from a variety

of sectors like R&D, education, healthcare, infrastructure development, finance and banking,

knowledge partners, multinationals, and small/ medium enterprises. The park is expected to act as

a global powerhouse with a focus on hi-tech innovation and entrepreneurship.

3.2 BioSimilars The expiry of patent protection and regulatory data protection for certain pharma and

biotechnological medicines has led to the development of medicines called biosimilars. Biosimilars

is an attempt to copy the process, which leads to the production of the original innovative

biotechnological medicine. The term ‘biosimilars’ is in use in the European Union and India, but in

the US the term ‘follow-on biologics’ is much popular.

As regulatory obstacles in the path of developing biosimilars are constantly being resolved, a

growing number of opportunities are being created for generic companies in the BioPharmaceutical

market.



The Indian biosimilars market will grow to more than EUR 1.36 billion by 2014 as patent of key

products, such as epoetin alpha, filgrastim, interferon beta 1a, interferon alpha, human growth

hormone (hGH), and insulinglargine is expected to expire by then. This offers manufacturers the

opportunity to position themselves in the biosimilars sector anticipating more lucrative targets.

India has a strong presence of firms engaged in the biosimilar space. For example, Reliance Life

Sciences launched three biosimilars - ReliPoietin [Erythropoietin (EPO)], ReliGrast [Granulocyte

colony stimulating factor (GCSF)], and ReliFeron (Interferon Alpha 2b) in the domestic market in

2008. Reliance Life Sciences is currently working on a range of biosimilars, which are at different

stages of development viz. clinical trials, pre-clinical studies, process development and molecular

biology. It is also concurrently conducting clinical trials for two biosimilars - EPO and GCSF - in

Europe. Further, Reliance Life Sciences has also built significant manufacturing capacity for

BioPharmaceuticals and all these facilities are compliant with USFDA and EMEA standards.

Currently, the global biosimilars market is highly fragmented with major players, such as Biocon,

Dr. Reddy’s Lab, Intas, LG LifeSciences, Ranbaxy, Reliance LifeSciences, Sandoz, Teva, and

Wockhardt engaged in diverse products.



3.3. Stem Cell Research Stem cell research is a very prominent segment of biotechnology having the potential to globally

revolutionise the treatment of incurable diseases in the next couple of decades. Stem cells are

‘master’ cells that possess the potential to repair tissues/ grow organs. Their sources may vary.

Globally, around 200 companies are working on stem cell research with majority of them in the US

followed by the EU, Israel, Thailand, Canada, and Australia. Stem cells are used to treat over 130

diseases worldwide. More than 500 clinical trials are being conducted to develop therapies using

stem cells.

The Government of India has supported more than 55 programmes on various aspects of stem cell

research. In March 2009, Bangalore based Stempeutics Research received a nod to conduct human

clinical trials to develop drugs using stem cells, making India the first developing country, after the

US, to allow human clinical trials to develop drugs.

Reliance Life Sciences, pioneer in stem cell-based research in India has already commercialised

two products namely, ReliNethra (launched in 2008 for corneal blindness) and ReliHeal-G (for quick

healing of wounds). The company has completed clinical trials for treatment of heart attack while

those for skin disorders, non-healing diabetic ulcers, Parkinson’s disease, etc. are still underway.

India’s largest stem cell banking company, LifeCell, and the US-based Harvest Technologies are

developing a unique treatment for heart attack in association with two Indian doctors while

Mumbai-based Jaslok Hospital and Reliance Life Sciences are also working together to find a cure

for Parkinson’s patients in India.

A ‘Draft Guidelines for Stem Cell Research’ prepared by the Indian Council of Medical Research

(ICMR) is on the anvil. The stem cell research guidelines have been finalised and have been

submitted to the Ministry of Health and Family Welfare, Government of India. A National Apex

Committee for Stem Cell Therapy (NAC-SCRT) is being constituted jointly by the DBT and ICMR as

per these guidelines.



3.4. WTG1XG - A Promising Next-Generation Fuel Technology

WTG1XG is a unique Biocatalysis technology that treats all types of organic waste and converts it

into useful biofuel products to replace the fossil based products. The proposed technology shall

allow effective management of all kinds of organic solid wastes and produce biofuels as by-

product.

3.5. Growdiesel WTG1XG: Waste to Biofuel Multi-Phase Process WTG1XG is capable to recover the intrinsic energy content from all kinds of waste (organic)

materials and capture the hydrocarbons contained in them for conversion to biofuel. In Growdiesel

WTG1XG a beneficial microbial culture is added in the incoming farm waste which safely degrades

the waste without producing any stinking smell. Thereafter, another set of bacteria convert the

volatile matter to natural gas that is captured for use in kitchen/generator/transportation. The

entire process, a complex one, is done on continuous scale & appropriately controlled with proper

instrumentation.

This multi-product and feedstock-flexible technology platform helps reduce greenhouse gas

emissions and contributes to a greener economy.

Growdiesel WTG1XG process is set to change the dynamics of the waste management by making

waste (that would otherwise be rotting & creating foul smell) a resource to generate cooking gas &

rich garden manure using an odourless process while the organisation earns the satisfaction of

being a green organisation.

3.5.1. Type of wastes that can be treated by Growdiesel WTG1XG Waste to Biofuel Multi-Phase Process

Solid Wastes:

All types of organic solid waste, including cattle waste, poultry waste, and human waste

All types of agro/gardening waste, including farm waste/coffee/sugar/natural rubber, etc.



Dairy & food processing plant effluents

All kind of biological waste oils, trap grease and used cooking oil

Vegetable leftover & mandi waste and used flowers, leafs, etc.

Office waste (including shredded paper)

Non-vegetarian food/Slaughterhouse waste

Sewage sludge and waste water

Liquid Wastes: Can be used as process input water for blending/diluting the solid waste

Farm-waste water

Sewage, municipal & all types of waste water

Valuable Products from “Growdiesel WTG1XG Waste to Biofuel Multi-Phase Process:

The principle goal of the project is to safely treat the waste with zero discharge. However,

WTG1XG also generates useful by-products which are as follows:

Growdiesel PNG/Cooking Gas (GCG) is a premium gaseous enriched biofuel comprising high

grade methane. It burns with a clean blue flame and is an excellent replacement of Liquid

Petroleum Gas (LPG) in kitchens. The gas can be filled in cylinders & transported like LPG fuel.

Bio-CNG can be used as a replacement of petrol in transportation just like CNG. The complete

equipment to enrich, compress & bottle the gas is supplied with the main equipments.

Growdiesel Natural Soil-Conditioner (GNS) is a premium soil conditioner comprising up to

30% stable & solid carbon. It is an excellent manure for gardens & potted plants and can turn

wastelands to cultivable lands thus increasing the land availability for food production.



3.5.2. Benefits of “WTG1XG Waste to Biofuel Multi-Phase Process”

For the first time, WTG1XG shall allow active environmental protection as well as optimised

energy production from food waste and biologically regenerate raw materials in perfect

combination. The various benefits of this unique process are as follows:

• 100% odourless-ZERO % foul smell

• 100% recycling-ZERO % pollution

• 24X7 Continuous operation

• Local treatment of waste and recycling of nutrients

• Safe investment & low payback period

• Tax Benefit

• Project with a purpose of waste recycling, carbon-sequestration, energy independence &

sustainable development

3.6. Pyrolysis- A Promising Next-Generation Fuel Technology Liquefaction of biomass/waste is extremely favourable as it eases transport, storage, and usage by

reducing the bulky biomass to compact liquid. Biomass fuels and residues can be converted to

energy via thermal, biological, and physical processes. Wood and other forms of biomass, including

energy crops and agricultural and forestry wastes are some of the main renewable energy

resources available. These can provide the only source of renewable liquid, gaseous, and solid

fuels.

