LifeScience India October-November 2012 issue

50 | $ 5 | Vol 01 Issue 02 Special Focus on
October – November 2012 (Pages 64+4) Agri Biotechnology

A confederation of Indian Industry Initiative

POLICY FEATURE OUTLOOK SPOTLIGHT
Battle over Drugs
Drug pricing policy: Contentious issues Biofuel: An emerging The global biosimilar
need resolution alternate solution outlook for 2020





Editorial Advisory Board October-November 2012

Mr. Apurva Shah Group Editor: Dilip Maitra
Group Managing Director Managing Editor: Vipin Balakrishnan
Veeda Clinical Research
Mr. Arun Sawhney Consulting Editor: Rolly Dureha
Chairman, CII National Committee on Consulting Editor: Shikha Dhawan
Drugs & Pharamaceuticals and CEO & Associate Editor: Hareeni Mageswaran
Managing Director Contributing Editor: Bindu Gopal Rao
Ranbaxy Laboratories Ltd
Dr. Arvind Lal Copy Editor: Nandhini Sundar
Chairman and Managing Director Special Correspondent: Jiggyasa Srivastava (Delhi)
Dr Lal PathLabs
Dr. Devi Shetty Co-Founder and Global Head-Business Development
Chairman Vivek Verma (Delhi)
Narayana Hrudayalaya [email protected]
Prof. N.K. Ganguly
President, JIPMER, CII Head-Life Sciences
Distinguished Biotechnology Research Dr. Chitra Gupta
Professor, DBT &
Former DG, ICMR ([email protected])
Mr. Hari Bhartia
Co-Chairman and Managing Director Editorial Advisor
Jubilant Life Sciences Ltd Vibhav Garg
Dr. Kiran Mazumdar-Shaw
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EDITOR'S NOTE

Waiting for a big-bang policy change

The government’s plan to introduce the Biotechnology Regulatory Authority of India (BRAI)

bill in the Parliament was postponed once again, the third time in a row, ostensibly to solicit
more opinions from major stakeholders. Since genetically modified crops, which differ in
several ways from conventional cross-breeding methods, are able to precisely introduce spe-
cific desirable traits into a species using the techniques of molecular cloning and transforma-
tion to directly alter the structure and characteristics of genes, there are major environmental
and pricing concerns linked with them.

Agricultural biotechnology has significant potential in addressing India’s food security needs
with increased yields and nutritional values; improved resistance to diseases, pests, and her-
bicides; improved tolerance to climatic variations; reduced maturation period; longer shelf-
lives; reduced consumption of pesticides, etc. But along with these potential benefits of GM
crops there is a range of concerns like the possible adverse impacts of biotechnology on ecol-
ogy, biodiversity, and human health. Surely, the BRAI Bill, which is empowered to set up the
regulatory authority will have to take into account the divergent views of all concerns but the
government must not further delay this important bill having a major bearing on the coun-
try’s food security. I am delighted to present our cover story, associated stories and interviews
that capture the need and the concerns on the agri-biotech policies from all angles.

In this issue we also have two stories on another contentious topic: the intellectual property
rights. While the multinational drug companies allege that despite being a part of the WTO,
Indian laws did not adequately protect the IPR of original inventors, Indian courts allowed
local manufacturing of patented drugs to make essential, life-saving drugs affordable to mil-
lions.

The article on the drug pricing policy, to be announced in the third week of November,
captures concerns of different segments of pharma companies and the NGOs fighting for
affordable healthcare in India. We also have a special report on why it is important to form a
implementable policy on Biofuels to reduce country’s dependence on fossil fuels.

Every issue of LifeScience India magazine will take you through the entire ecosystem,
weaved across research, academia, innovation, government, venture capitalists, policy mak-
ers and entrepreneurs who make the Life Sciences industry in India vibrant and steer the
India Advantage in the global arena.

Our mission is to be the unbiased voice of all stakeholders in the sector, provoking the
thought process, helping decision making and innovation. We look forward to your valuable
feedback, ideas, criticisms and the expectations you have to make LifeScience India ‘The’
platform for interactivity and meaningful dialogue.

Dilip Maitra

[email protected]
[email protected]

CONTENTS

LSI | October - November 2012

Cover Stories on Agri-biotech Sector

20 Ten years of Bt cotton:

Big leaps by cotton farmers

Bt cotton has transformed cotton cultiva-
tion in India, bringing 10.6 million hect-
ares under its crop in 2011, making it the
most pro table crop in the country.

24 Biotech Crops: The

Global scenario

Year 2011 marked the sixteenth year of
commercialization of biotech crops glob-
ally. The number of countries, biotech
crops, their hectarage and the number
of farmers adopting this new technology
have increased year on year.

28 Global Food security

through GM crops

10 Biotechnology Policy: The way forward Crop production is declining because of
the negative impact of various factors in-
The government’s plan to create an autonomous biotechnology regulatory cluding abiotic and biotic stresses. Global
authority is a much needed move to strengthen the agri-biotech sector in India. warming and climate change have wors-
ened the situation posing major threat to
But the introduction of the Biotechnology Regulatory Authority of India food security and agricultural sustainabil-
(BRAI) Bill 2011 in the Parliament has been held back several times due to sti ity, calling for an urgent solution.
opposition from many quarters, resulting in a frustrating policy stalemate.

CONTENTS

44 GM crops: Future in limbo 46 Policy

Drug pricing policy: Contentious issues

need resolution

Thanks to Supreme Court’s interven-
tion, the long-pending drug pricing
policy will soon be announced by
the government. But now it will
have to tackle many prickly issues.

Research in GM crops faces road blocks as landmark 49 Spotlight
Parliamentary Committee decision comes out strongly
against genetically modi ed crops, virtually blocking future Battle over Drugs
developments in this area.
India’s patent rules for drug trade is grabbing global eyeballs
33 Interviews ever since we acceded to WTO agreement in 2005. Recent court
rulings have again raised a major debate on Indian rules failing to
- M S Swaminathan, Member of Parliament (Rajya Sabha) protect IPR of original inventors.

- Ajay Vir Jakhar, Chairperson, Bharat Krishak Samaj 53 IPR: The Indian scenario

- M F Farooqui, Additional Secretary, Ministry of The Indian patent regime is grap-
Environment & Forest pling with two issues, one ad-
dressing core patenting and the
- Dr KC Bansal, Director, National Bureau of Plant Genetic other related to life-saving drugs.
Resources An appropriate answer balancing IP
protection obligations and domestic
- Dr Swapan Kumar Datta, Deputy Director needs would have a huge positive
impact.
General (Crop Science), ICAR
55 Outlook
- Dr Gyanendra Shukla, Director, Monsanto India
Shaping the opportunity
- Ashwin Shro , Chairman Excel Industries
The global biosimilar outlook for 2020
- Dr Alok Adholeya, Director, Biotechnology &
Bioresources 60 Feature
Division, TERI
Biofuel: An emerging alternate solution
- Prakash Apte, Non-executive Chairman, Syngenta India
The world is facing fast depletion
- P Chengal Reddy, Secretary General of Consortium of of fossil fuel, forcing countries to
Indian Farmers Association urgently look for sustainable supple-
ments. Biofuels have emerged as a
possible alternative.

65 LSI Event

ASEAN Conclave

70 News

LSI
COVER STORY

The government’s plan to create an autonomous biotechnology regulatory authority is a
much needed move to strengthen the agri-biotech sector in India. But, the introduction of the
Biotechnology Regulatory Authority of India (BRAI) Bill 2011 in the Parliament has been held
back several times due to sti opposition from many quarters, resulting in a frustrating policy
stalemate.

10 LIFESCIENCE INDIA | October-November 2012

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-Rolly Dureha Clarifying on the issue, the Science and Technology Min-
ister Vayalar Ravi said that some members pointed out to
The creation of an autonomous biotechnology regulatory him that there was no reference in the Parliamentary pa-
authority is seen as the next logical step to streamline the pers about referring the Bill to a Select Committee as was
agri-biotech sector. This has been a long-standing demand agreed earlier this year. The bill was first listed for intro-
of the various stakeholders in the sector. However, the introduc- duction in Parliament in December last year, which was
tion of the Biotechnology Regulatory Authority of India (BRAI) then postponed following opposition from members. It
Bill 2011 has once again (three successive times in a row) been was later to be tabled during the Budget Session this year
pushed to the next session of the parliament. The bill was last but was again stuck in procedural issues. Subsequently, the
scheduled to be introduced on the final day of the Monsoon ses- then Science and Technology Minister Vilasrao Deshmukh
sion of Parliament on September 7, 2011 but was put off at the had agreed to refer the Bill to a select committee to address
last minute. the various concerns of the members.

BRAI Bill

The Biotechnology Regulatory Authority of India (BRAI) is
proposed to be an independent entity with a focussed ap-
proach towards innovation, regulation, and commercial-
ization of modern biotechnology. Highlighting the impor-
tance of an apex regulatory authority, the previous Science
and Technology minister Vilasrao Deshmukh had said,
“The current regulatory system and its capacity to handle
future challenges of safety assessment is limited. There-
fore, the Government of India has taken a proactive step,
based on recommendations of various experts committees,
to establish an independent and autonomous regulatory
authority which is inclusive and transparent." Speaking at
the World Cotton Research Conference last year, he added,
"Besides, streamlining regulations on GM crops, there is a
need to institutionalise a communication mechanism for
improving public understanding and perception of bio-
technology.”

The Industry, too, has been clamouring to simplify and
streamline lengthy regulatory processes. The collective
voice of the industry has emphasized that the system of
dealing on a case-by-case basis should be discouraged, and
the early establishment and functioning of the Biotechnol-
ogy Regulatory Authority (BRA) may solve this problem
to a great extent. The industry believes that while India’s
regulatory procedure is strong and in line with Cartagena
protocols on bio safety, the present mechanism is not very
transparent. The procedure should be smooth and effec-
tive towards bio-safety clearances.

The industry has great hopes from such an apex regulatory
authority. According to a senior scientist in the industry,
“With the commencement of the BRA, the existing ad hoc
and often knee-jerk responses to several crucial biotech
and bio-safety issues are expected to receive better atten-
tion. We also expect that national policy towards GM crops
is crystallized in a manner that brings clarity to all the
stakeholders. Agri-biotech Industry is, and shall remain,
the mainstay of country’s advancement in agri-biotechnol-
ogies of national importance.”

LIFESCIENCE INDIA | October-November 2012 11

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COVER STORY

Significance of the policy Adding to the woes of stagnant agri- land and water is another concern for
cultural production are the burgeon- the agriculture sector. Here again, ap-
Finite natural resources, mounting ing population blues. Together, these plication of technology to agriculture
population, and developmental pres- factors are a formidable combination can play a pivotal role in getting high-
sures coupled with stagnant agricul- compounding the problem. Consider er returns per unit land and water.
tural production are the key triggers this: The Indian population base of Other countries are doing a better job
for the next wave of agricultural re- 1.2 billion is adding approximately of maximizing the farm productivity
forms. The aim is to make farm- 23–24 million children every year. using modern technologies. For exam-
ing more profitable and productive Thus, the Millennium Development ple, China has just about 100 million
through better seeds and higher re- Goals (MDG) target of cutting the hectares of arable land as compared
turns per unit of land and water. 50 proportion of hungry people to half to India, which has about 140 million
years after the first green revolution, is not going to be easy to achieve. In hectares. But yield and productivity of
application of biotechnology in agri- fact, the per capita availability as well different crops is higher, with China
culture can show the way forward. as consumption of food grains in In- producing more food than India. For
The Indian growth story, post 1990s, dia has actually declined since 1996. any major crop, China’s yields per
has not been inclusive. It has not cut hectare are almost double than that
across various sectors, and one sec- According to statistics, percentage of of India. Putting the issue of lim-
tor that stands out as having lagged underweight children has remained ited natural resources into perspec-
behind is the agriculture and rural stagnant between 1998 and 2006 tive, Dr Prakash Apte, Non-executive
sector. According to the 2001 census, and calorie consumption of the bot- Chairman, Syngenta India says, “The
agriculture employs more than half tom half of the population has been amount of land under food cultivation
(almost 58 percent) of the Indian pop- consistently declining since 1987. The is the same. Besides, water availabil-
ulation. However, the current con- availability of food grains, which rose ity is a major concern with 70 percent
tribution of agriculture to the Indian from 416 grams in 1950–55 to 485 of our fresh water currently used for
GDP is just about 14.6 percent. This grams in 1989–90, has been statis- agriculture. We need to address the
indicates serious gaps in the agricul- tically and gradually coming down issue of food availability in terms of
ture sector. since then. Currently it is around 450 quantity, affordability, sustainability
grams. Compared with other parts of of output and quality of food and nu-
Half a century after the green revo- the world, India is not very high on trition offered to our people.”
lution, the agriculture and rural sec- the list: our per capita consumption is
tor are rooting for another round nearly one-fifth of what US consumes Although agricultural biotechnology
of reforms. Elaborating this point, in cereals. Compared with China, we is not touted as the silver bullet, it has
Dr Rajesh Jain, Chairman, National are just half in terms of their con- significant potential in addressing In-
Committee on Biotechnology and sumptions. So there is every basis to dia’s food security needs. Proponents
Joint MD, Panacea Biotec said, “The conclude that there is a need to in- of biotechnology argue that it has the
green revolution launched in 1960s crease production and productivity. potential to introduce “value added”
did create a paradigm shift in the In- We have to ensure that the 1.2 billion or “enhanced” crops with increased
dian agriculture, but it mainly helped plus Indian people gets access to basic yields and nutritional values; im-
in increasing the yields of rice and products beyond wheat and rice now proved resistance to diseases, pests,
wheat, a national priority at that time. for their day-to-day consumption. and herbicides; improved tolerance
Now, in the twelfth five-year plan, the to climatic variations; reduced matu-
country is looking forward to reforms The mounting pressure on the al- ration period; and longer shelf-lives.
that can help it move beyond the sta- ready shrinking natural resources of Many public sector and private indus-
ples (rice and wheat).” try scientists are focusing on appli-
cations of biotechnologies, both GM
and non-GM in their R&D. The major
application hovers around food crop
improvement for biotic and abiotic
stress resistance and yield enhance-
ment. Some initiatives also focus on
nutritional improvement of crops such
as addressing protein and vitamin A
deficiency, among others.“The quan-
tum jump in agricultural productivity
definitely needs a technology boost.