Pyrolysis is the thermal decomposition of fuel into liquids, gases and solid residue (char) in the

absence of oxygen and is usually anhydrous (without water). Pyrolytic products are more refined

and, therefore, can be used with greater efficiency. Materials suitable for pyrolysis processing

include coal, animal and human waste, food scraps, paper, cardboard, plastics, rubber and

biomass. The thermal properties of the components of biomass and aggregates are highly



influenced by the presence of inorganic material and various heat treatments. This results in a

series of complex reactions that occur repeatedly yielding a variety of products, including bio oil,

char, and gases. As a clean fuel bio oil has a number of practical advantages:

It is renewable and locally produced from waste

It can be easily stored and transported

It is greenhouse gas neutral and can generate carbon credits

It generates lower NOx emissions than light fuel oil in gas turbines and diesel fuel in

stationary diesel engines.

Advantages of next-generation fuels over first-generation biofuels

Next Generation Fuels The 1st generation of biofuels produced primarily from food crops such as grains, oil seeds and

others are limited in their ability to achieve targets for oil-product substitution, climate change

mitigation & economic growth. Many problems are associated with first generation biofuels like

food vs. fuel thought process, low availability of feedstock, and higher cost of feedstock. These can

be addressed by producing next generation clean fuels manufactured from agriculture/forest

residues, municipal waste and non-food crops, biomass, ligno-cellulosic feedstock including

materials like cereal straw, bagasse, and algae.

Next generation clean fuels like Drop in fuels, Algae Biofuels, Synfuels, Green Diesel, Biobutanol,

Biofuels from biomass, Biofuels from all types of wastes, including city/farm waste, etc., offer

greater cost reduction potential in the long run.

Present Stage of development of Next-generation biofuels/clean fuels

1. Microorganism ( Algae, Blue Green Algae) for ethanol, oil

At pilot scale

Cost-benefit analysis not favorable currently

2. Organic waste to Biogas (Biomethanation)



Developed

Techno-commercial feasibility getting established with a possible distribution

system

3. Solid catalysts for bio-diesel

Eco-friendly

Great potential to replace Alkali process with economic advantage

Requires innovative business model

Conversion routes

The production of next generation clean fuels from ligno-cellulosic feedstock can be achieved

through two very different processing routes. They are:

1. Biochemical where enzymes & other micro-organisms are used to convert cellulose &

hemicellulose components of the feedstock to sugars prior to the fermentation to produce

ethanol.

2. Thermo-chemical where pyrolysis/gasification technologies produce a synthesis gas (CO

+ H2) from which a wide range of long carbon chain biofuels, such as synthetic diesel or

aviation fuel can be reformed.

Substantial government grants have been provided to help reduce the commercial and financial

risks from upcoming technologies and fluctuating oil prices. Both the biochemical enzyme

hydrolysis process and the thermo-chemical biomass to liquid (BTL) process have reached the

demonstration stage.

3.7. Environmental Protection In view of the galloping developments in both research and commercialisation of modern

biotechnology there are concerns with respect to the impact of genetically modified organisms

(GMOs) on human health and environment. Therefore, it is extremely important that research

programmes, field trials, and commercial activities involving GMOs are monitored right from the



time of initiation for due assessment of risks and incorporation of required management measures

as per the regulations in the country.

For the research work on GMOs & products thereof at laboratory scale and also in commercial

facilitating and regulating applications, the Government of India has notified “Rules for the

Manufacture/Use/Import/Export and Storage of Hazardous Microorganisms, Genetically Engineered

Organisms or Cells” under the provisions of Environment (Protection) Act, 1986 through the

Ministry of Environment & Forests (MoEF).

These rules are commonly referred as ‘Rules 1989’. The two main agencies identified for

implementation of the Rules 1989 are the Ministry of Environment & Forests and the Department

of Biotechnology (DBT), Ministry of Science and Technology, Government of India. The Rules 1989

have also defined Competent Authorities and the composition of such Authorities for handling of

various biosafety aspects.

Recombinant DNA Advisory Committee (RDAC): This committee shall review developments in

Biotechnology at national/ international levels and shall recommend suitable and appropriate

safety regulations for India in recombinant research, use and applications from time to time.

Review Committee on Genetic Manipulation (RCGM): This committee shall monitor the

safety-related aspects of on-going research project/ activities involving genetically engineered

organisms/hazardous microorganisms. The committee shall include representatives of Department

of Biotechnology, ICMR, ICAR, CSIR and other experts in their individual capacity.

Institutional Biosafety Committee (IBSC): This committee shall be constituted by an occupier/

person, including research institutions handling microorganism/genetically engineered organisms.

The committee shall comprise the Head of the Institution, Scientists engaged in DNA work, a

medical expert and a nominee of the Department of Biotechnology. It relates to preparation of site

emergency plan as per the RCGM guidelines.

Genetic Engineering Approval Committee (GEAC): This committee shall approve activities

involving large scale use of hazardous microorganisms and recombinants in research and industrial



production from the environmental angle. It shall also approve proposals for releasing genetically

engineered organisms and products into the environment, including experimental field trials.

3.7.1. Approval and Prohibitions 1. No person shall import, export, transport, manufacture, process, use or sell any hazardous

microorganism or genetically engineered organism/substance or cells except with the approval

of the Genetic Engineering Approval Committee.

2. Use of pathogenic microorganism or any genetically engineered organism or cell for the

purpose of research shall only be allowed in laboratories or inside laboratory areas notified by

the Ministry of Environment and Forests for this purpose under the Environment (Protection)

Act, 1986.

3. The Genetic Engineering Approval Committee shall give directions to the occupier to determine

or take measures concerning the discharge of micro-organisms/genetically engineered

organisms or cells mentioned in the schedule from the laboratories, hospitals and other areas,

including prohibition of such discharges and laying down preventive measures for such

discharges.

4. Any person operating or using genetically engineered organism/ microorganism mentioned in

the schedule for scale up or pilot operations shall have to obtain licence issued by the Genetic

Engineering Approval Committee for any such activity.

5. Certain experiments for the purpose of education within the field of gene technology or

microorganism may be carried out outside the laboratories and laboratory areas mentioned in

sub-rule and will be looked after by the Institutional Biosafety Committee.

PERMISSION AND APPROVAL FOR CERTAIN SUBSTANCES

Substances and products which contain genetically engineered organisms or cells or

microorganisms shall not be produced, sold, imported or used except with the approval of genetic

engineering approval committee.

PERMISSION AND APPROVAL FOR FOOD STUFFS



Food stuffs, ingredients in food stuffs and additives, including processing aids containing or

consisting of genetically engineered organisms or cells, shall not be produced, sold, imported or

used except with the approval of the Genetic Engineering Approval Committee.

3.8. Carbon Credit Global trends

As the initial year of the first Kyoto commitment period (2008- 2012) is nearing completion, it is

expected that by 2012 the world carbon market will witness an exponential growth at EUR 136 bn

p.a. transferring half of that amount from the industrialised nations to the developing ones. As per

the World Bank’s State and Trends of Carbon Market 2008 report, Asia continues to dominate the

market with about 87% of volumes transacted and 91% of values led by China with CDM

transactions at 73%, followed by India and Brazil (6%), Africa (5%), Eastern Europe and Central

Asia (1%).

Although India has 259 projects, the average annual income from registered projects through 2012

is expected to be only 15%.

What is Carbon Credit?

Carbon Credit is an internationally known term drawing its inference from Kyoto Protocol. The

Kyoto Protocol sets binding targets for 37 industrialised countries and the European community for

reducing greenhouse gas (GHG) emissions. One of the mechanisms to achieve this target is ‘Clean

Development Mechanism’ and carbon credits come under the same. Under this mechanism, a

country (with an emission-reduction or emission-limitation commitment under Kyoto Protocol) will

be allowed to set up/ implement an emission–reduction project in the developing countries. Those

projects will earn saleable certified emission reduction (CER) credits, each equivalent to one tonne

of CO2, which can be counted towards meeting Kyoto targets.



Thus, Carbon Credits are certificates issued to countries that reduce their green house gas

emissions responsible for global warming. These are measured in units of certified emission

reductions (CERs).

Role of Indian Government:

India has entered into CDM projects with companies investing in Windmill, Bio-gas, Bio-diesel, and

Co-generation and these companies are generating Carbon Credits to be later sold to developed

nations. Polluting industries like steel, power generation, cement, fertilisers, waste disposal units,

plantation companies, sugar companies, chemical plants and municipal corporations, etc. can also

earn carbon credits by reducing emission levels and can earn money from the same.

Government has taken various initiatives and launched projects to make the state governments/

industries reduce their carbon emissions, earn carbon credits and receive monetary benefits. One

of such schemes is ‘Rural Tree Plantation Scheme’. Other government scheme is to provide CFL

lamps to the people at cheaper costs. The government Bureau of Energy Efficiency (BEE) had

announced implementation of the Bachat Lamp Yojana (BLY). The BLY promises to save India 17

billion or 400 MW of energy by replacing incandescent lights that waste 95% electricity with

compact fluorescent light (CFL) lamps.

Indian Government is also allowing various benefits and exemptions to the companies carrying out

carbon credit projects. Fiscal benefits to companies include duty exemptions, income-tax holidays,

accelerated depreciation norms, etc. Policy measures are in place to promote specific renewable

energy alternatives, including bio-diesel, ethanol, and solar thermal-water heaters.

The Government is also in the process of setting up 16 carbon credit-accredited centres across

India with a funding of EUR 23,437.5 (INR 15 lakhs) per centre as a grant. Various state

governments have also taken initiatives in this regards. The State of Haryana has decided to set up

a carbon credit cell in the state which would guide the local entrepreneurs to adopt energy-efficient

and eco-friendly technologies to earn carbon credits.



The Delhi Metro Rail Corporation (DMRC), which is the first rail project in the world to earn carbon

credits for using regenerative braking system in its rolling stock, earned EUR 368,742 from the

sale of 82,000 certified emission reductions (CER) under the carbon credits scheme by the Japan

Finance Carbon Ltd. in 2008 and 2009.

The Government of India has constituted the National Clean Development Mechanism

Authority for the purpose of protecting and improving the quality of environment in terms of the

Kyoto Protocol. The Authority has the following powers:

a) to invite officials and experts from Government, financial institutions, consultancy

organisations, non-governmental organisations, civil society, legal profession, industry and

commerce, as it may deem necessary, for technical and professional inputs and may co-opt

other members depending upon need;

b) to interact with concerned authorities, institutions, and individual stakeholders for matters

relating to CDM;

c) to take up any environmental issue pertaining to CDM or Sustainable Development projects

as may be referred to it by the Central Government, and

d) to recommend guidelines to the Central Government for consideration of projects and

principles to be followed for host country approvals.

Further, the National Clean Development Mechanism Authority (NCDMA) is a single-window

clearance for CDM projects in the country.

3.9. Clean Energy India has been unanimous in demanding environmental improvement through the use of clean and

green energy.

In a notable initiative, the Indian Government announced the Jawahar Lal Nehru National Solar

Mission (JLNNSM) in 2010, which is planned to generate 20,000 MW of grid connected solar energy

by 2022. As a subset of this policy initiative, India also aims to generate 2,000 MW of solar

energy—completely off-grid. This implies the installation of high quality solar systems, including

solar lighting, fans, and micro power plants (1 KW to 100KW).



Today, there are nearly 80,000 villages in India which are un-electrified in addition to 500,000

villages facing an extremely erratic electricity supply. Kerosene and diesel are the most widely

used solutions to this problem with over 80 million households using kerosene lamps for lighting,

and millions of shopkeepers and vendors using kerosene lanterns, petromax lamps, or diesel

generator sets for their daily needs.

This presents a clear opportunity to target a range of commercially viable propositions, whilst

simultaneously reducing environmental impacts. There is a market of more than EUR 1.36 billion in

India for clean energy products such as solar lanterns and solar home lighting systems required for

the lower strata of the society. There are hundreds of indigenous as well as international

companies which are eying this market and trying to make cheaper and durable products.

This socio-economic classification of rural customers in the income segment falling between EUR

45.56 – EUR 121.04 per month and running small businesses such as kirana stores (local grocery

stores), cement shops, manure shops, fruit / vegetable hawkers, and other small business owners

is the key segment to be addressed.

According to the Indian Finance Ministry, year-on-year GDP growth could be increased by 2% if the

country is able to generate optimal power and improve infrastructure.

Cleantech Switzerland, a Swiss government-sponsored entity into renewable energy and water

technology, has entered into an agreement with the Confederation of Indian Industry (CII) to

explore business opportunities in the clean energy sector for both Indian and Swiss entities.



4. Government Initiative Since early 80’s the Government of India has been involved in stimulating growth of Biotech Sector

in India. The establishment of The National Biotechnology Board (NBTB) in 1982, presently known

as the Department of Biotechnology (DBT) under the Ministry of Science and Technology has been

instrumental in fuelling the development of biotechnology in India.

4.1. Regulatory Approvals The Government, on its part, has initiated certain legislations to promote the growth of the

biotechnology industry in the country. In India, several organisations are involved in the regulatory

structure of the biotech industry.

In order to streamline the regulatory process, the Government has proposed the establishment of

the National Biotechnology Regulatory Authority (NBRA) to provide a consistent mechanism for

regulatory approval. In July 2008, the DBT introduced the National Biotechnology Regulatory Act,

which would establish the NBRA as an empowered body to approve genetically modified crops,

food, recombinant biologics like DNA, vaccines, recombinant gene therapy products, and

recombinant and transgenic plasma-derived products such as clotting factors, veterinary biologics

and industrial products.

The enactment of New Patents Act, 2005, brought a paradigm shift in research and development in

the sector. Previously, India had a patent protection for process and not for the product, which

brought about complacency without initiating much effort upon the development of new products.

The New Patents Act of 2005 enforces product patents and thus inspires firms and research

institutions to undertake the innovation with greater zeal.

4.2. Government Funding Government funding to the Science & Technology sector increased by nearly three times from the

Tenth Five-Year Plan to the Eleventh Five- Year Plan, while support to the biotech industry steadily

increased by four times during the same period. The budgetary allocation increased from EUR 4



billion in the 10th Plan to EUR 12 billion in the 11th Plan. The Department of Biotechnology was

allocated an amount of EUR 0.14 Billion for the year 2008-09. The budget allocation for 2009-10 is

EUR 0.15 billion, nearly 8.5% of the total allocation in this sector.

Though the DBT remains the main funding organisation for the Biotech industry in India, there are

other scientific departments in universities and otherwise, which have also started contributing in

this field though they are at a nascent stage.

Availability of Funds for Department of Biotechnology through the Plans*

* It is to be noted that biotechnology sector receives funding from several sources such as CSIR,

DST, ICAR, ICMR, MHRD and others.

97.03

226.56

1015.62

0.00

200.00

400.00

600.00

800.00

1000.00

1200.00

9th Plan 10th Plan 11th Plan

EURO in Million



4.3. Biotechnology Industry Partnership Programme (BIPP) In February 2009, DBT implemented a new scheme “BIPP” for enhancing the scope of public-

private partnership, which is expected to provide research at a cost-sharing basis to industries

facing a credit squeeze following the global financial crisis.

The scheme is a Government partnership with industries for public support on following aspects:

1. Path-breaking research in futuristic technologies with major economic and global

advantage;

2. Development of nationally relevant technologies in the areas of agriculture, health, bio-

energy and green manufacturing.

Up to 100% grant-in-aid support is proposed to be provided for Phase-I, II and III clinical trials of

biotech based research leads; and for limited and large scale field trials in the case of agriculture

products. The EUR 54.68 Million package will underwrite the risk of research and development of

innovating molecules and processes.

The scheme is open to all innovative biotechnology companies looking forward to conduct research

in agriculture, health, bioenergy, and green manufacturing.

4.4. Biotechnology Industry Research Assistance Council (BIRAC) BIRAC is an autonomous body aiming to provide financial, infrastructural, social, professional and

institutional network support. A “Pilot BIRAP”- Biotechnology Industry Research & Development

Assistance Programme – has been launched in partnership with the Association of Biotechnology

Led Enterprises (ABLE), and Biotech Consortium India Ltd. (BCIL).