12 LIFESCIENCE INDIA | October-November 2012

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COVER STORY

Anti GM group voices concerns

-Rolly Dureha “given the nature of open eld trials of property rights (IPR) held by the seed
GM crops, it has been a well-established companies can lead to massive control
Time and again green activists and anti- fact that such trials, irrespective of the of seed sector by a select few and they
GM farmers have voiced various concerns scale, are the rst step to contamination. can arm twist the governments on seed
regarding genetically modi ed crops. Contamination is serious given that it is pricing. “The e orts by Monsanto, who
Some of the major concerns raised are: irreversible in nature, and threatens to controls 93 per cent share of Bt cotton
wipe out biodiversity and endanger our seed in the country, to force State gov-
Negative impact on human health: It is food safety.” ernments to increase cotton seed prices
is a classic example. This along with the
claimed that GM food crops are hazard- Farmer’s socioeconomic security: Ac- aggressive marketing techniques and
ous to health as shown by the toxic ef- tivists claim that GM crops (such as Bt. removal of non-Bt cotton seeds from the
fects on animals through numerous ex- cotton) have bene ted the seed industry market has left the Indian cotton farm-
periments. There is also fear that transfer without a “trickle-down” gain to farmers. ers at the mercy of Monsanto,” stated
of antibiotic resistant markers and cross- According to them, in the case of Bt cot- Greenpeace activists. According to the
breeding of biotech crops with conven- ton, there has been an increased case anti-GM groups, IPRs impede scienti c
tional crops will have negative e ects on of secondary pest attacks and resultant progress as it has been evident from the
human health as no long term tests have pesticide usage, along with recorded western countries where scientists are
been conducted to determine the po- cases of boll worm (the target pest of Bt unable to do independent impact stud-
tential side e ects and allergies. It is also toxin of Bt cotton) getting tolerant to it. ies on existing GM varieties as they are
alleged that companies promoting GM Altogether there is an increased pesti- patent protected.
crops produce their own biosafety stud- cide usage which is expected to go up
ies but they deny public access to such further, they opine. This has adversely Inadequate regulatory norms:The Gov-
information. a ected the farmers, especially the small ernment must put the regulatory, moni-
and marginal ones, who are badly hit by toring, oversight and surveillance sys-
Environmental Risks: There is a pos- the increased input costs and diminish- tems in place before allowing cultivation
sibility of potential impact on environ- ing returns. of GM crops. On the regulatory side the
ment, especially due to the potential activists have highlighted many points
movement of genes from genetically Monopoly of multinationals: The green on the requirement of a need assess-
modi ed plants into conventional crops activists are of the rm view that no life ment, long term biosafety assessments,
or species in the wild (‘outcrossing’) and form should be patented. In case of GM looking for availability of ecologically and
the possibility of development of resis- crops, they believe that the intellectual socially sustainable alternatives for pest
tance. According to Greenpeace group, management, safeguarding of the coun-
try's seed sovereignty, building public
con dence and scienti c credibility be-
fore approval of novel technologies and
their products. According to the various
organisations, the crux of the argument
is the fact that genetic modi cation in its
current form is a manifestation of all that
is wrong with agriculture-seed monopo-
lies through patents, mono-cropping
even at a molecular level, degradation of
agro biodiversity, among others. Hence
it can never be sustainable, ecologically,
socially and economically, they add.

LIFESCIENCE INDIA | October-November 2012 13

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Given the limitations to tissue cul- them would ask for agri-biotechnolo- The green activists are however of the
ture and molecular marker technol- gy. Unfortunately, we have been un- view that the bill is fundamentally
ogy, genetic manipulation technol- able to convince the deciding authori- flawed, unscientific, and undemo-
ogy is a good option with its cutting ties on our requirement. It is left to the cratic. “A legal analysis of the bill by
edge technology and has already seen industry, media and scientists to make Supreme Court lawyer Ritwick Dutta
some remarkable applications in agri- this happen.” underscores serious lacunae in the Bill
culture and health”, said M F Faroo- including the complete lack of need
qui, Additional Secretary, Ministry of Major concerns assessment of a product; overriding
Environment & Forest. of the Right to Information Act 2005;
When talking about the BRAI bill, the absence of long-term independent
The statistics of Bt Cotton over the last scientists, economists, policy makers, tests; serious conflict of interest given
10 years prove this point. Earlier this and government officials do acknowl- that the authority is housed under the
year, Sharad Pawar, Minister of Ag- edge genuine concerns along with the Ministry of Science and Technology,
riculture and Food Processing Indus- misapprehension and misinformation which also has the mandate to pro-
tries, quoted the data on Bt cotton and existing regarding the Bill leading to mote the use of modern biotechnol-
its role in increasing the net cotton its opposition from several quarters. ogy; no liability mechanisms in place,
production in Lok Sabha. In a written making it weaker than the current
reply to a question on hybrid cotton According to the scientific community, GEAC; no measures to ensure effec-
cultivation, he informed the House, one of the main reasons for a section tive public participation in decision
“Introduction of Bt cotton hybrids has of people to oppose genetically modi- making as recommended by the In-
helped in production increase from fied organisms (GMOs) is that they ternational and national environmen-
156 Lakh bales in 2001 to an estimat- were adopted before many could get tal jurisprudence; last but not the least
ed 356 Lakh bales in 2011. Bt cotton accustomed to the idea, and that built taking away the decision-making role
was introduced in 2002 and the area unfounded apprehensions. Since the of the state governments on any re-
increased from 0.29 Lakh hectares in BRAI bill streamlines the processes for lease of GM crops in their respective
2002 to 95.04 Lakh hectares in Kharif fast decision on newer applications of state despite the fact that agriculture
2011. Before the introduction of Bt cot- biotechnologies, it is being opposed. is a state subject. All this seems de-
ton, the productivity in 2001 was 309 signed purely to permit GMOs disre-
Kg/ha, and it increased to 495 Kg/ha “That the first introduction came from garding socio-economic, ecological,
in 2010. ” Significantly, “The Bt. cot- a US-based MNC also has not helped ethical and cultural implications alto-
ton hybrids approved till date do not in the psyche of NGOs which ideo- gether”, stated Greenpeace India.
require any herbicide, in addition to logically remain committed to the
those required by their non Bt coun- socialistic stream. The delay will cost The organization goes further to add,
terparts for enhancing the results”, India, and mostly the agriculture sec- “Given the various concerns with
he added. Experiencing the success of tor, from deriving benefits of an ad- GM crops, the need of the hour is a
Bt cotton, even the farmers are root- vanced technology that is more precise Bio-safety protection authority whose
ing for new technologies. Replying than and as harmless as what is now main mandate will be to safeguard
to the critical question of what does deemed as conventional breeding. In the health of the citizens, the envi-
the farmer at the grass-root level de- the 1920s, gene-based breeding (now ronment, and livelihoods attached to
sires, Ajay Jakhar, Chairman, Bharat recognised as conventional breeding) farming, and which keeps in mind
Krishak Samaj stated, “The farmer drew equally vehement opposition”, the socio-economic and cultural re-
wants new technologies. 99 per cent of expounded Dr GK Garg, Director, alities of our country while regulating
Krishidhan Research Foundation. modern biotechnology and products
thereof.”
In the 1920s, gene-based breeding
(now recognised as conventional The bio-safety risk
breeding) drew equally vehement
opposition, expounded Dr GK Garg, Despite the extensive research in agri-
Director, Krishidhan Research biotechnology, not every aspect about
Foundation the interactions between the GMOs
and various ecosystems can be pre-
dicted, as it is an evolving science. This
has led to concerns regarding the bio-
safety and biodiversity. However, the
scientific community is unanimous
about the fact that the prevailing bio-

14 LIFESCIENCE INDIA | October-November 2012

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safety guidelines and procedures are Dr T M Manjunath, Consultant
as stringent as anywhere in the world. in Agri-biotechnology explained
The regulatory committees such as that in case of Bt cotton, the bio-
the Review Committee on Genetic safety and agronomic studies
Manipulation (RCGM) and Genetic were supervised and the data
Engineering Approval Committee scrutinized by about 150
(GEAC) and their sub-committees are scientists in 26 teams
comprised of eminent experts drawn in 9 states
from various institutions like the In-
dian Council of Agricultural Research is really no problem with genetically is no sexual transmission, there is no
(ICAR), Indian Agricultural Research engineered foods. effect. Even otherwise, a very large
Institute (IARI), Indian Council of number of gene banks these days are
Medical Research (ICMR), Council Loss of biological diversity is a major making sure that the existing diver-
of Scientific and Industrial Research concern associated with the promo- sity is stored and conserved in a sci-
(CSIR) and various universities. tion of agricultural biotechnology in entific manner.” A senior government
the country but this premise is largely regulatory official pointed out that
They examine the scientific data and unfounded. Currently, India is home all measures are taken for environ-
take collective decision on the safety to a large number of local varieties/ mental safety, including the issues
and benefits of biotech products. Talk- hybrids – be it cotton, brinjal, rice or on cross-pollination and biodiversity.
ing about Bt cotton, Dr T M Manju- any other crop – which have competed The fear of endangering the diversity
nath, Consultant in Agri-biotechnol- and co-existed for long years. If they of traditional varieties is unfounded
ogy and Integrated Pest Management, were to cause any adverse effect on as research until date has not shown
explained that the bio-safety and each other or on general biodiversity, anything to support it. All the tests
agronomic studies were supervised it would have happened long back. All are conducted as per the breeder seed
and the data (comprising about 5,800 these cultivars are susceptible to their production norms. “We follow the
pages) scrutinized by about 150 scien- respective pests, leading to heavy use precautionary approach, and all pre-
tists in 26 teams in 9 states involving of insecticides for pest control, often cautionary measures are taken when
13 agricultural universities and 9 cen- without much success. It should be developing GM crops or doing the
tral institutions (ICAR, IARI, ICMR, clearly understood that the Bt gene (in field trials for environmental safety”,
CSIR, etc.) before it was approved for the case of cotton) is responsible only he said.
commercialization. “Where can one for insecticidal trait. The Bt gene is in-
find more competent scientists than serted into selected hybrids or variet- Socio-economic Security:
in these institutions?” he questioned. ies that are already under cultivation
with a view to make them resistant to In the ongoing debate about the pros
Even the Supreme Court of India, in the concerned pests. Thus, the crop is and cons of adopting technological
an earlier ruling, had given the stamp better equipped to protect itself from innovations in agriculture, there is a
of approval to GM Seeds, indicating pest attacks. considerable concern about the socio-
that the biotechnology route is, per- economic security of the farmers.
haps, the only way to sustain food Elaborating this point further, Dr The activists have pointed out that
security of the nation. The Court ob- Garg said, “As scientists, we are the financial risk-taking capacity of
served that GM seeds could possibly aware that spontaneous mutation is an average Indian farmer is very low.
become a means to eradicate hunger the rule of nature, and environment Therefore, technologies that involve
and poverty; and that poverty is prob- helps selection for a particular trait lot of investment are distinctively go-
ably more dangerous than the side ef- as needed. It is these characteristics ing to be far more risky in relation to
fects of GM seeds. that are used by breeders. Addition of the farmer’s risk-taking appetite and
a couple of genes is going to further his ability to cope with it. This is one
In the US, which has adopted a num- the genetic diversity in same and re- of the key arguments used by the ac-
ber of GM food crops, the Food and lated species. For others where there tivists to oppose the introduction of
Drug Authority has tested 50 bio- genetically modified crops. Although
tech food products including canola
oil, corn, potatoes, soya beans, sugar
beet, tomatoes and has found them
to be as safe as conventional foods.
There is substantial evidence and
studies done, which show that there