4.5. Research & Development Facilitation Apart form the various departments, the Government of India has been proactive in creating

institutional infrastructure (for example, microbial culture collections, cell and tissue lines, gene

banks, laboratory animals, facilities for oligonucleotide synthesis, etc.) and a strong research base



in the country in areas related to agriculture and forestry, human health, animal productivity,

environmental safety, and industrial production.

4.6. Biotechnology Information System (BTISnet) Biotech programmes were launched way back in 1986-87 recognising the importance of

information technology for pursuing advanced research in modern biology and biotechnology. This

bioinformatics programme was envisaged as a distributed database and network organisation.

The Biotechnology Information System (BTISnet) is the National Bioinformatics Network that links

more than 150 centres/institutions spread all across India. These centres are developing new

databases and tools, creating human resource, and conducting research in different areas of

“Bioinformatics and Computational Biology” sharing information through a Virtual Private Network

(VPN) in the form of BioGrid India.

4.7. Public investment for promotion of innovation and knowledge commercialisation

SBIRI (Scheme by DBT):

The Small Business Innovation Research Initiative (SBIRI) is the new scheme launched by the

department to boost public-private-partnership effort in the country. The scheme brings together

users and producers of technology creating direct focus and a sense of urgency for producing

defined results that can only be produced by private sector engagements. National consultations

will be held after every three to six months to generate ideas in different sectors of biotechnology,

namely medical, agriculture, food, industry and environment. The scheme covers all areas in

biotechnology related to health-care, agriculture, industrial processes and environmental

biotechnology, and bio-medical devices and instruments.



The SBIRI aims to:

• enable and strengthen the existing private industrial units where product development is

based on in-house innovative R&D,

• encourage other smaller businesses to increase their R&D capabilities and capacity,

• create opportunities for starting new technology-based or knowledge-based businesses by

science entrepreneurs,

• stimulate technological innovation,

• use private industries as a source of innovation and thereby fulfill government objectives in

fostering R&D, and

• increase private sector commercialisation derived from Government funded R&D.

Who can apply?

The proposals can be made solely by in-house R&D unit(s) of industrial firms, or Jointly by

Industry and National R&D Organizations and Institutions, or Collaborative projects of common

interest to the concerned sector/area proposed by a group of industries/users, national research

organizations, etc.

If the project involves collaboration among two or more partners, the scope of work and

responsibilities of each participating establishment in the project should be highlighted. Public-

Private Partnership is encouraged and all things being equal, this model will be preferred.

Eligibility criteria for Industry Partner

• The unit should be registered in India and must fulfill the criteria of Small Business Unit

being an enterprise with not more than 500 employees in R&D.



• At least 51% of the company’s share should be held by Indian promoters, family & friends,

and the general public.

• The Company should either have an in-house R&D unit recognised by Department of

Scientific and Industrial Research (DSIR) or patent rights (National or International) in the

proposed activity.

• Joint ventures and limited partnerships would be eligible for SBIRI support, provided the

entity created meets the above requirements.

Management

The scheme is coordinated by the Special Purpose Vehicle (SPV) under the guidance and directions

of Department of Biotechnology, Ministry of Science & Technology, and Government of India

through Apex committee of SBIRI (ACS).

Biotech Consortium India Limited (BCIL) is the SBIRI Management Agency (SMA) since the

inception of SBIRI scheme. BCIL coordinates all the activities of SBIRI as directed by DBT and

takes the necessary steps required for smooth operation of SBIRI.

Monitoring

Each and every project supported under the scheme SBIRI will be monitored by the Internal

Monitoring Committee (IMC) to be chaired by emeritus scientist/technocrat in that particular area

designated by ACS and the project investigators from all participating institutions and companies

as members of this Committee. The Committee can have 3-4 external experts depending on the

requirement. IMC is required to submit half yearly progress report to ACS for review.



Provision of support under Phase-I:

a) If the actual project cost is up to EUR 39,062.5, 80% of the project cost will be available as

a government grant.

b) If the actual project cost is between EUR 39,062.5 and EUR 156,250, 50% of the project

cost will be available as government grant subject to a minimum of EUR 31,250 and

maximum of EUR 78,125.

c) If the project cost is beyond EUR 156,250, in addition to the Govt. grant of EUR 78,125 the

unit will also be eligible for interest free loan upto 50% of the amount (subject to a limit of

EUR 78,125 as loan) by which the total project cost exceeds EUR 156,250.

Provision of support under Phase-II:

Soft loan upto EUR 1,562,500 for a project can be given as per its requirement. Soft loan upto EUR

156,250 will carry a simple interest of 1% while the interest rate will be 2% (simple interest) on

the amount of loan beyond EUR 156,250 per annum on the outstanding amount of the loan.

a) Interest will become due from the date of release of funds to industrial partners.

b) Repayment of the loan component by the Industry/ies to DBT/SMA shall be in 10 equal

annual installments and recovery shall commence six months after the scheduled

completion of the project.

c) The project implementation period shall be the moratorium period and during this period,

there shall be no liability for repayment of installments of loan and interest. However, the

entire interest accrued up to the repayment of the loan, including the interest accrued

during the moratorium period shall be amortized on the date of repayment of last

installment of loan and recovered in two equal yearly installments.

d) The Industrial Partner will ensure timely repayment of the loan along with installment of

interest as per the schedule notified. Any delays in repayment will entail payment of penal



interest @ 12% P.A. compounded monthly for the period of delay. Two successive defaults

will entail recall of the total outstanding loan immediately.

e) The Industrial Partner will maintain a separate account for the expenditure from loan

amount for the project. Any interest earned by the firm on the loan amount will be shown

as such, credited into the project account and adjusted against subsequent release of

installments.

f) The Industrial Partner will utilise the funds only for the purpose of the project and not for

any other purpose, including civil constructions & renovation of the R&D and associated

facilities. Diversion of funds to other purposes will entail cancellation of the loan and

immediate repayment of the outstanding loan amount with a penal interest @ 12%

compounded monthly.

g) The Industrial Partner will meet any expenditure incurred on the project over and above the

loan amount.

4.8. Clean Development Mechanism (CDM) The Clean Development Mechanism (CDM), defined in Article 12 of the Kyoto Protocol, allows a

country with an emission-reduction or emission-limitation commitment to implement an emission-

reduction project in developing countries. Such projects can earn saleable certified emission

reduction (CER) credits, each equivalent to one tonne of CO2, which can be counted towards

meeting Kyoto targets. A CDM project activity can involve a rural electrification project using solar

panels, or the installation of more energy-efficient boilers, or any such measures.

It is the first global, environmental investment and credit scheme of its kind providing standardised

emissions offset instrument, CERs. The mechanism stimulates sustainable development and

emission reductions, while giving industrialised countries some flexibility in how they meet their

emission reduction or limitation targets.



4.8.1. Operating details of the CDM A CDM project must provide emission reductions that would have occurred otherwise. The projects

must qualify through a rigorous and public registration and issuance process the approval for which

is given by the Designated National Authorities. Public funding for CDM project activities must not

result in the diversion of official development assistance.

The mechanism is overseen by the CDM Executive Board answerable ultimately to the countries

that have ratified the Kyoto Protocol.

Since 2006, the mechanism has already registered more than 1,650 projects and is anticipated to

produce CERs amounting to more than 2.9 billion tonnes of CO2 equivalent in the first commitment

period of the Kyoto Protocol, 2008–2012.

4.9. National Mission for a Green India A National Mission called “Green India” has been launched to enhance ecosystem services. India

understands that forests play an indispensable role in the preservation of ecological balance and

maintenance of bio-diversity and also constitute one of the most effective carbon-sinks.

The Prime Minister has already announced a Green India campaign for the afforestation of 6 million

hectares. The national target of area under forest and tree cover is 33% while the current area

under forests is slightly above 23%.

The Mission “Green India” focuses on degraded forest lands through direct action by communities,

is organised through Joint Forest Management Committees and guided by the Department of

Forest in state governments. An initial corpus of over EURO 1 Billion has been earmarked for the

programme through the Compensatory Afforestaion Management and Planning Authority (CAMPA)

to commence work. The programme will be scaled up to cover all remaining degraded forest lands.



4.10. India's policy structure relevant to GHG Mitigation India has in place a detailed policy, regulatory and legislative structure that relates strongly to

GHG mitigation: The Integrated Energy Policy was adopted in 2006. Some of its key provisions

are:

Promotion of energy efficiency in all sectors

Emphasis on mass transport

Emphasis on renewables, including biofuels plantations

Accelerated development of nuclear and hydropower energy

Focused R&D on several clean energy related technologies

Several other provisions relate to reforming the energy markets to ensure that they remain

competitive and energy prices reflect true resource costs. These include: Electricity Act 2005, Tariff

Policy 2003, Petroleum & Natural Gas Regulatory Board Act, 2006, etc. The provisions taken

together are designed to:

Remove entry barriers and raise competition in exploration, extraction, conversion,

transmission, and distribution of primary and secondary energy

Accomplish price reform through full competition at point of sale

Promote tax reform for optimal fuel choices

Augment and diversify energy options, sources, and energy infrastructure

Provide feed-in tariffs for renewables (solar, wind, biomass cogeneration)

Strengthen, and where applicable, introduce independent regulation

The Rural Electrification Policy, 2006, promotes renewable energy technologies where grid

connectivity is not possible or cost-effective. The New and Renewable Energy Policy, 2005,

promotes utilisation of sustainable, renewable energy sources and accelerated deployment of

renewables through indigenous design, development, and manufacture.

The National Environment Policy, 2006 and the Notification on Environment Impact Assessment

(EIA), 2006 have reformed India's environmental assessment regime. A number of economic

activities are required to prepare environment impact assessments and environment management



plans which are appraised by regulatory authorities prior to start of construction. The EIA

provisions strongly promote environmental sustainability.

4.11. CDM Projects in India The Ministry of the Environment and Forests established an ‘Activities Implemented Jointly’ (AIJ)

Task Force in 1996 with a purpose to consider AIJ proposals submitted to the government of India

and act as an effective interface between investing and host parties and their governments.

In 1997 an Indian NGO, Development Alternatives, volunteered to become a focal point for the

Asia- Pacific in design and implementation of AIJ projects in the region. In late 1997 and early

1998 the government of India endorsed five AIJ projects in co-operation with parties from Japan,

Netherlands, and the USA.

The government of India is an active participant in regional climate change initiatives such as Asian

Development Bank's ALGAS program, which serves as an investment co-ordinating international

centre for potential Indian Clean Development Mechanism (CDM) projects. India has significant

CDM potential in the areas of hydropower and biomass energy, transport (including alternative fuel

vehicles and development of mass transport system), cogeneration (particularly in the sugar and

paper industries), energy-efficient projects, methods related to manufacturing processes, and

development of natural gas infrastructure.

In 1999 the Confederation of Indian Industry (CII) organised the first US-Indian meeting on the

CDM. The CDM Potential investment in India arising from CD projects is expected to be US$1

billion per annum.

In March 2000, the United States announced the following new initiatives to encourage clean

energy development in India.

EUR 136 million credit from the Export-Import Bank;

EUR 13.6 million from the U.S. Agency for International Development (AID) to reduce

greenhouse gas emissions;



EUR 17 million to promote energy-efficient technologies; and

EUR 34 million to promote clean energy throughout South Asia.

AIJ projects endorsed by the Indian Government (to mid 1999) include the following:

Direct Reduced I project (Gujarat) in conjunction with the New Energy Development

Organisation (NEDO) of Japan.

Energy Recovery from waste gas and liquids (Gujarat) in collaboration with NEDO of Japan.

Integrated Agricultural Demand Side Management project hosted in Andrea Pradesh with

the assistance of the World Bank.

Biomass gasification at 20 sites hosted by the DESI Power and Development in collaboration

with the Netherlands.

Tamarin Orchard Agro Forestry for Dry Land, under development in Karnataka with the

participation of the USA, hosted by ADAT, Bagepalli.

Energy Efficiency / Integrated Agriculture Demand Side Management AIJ Pilot Project in

collaboration with Norway with the projections of CO2 emission reduction of 1,494,608

metric tons of CO2 equivalents over the life-time of 20 years.

4.12. Kyoto Mechanisms for Technology Transfer On analysing the Kyoto Protocol Mechanisms, it primarily suggests that if they are implemented

the Mechanisms may have potential to affect the transfer of environmentally benign technologies.

The Joint Implementation (JI) and Clean Development Mechanism (CDM) can provide financial

incentives and influence the choice of mitigation technologies. As voluntary mechanisms they

require co-operation among developed nations and between developed and developing countries,

as well as between governments, private sector entities, and community organisations.

4.13. Climate Technology Initiative (CTI) The Climate Technology Initiative (CTI) is an initiative of 23 OECD countries and the IEA to

promote the diffusion of climate-friendly technologies. It is about supporting activities to promote

clean energy technology cooperation work in India. CTI members like Japan, Australia, and the



U.S. are partnering with the Indian government on the Cooperative Technology Implementation

Plans (CTIP) programme for India. CTIP India will support activities to advance the implementation

of selected clean energy technologies that are high priorities for the government of India. CTIP

India will leverage the resources of multiple donors to support a country-driven, market relevant

and technology transfer process.

CTIP India’s objective would be to build on the past and ongoing activities to create an enabling

environment for private investment in energy efficient and renewable energy technologies based

on following criteria:

1. Technologies that are replicable after the initial project;

2. Technologies with short-term implementation horizons; and

3. Projects with potential links to emerging carbon trading markets.

Areas of particular interest identified included energy efficiency (industrial and power sectors),

rural electrification, solid waste management, and biomass technology. The following initial

technology assistance interests were also noted:

1. Japan is interested in solid waste management technologies (urban waste-to-energy

technologies), clean coal/power plant energy efficiency (refurbishing plants, regenerative

furnaces, variable speed applications), and solar home systems.

2. Australia indicated that the technologies of initial interest are solid waste management

(municipal waste management) and solar and wind energy as well as a possible interest in

power plant energy efficiency.

3. The U.S. has previously indicated its flexibility in terms of technology interests. MNES

suggested that U.S. assistance with solar-powered technologies (thin film solar cells)

continue through CTIP India. The U.S. may be interested in power plant energy efficiency,

solar technologies, and small hydropower projects based on significant past work in these

areas.

Each CTI partner country would finalise a list of clean energy technologies and an in-country

partner would be engaged to identify opportunities to increase investment in each priority

technology to gain business input. Specific implementation plans to promote private investment in



each priority technology would then be developed in consultation with Indian and international

businesses, government officials.

4.14. UNDP/ GEF Project for High Rate Biomethanation The main aim of UNDP/ GEF assisted project on Development of High Rate Biomethanation

Processes is to reduce Green House Gases emission (GHGs). The project was started in September

1994 for a duration of five years with an outlay of EUR 6.25 Million; UNDP/ GEF provides financial

assistance of EUR 3.74 million, MNES – EUR 2.21 Million and EUR 1.56 Million from the beneficiary

organisations.

The project is being implemented by the National Bio-energy Board (NBB), an apex body

established under the Chairmanship of Secretary MNES.

The key activities included in the project are:

1. Institution building

2. Capability building

3. Promotion of biomethanation technology for solid/ liquid wastes

4. Organisation of seminars, workshops & training courses for imparting knowledge and

creating technical expertise

5. Development of a 'National Master Plan for waste- to- energy conversion”

6. Setting up of demonstration sub-projects to find out its feasibility and benefits.

Seven projects have been commissioned and four projects are being set up under UNDP-GEF

programme in India in seven waste sectors viz., sewage, tannery and abattoir wastes, pulp and

paper industry effluent, vegetable market waste, utilisation of biogas for power generation,

animal/agro residues and fruit/ food processing wastes.



4.15. National Mission on Enhanced Energy Efficiency Government of India has designed a National Mission on Enhanced Energy Efficiency (NMEEE),

which is one out of eight missions planned under the National Action Plan on Climate Change. The

major contents of the plan are as follows:

1. Perform Achieve and Trade (PAT)

The Perform Achieve and Trade scheme is a market-based mechanism to enhance energy

efficiency in the huge energy-intensive industries and facilities called as ‘Designated Consumers’.