LIFESCIENCE INDIA | October-November 2012 15

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the statistics of Bt cotton have proved of Biotechnology in Agriculture. The state subject, and thereby, the State is
otherwise, there is a considerable de- Task Force committee was Chaired mandated to work for development of
bate and apprehension around this under the leadership of Dr M S Swa- agricultural activities. But in reality, it
point. No doubt, the socio-economic minathan, Father of the Indian Green is neither the Centre nor the State that
security of the farmer is an important Revolution and Member of Parliament decides on GM crop cultivation. Once
issue and it should involve greater fi- (Rajya Sabha) and Chairman, M S the GM crop is approved by Genetic
nancial inclusion, and therefore, ap- Swaminathan Research Foundation. Engineering Approval Committee
plication of technology to the entire Keeping the rural dynamics of a ma- (GEAC), farmers have the freedom to
sector of agriculture as opposed to jority of farmers along with the uncer- grow whatever they like. Even if the
merely agricultural solutions. “It has tainties of Indian agriculture in view, State discourages or bans a particular
to encompass and cover economists, Dr Swaminathan had factored in a GM seed/crop in their state, the farm-
policy making, market, supply chain special insurance facility for farmers ers have the freedom to purchase from
management, post-harvesting, and to circumvent losses in case of acute the neighbouring state.
many others. We need to start look- crop failure. “A majority of farmers
ing at the big picture now”, was aptly are small scale and marginal. If they Ideally, the policies of the Centre and
pointed out by Farooqui. buy seeds at a high price and the crops the State should be aligned for prog-
fail, then there is nobody to insulate ress of agri-biotechnology in the state,
This issue probably goes beyond the them from loss. This is why we rec- otherwise it will lead to a Catch-22
direct purview of the BRAI bill, as this ommended a special insurance, which situation where the Centre is promot-
would be a nodal agency with a fo- could be given along with a packet of ing GM crop research, but the States
cussed approach towards innovation, seeds,” explained Dr Swaminathan are reluctant to allow even contained
regulation, and commercialization of field trials. Often, it is seen that other
modern biotechnology. Once a tech- Who should regulate considerations like political and ideo-
nology is accepted, no matter who de- logical leanings of the State govern-
veloped it, the bill should concentrate The anti-GM lobby has alleged that ment play a major role in deciding
on assessing its safety and benefits the BRAI Bill will hijack the decision- policies towards GM rather than the
before approving its commercializa- making role of the state governments merits of crop.
tion. “The seed cost, socio-economic on any release of GM crops in their
impact, relative performance of a respective state despite the fact that However, when farmers fully realize
product, etc., would depend upon the agriculture is a state subject. the benefits of technology in agricul-
merit of the product and it is better ture, no political party will be able to
that the bill does not try to exercise For now, GM crops are controlled take a stand against technology. Prac-
control over these issues,” averred Dr under the Environmental Protection tically, too, it is not feasible for a state
Manjunath. Act, which is a Central Act and the to isolate itself from its surroundings.
regulatory authority, GEAC, func- This is evident in the cotton-growing
A solution by way of a special insur- tions under the Ministry of Environ- states of the country, where one state
ance scheme was suggested in the ment & Forests, Government of India. cannot act as an exception.
2004 Task Force report on Application However, as per the provision in the
Indian Constitution, agriculture is a The policy makers feel that the In-
dian regulatory system is most rigor-
ous and comprehensive, and different
States should repose faith in the apex
regulatory authority. Rather than cre-
ating hurdles in the path of the central
regulatory regime for GMOs in the
country, the scientific community be-
lieves that the states should facilitate
its implementation in their regions.

Right communication

Another cause of disagreement is
which ministry should house the apex
regulator. Currently, many green ac-
tivists are against a provision in the
bill, which allows Department of Bio-

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technology (DBT) under the Ministry Along with education, grievance redressal is an
of Science and Technology to have a equally important step to gain public con dence
say in deciding regulatory policy on on biotech crops. It appears that whenever there is a
GM crops in India. With DBT being controversy, there is a tendency to go on the defensive and
the department for promoting bio- sweep all criticism under the carpet
technology, critics claim there is a
conflict of interest. This is actually a more on education, communication, been cases where Chief Ministers of
non-issue, as it is believed that the and discussion with the local people. different states have written to Min-
DBT officials are open to put the BRAI The emphasis has to be on Education, istry of Environment and Forests that
under some other administrative Social mobilization to Panchayats, they do not want to allow testing even
ministry like the Ministry of Agricul- and finally Regulations. Regulation of genetically modified crops in con-
ture, but would prefer to make those alone will not help without the other tained conditions in their states. This
changes once the bill is introduced two components," he says. Referring again points to a lacuna in education
in the House and sent to the House to the 2004 Task Force report on ap- at the highest level. Speaking from
panel for review. plication of biotechnology in agricul- experience, M F Farooqui said, "The
ture he said, solution is to convince them. If you
The common point stressed by all the cannot convince first of all the po-
stakeholders is that this technology "The Committee has made number litical leadership or scientists, I think
march can be successful only if it is of recommendations including media chances that you will be able to con-
inclusive of the farmers and the com- resource centre for putting out au- vince the others at the lower level is
mon public. Hence, there is a need thentic information. We are required definitely more remote."
to institutionalise a communication to invest little more on public infor-
mechanism for improving public un- mation. The Krishi Vigyan Kendras Along with education, grievance re-
derstanding and perception of bio- (these are district-level Farm Science dressal is an equally important step to
technologies Centre established by the ICAR) may gaining public confidence. It appears
be strengthened wherever there are that whenever there is a controversy,
It is an accepted fact that regulatory opportunities for genetically modified there is a tendency to go on the de-
reforms or technology adoption alone crops."Ironically though, the Centre fensive and sweep all criticism un-
will not solve the problems prevailing is pursuing a proactive approach to- der the carpet. Everyone tends to talk
in the agri-biotech sector. These are wards biotechnology, yet there have more about positives that the tech-
in fact the latter stage steps in the se-
ries leading to acceptance of modern
technologies in the Indian agricul-
tural scenario.

The primary step is to understand
the need of farmers and disseminate
information about how has the gap
or need been addressed by the sci-
entific community. As M F Farooqui
observes, “When we talk of reforms
in the agricultural sector, what is the
thing that needs to be changed? Is it
only the infusion of technology? This
is a very big question because tech-
nology does not operate entirely on
its own. Technology does have a lot of
things to offer, but we must first un-
derstand the need of the people.”

There is definitely a need for greater
understanding of science in our vil-
lages, which is termed as “genetic
literacy" by Dr Swaminathan. "In a
democratic society, one has to spend

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nology has delivered and completely substantial promise as seen from the society to change the risk perception
underestimate the issues which some case study of Bt cotton. The setting of about GM crops; provide extension
of the stakeholders have faced. Touch- a Biotechnology Regulatory Authority services to the farmers on using bio-
ing upon this crucial point Dr Rajesh of India will definitely facilitate faster technology; capacity building and
Jain said, "In our whole approach of decision-making on newer applica- focus on sustainable biotech crop re-
building our credibility of science with tions of biotechnologies. So a quick search; a campaign to prepare a posi-
society at large, our communications passage of the pending Bill to estab- tive mindset, enabling environment
need to give them a balanced view – lish an apex regulatory authority with and instilling confidence among the
not only what we have achieved and a wider remit than the present GEAC stakeholders.
delivered but also where we fell short is desirable. But with the present po-
and could not deliver.: litical turmoil in the country, it is far These measures will go a long way in
too optimistic to hope that an objec- the smooth passage of the BRAI bill
Game Plan tive debate can take place, even if the whenever it is tabled in the Parlia-
matter comes for discussion in winter ment.
Unless we see how our agriculture session of parliament.
grows and our rural areas prosper, the (The views of some of the people quoted in
growth of India will also touch a pla- This breather can be positively uti- the article above have been taken from their
teau, as the agriculture production had lized to kick-start a mass education addresses at the CII-organized “Conference on
touched the plateau in the 90s. Ap- and awareness campaign on biotech- Agri-biotechnology”, held in December 2011
plication of biotechnology to agricul- nology; extensive dialogue across the in New Delhi.)
ture clearly has a huge potential and

Many disagree with the BRAI Bill

The BRAI Bill, 2011 is an in-depth document detailing ceeded Rs 14,200 Crore approximately. The potential
the structure, composition, function, powers of the of biotechnology with respect to food security, public
apex regulatory body. It also elaborates on the divi- health, employment generation, intellectual wealth cre-
sions, units, and product rulings committee; field trials and ation, expanding entrepreneurial opportunities, and
clinical trials; and Biotechnology Regulatory Appellate Tri- augmenting industrial growth warrants a focussed ap-
bunal among others. proach towards innovation, regulation, and commer-
cialization.
The statement of objects and reasons of the Bill clearly 2. There are public concerns in respect of organisms and
states the need and urgent requirement to establish products derived from modern biotechnology on hu-
such a regulatory body. It enunciates: man, animal, and environmental safety. Various coun-
1. Biotechnology Industry in India has been growing tries have developed regulatory mechanisms to ensure
safe and responsible use of biotechnology organisms
at an average annual rate of 20 to 30 per cent during and products. In India, activities and processes involv-
the last five years and its turnover during 2009-10 ex- ing the genetically engineered organisms and products
thereof, are at present, broadly regulated under the rules
titled as "Rules for Manufacture, Use/Import/export and
storage of Hazardous Micro organisms/Genetically En-
gineered Organisms of cells, 1989" notified under the
Environment (Protection) Act, 1986 and the guidelines
published by the Department of Biotechnology in the
Ministry of Science and Technology.
3. Subsequent to making of aforesaid rules and publication
of guidelines, biotechnology regulatory system in India
has experienced a number of challenges. The taskforce
on the Application of Agriculture Biotechnology con-
stituted by the Ministry of Agriculture in 2003 recom-
mended the establishment of an "autonomous, statutory
and professionally led ‘National Biotechnology Regula-
tory Authority’ for generating the necessary public, po-
litical, professional, and commercial confidence in the

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science-based regulatory mechanism. Subsequently, entific officers, product ruling committee and environ-
the other task force constituted by Ministry of Envi- mental appraisal panel for elaborate risk assessment
ronment and Forests in 2004 on recombinant pharma process involving scientific experts and representatives
also supported the establishment of the Biotechnology of concerned ministries including a special public re-
Regulatory Authority. view system for evaluation of application before the fi-
4. India is a party to the United Nations Convention on nal approvals
Biological Diversity signed at Rio de Janeiro on June 5, f. Provides for notification by the authority of accredited
1992, which came into force on December 29, 1993; and laboratories and research institutions for the purpose of
the Cartagena Protocol on Biosafety that was adopted proposed legislation
in Montreal on September 29, 2000, and came into force g. Provides for Biotechnology Regulatory Appellate Tribu-
on September 11, 2003. nal to hear the appeals against the decision or order or
5. In order to implement the recommendations of the direction of the authority
aforesaid Task Forces, and to give effect to certain pro- h. Provides for offences and penalties for contravening the
visions of the aforesaid Convention and Protocol, it provisions of the proposed legislation
has been decided to establish an independent statu- i Empower the Central Government to supersede the
tory regulator to regulate the research, transport, im- Authority in certain circumstances.
port, manufacture and use of organisms and products
of modern biotechnology so as to keep pace in regula- Present Structure of Regulation
tory measures with the rapid technology advancement Currently the activities and processes involving genetically
in the field of modern biotechnology, and at the same engineered organisms and products are broadly regulated
time, ensure safety to human and animal health and under the rules titled as "Rules for Manufacture, Use/Im-
the environment. port/export and storage of Hazardous Micro organisms/
6. The proposed statutory independent regulatory that is Genetically Engineered Organisms of cells, 1989" notified
the Biotechnology Regulatory Authority of India (BRAI) under the Environment (Protection) Act, 1986 by the Minis-
would be a nodal agency of the Government of India to try of Environment and Forests (MoEF) and the guidelines
ensure comprehensive safety assessment of organisms published by the Department of Biotechnology (DBT) in the
and products of modern biotechnology. Commercial- Ministry of Science and Technology (MoST). As per a TERI
ization of biotechnology products in agriculture and Policy Brief, these committees, along with their functions
healthcare would be subject to all other laws whether and the ministries in which they are housed are as follows:
Central or State, for the time being in force and the
rules and regulations made there under. The organiza- For regulations/guidelines
tional plan of the Authority also provides collaborative 1. Recombinant DNA Advisory Committee (RDAC) under
arrangements, co-ordination and mechanisms with
other existing regulatory agencies. BRAI also proposed the Ministry of Science and Technology (MoST): Regu-
to regulate the trials preceding the clinical trials in the lations/guidelines, Monitoring, review, and approvals
health sector and present mechanism for regulating 2. Institutional Biosafety Committee (IBSC) under MoST:
clinical trials would continue. Prepares site-specific plans
7. The Biotechnology Regulatory Authority of India Bill, 3. Review Committee on Genetic Manipulation (RCGM)
2011, inter alia, provides for the following: under MoST: Monitors safety-related aspects of ongo-
a. Establishment of the Biotechnology Regulatory Au- ing research projects
thority of India to regulate the research, transport, im- 4. Monitoring-cum-Evaluation Committee (MEC) under
port, manufacture, and use of organisms and products MoST: Conducts large scale, multi-site field trials
of modern biotechnology For punitive actions
b. Constitution of inter-ministerial governing board to 1. State Biotechnology Coordination Committee (SBCC):
oversee the performance of the authority Addresses violations of safety and control measures
c. Constitution of Biotechnology Advisory Council to 2. District Level Committee (DLC): Monitors safety regu-
render strategic advice to the authority on the matters lations and takes appropriate measures
relating to developments in modern biotechnology and
their implications in India Thus, the current regulatory regime is spread across three
d. Providing for regulatory divisions of the authority deal- different ministries and departments: the Ministry of Ag-
ing with agriculture, forest and fisheries, human health riculture (MoA), Ministry of Environment and Forests
and veterinary products, and industrial and environ- (MoEF), and the Department of Biotechnology in the Min-
mental applications for implementation of safety as- istry of Science and Technology (MoST). These diverse
sessment procedures and processes committees working under different ministries will give
e. Constitution of risk assessment unit comprising of sci- way to an autonomous and independent regulatory regime
through the BRAI Bill.