The scheme includes the following steps:

Goal setting: Set a specific energy consumption (SEC) target for each plant depending on

level of energy intensity (specific energy consumed = energy use / output) of that plant.

The target will specify by which percentage a plant has to improve its energy intensity from

the base line value in a period of three years.

Reduction phase: Within a three-year period (2009-2012) the designated consumers try to

reduce their energy intensity according to their target.

Trading phase: Those consumers who exceed their target SEC will be credited tradable

energy permits. These permits can be sold to designated consumers who failed to meet

their target and have to compensate this failure by buying permits. If they fail to do either

of this, they may have to pay penalties.

The energy consumption reported by designated consumers is based on an audit by any of the

Bureau of Energy Efficiency (BEE) accredited agencies which also verifies the correctness of

reported values.

2. Market Transformation for Energy Efficiency (MTEE)

There is an emphasis to shift towards energy efficient appliances in designated sectors. This is

targeted to be achieved by making such products more affordable. The initiative includes the

following activities:

Creating a National CDM Roadmap.



Programmatic CDM: BEE is planning to undertake CDM Programme of Activities for the

following sectors: Lighting (Bachat Lamp Yojana), Municipal DSM, Agricultural DSM, SME

sector, Commercial Building sector and for Distribution Transformers.

Standards and Labeling: Step-by-step notification for mandatory labeling of Equipment

& Appliance for Domestic Sectors, Hotel Equipments, Office equipments, Industrial

Products, and Transport Equipments.

Public procurement: Amendment of procurement rules to explicitly mandate

procurement of energy efficient products for all public entities.

Technology program: Replacement of inefficient appliances by efficient products such as

efficient lighting, ballasts, AC, and refrigerators in domestic sector. Reduction of

Transmission & Distribution (T&D) losses.

Energy Conservation Building Code (ECBC): Mandate maximum energy consumption

norms (per square feet) for new commercial buildings and existing buildings (through

retrofit).

ESCos Promotion: Assuring ESCo quality through accreditation. Promoting their capacity

through set of 1200 bankable efficiency retrofit demonstration projects covering all

sectors and the entire country.

Capacity building and information: Creating a pool of trained manpower in states,

government agencies, banks and financial institutions. Continuing the training of Energy

Auditors and Energy Managers.

Policy transparency.

3. Financing of Energy Efficiency

This initiative converges on the creation of mechanisms to assist financial demands of these

management programmes in all sectors by capturing future energy savings. The initiative includes

the following activities:

Fiscal instruments: Tax exemptions for the profits and gains made from energy-efficient

projects by ESCos and Venture Capital funds. Reduction of VAT for energy-efficient

equipment (e.g. CFLs)

Revolving fund: To promote carbon finance



Partial Risk Guarantee Fund: To provide commercial banks with partial coverage of risk

exposure against loans made for energy-efficient projects. The fund will charge a small fee

on all projects seeing the risk guarantee.

4. Power Sector Technology Strategy

a. This strategy is aimed to enhance energy efficiency in power plants

b. Adopt energy efficient generation technologies in new plants, including supercritical

boilers

c. Enhance energy efficiency in existing plants

d. Roadmap for IGCC demonstration plants

e. Development of know-how for advanced super-critical boilers

f. Road map for fuel shift

5. Other initiatives

In addition to the above mentioned activities, following activities will supplement the overall plan:

Set up Energy Efficiency Services Ltd.: A public sector company is planned to be set up to

facilitate the progress and to address all the issues / barriers which impede investments in

energy-efficient projects. This company will be an implementing agency, while BEE will

concentrate on its quasi-regulatory role. In addition to being an implementing body, this

company will also function as consultancy organisation, resource centre, and an ESCo.

Strengthening of State Designated Agencies (SDAs): The scheme seeks to build institutional

capacity of the newly created SDAs to perform their regulatory and facilitative functions in

the respective states.

Strengthening of BEE: Government funding for infrastructure creation is necessary for BEE

to implement 8 new projects/ schemes through the country with an allocation from the 11th

plan.

Awareness Programs: Awards and information campaigns in schools, industry, commercial,

agriculture, domestic sector, etc.

All missions under the NAPCC would report once a year to the Prime Minister’s Office (PMO).



4.16. Energy Recovery from Urban and Industrial Wastes - Ministry of New and Renewable Energy

WTE Technologies

• Bio-methanation

• Incineration

• RDF

• Gasification

• Integrated systems

Projects Installed for Energy from Urban Wastes

• 6.6 MW project based on MSW at Hyderabad

• 6 MW project based on MSW at Vijayawada

• 5 MW project based on MSW at Lucknow

• 1 MW power from Cattle Dung at Ludhiana

• 150 kW plant for Vegetable Market, sewage and slaughterhouse waste at Vijayawada

• 250 kW power from Vegetable Market wastes at Chennai

Programmes on Waste-to-Energy by Ministry of New and Renewable Energy

The programmes by the MNRE provide for the following:

• Financial/Fiscal incentives – depending upon type of wastes and technologies



• Awareness creation / information dissemination

• Research and Development

• Project Development Assistance

4.17. International Collaborations The Department of Biotechnology has been at the forefront of maintaining many international

collaborations and introducing joint proposals with countries like EU, Australia, Canada, USA, and

Japan.

Some notable international collaborations in recent years with different countries and institutions

are as below:

1. An Indo-Australian Biotechnology Fund has been created to develop and support

collaborative research activities in the fields of biomedical devices and implants, stem cells,

vaccines/ medical diagnostics, transgenic crops, nutraceuticals and functional foods, and

bioremediation.

2. Department of Biotechnology is a part of the International ERA-net project (European

Research Area- ERA) named NEW INDIGO, which is aimed at fostering and coordinating the

scientific cooperation between ERA and India thereby strengthening multilateral science and

technology cooperation between EU and India. The European Community has committed

EUR 1.5 million for various programmes in India.

3. A Memorandum of Understanding was signed on 9.2.1998 for cooperation in the area of

Biotechnology and Biological Sciences between DBT and BBSRC, UK. Projects are being

developed through interaction between experts. Areas identified are Food Biotechnology,

Vaccines for communicable and non communicable diseases, Diagnostics for infectious and

non-infectious diseases, Bioprocess engineering and downstream processing, and Exchange

of information on technology transfer.



4. Namaste is a collaborative small or medium-scale focused research project between

European Commission and Department of Biotechnology, India. The project Namaste EU

was launched on 1 February, 2010 while Namaste India was launched on 26 March, 2010

for 3-year duration.

a. Namaste project aims at developing eco-efficient processes leading to the

valorization of by-products for the formulation and characterisation of new foods

(fiber-based foods and functional beverage) and a feed for fish.

b. The Project focuses on research for exploitation of by-products of fruits and cereal

processing industry both in India and in Europe as they are:

i. largely cultivated but partially valorized at low value-added levels

ii. priced very low being classified and managed as byproducts of environmental

concern

iii. suitable matrices to obtain healthy oligosaccharides and oligopeptides for

generating new foods and feeds with improved nutritional quality.

c. The new foods and feeds to be produced are selected based on

i. the needs and opportunities of the current and future Indian–European

Market and

ii. analysis for efficiently exploiting the nutritional and biochemical features of

by-products adopted in the project.

5. The Indian Department of Biotechnology and The Academy of Finland are inviting food

biotechnology proposals. Researchers are invited to send joint proposals to the Academy

and the Department of Biotechnology by 29th April 2011.

a. The project aims at long-term systematic research collaboration, creation and

strengthening of research collaboration networks, and increased researcher mobility

between India and Finland.

b. The Academy of Finland will fund the Finnish researchers, while DBT will provide the

research funding to the Indian researchers. The funding for joint projects is granted

for three years.



6. An Indo-Finnish Diagnostic Research Centre has been proposed with commitment from

Tekes; a funding agency of the Government of Finland.

7. Department of Biotechnology has partnered with UK based Wellcome Trust (WT) to a three-

tier fellowship programme on biomedical research at postdoctoral level.