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10 years of Bt cotton: Big leaps by
small cotton farmers in India

Bt cotton has transformed cotton cultivation in India, bringing 10.6 million hectares under its
crop in 2011, making it the most pro table crop in the country.

By Bhagirath Choudhary cotton. Bt cotton has transformed cotton production in In-
dia by increasing the yield, decreasing insecticide applica-
The year 2011 marked the tenth anniversary of Bt cot- tions and through welfare benefits contributed to the alle-
ton in India. In the ten years from 2002 to 2011, Bt viation of poverty of 7 million small, resource-poor farmers
cotton cultivation has achieved phenomenal success and their families in 2011 alone.
in transforming cotton cultivation into one of the most pro-
ductive and profitable crop in the country. In 2011, plant- India has successfully harnessed the significant benefits
ings of Bt cotton reached 10.6 million hectares, surpassing that Bt cotton offers (from both single and double Bt genes)
the 10 million hectare mark for the first time and occupied and the future holds enormous potential as the next gen-
88 per cent of the record 12.1 million hectare cotton crop. eration of biotech cotton offers India a range of beneficial
The principal beneficiaries of this transformation were the new traits including stacked Bt/HT, salinity and drought
7 million farmers growing, on an average, 1.5 hectares of tolerance, disease resistance and other traits.

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The ten-year period from 2002 to 2011 has been referred million hectares of Bt cotton, compared to China’s 3.5 mil-
to by some as the white gold revolution on cotton farms lion hectares. In 2011–12, the adoption of Bt cotton in India
in India. Subsequent to 2002, millions of marginal cotton soared past the 10 million hectare milestone for the first
farmers, mostly in rain-fed areas, have returned to planting time, reaching 10.6 million hectares – almost 3 times the Bt
Bt cotton year after year. Prior to 2002, these former cot- cotton area of China at 3.9 million hectares. Area under Bt
ton farmers had become disillusioned and given up cotton cotton cultivation increased by 1.2 million hectares to reach
cultivation because of the high costs of production – par- 10.6 million hectares in 2011 from 9.4 million hectares in
ticularly expensive and ineffective pest control – and very 2010. Historically, the increase from 50,000 hectares of Bt
low productivity. cotton in 2002 (when Bt cotton was first commercialized) to
10.6 million hectares in 2011 represents an unprecedented
However, in the last ten years, the situation has changed 212-fold increase in ten years.
with Bt cotton offering a new lease of life to cotton farmers,
the cotton industry and the farm economy of the country. India is unique in that it is the only country in the world
Ten significant milestones were achieved during the first where cotton hybrids, as opposed to varieties, are the prin-
decade, 2002–2011, of Bt cotton cultivation in India. These cipal commercial crop. The first commercial cotton hybrid,
highlight the spectacular
success of Bt cotton flourish-
ing in the small cotton farms
in the country.

India planted the highest- Fig 1. A Decade of Adoption of Bt Cotton Hybrids in India, 2002 to 2011
ever hectarage of cotton, 12.1
million hectares in 2011–12,
increasing from 7.7 million
hectares in 2002–03. This sig-
nificant increase in hectarage
in cotton has been attributed
by and large to Bt technol-
ogy that has substantially
increased the profitability
of cotton production in the
country. Coincidentally, the
number of cotton farmers
cultivating cotton increased
significantly from 5 million
small and resource poor cot-
ton farmers in 2002–03 to
8 million cotton farmers in
2011–12. The number of Bt
cotton farmers who planted
and benefited significantly
from Bt cotton hybrids in-
creased from 50,000 farmers
in 2002–03 to 7 million Bt
cotton farmers in 2011–12,
representing approximately
88 per cent of 8 million cot-
ton farmers in 2011–12.

India plants more Bt cotton Fig 2. Growth of Long Staple Cotton in India, 2002 to 2011
than any other country in the
world. In the fifth year of Bt
cotton adoption, 2006–07,
India eclipsed China for the
first time by cultivating 3.8

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H-4, derived from an intra-specific cross (G. hirsutum x G. hybrids in 2002–03 to 884 Bt cotton hybrids in 2011–12.
hirsutum) was released commercially in 1970 in a landmark India was traditionally a producer of short, medium, and
event. In 2011–12, 88 per cent of the cotton area featured medium-long staple cotton due to the prevalent large-scale
both intra-specific and inter-specific hybrids. This is almost cultivation of local cotton varieties. Thus, the country was
double the 45 per cent adoption level in 2001–02. The rapid deficient in long staple and extra-long staple cotton, which
increase in the area under cultivation of hybrid cotton is is the major raw material demanded by the cotton mills and
credited to the introduction of Bt technology, which spurred the textile industry. The introduction of hybrid technology
hybridization resulting in an increase from three Bt cotton in the seventies and the deployment of Bt technology in

2002 improved cotton hybrids
substantially and changed
the composition of total cot-
ton production in favour of
long staple cotton. In 1947,
there was almost no long sta-
ple cotton, but this increased
to 38 per cent of supply in
2002–03 and to 77 per cent
in 2010–11. Furthermore, the
volume of long staple cotton
production registered a five-
fold increase from 5.1 million
bales in 2002–03 to 24.1 mil-
lion bales in 2010–11.

Fig 3. Cotton Hectarage and Production in India, 2002 to 2011 The commercial approval
of Bt cotton was a cardinal
breakthrough that revived
the ailing cotton sector in the
country. Prior to 2002, cotton
production had stagnated
and yields were declining.
This resulted in over-reliance
on cotton imports for many
decades.

Along with the steep in-
crease in adoption of Bt cot-
ton between 2002 and 2011,
the average yield of cotton in
India, (which used to have
one of the lowest lint yields
in the world), increased from
308 kg per hectare in 2001–
02, to 499 kg per hectare in
2011–12. Cotton production
increased from 13.6 million
bales in 2002–03 to 35.5 mil-
lion bales in 2011–12, which
was a record cotton crop for
India.

Fig 4. Percentage Reduction of Insecticides on Cotton Relative to Total Insecticides/ At the same time, the country
Pesticides Used in Agriculture in India, 2001 to 2010 was transformed from a net
importer of raw cotton until
2002–03 to a net exporter of

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cotton. The large-scale adoption of Bt cotton in India was Last but not the least, the annual global study of benefits
a major contributor to the doubling of cotton production generated by biotech crops, conducted by Brookes and Bar-
domestically and also contributed significantly to global foot, estimated that India enhanced farm income from Bt
cotton production from 2002 to 2011. In 2011, India con- cotton by US$9.4 billion (or Rs. 42,300 Crore) in the period
tributed 10.6 million hectares of biotech cotton (equivalent 2002 to 2010 (nine-year period) and US$2.5 billion in 2010
to approximately 30 per cent of total global cotton area at 36 alone.
million hectares) and a substantial 7 per cent to the global Typically, yield gains are up by 31 per cent and there is a
total of biotech cotton hectarage of 160 million hectares in significant 39 per cent reduction in the number of insecti-
2011. As a result, Indian cotton now accounts for more than cide sprays, leading to an 88 per cent increase in profitabil-
one fifth (21 per cent) of the total world cotton production ity – equivalent to a substantial increase of approximately
in 2011–12. This is substantially higher than the 14 per cent US$250 per hectare.
in 2002–03. Because of the higher productivity of Bt cotton, Thus, Bt cotton has transformed cotton production in India
India overtook the USA in 2006 to become the second-larg- by increasing yields, decreasing insecticide applications,
est cotton producing country in the world after China. and, most importantly, through welfare benefits, contrib-
uted to the alleviation of poverty for over 7 million small
Over the ten-year period from 2002–2011, Bt cotton has resource-poor farmers and their families in 2011 alone, and
been successfully used as a multiple-purpose crop, to de- future prospects look encouraging.
liver three principal products: edible oil for human con- The writer is a researcher based at ISAAA, a not-for-profit
sumption, de-oiled cake as an animal feed, and kapas for public charity co-sponsored by the public and private sec-
fibre. Impressively, the production of cottonseed and its by- tors working to alleviate poverty in developing countries by
products, oil and meal, has increased three-fold from 0.46 facilitating the transfer and sharing of knowledge on crop
million tons in 2002–03 to 1.31 million tons in 2011–12. biotechnology applications to increase crop productivity
As a result, Bt cotton meal (de-oiled cake) contributes one and income generation.
third of the country’s total and increasing demand for ani-
mal feed, whereas cotton oil also contributes 13.7 per cent Bhagirath Choudhary (centre) with Mr Habib and Mr Pasha,
of total edible oil production for human consumption in the Bt cotton farmers in Husanpur village, Shankar Pally Mandal, Ranga
country. Reddy District, Andhra Pradesh.

Consumption of insecticides, measured in active ingredi-
ent, has exhibited a consistent and significant downward
trend since the introduction of Bt cotton in 2002–03. No-
tably, the large-scale adoption of Bt cotton has halved in-
secticide usage from 46 per cent of total insecticides used
in 2001–02 to 21 per cent of total insecticide used in India
in 2010. The steep decline in the percentage of insecticides
applied on cotton relative to total insecticides used on all
crops, is a welcome environmental relief, particularly to
cotton growers and farm labourers who, prior to 2002, suf-
fered from the intensive usage of insecticides to control the
major cotton pest – American bollworm complex, now ef-
fectively controlled by Bt.

The introduction of Bt technology in cotton, (the first ge-
netically modified cotton was approved for commercializa-
tion in 2002–03) contributed immensely to the establish-
ment of the vibrant hybrid cotton seed and agri-biotech
industry in India. The high adoption rate of Bt cotton by
Indian farmers contributed significantly to the steep year-
on-year growth in commercial hybrid seeds and the biotech
industry in the country from 2002 to 2011. Agri-biotech in-
dustry annual revenues grew consistently at a double/triple
digit rate during the 2002 to 2011 period. More specifically,
the agri-biotech industry market increased twenty-two-
fold from Rs.110 Crore (US$25 million) in 2002–2003 to Rs.
2480 Crore (US$551 million) in 2010–11.

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-Rolly Dureha

The year 2011 was the 16th year of commercialization of
biotech crops (1996-2011), when growth continued after
15 consecutive years of increase. Biotech crops reached
160 million hectares, up 12 million hectares on 8 per cent
growth from 2010, as the global population reached a mile-
stone of 7 billion on 31 October 2011.

Biotech is fastest adopted crop technology

A 94-fold increase in hectarage from 1.7 million hectares in
1996 to 160 million hectares in 2011 makes biotech crops the
fastest adopted crop technology in the history of modern ag-
riculture.

During the 16-year period, millions of farmers in 29 countries
worldwide elected to make more than 100 million indepen-
dent decisions to plant and replant an accumulated hectarage
of more than 1.25 billion hectares – an area 25 per cent larger
than the total land mass of the US or China. There is one prin-
cipal and overwhelming reason that underpins the trust and
confidence of risk-averse farmers in biotechnology – biotech
crops deliver substantial and sustainable socio-economic and
environmental benefits.

Year 2011 marked the sixteenth year Top 10 countries are very big in biotech crops
of commercialization of biotech crops
globally. The number of countries, Of the 29 countries planting biotech crops in 2011, 19 were de-
biotech crops, their hectarage and the veloping and 10 were industrial countries. The top 10 countries
number of farmers adopting this new each grew more than 1 million hectares providing a broad-
technology have increased year on based, worldwide foundation for diversified growth in the fu-
year. Here is an extract from the Brief ture. In fact, the top nine each grew more than 2 million hect-
43 on “Global Status of Commercialized ares. Almost 60 per cent (approx. 4 billion) people live in the 29
Biotech/GM Crops: 2011” published countries planting biotech crops.
by the International Service for the
Acquisition of Agri-biotech Applications Around 16.7 million farmers grew biotech crops in 2011, up 1.3
(ISAAA). million from 2010. Notably, 15 million or 90 per cent were small,
resource-poor farmers from developing countries. Bt cotton in-
creased the income of farmers significantly by up to US$250 per
hectare and halved the number of insecticide sprays.