8. The INDO-US Vaccine Action Programme (INDO-US VAP) has been developed to provide

vaccines of national health relevance in a collaborative manner.

9. Department of Biotechnology and Advanced Industrial Science and Technology (AIST),

Japan has signed MoU to work jointly in the field of Life Sciences and Biotechnology.

10. Bharat Immunologicals and Biologicals Ltd. (BIBCOL), a public sector undertaking under

DBT, has also collaborated with Russia for production of IPV, BCG, DPT+, JEV Vaccine and

Rabies.

11. The Indo-Swiss programme in Biotechnology (ISCB), jointly funded by DBT and the Swiss

Agency for Development and Cooperation (SDC), has completed two Phases in March 2008.

Currently, Phase–III (2007- 2011) is under implementation which is aimed at technology

advancement and product development.

4.18. Taxation Biotechnology firms are by far the most research intensive among major industries. On an average

the biotechnology sector invests 20-30% of its operating costs in R&D or technology outsourcing.

Government support, fiscal incentives and tax benefits are, therefore, critical to this sector. These

measures will also help to capitalise on the inherent cost-effectiveness of the Indian biotech

enterprise.



4.18.1. Direct Tax

1. Export Incentives – Tax holiday under Section 10A and 10B of Income Tax Act for units

established in Free Trade Zone and EOUs. However, the Budget has not extended the tax

holiday under Section 10A and 10B of the Act beyond 31 March, 2011. This will

significantly impact the effective tax cost of players operating out of Free Trade Zone / EOU

units.

2. Special Economic Zone (Section 10AA)

Special Economic Zone is a specifically delineated duty-free area deemed to be foreign. As

per Section 10AA, Income Tax Act 1961, the profit and gain derived from export of

goods and services shall be exempted in the following manner:

The Unit in Special Economic Zone which begins to manufacture or produce article or

provide any service during the previous year on or after the 1st April, 2006 shall be

eligible for a deduction of:

a. 5 Years – 100% of profit and gains from the export

b. 5 Years – 50% of profit and gain from the export

c. 5 Years – 50% of profit and gain from export but subject to the conditions explained

above. The amount not exceeding 50% of the profit and such amount is credited to

a reserve account (SPECIAL ECONOMIC ZONE RE–INVESTMENT RESERVE ACCOUNT)

and utilise for the purpose of business in the manner laid down in next paragraph.

The amount credited to the Special Economic Zone Re-Investment Reserve Account

shall be utilised for the following purpose:

a. For the purpose of acquiring machinery or plant which is first put to use before

expiry of a three years following the previous year in which reserve was created,

and

b. Until acquisition of the machinery or plant the amount shall be utilised for the

purpose of the business other than distribution of dividend or profit, or for

remittance outside India, or for creation of any asset outside India.



3. R & D Expenditure – Tax Benefit

a. Section 35 (2AB), any expenditure on scientific research (not being expenditure in

the nature of cost of any land or building), on in-house research, and development

facility as approved by the prescribed authority shall be allowed a deduction of a

200%.

b. Section 35(2AA) – Weighted deduction for contributions to approved scientific

research programme.

With a view to promote research and development activities undertaken by the

National Laboratory, any University, any Indian Institute of Technology or any

approved scientific research programmes, the weighted deduction for the

contribution in relation to the same is proposed to be increased from 175% to

200%. (Effective from 1st April, 2012 and will, accordingly, apply in relation to

assessment year 2012-13 and subsequent years.)

4. Deduction for capital expenditure for specified business (Investment Linked Deduction of

Capital Expenditure under Section 35AD) – Two New Businesses have been introduced

during the current budget:

a. Developing and building affordable housing projects under a scheme framed by the

Central Government or a State Government; or

b. Production of fertiliser in a new plant or in a newly installed capacity in an

existing plant in India.

The above specified businesses should commence activities on or after 1 April, 2011.



4.18.2. Indirect Tax Life-saving drugs imported and sold in India are exempted from paying custom duty; whereas

custom duty has been levied on raw materials for diagnostics and other pharmaceutical biotech

products manufactured in India. To promote the indigenous manufacturing industry and make it

globally competitive, raw materials imported by Indian manufacturers should be eligible for Duty

Drawback.

• Diagnostic kits used for detection of HIV Antibodies are exempt from Custom Duty/ Excise

duty under List 4 and CVD/CED under the Central Excise Act.

• Full exemption from basic custom duty is being extended on bio-based asphalt sealer and

preservation agent, millings remover and crack filler, asphalt remover and corrosion

protectant and sprayer system for bio-based asphalt applications.

• Full exemption from basic custom duty is being provided to bio-polymer/bio-plastics (HS

Code 39139090) used for manufacture of bio-degradable agro-mulching films, nursery

plantation & flower pots.

• Full exemption from excise duty on all items of machinery, including prime movers,

instruments, apparatus and appliances, control gear and transmission equipment and

auxiliary equipment (including those required for testing and quality control) and

components, required for initial setting up of a project for the generation of power using

non-conventional materials, namely, agricultural, forestry, agro-industrial, industrial,

municipal and urban waste, bio waste, or poultry litter.

• As per Notification No. 4/2007-Central Excise, excise duty on Bio-Diesel (Alkyl

esters of long chain fatty acids obtained from vegetable oils) are exempted.

• Special Economic Zone

o Any sale within the Special Economic Zone shall be exempted.

o Any sale from a Special Economic Zone to outside India shall be exempted.



4.19. Enabling Research Infrastructure R&D Centre

4.20. Biotech Parks & Incubators Establishing biotechnology parks either through public-private alliance or public/private

sponsorships is essential for the growth of the biotechnology industry. With its large human

resource in molecular biology, microbiology, biochemical engineering, synthetic organic chemistry,

chemical engineering, allied branches of engineering, and strong institutional base at the

universities, CSIR, ICMR and ICAR, India is well placed to support a number of biotech parks.

Biotechnology Parks can provide a viable mechanism for licensing new technologies and facilitate

the lab-to-land transfer of the technologies by serving as an impetus for entrepreneurship through

partnership among innovators from universities, R&D institutions and industry.



Basic minimum components for parks include research laboratories, multi-purpose pilot facility for

manufacturing and process development, quality control and validation of technologies, common

effluent treatment plant, a GLP Animal House, a recognised human resource training centre,

administrative support centre, etc. The biotech parks should be easily accessible for all the

stakeholders, tenants, and academia with connecting roads and adequate water and power supply

and should also attract less administrative clearances from the government.

Source: ibef

Parks City Area (in acres)

Shapoorji Pallonji Biotech Park Hyderabad 300

ICICI Knowledge Park Hyderabad 200

International Biotech Park Pune 103

Lucknow Biotech Park Lucknow 20

Golden Jubilee Biotech Park Chennai 8

Ticel Bio Park Chennai 5

The Eleventh Five Year Plan aims to

establish biotechnology parks to involve

small and medium enterprises in product

development and translational research.

Biotechnology infrastructure is

witnessing a shift from traditional

clusters to specialised industrial

infrastructure such as biotech or science

parks. Currently, around 27 parks are

operational in India.



5. Intellectual Property Rights

5.1. IPR and Biotech Industry With the emergence of modern biotechnology, there is a need for the legal characterisation and

treatment of trade related biotechnological processes and products.

Intellectual property is intangible property and includes 'patents', 'trade secrets', 'copyrights' and

'trademarks'. The rights to protect this property prohibit others from making, copying, using or

selling the proprietary subject matter.

Protection of intellectual properties encourages industries to allocate labour, research and

development (R&D) units and funds to facilitate the production of commercially marketable items.

5.2. Global IPR scenario The global intellectual property system has been designed to ensure a creator’s monopoly on the

use and sale of his or her invention. Patents have been extended (with some controversy) to

processes and to living organisms that have been developed through biotechnology. In all of these

cases, the current legal structure allows the inventor to benefit from the monopoly for a certain

amount of time, after which the property falls into the public domain.

WIPO, established in 1967 was strengthened by the 1994 TRIPS regime. In agreeing to TRIPS,

countries acknowledged that the protection of intellectual property rights is central to free trade,

and each country agreed to combat piracy and respect patent and copyright protection.