Developing countries' share is 50 per cent

Developing countries grew close to 50 per cent (49.875 per cent)
of global biotech crops in 2011. For the first time, they are ex-

24 LIFESCIENCE INDIA | October-November 2012



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pected to exceed industrial countries hectarage in 2012. In Status of approved events
2011, the growth rate for biotech crops was twice as fast
and twice as large in developing countries, at 11 per cent or While 29 countries planted commercialized biotech crops
8.2 million hectares, versus 5 per cent or 3.8 million hect- in 2010, an additional 31 countries have granted regula-
ares in industrial countries. During the 1996–2010 period, tory approvals to biotech crops for import for food and feed
cumulative economic benefits were the same for developing use and for release into the environment since 1996. A to-
and developed countries (US$39 billion). For 2010 alone, tal of 1,045 approvals have been granted for 196 events for
economic benefits for developing countries were higher at 25 crops. Thus, biotech crops are accepted for import for
US$7.7 billion compared with US$6.3 billion for developed food and feed use and for release into the environment in
countries. 60 countries, including major food importing countries like
Japan that do not plant biotech crops. Of the 60 countries
Biotech soybean dominates that have granted approvals for biotech crops, USA tops
the list followed by Japan, Canada, Mexico, South Korea,
Biotech soybean continued to be the principal biotech crop Australia, the Philippines, New Zealand, the European
in 2011, occupying 75.4 million hectares or 47 per cent of Union, and Taiwan. Maize has the most events approved
global biotech area, followed by biotech maize (51.00 mil- (65) followed by cotton (39), canola (15), potato and soy-
lion hectares at 32 per cent), biotech cotton (24.7 million bean (14 each). The five leading developing countries that
hectares at 15 per cent) and biotech canola (8.2 million have adopted biotechnology in a big way are China, India,
hectares at 5 per cent) of the global biotech crop area. Brazil, Argentina, and South Africa, who grew 71.4 million
hectares, 44 per cent of global biotech crops, and house ap-
Adoption by traits proximately 40 per cent of world population

From the genesis of commercialization in 1996 to 2011, her- US lead producer of biotech crops
bicide tolerance has consistently been the dominant trait. In
2011, herbicide tolerance occupied 59 per cent or 93.9 mil- The US continued to be the lead producer of biotech crops
lion hectares of the global biotech area of 160 million hect- globally with 69.0 million hectares, with an average adop-
ares. In 2011, the stacked double and triple traits occupied tion rate of approximately 90 per cent across its principal
a larger area (42.2 million hectares, or 26 per cent of global biotech crops. It showed particularly strong growth in
biotech crop area) than insect resistant varieties (23.9 mil- maize and cotton in 2011, and resumed the planting of
lion hectares) at 15 per cent. The stacked genes were the RR®alfalfa.
fastest growing trait group between 2010 and 2011 at 31 per
cent growth, compared with 5 per cent for herbicide toler- Brazil, the engine of biotech crop growth
ance and 10 per cent for insect resistance.
With 30.3 million hectares, Brazil ranks second only to the

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The ve leading developing countries rate to-date of 71.5 per cent. Government has reconfirmed
that have adopted biotechnology in the national importance of biotech crops to be developed
a big way are China, India, Brazil, Argentina, under strict biosafety standards. ds.
and South Africa, who grew 71.4 million
hectares, 44 per cent of global biotech crops, Mexico seeks self-sufficiency with biotech
and house approximately 40 per cent of
world population In 2011, Mexico planted 161,500 hectares of biotech cotton,
equivalent to an adoption rate of 87 per cent and 14,000
USA in biotech crop hectarage in the world and is emerging hectares of biotech RR®soybean for a country total of
as a global leader in biotech crops. For the third consecutive 175,500 hectares, compared to 71,000 hectares in 2010 – an
year, Brazil was the engine of growth globally in 2011, in- increase of 146 per cent.
creasing its hectarage of biotech crops more than any other
country in the world. Progress in Africa

Argentina and Canada continue to gain Africa made steady progress in 2011 in planting, regulatory,
and research activities on biotech crops. The three coun-
Argentina and Canada ranked third and fifth respective- tries already commercializing biotech crops (South Africa,
ly retained their world rankings, and both posted record Burkina Faso and Egypt), together planted a record 2.5 mil-
hectarage of biotech crops at 23.7 million hectares and 10.4 lion hectares. An additional three countries (Kenya, Nige-
million hectares, respectively. The largest gain in Argentina ria, and Uganda), conducted field trials, with others like
was biotech maize increasing by ~900,000 hectares and in Malawi having already approved pending trials.
Canada herbicide tolerant canola increased by ~1.6 million
hectares after Canada reported its largest ever canola crop. Australia plants 99.5 per cent biotech cotton

China benefits from Bt cotton Australia planted its largest ever hectarage of cotton of
which 99.5 per cent was biotech, equivalent to 597,000 hect-
In China, 7 million small resource-poor farmers grew a re- ares of which 95 per cent was the stacked trait for insect
cord 3.9 million hectares of Bt cotton at the highest adoption resistance and herbicide tolerance. In addition, Australia
grew approximately 140,000 hectares of herbicide tolerant
canola.

EU adopts biotech maize

Six EU countries (Spain, Portugal, Czechia, Poland, Slo-
vakia and Romania) planted 114,490 hectares of biotech Bt
maize, a 26 per cent higher than 2010, with Spain growing
85 per cent of the total in the EU with a record adoption rate
of 28 per cent.

Two other countries (Sweden and Germany) planted a to-
ken 17 hectares of the new biotech-quality starch potato
named 'Amflora' for 'seed' production.

The Future

The world needs at least 70 per cent more food by 2050. For
the developing countries, where 2.5 billion small resource-
poor farmers survive, food production needs to be doubled
by 2050. Today, poverty is mainly a rural phenomenon.
However, this will change in the future as urbanization
continues to increase from its current level of just over half
the world’s population.

Almost 70 per cent of the world’s poor are dependent on ag-
riculture. Some view this as a problem. However, it should
be viewed as an opportunity, given the enormous potential
of both conventional and the new biotechnology applica-
tions to make a significant contribution to the alleviation
of poverty and hunger and to doubling food, feed, and fibre
production by 2050.

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Crop production is declining because of the negative impact of various factors including
abiotic and biotic stresses. Global warming and climate change have exacerbated the situation
posing major threat to food security and agricultural sustainability, calling for an urgent
solution.

-Narendra Tuteja world's population is increasing at a frightening rate and
may reach over 9 billion by the year 2050 (Fig. 1). This will
Food security is achieved only when everybody can have make it difficult to meet the increasing demand for food
physical, social and economic access to safe, adequate and supply. To ensure food security, it is necessary to develop
nutritious food (World Food Summit, 1996). The WHO de- multi stress-tolerant varieties which will help to improve
fines food security as having three facets: food availability, crop yield under adverse conditions of stresses.
food access, and food use. Due to extreme poverty, around
925 million people are chronically hungry worldwide with Improved varieties are developed by traditional plant
up to 2 billion people lacking food security due to poverty breeding methods either by selecting plants with desirable
(FAO). Over six million children die of hunger every year. characteristics or by combining qualities from two closely
Food security is in danger under the continuous growing related plants through selective breeding. The increasing
threat of various stresses including climate change and crop production through this traditional approach is time-
global warming, which ultimately lead to reduction in crop consuming and in some cases, a trait can be suitably ex-
yield. Lesser availability of food leads to higher food prices pressed only after hundreds of crossings. The transgenic
and more food insecurity. There is hence a need to develop approaches could be one of the fastest ways to produce
or follow the fast technology which can enhance food pro- genetically modified (GM) or improved varieties that can
duction even under stress conditions. tolerate stresses and produce good yield.

Plants are subject to a variety of abiotic and biotic stresses In genetic engineering of plants, changes are made di-
and show rapid molecular response to changing climate rectly to the plant's genome. Once the gene determining
conditions (Fig. 1). Crop yield has decreased due to natural a desirable trait is identified, it can be selected, extracted,
agricultural production resources, particularly water and and transferred directly into another plant genome. Plants
land, which have shrunk and degraded. On the other hand

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Fig. 1. Di erent types of abiotic and biotic stresses and their negative insecticide use by as much as 85 per cent. Interestingly, our
e ect on declining the agricultural production. To cope up with the up- present state of food crops is a far cry from its original wild
coming problem of food security, it is important to develop stress toler- varieties.
ant crops.
Notable steps leading to the current state:
that have genes from other organisms are referred to as 1. Discovery of structure of DNA.
transgenic or GM crops. Several GM crops including cot- 2. Discovering genes that move (transposons).
ton, soya, maize, potato, sugar beet, alfalfa and canola are 3. Tissue culture and plant regeneration.
grown across the world. The US, Brazil, Argentina and 4. Embryo rescue.
China are massive producers. 5. Protoplast fusion.
6. Genetic engineering which deals with purposeful
The global GM crops area increased from 4.3 million hect-
ares in 1996 to 148 million hectares by 2010. However, transfer of DNA between organisms, whether closely
GM crops have to undergo a costly authorization process, or distantly related resulting in new crop varieties con-
which is also lengthy and involves extensive risk assess- taining traits such as tolerance to stresses, enhanced
ment for human and animal health as well as environment nutritional profiles, and increased yield.
safety. Public acceptance to GM food is low because of
non-awareness among general public, media and NGOs. Plant response to stress
However, GM crops could be as safe as conventional crops
as the countries where transgenic crops are grown, have Plants can respond to stresses as individual cells and syn-
no verifiable reports of health or environment harm (UN- ergistically as a whole organism. Stress conditions cause
FAO). This however does not eliminate the need for best plants to produce a stress hormone which activates a set
monitoring, oversight and surveillance mechanism of GM of protein molecules called receptors. These receptors then
crops before release. activate a series of changes to help the plant survive. The
stress signal is first perceived at the membrane level by the
The genetically designed crops carry specifically selected receptors and then transduced into the cell, which results
genes with traits that allow them to grow in particular en- in activation of various stress responsive genes to provide
vironment or produce good yield under stress. It is to be stress tolerance. After this a large and complex signaling
noted that an estimated 86 per cent of all corn and 93 per cascade is activated. The products of these stress-respon-
cent of soy crops grown in the U.S. are genetically modi- sive genes may provide the stress tolerance either directly
fied according to statistics quoted in the Tribune. According or indirectly, which ultimately lead to plant adaptation and
to Monsanto the GM sweet corn will help farmers reduce help the plant to survive and surpass the stress conditions
(Fig. 2). Understanding this mechanism of stress tolerance
along with large number of genes involved in stress signal-
ing network is vital for crop improvement.

Adverse effect of high salinity stress

Salinization of agricultural land is a major concern across the
globe. According to FAO more than 800 million ha of land
is salt-affected worldwide. Soil salinization is getting worse
because of heavy utilization of ground water for agricultural
and industrial purposes, scanty rainfall, repetitive seawa-
ter invasion and degradation of saline parent rock. High
salt concentration in soil imposes both ionic and osmotic
stresses on plants and these primary effects lead to second-
ary stresses by enhancing the production of reactive oxy-
gen species (ROS) which ultimately cause oxidative stress,
damaging proteins, lipids, carbohydrates and nucleic acids.
Many major physiological pathways like photosynthesis,
respiration, nitrogen fixation and carbohydrate metabolism
have been observed to be affected by high salinity.

Salinity stress brings about several adverse effects:
1. Toxicity to plants because of the presence of high levels

of sodium ions that arise from saline soils.
2. Cause adverse effects on K+ ion nutrition (nutrient im-

balance),

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Fig. 2. Schematic representation of stress response and cellular pro le after genesis and translation initiation (Fig. 3). The DEAD-box
the stress perception. With help of receptor (not well known) a plant cell [a motif named after its amino acid sequence (Asp-Glu-
perceive the stress stimuli extracellularly and transduced them to intracel- Ala-Asp)] family of proteins includes a large number of
lular, which activate a large and complex signaling cascade. This resulted in conserved proteins which are found in all organisms from
into the expression of early and delayed stress responsive genes. The prod- bacteria to humans.
ucts of these genes may provide the stress tolerance directly or indirectly.
At the sequence level, helicases have been divided into five
3. Cause disruption of ionic equilibrium (influx of Na+ fa- main groups named as Superfamily (SF) 1 to SF5. The larg-
cilitates uptake of Cl-). est of these groups are SF1 and SF2. These all contain nine
so called helicase motifs, Q, I, Ia, Ib, II, III, IV, V and VI (Fig.
4. Inhibit several cytosolic enzyme activities. 3). In both the SFs, motif I (Walker A) and II (Walker B) are
5. Induce the production of various reactive oxygen spe- highly conserved sequence characteristic of ATPases. All
the helicases exhibit nucleic acid dependent ATPase activi-
cies (ROS) which reduce photosynthesis & cellular me- ty, which provide energy for the helicase action. Since RNA
tabolism. molecules are more prone to forming stable non-functional
6. Cause toxicities (oxidative stress). secondary structures, their proper functioning requires
7. Cause water deficit. RNA chaperones. DEAD-box RNA helicases are the best
8. Decrease soil porosity and thereby reduce soil aeration. candidates for RNA chaperones as these proteins can use
9. Salinity impairs crop production on at least 20 per cent energy derived from ATP hydrolysis to actively disrupt mis-
of irrigated land worldwide. folded RNA structures so that correct folding can occur.

Many genes have been used to overexpress in plants in or- DEAD-box helicases are becoming a subject of increasing
der to develop stress tolerant varieties. One of the impor- importance as they play an important role during develop-
tant gene of DNA/RNA metabolism and protein synthesis ment and stress responses in various organisms. DEAD-
known as PDH45 (helicase/eIF4A) has been used to devel- box helicases constitute a multigene family. Each DEAD-
op salinity stress tolerant crops. box helicase is thought to be differentially regulated during
development and in response to environmental stresses
Stress and helicases in plants. Pea DNA helicase 45 (PDH45), a homologue of
eukaryotic translation initiation factor 4A (eIF4A), was
Since stresses affect the cellular gene expression machin- found to be induced in pea seedling in response to high
ery, molecules involved in nucleic acid metabolism includ- salt (NaCl). When this gene was transformed to tobacco, it
ing helicases are likely to be the target. Most helicases are provided salinity tolerance. This response was specific to
members of DEAD-box protein superfamily and play es- Na+ ions stress, as treatment with Li+ did not induce the
sential roles in basic cellular processes such as DNA repli- transcript.
cation, repair, recombination, transcription, ribosome bio-
The PDH45 transcript was also up-regulated in response
to other abiotic stresses (dehydration, wounding and low
temperature), which suggested that the transcript increase
could be due to water stress resulting from salinity- and
mannitol-induced desiccation. The induction of PDH45
transcript was observed to be induced by the phytohor-
mone, ABA, which suggested that the stress effect may be
mediated through ABA-mediated pathways. The first di-
rect evidence that overexpression of PDH45 confer salinity
stress tolerance in crops without yield loss, has already been
reported. A rice DEAD-box RNA helicase (OsBIRH1) was
shown to function in defense responses against pathogen
and oxidative stresses. Recently, soybean DEAD-box RNA
helicase gene was shown to be induced by low temperature
and high salinity stress.

Development of salinity stress tolerant rice

To begin with, a full-length cDNA (1.63 kb) encoding
PDH45 was cloned (Accession number AY17186) from pea
cDNA library. The 1.22 kb open reading frame (ORF) of

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Fig. 3. (A) Role of helicases. (B) Conserved Sequence Motifs of eIF4A/ sue after 96 h. It was evident that transgenic plants have a
DEAD-box Helicases of Superfamily 2 and their functions. Motif II (Walker better ability to tolerate salinity stress.
B) contains the amino acids DEAD in DEAD-box RNA helicases. The Q mo-
tif is speci c to the family of DEAD-box proteins. Possible mechanisms of helicase action

the PDH45 gene was cloned in plant transformation vec- The structural studies of DEAD-box helicases have sug-
tor (pCAMBIA-1301) containing the hygromycin phospho- gested that the conserved helicase domains cluster together
transferase selectable marker and the reporter GUS gene for the helicase action. However, the exact mechanism of
(Fig. 4A). A competent strain of Agrobacterium tumefaciens helicase-mediated stress tolerance is not currently under-
(LBA4404) was transformed with the construct pCAMBIA- stood. The possible sites of action for the stress-induced
1301/CaMV35S-PDH45 using standard protocols. An im- RNA helicases (or eIF4A) could be at the level of transcrip-
proved Agrobacterium-mediated transformation technol- tion or translation to enhance or stabilize protein synthesis.
ogy developed by us (GM Crops & Food 3(2); http://dx.doi. The possible mechanism of helicase action during stress is
org/10.4161/gmcr.20032) for mature seed-derived callus tis- depicted in Fig. 5.
sues of indica rice cultivar IR64 was used to transform the
PDH45 gene. In response to stress the extra secondary structures could
be formed in the 5’-untranslated region in mRNA of many
The different stages of transformation from mature seeds essential genes, which could be inhibitory for translation.
of rice to mature transgenic rice plants are shown in the These inhibitory secondary structures need to resolve in
Fig. 4B to I. Analysis for the PDH45 transgene integration order to have active translation, as otherwise these RNA
was carried out on the T1 generation of transgenic plants. will act as nonfunctional RNA where protein synthesis
As an initial test, the plants were analyzed by PCR for the cannot proceed.
presence of 1.2 kb PDH45 gene. The integration was then
confirmed by amplification of the expected sizes of 1.2 kb The stress-induced RNA helicase (e.g. PDH45/eIF4A) rec-
in randomly selected five transgenic lines (Fig. 4J). The ognized these nonfunctional RNAs and unwound to re-
transgenic lines were further confirmed by using another solve the secondary structures, which permit the translation
PCR with gene specific forward primer and vector specific initiation to proceed (Fig. 3). Overall, these stress-induced
reverse primer and the expected size of the fragment was helicases help in recovering the functions of the genes for
observed. The Gus activity was visualized in leaf tissue of stress adaptation, which were stopped previously because
all the five transgenic lines. The results show that all were of the negative impact of the stress.
Gus positive (Fig. 4K).
Conclusions
To determine whether PDH45-imparted salinity tolerance
is functionally and genetically stable, the T1 progeny was It is now clear that crops production is decreasing fast be-
analyzed. Seeds from the T0 plants, when plated onto hy- cause of the negative impact of various factors including all
gromycin-containing medium, segregated in the expected kinds of abiotic and biotic stresses. The problem has been
3:1 ratio of Hygr/Hygs. Only the lines germinated on hy- further exacerbated by global warming and climate change.
gromycin plated were carried forward for growth, nutrient, Rise in level of green gases causes global warming which
stress tolerance and yield analysis. To test for salinity toler- disturbed rainfall pattern resulting in frequent drought and
ance, leaf disks from T1 transgenic and wild type (WT) rice flood, sea level rise etc. Such negative factors are emerg-
plants were floated separately on 300 mM NaCl and H2O ing as major threat to food security and agricultural sus-
for 96 h. Salinity-induced loss of chlorophyll was lower in tainability. These negative factors need to be managed ad-
PDH45 over expressing lines compared with those from the equately as agricultural yields may drop by up to 20 per cent
wild type plants (Fig. 4L). The damage caused by stress was otherwise by the year 2050, with national GDP eroding an-
reflected in the degree of bleaching observed in the leaf tis- nually at least by 1per cent or more.

It is presumed that India will be the most populous country
in the world by 2050, with a projected population of over 1.5
billion and will need to double its food production by then
to ensure its food security. High food inflations and food
security have been recurrent features in many countries in-
cluding India.

Ensuring food security then becomes imperative through
improved designer crops that offer more yield under stress
or more nutritional value through transgenic approach.
Where possible, efforts need to be made to mobilize

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conditions. DEAD-box helicases could be good candidates
for developing abiotic stress tolerant crop plants for en-
hanced agricultural production under adverse conditions.

For developing stress tolerant crops with more yield, the
transgenic approach is challenging and is the fastest way
of research for future crop improvement programs. Trans-
genic crops are not to be feared as they are as safe as other
crops. Many GM crops are grown across the world includ-
ing Argentina, Brazil, China and US. India has excellent
expertise and huge potential in developing many GM crops
faster than other countries. With proper opportunity In-
dia could be the leading country in solving the problem of
global food security.

Fig. 4. Di erent stages of developing transgenic PDH45 plants from prepara- Regarding the acceptance of GM crops there is an urgent
tion of gene construct to plant regeneration in indica rice variety, IR64, and need to educate general public, media, NGOs, Ministers
con rmation of gene (PDH45) integration by PCR, Gus assay and Leaf disk and also the scientific community. There is also need to en-
senescence assay. (A) Structure of T-DNA region of pCAMBIA1301 containing hance the public-private co-operation. Besides, innovations
PDH45 gene (1.2 kb) with CaMV35S promoter and poly A terminator (pCAM- in agricultural biotechnology should be need-driven rather
BIA1301-PDH45). (B) Mature seeds of IR64 in callus induction medium for 20 than profit-driven. Genetically engineered food should also
days. (C) After 20 days of calli initiation. (D) Calli sub-cultured on fresh callus be properly labeled.
induction medium for 2 days. (E) Calli in co-cultivation media after transforma-
tion (F) Selection of transformed calli on selection medium having hygromycin
50 mg/l. (G) The resistant calli in MS regeneration medium and emerging shoot
buds on regeneration medium. (H) Shoots in rooting medium. (I) Hardening of
plant and transfer to soil. (J) PCR analysis of the transgenic (T1) lines (L1-L5)
showing the required ampli cation (1.2 kb). (K) Visualization of Gus activity
in the leaf tissue of transgenic lines. (L) Leaf disk senescence assay for salinity
tolerance in transgenic rice plants in 300 mM NaCl and water. Transgenic lines
showing high salinity tolerance as compared to WT. Reproduce with permis-
sion (Plant Signaling & Behavior 7(8), Aug. 2012).

important transgenes, from crops where it has been suc-
cessfully tested, to other elite varieties and close relatives
through conventional breeding methods. Overall, the in-
volvement of DEAD-box helicases in various metabolic
processes in plant cells might have general implications.
Since RNA helicases are known to play key roles in all cel-
lular processes that require modulation of RNA structure, it
is speculated that plant stress-induced RNA helicase might
be required to remove the stress-induced secondary struc-
ture formed in RNA.

This is expected to help in translation of those proteins Fig. 5. Possible mechanism of stress tolerance by a helicase. Eukaryotic
whose synthesis was inhibited due to RNA secondary initiation factor 4A (eIF4A) is a prototypic member of DEAD-box RNA heli-
structures created under the stress conditions. The overex- case family. Abiotic stresses enhance the formation of inhibitory secondary
pression of stress-induced DEAD-box helicase can provide structure at the 5’ UTR of mRNA. This protein is responsible for the removal
a good example for the exploitation of RNA metabolism of the secondary structure of the mRNA. eIF4A along with eIF4B bind to 5’
pathways for engineering stress tolerant crop plants. UTR and unwind the secondary structure in an ATP-dependent manner. This
facilitates the binding of ribosome. After this ribosome scans for start codon
The study on PDH45 provided new insight into a first direct (AUG) and protein synthesis begins normally (adopted from Vashisht and
evidence for a novel function of helicase in conferring sa- Tuteja, 2006).
linity and dehydration stress tolerance in transgenic plants,
without affecting yield, thus suggesting a previously not Narendra Tuteja, Group Leader & Senior Scientist at International
described pathway for manipulating stress tolerance in crop Centre for Genetic Engineering & Biotechnology
plants. These results are an important success and indicate
the potential for improving crop production at sub-optimal

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Need for better understanding
of science in villages

There is a need for greater understanding of science in our villages
and scientists have to share the knowledge and discuss its various
aspects with the local community, said M S Swaminathan, Member
of Parliament (Rajya Sabha), and Chairman, M S Swaminathan
Research Foundation in an address at a CII conference on agri-
biotechnology.

Q. What is the role of education and is need for public education. Actually, In other words, pre breeding and par-
awareness in popularizing the new all the three, education, social mobili- ticipatory breeding is a very powerful
technological innovations in the zation to Panchayats, and regulations method of combining genetic diversity
agri-biotech arena? are important. Regulation alone will with genetic efficiency.
There is definitely a need for greater not help without the other two com-
understanding of science in our vil- ponents. Biotechnological interventions, re-
lages, which I call as genetic literacy. combinant DNA or otherwise, have
In a democratic society, the spent on Q. What other molecular biology added a new dimension to our sci-
education, communication, discussion approaches are used in agriculture entific capability. These are what we
with the local people is important. other than recombinant DNA tech- call as Transformational technology.
nology? And we have to convince people that
Our scientific establishments have to Molecular Biology not always neces- it is a transformational technology–
take home the reality of a democratic sarily means recombinant DNA tech- transformation for good and not for
society where the scientist cannot be nology. We have marker-assisted se- disaster.
the sole proprietor of knowledge. They lection (MAS) breeding. In fact, even
have to share the knowledge and dis- organic agriculture approves varieties Q. How can the socio-economic se-
cuss its various aspects with the local developed by MAS breeding for inclu- curity of the farmer be ensured?
community. sion in organic certification though In the 2004 Task Force report on Ap-
genetically modified crops are pre- plication of Biotechnology in Agricul-
The 2004 Task Force report on Appli- cluded. ture, we had recommended a special
cation of Biotechnology in Agriculture insurance facility.
had made a number of recommenda- The Chinese have used MAS very ef-
tions including media resource centre fectively, and India has a good number Majority of farmers are very small and
for putting out authentic information. of success stories in this area. Another some of them do not even have proper
There is a difference between public approach is Micropropagation that In- irrigation facility. Earlier they used to
relations and public information. Pub- dian Council of Agricultural Research keep their own seeds but now they
lic relation is propaganda, while Public (ICAR) has been focusing on for quite will have to buy seeds at a high price.
information is authentic information. some time. And if the crops fail, then there is no-
We are required to invest little more body to insulate them from loss.
on public information. There is a need for pre- breeding cen-
tres. Many of them can be excellent This is why in the 2004 recommen-
The Krishi Vigyan Kendras (district- breeding centres creating novel ge-
level Farm Science Centre established netic combinations and that can be
by the ICAR) should be strengthened fed into an all-India coordinated grid
wherever there are opportunities for among universities and institutions or
genetically modified crops. it can also be done through participa-
tory breeding method with farming
In a highly democratic society, there families.