5.3. TRIPs and its impact on Indian Biopharma Sector The Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) is an

international agreement administered by the World Trade Organization (WTO) that sets down



minimum standards for many forms of intellectual property (IP) regulation as applied to nationals

of other WTO Members.

The TRIPS agreement introduced intellectual property law into the international trading system for

the first time and remains, till date, the most comprehensive international agreement on

intellectual property.

In order to develop domestic innovations, developing countries like India require utility models or

petty patents available for a shorter period of time for process innovations made over an existing

product. The TRIPS agreement leaves it on members to introduce such legislation as there are no

specific rules on this subject. Such patents will encourage the small firms.

5.4. Organisation and statutes having overview of the IPR in Biotech Sector

i. World Intellectual Properties Organization (WIPO) was formed in 1967 and it

ensures an invention receives global patent protection the first time it is patented

anywhere in the world. In addition, WIPO promotes adherence to IPR among its member

countries and thus is referred to as the global champion of intellectual property

protection.

ii. Trade Related Aspects of Intellectual Property Rights (TRIPS) is an international

agreement administered by the World Trade Organization (WTO) that sets down

minimum standards for many forms of intellectual property (IP) regulation as applied to

nationals of other WTO Members. It was negotiated at the end of the Uruguay Round of

the General Agreement on Tariffs and Trade (GATT) in 1994.

iii. Indian Copyright Act, 1957 has been passed by the Parliament to amend and

consolidate the law related to copyright in India.

iv. The Patent Act, 1970 has been passed by the Parliament to amend and consolidate

the law related to Patent in India.



v. The Trademarks Act, 1999 has been passed by the Parliament to amend and

consolidate the law related to Trademarks in India.

vi. Biotechnology Patent Facilitating Cell (BPFC) has been set up by the Department

of Biotechnology in July 1999. It is a single window awareness-cum-facilitation

mechanism established under DBT, Ministry of Science and Technology. It aims to

create awareness and understanding about Intellectual Property Rights (IPRs) among

scientists and researchers by arranging workshops, seminars, conferences, etc. at all

levels. It is also responsible for introducing patent information as a vital input in the

process of formulation of R&D programmes in biotechnology and providing patenting

facilities to biotechnologists in the country for filing Indian and foreign patents on a

continuous basis.

vii. Foundation of Biotechnology Awareness and Education (FBAE) strongly supports development of an IPR regime in India that rewards bio-innovations through an effective IPR system so as to promote private investment in biotechnology development and overall economic development.

viii. National Research Development Corporation (NRDC) has come forward, taken

initiative, and started organising seminars from time to time in support of Department

of Biotechnology, Ministry of Science & Technology, Government of India for spreading

awareness for protection of intellectual property rights in India.

5.5. Interface between Competition policy and IPR in India As the era of globalisation and privatisation materialised and the markets across the world opened

up to this new concept, there was a need for appropriate regulatory and statutory methods which

could promote consumer interest and welfare and also prevent any type of misuse or abuse of

power.



The Competition Act, 2002, was introduced with an aim to broaden the scope and the foundation

laid down by its predecessor. The statute goes beyond the narrow consumer focus and provides

effective advocacy measures simultaneously dealing with the competition issues that may arise by

granting effective intellectual property rights and the consequences, thereon.

5.6. Intellectual Property is the key An effective IPR strategy optimises the protection and utilisation of innovation as it:

• facilitates technology transfer;

• identifies opportunities for research collaboration, strategic alliances, and outsourcing;

• assists with vertical integration, including marketing strategy;

• raises venture capital where required; and

• develops and sustains entrepreneurship through networking.

An effective IPR strategy must be designed according to the needs of the clients. For example, a

client may want to implement a vertical integration strategy—the development, production and

marketing of a product—or development of a single innovative concept with a view to later sell or

licence the concept.

Scope of protection

A good IPR strategy shall have the following scope of protection:

(a) In general, intellectual property may assist an enterprise in almost every aspect of the

business development and competitive strategy. For most small and medium-sized

enterprises marketing products or services is a major challenge. However, all the above

may be protectable as patents, trademarks, copyright, design rights and registered designs,

and confidential information (know-how and trade secrets).

(b) Intellectual property combined with other marketing tools (such as advertisements and

other sales-promotion activities) is crucial for:



• Differentiating between products and services and making them easily recognisable;

• Promoting the products or services and creating a loyal clientele;

• Diversifying market strategy to various target groups.

The strategic utilisation of intellectual property assets can, therefore, substantially enhance

the competitiveness of a company.

(c) Corporates are interested in expanding an existing business by improving the quality of the

goods or services of the company and, thereby, its market position. In many situations,

licensing of intellectual property rights can be an effective tool for achieving these business

goals in exchange for an agreed payment (fee or royalty).

(d) Intellectual property rights can be crucial for turning innovative ideas and inventions into

competitive products that significantly increase profit margins through licensing of patented

technologies and trademark.

5.7. Methods of protecting IPR & steps to ensure the protection is valid throughout the tenure Intellectual Property Rights laws in India prescribe the procedure for registration of intellectual

property for the owner to enjoy the protection through out the period as available after registration

of the same. In India, the Intellectual Property Rights Laws prescribe the protection period/tenure

after registration of the same, some of them are as below:

(a) Patent protection is a territorial right and, therefore, it is effective only within the territory

of India. However, filing an application in India enables the applicant to file a corresponding

application for same invention in convention countries, within or before expiry of twelve

months from the filing date in India. Therefore, separate patents should be obtained in each

country where the applicant requires protection of his invention in those countries.

Term of every patent in India is 20 years from the date of filing of patent application

irrespective of whether it is filed with provisional or complete specification. However, in



case of applications filed under PCT the term of 20 years begins from International filing

date.

(b) A trade mark is a visual symbol which may be used by an undertaking on goods or services

or other articles of commerce to distinguish it from other similar goods or services

originating from a different undertaking. The validity of registration of a trade mark is

initially for a period of 10 years, but may be renewed from time to time in accordance with

the provisions of the Trademarks Act, 1999.

(c) The Indian Copyright Act, 1957 has been passed to provide for the registration and

protection of copyrights in India and to encourage authors, artists and composers to create

original works by rewarding them with exclusive right for a fixed period to reproduce the

works for commercial exploitation. The general term for the Copyright is for 60 years

following the year in which the work is published or created. In case of unpublished works

the copyright shall remain for 60 years following the year when the author dies.

(d) The duration of the registration of a design is initially 10 years from the date of registration,

but in cases where claim to priority has been allowed the duration is 10 years from the

priority date.

(e) Geographical Indications of Goods (Registration and Protection) Act, 1999 seeks to provide

for the registration and better protection of geographical indications relating to goods in

India. The Act would be administered by the Controller General of Patents, Designs and

Trade Marks-who is the Registrar of Geographical Indications and the registration is valid

for a period of 10 years.



6. Future Opportunities – New Business Model

DISCLAIMER

All information provided in this Publication has been compiled from reliable sources. Although reasonable care

has been taken to ensure that the information in this Publication is true and accurate, such information is

provided ‘as is’, without any warranty, express or implied as to the accuracy or completeness of any such

information. India Law Offices shall not be liable for any losses incurred by any person from any use of this

publication. This Publication can use as a research tool only. Readers should consult their legal, tax and other

advisors before making any investment or other decision with regard to any business in India.

Collaborative R&D

Indian companies can partner with foreign players to enter into collaborative R&D efforts as an initial step towards developing an R&D focus.

New revenue

streams

Revenues from patent licencing and litigation can re-define existing business models completely, and shift them to a higher value-generation plane.

Emerging business Opportunities

India will become a highly lucrative option for contract research once strong IP-protection legislation is introduced.

Capturing the Indian Market

Indian companies can introduce entry barriers for foreign players in the Indian market by using IP to protect their own innovations.



EBTC New Delhi (Head Office)IBC Building, M-38/1, Middle Circle Connaught Place, New Delhi 110 001, INDIATel: +91 11 4517 2200Fax: +91 11 4517 [email protected]

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