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dation, a special insurance was recom- Subsidised food will
mended that could be given along with a
packet of seeds so that the farmers do not prevent demand for
have any difficulty.
new technology
Q. There are many apprehensions re-
garding the forthcoming BRAI 2011 Bill. Urban population will not care about new technologies until the
What are your observations? government stops providing cheap food, says Ajay Vir Jakhar,
There is a need for a considerable degree Chairperson, Bharat Krishak Samaj, in his chat with Jiggyasa
of understanding on how this regulation Srivastava on issues in Indian agriculture.
is really going to lead to a very transpar-
ent and authentic assessment of recent Q. Why adoption of new agri-technologies not a priority for Government?
benefits. There must be media confi- The focus of the government, like in most third world countries, is on provid-
dence, public confidence, professional ing cheap food. As long as the government keeps providing cheap food, the
confidence, and political confidence. urban population will not care about new technologies. In fact, they will be
As you know many states are declaring opposed to it and the demand for new technologies to increase agriculture
themselves as GMO-free states, organic production will never come up.
farming states, and so on.
The urban class does not care if the agriculture production goes up or down.
Therefore, the future of biotechnology If prices go up, government will import and if prices fall, it is good for urban
will depend upon our ability to convince consumers. Ultimately, it is the consumer who is being subsidized and until
people that it has benefitted us; that the subsidies to the consumer keep increasing, there will be no public outcry for
apex regulatory body will add to the better technologies. The focus of the government is to reduce prices, while the
strength of the science. focus should also be on farmer prosperity. These are two completely different
goals. Ironically, everyone is talking about increasing agricultural production
We should develop systems that in- but the moment production goes up, prices come down and the farmer suffers.
spire public confidence. The structure of Only way to bridge this gap is through agricultural reforms.
the Biotechnology regulatory authority
should be at three levels. It should follow Q. What do you think is the need of farmers?
the same template as the biodiversity au- The farmer wants new technologies. About 99 per cent of the farmers will
thority bill because, after all, biodiversity ask for agri-biotechnology. Unfortunately, we have failed to impress upon the
is the feedstock for the Biotechnology in- deciding authorities on the merits of adopting this technology. Here is where
dustry. the industry, media, scientists will have to play a significant role to send the
message across.
There should be a Panchayat-level Biodi-
versity committee, then a state-level Bio- Q. Are many farmers committing suicide due to failure of Bt cotton crop?
diversity board, and a finally a National Many misleading reports exist, stating that farmers are committing suicides
Biodiversity authority. We have to have because of Bt cotton. Bt cotton has been only growing in size year after year.
a similar mechanism for the regulatory Currently, 95 per cent of India’s cotton farmers are growing Bt cotton because
authority at three levels in order to en- of the profit arising out of it. Given this scenario, the talk about suicides is
able people to understand the possibili- simply ridiculous.
ties and potential of biotechnology, and
to take precautions to prevent breakdown There is opposition from many organizations to Bt cotton because of the re-
of resistance after a certain time. luctance to let India become self-dependent. I have personally had a very
good experience with the growth of Bt cotton over the last ten years. Un-
I hope that the final regulatory authority fortunately, more such biotech-enhanced products are not coming into
will be set up soon. We are also making the market. This does not mean that Bt cotton or application of biotech-
large investment in our universities to nology to agriculture is the solution to all problems. But it is a key compo-
train people and they must have a future, nent. Agri-biotechnology is one of the things required though it is not the
and that means we must have a regula- only solution.
tory system that inspires the said public
confidence. And from experience, I know
that it will take time. We have to spread
public education and allay the public ap-
prehension.

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Promote technology at the
grass root level

E orts to promote technology should start at the grass root level,
said M F Farooqui, Additional Secretary, Ministry of Environment &
Forest in an address at a CII conference on Agri-biotechnology.

Q. Why is there a need to adopt good option, as it is a cutting-edge of the answers. This awareness needs
modern technologies in agriculture? technology and has already seen some to be taken across to all stakeholders
Of late, there has been certain moder- remarkable applications in agriculture in a subtle manner, with a deeper and
ation in the Indian growth story. The and health. It crosses the species bar- sustained involvement. Unless our ag-
growth too has not been inclusive. It rier and can take the strong point of riculture grows and rural areas pros-
has not cut across various sectors, and one species and incorporate it into an- per, growth of India will also touch a
one sector that has lagged behind is other species. The power of this tech- plateau, the same way as agriculture
agriculture. This sector touches a large nology is phenomenal. production touched the plateau in the
number of people, and it is hence im- 90s.
perative that the next wave of reforms Q. How important is the role of
is rooted in rural and agricultural sec- information dissemination and Q. Will the adoption of biotechnol-
tor. The Millennium Development involvement of all stakeholders in
Goals (MDG) target of cutting down successful technology adoption? ogy in agriculture further aggravate
the proportion of hungry people to The public has a lot of misinforma-
half is not going to be easy for India tion and misapprehensions about the the poor socioeconomic condition of
to achieve. In fact, the per capita avail- adoption of biotechnology in agricul-
ability as well as consumption of food ture. If we want to address the con- the Indian farmer?
grains in India has declined since cerns, we need to engage the public It is extensively contended that the
1996. According to statistics, the per- in discussions and convince them. We risk taking capacity of an average In-
centage of underweight children has need to reach out to the larger section dian farmer is very low; therefore, a
remained stagnant between 1998 and of the stakeholders – the man at the technology that involves a lot of in-
2006, and the calorie consumption of grass root level – as he plays an equal- vestment is clearly and distinctively
the bottom segment of the population ly important role in democracy. Efforts more risky than the farmer’s risk-
has been consistently declining since to promote technology should start at taking ability. What is needed here
1987. the grass root level. is greater financial inclusion, and ap-
plication of technology to the entire
Food grain availability, which rose There have been cases of Chief agriculture sector, than merely sup-
from 416 grams in 1950-55 to 485 Ministers informing the Ministry of plying agricultural solutions. It has
grams in 1989-90, is currently around Environment and Forests about their to encompass and cover economists,
450 grams. Compared to other parts reluctance to allow even testing of ge- policymaking, market, supply chain
of the world, India’s per capita con- netically modified crops in contained management, post harvesting and
sumption is nearly one-fifth of what conditions in their states. If politi- many others. There is a need to look
US consumes in cereals and half with cal leadership or scientists cannot be at the big picture and this is more rel-
regard to China. There is thus a strong convinced, chances of convincing sec- evant in the context of Biotechnology
need to increase production and pro- tions at the lower level are definitely where investments are high and so is
ductivity by using modern technolo- more remote. vulnerability.
gies.
India, even in the worst of times, has
Q. What is the signi cance of DNA been receptive to technology and new
technology in agriculture? ideas. India has followed a growth
With limitations to tissue culture and path that has been knowledge-driven.
molecular marker technology, genetic Being receptive to new ideas, we are
manipulation technology offers a very aware that biotechnology has many

LIFESCIENCE INDIA | October-November 2012 35

LSI
INTERVIEW

Biotechnology does not
hamper biodiversity

In a freewheeling discussion with Rolly Dureha, Dr KC Bansal,
Director, National Bureau of Plant Genetic Resources (NBPGR),
expresses his views about the merits of adopting modern
technological innovations in farming.

Q. Are GM crops relevant to India? by developing GM chickpea and pi- rules cover areas of research, develop-
Looking at the progress of GM crops geon pea resistant to pod borer. Other ment, large-scale use and imports of
globally, it is clear that a country traits which can be introduced include biotech organisms and their products
like India with focus on agriculture, disease resistance (against viruses), and have identified six competent au-
should embrace GM technology to sucking pest resistance, drought and thorities for handling these tasks. In
bring all the benefits which Indian salinity tolerance and nutritionally en- 1990, the Department of Biotechnol-
farmers deserve. Since GM technol- riched traits. Indian agriculture needs ogy (DBT), in the Ministry of Science
ogy is scale neutral, equally beneficial to deal urgently with the frequency and Technology formulated Recombi-
to small and big holding farmers, it as- and severity of drought conditions. nant DNA Guidelines that were fur-
sumes greater significance for increas- With 65 per cent of our agriculture be- ther updated in 1994. Additionally, in
ing profitability of small and marginal ing rain-fed, it is vital to develop crops 1998, the DBT issued separate guide-
farmers. With nearly 60 per cent of the resilient to drought and ones which lines for carrying out research on bio-
population dependent on agriculture, can efficiently utilize available soil tech plants and imports and shipment
there is a need to enhance agricultural moisture. of biotech plants for research use. Over
productivity, efficiency and produc- the years, the regulatory agencies in-
tion in a safe and affordable manner Q. Does promoting agricultural volved have come up with guidelines
and this is where GM technology and standard operating procedures.
comes in. Besides, GM crops assume biotechnology cause loss of biodi-
greater relevance, if developed with Q. How has the rst decade of Bt
traits where conventional breeding versity?
methods have no such scope. While it is perceived that biotech cotton been and what do you expect
would reduce biological diversity, de-
Q. What agronomic traits can be velopments in agriculture through from the second decade?
conventional or GM technology have The first decade of Bt cotton was one
introduced to increase food produc- helped save biodiversity. This is par- of fast adoption of GM technology
ticularly true with GM crops toler- with cotton farmers reaping enormous
tion through GM technology? ant to herbicides and insect/pests, benefits. The average national cotton
Green Revolution, with the introduc- resulting in adoption of conservation yield rose to 500 kg lint per hectare in
tion of dwarf varieties of wheat and technology and reduced insecticide 2010 from a mere 300 kg lint per ha
rice in 1970s, ensured food security use. Interaction with Punjab farmers prior to the introduction of Bt cotton
and self-sufficiency. However over the growing Bt cotton confirmed signifi- in 2002. This increase in yield had a
last decade, yields of cereal crops have cant increase in bee population over significant impact on the profitability
stagnated. While self-sufficiency ex- the last few years. Further, GM crops, of cotton farmers, who were losing
ists in cereal grains, yield and produc- which are high yielding, will use less cotton crop year after year to Halicov-
tivity of dry land crops, mostly grain land to meet the increased demand, in erpa armigera – a deadly insect-pest
legumes and oil seeds remain low. No turn conserving agro-biodiversity on of cotton, prompting millions of small
major breakthrough in productivity farm. farmers to return to cotton crop. Cot-
enhancement has been achieved. It ton acreage increased significantly
is important to increase production Q. How rigorous is biosafety regu- with a harvest of 35 million bales in
of pulses, particularly chickpea and 2010, almost triple as compared to 13
pigeon pea, which can be achieved lation of GM Crops in India? million bales recorded as highest prior
India has one of the most comprehen- to Bt cotton in 2002. The second de-
sive biosafety regulatory systems as cade of GM technology needs to focus
compared to other developing coun- on broadening and extension to other
tries and is on par with the regula- crops including pulses – chickpea and
tory system in developed countries. Its

36 LIFESCIENCE INDIA | October-November 2012

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INTERVIEW

pigeon pea, rice, wheat, maize, mustard and Scientists should
fruits and vegetables for ensuring food and in uence
nutritional security. government policy

Q. What other biotechnological approach- Science has moved faster than public perception, says
Dr. Swapan Kumar Datta, Deputy Director General (Crop
es are relevant to Indian Agriculture? Science), ICAR (Indian Council of Agricultural Resources)
There are several biotechnological approaches in a chat with Jiggyasa Srivastava on the need for a
useful for improving food production such as stringent and sustainable BRAI Bill.
molecular marker aided selection techniques
and TILLING and Eco-TILLING to harness Q. Do you think India should adopt GM technology?
the natural genetic variability for creation GM technology is a science based technology to address present needs and
and/or identification of genetic resources with modernize agriculture.
novel traits. Plastid transformation is another
such transformation technology which can Q. Is agri-biotechnology the answer to address food challenges?
assist crop improvement, particularly by em- Productivity of food crop has been stagnant over the last three decades.
ploying native bacterial genes. Other useful With water scarcity and adverse climate change, it is important to produce
genomics based tools are fast becoming an climate resilient crops. With horizontal growth in agriculture no more pos-
integral part of plant breeding system. sible as land is limited, we need to look at vertical growth. Both soil fertility
and genetic resources have reached bottom line, which calls for a science &
Q. How do you rate plastid transformation technology based plant breeding.

potential in crop improvement? Q. What ecosystem and policies are needed to support stakeholders?
Plastid transformation is an alternative to Government policy needs to be open and neutral. Scientists need to be
nuclear transformation technology for crop given freedom as their efforts may sometimes produce effective results,
improvement. This technology is of para- sometimes fail and yet at other times take longer to complete. Government
mount importance for expressing native policy should support and promote scientists.
bacterial genes, individually or in combina-
tion of 3-4 genes, in plants/crops of agricul- Q. What is your view on allegations that GM crops can be hazardous?
tural importance. Using plastid transforma- Science has moved faster than public perception, with tremendous achieve-
tion method, researchers have shown native ment made over the last two decades. We have however failed to make
Bt genes to express at high levels of protein people understand about science and its importance. Scientists should in-
product, ranging from 3-40 per cent of total fluence government policy as well as convey their message effectively to
soluble proteins in leaves. Further, introduc- the public.
tion of a single operon to express several
genes can avoid the use of different selection Q. Should biotechnology regulatory body be autonomous?
markers. Introduction of several agronomic It is a good idea to have an independent, autonomous and professionally
traits such as resistance to herbicide, insects led body to provide a single window mechanism for biosafety clearance of
and pathogens, abiotic stress tolerance and genetically modified products and processes.
increased photosynthesis have been dem-
onstrated through plastid transformation Q. What are your expectations from BRAI Bill?
in model plant tobacco and few crop plants. The bill should be introduced in the Parliament quickly. There should be
However, there are limitations to its routine discussion amongst stakeholders with scientists and subject experts an-
employment for crop improvement such as swering queries. Besides, the bill should be passed in a single window sys-
the pre-requisite of an efficient regeneration tem. While biotechnology is vitally needed for agriculture, industry is not
system preferably employing green tissues yet ready to invest money, due to lack of clarity about its future. A stringent
with abundant chloroplasts. This is the rea- and sustainable government policy is needed to strengthen and boost bio-
son plastid transformation is mostly success- technology.
ful in tobacco or other solanaceous plants like
potato, tomato and brinjal. Major challenge is
to extend this technology to crops, especially
cereals like rice, wheat and maize that mostly
regenerate through somatic embryogenesis.
Efforts are in progress globally to overcome
these limitations.

(The views expressed belong to the individual
and not necessarily to his organization.)

LIFESCIENCE INDIA | October-November 2012 37

LSI
INTERVIEW

Biotech crops most rigorously
tested food in history

Small and large farmers worldwide are adopting biotech crops
due to the bene ts of the technology says Dr. Gyanendra
Shukla, Director, Monsanto India in his discussion with Hareeni
Mageswaran on the issues dogging Indian agriculture.

Q. What options do you think India into the environment since 1996. nies result in frequent increase in
has to ensure a sustainable food se- Many prestigious groups and scien- prices and make it di cult for small
curity for its people? tific and regulatory authorities across farmers to adopt the technology?
Farmers need to produce more food, the globe have found biotech crops to In kharif 2012, 60 lakh farmers across
feed, and fibre using stagnant or di- be as safe as conventional crops, and nine cotton growing states chose from
minishing natural resources and stated that foods from biotech crops 850+ hybrid Bt cotton seed brands
amidst a changing climate. are thoroughly evaluated through with five in-the-seed insect protection
comprehensive testing for food, feed, Bt cotton technologies approved; plus
The solution is to enable farmers to and environmental safety. non-Bt varietal cotton seeds. Indian
produce more using fewer natural cotton farmers have the widest choice
resources. Given land availability is Twenty-five Nobel Prize recipients of cotton seeds in the world.
constant and productivity require- and more than 3,400 prominent sci-
ments are increasing, we believe in- entists have expressed their support Hybrid cotton seeds with insect-pro-
novation and partnerships can make for plant biotechnology as a “powerful tection Bt cotton technologies consti-
India a self-sufficient global contribu- and safe” way to improve agriculture tute only 10-12 per cent of farmers'
tor in agriculture. and the environment. per acre production cost of Rs. 12,000-
14,000 per acre.
Q. What is your view on GM crops Q. What is your view on the eld tri-
labelled as hazardous for both hu- als these crops undergo? How do you If one considers the insecticide sav-
mans and environment? think they can be made foolproof? ings for bollworms, and the incremen-
Small and large farmers worldwide The Indian Regulatory system has tal yield, the farmer income increases
are adopting biotech crops due to the evolved taking into cognizance the per acre in comparison with the farm-
benefits of the technology such as Regulatory systems from around the er choice of using non-Bt cotton seeds
in-built protection against pests and world. It is compliant with Codex Ali- along with insecticide spraying.
other stresses. mentarius Commission (created by
FAO and WHO to develop food stan- Q. Do you think the regulatory body
Globally, 55 countries have granted dards, guidelines, and related texts for should be independent?
regulatory approvals to biotech crops safety testing of biotech crops), and is With the Government’s articulation
for food and feed use and for release comparable with other nations that of its policy to use newer tools and
approve biotech crops for cultivation technologies including applications of
and import. biotechnology to address agriculture
productivity and stresses related chal-
Biotech crops are among the most rig- lenges, we believe the Biotech Regu-
orously tested food in history. Before latory Body should consist of experts
commercialization, they undergo rig- in relevant areas of science and lay out
orous government-mandated safety fair, predictable, transparent, science-
testing and regulatory assessment, based, and time-bound process in-
spanning multiple years and system- cluding data requirements.
atic testing.
In the interest of farmers accessing
Q. Doesn’t monopoly and patent cutting–edge technologies as their
protection on MNC seed compa- global counterparts, this body should

38 LIFESCIENCE INDIA | October-November 2012

LSI
INTERVIEW

be free to take science-based decisions Biotechnology
without any political interference. is extension of
If that is ensured, then the Biotech Regula- nature
tory Body can be affiliated to any relevant
ministry or be independent. We need to welcome new concepts with an open mind, says
Ashwin Shro , Chairman Excel Industries, in his chat with
Q. In your opinion what should be In- LifeScience India on issues concerning Indian agriculture.
dian regulator’s stand, product-based or
process-based? Q. What ecosystem and policies are required to ensure a sustainable
We believe regulators should evaluate food security?
safety and efficacy of the product and the The need of the hour is to welcome new concepts with an open mind
process that may have been followed to – bearing in mind global and local experience – and implement it in
develop the product, if the end product re- phases. For example, introduce non-edible crops first and then move to
mains the same. edible crops. Ancient wisdom and practices should not be discarded as
old and outdated. There is a need to retain and practice what is good and
To simplify the same, if a traited product is relevant, and modify known practices with new knowledge as needed.
developed using mutagenesis as a process
and the same traited product is developed Biotechnology is an extension of nature with healthy and constructive
using transgenic technology, the process intervention. All elements of agriculture and food production and
to assess both the products should remain processing–be it soil, water, seeds and planting material, nutrients,
the same irrespective of what process was pest management, post-harvest storage and processing, farm and
used to develop these products. This is the transport energy needs for agricultural production – can benefit from
“Product based” model. biotechnology, if properly understood and applied.

Q. There is no such labelling of GM It is also important to educate and impart knowledge of agri-
foods, nor do they undergo any compul- biotechnology to consumers, besides policy makers and decision
sory testing. Isn't this a violation of con- makers.
sumer rights?
Most consumers expect food labels to pro- Q. What is your view on the allegations that GM crops could be
vide nutrition and safety information. For hazardous for both human and environment?
more than a decade, food manufactur- GM crops produced by applying biotech sciences to crop varieties with
ers have been using GM grain and oils in the idea of imparting different traits have been developed, grown,
many of their foods products – corn or soy and consumed for a sufficiently long time to dispel unfounded and
ingredients, for example – and are not re- imaginary fears.
quired to label the products because there
is no difference in the safety or nutrition However, like with any technology and innovative concepts, monitoring
compared to the conventional corn or soy and observation to detect and if possible, rectify any undesirable side
ingredients. effects have to be undertaken. New concept must be discarded if
harmful effects outweigh benefits. These ideas need to be objectively
The FDA would require labelling if a GM evaluated and propagated.
ingredient changed the nutritional content
of the food or presented a safety or aller- Q. Do you think the regulatory body should be an independent?
gy risk. Most food manufacturers haven’t The regulator should be an independent body as has been the trend in
heard from customers that want informa- India in last decade or so. It should be manned by persons of knowledge
tion about GM ingredients on product la- and integrity.
bels and accordingly haven’t put such in-
formation on their products voluntarily.

We respect people's right to choose the
foods they eat. For those who want to
avoid foods containing GMOs, products
produced and labelled according to US-
DA’s National Organic Program already
provides an option.

LIFESCIENCE INDIA | October-November 2012 39

LSI
INTERVIEW

Agri-biotech is the solution
for food security of future

Introducing GM crop varieties is certainly necessary for a
developing country like India, says Dr. Alok Adholeya, Director,
Biotechnology & Bioresources Division, The Energy and Resources
Institute (TERI), in his lengthy chat with Jiggyasa Srivastava on the
pressing issues in Indian agriculture that need to be addressed.

Q. With India’s population expected efficiency become very important as- (MSP) for some crops. MSP for a mar-
to reach 1.5 billion by 2025, coupled pects. ginal farmer with a very small holding
with dwindling water and land re- works well because of the assurance of
sources, what are the options to en- Q. Would agri-biotechnology pro- purchase price.
sure food security? vide solution to this problem? To increase productivity and area cov-
Food security is a global issue and es- Agri-biotechnology is the solution for erage of pulses and oilseeds, which
pecially in India, with its vast popu- future progress, meeting requirements the country is currently importing,
lation and growing economy. What and providing food security. Besides, incentives through policies need to
compounds the situation is our cur- it requires understanding at the scien- be in place to induce farmers to grow
rent low per unit area productivity as tific level to figure out the gap areas them. To further improve productiv-
compared to global standards. that need to be addressed. There also ity, resource efficiency as stated earlier
has to be a very good extension sys- and match the crop in the given region
Unfortunately, our resources such as tem that could bring in the problems needs to be in place.
fertilizer inputs are insufficient and at the research level.
our farming practices are yet to reach Currently there are problems of mis-
the stage of precision farming or mod- A comprehensive network effort matching of crops. For instance, Pun-
ern farming. Policies opted for pro- should be in place through which so- jab is facing a major problem due to
viding subsidy are not able to align lutions can be found as well as take paddy cultivation, while earlier it used
with resource efficiency. Efforts have the solutions back to the inducer. to be a corn- and soybean-producing
certainly been made with the govern- From this context, agri-biotechnology state. These are lessons to be learnt
ment coming up with a nutrient-based is definitely the need of the hour and and implemented.
subsidy proposal though this is yet to the amalgamation of knowledge shar-
take shape. ing, logistics, and management are Q. How do you view the allegations
important. that GM crops could be hazardous
Introducing GM crop varieties are for human consumption and the en-
certainly necessary for a developing Q. What kind of ecosystem and poli- vironment?
country like India. However, a point cies are needed to support key stake- Science and technology has a ma-
to be noted is that, no plant with im- holders to achieve their best? jor role to play in terms of what can
proved genetic character can result In a country like India, with its large cause an impact on human life. It is
in high yield unless the resources are ecological zones, diversity and sys- important to devise ways by which
provided. Food security should hence tem, a single recommendation or sin- exposure is minimised and productiv-
be looked at from the point of efficient gle solution is not the answer. What ity is maximised. Many success stories
resource utilization. For this, soil, is needed is mapping of resources prevail across the globe but replicating
nutrient system, land, and water use and their potential and matching the them is possible only when that tech-
cropping areas, keeping in view the nology and knowledge is customised
resource availability of that region. to suit regional conditions. The GM
The next step is to develop further the crops, the hybrid technology are a
systems like Minimum Support Price very important breakthrough. But it

40 LIFESCIENCE INDIA | October-November 2012

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INTERVIEW

is important to ensure that the movement We need to
is sustainable. In a recent interaction with make India
industry-based plant breeders, it became food surplus
evident that breeded lines do not get sup-
port from soil microorganisms, which
otherwise used to provide several benefits
in terms of disease protection, nutrient
uptake and so on. Unfortunately, in the
process of development, inadvertently,
desirable traits of nature are left out.

These breeders are now looking forward Consensus amongst stake holders and appropriate application of
to select new lines that can utilise these
traits. But new lines do not favour these technology can turn India into a food surplus state, says Prakash
organisms.
Apte, Non-executive Chairman, Syngenta India in his chat with
This means, we need to find those organ-
isms, bring them back, produce them on LifeSciences India on issues concerning agriculture and bio-
large quantities and then bring back a
system which was more sustainable. technology.

Q. Should the biotechnology regula- Q. What is the promise and potential of agri-biotechnology?
tory body be totally independent or at- Speaking of agri-biotechnology, it is important to first check if deploying
tached to a government arm? this technology on the ground will impact the environment or the delicate
I think that the regulatory agency should ecological balance. On the same lines, its benefit on the future generations
be independent, but at the same time, it in terms of its impact also needs to be assessed. For instance, special needs,
has to be highly pragmatic. They should such as enriching the food with vitamin A for the children as the deficiency
be able to collect, absorb and analyse data of vitamin A is a major issue in the country, is a possible benefit that can
and also be able to draw directions and happen. The question here is: does biotechnology have the potential to deliver
advices from several stakeholders in the solutions? If it has, then it certainly needs to be looked at it with an open
sector, so that progress in each sub-sector mind. It is a good idea to assess the cost-benefit ratio too, as well as where the
is simultaneous. benefits are going. Matters such as the long-term impact of this technology,
whether it is worthwhile to absorb and assimilate this technology, are other
Q. Should our Biotechnology regulato- key areas to be dealt with. The performance of Bt cotton over the last 10 years
ry regime be product-based or process- has proved beyond doubt that this technology is beneficial. It has changed
based? India from being a net importer of cotton to a net exporter of cotton. India
Historically, the best practices from every- today has become the third largest cotton growing country in the world.
where has been picked and incorporated. About 6.4 million small farmers having very small fields have benefitted from
While that may seem like a smart choice, this technology. So it is not just about big farmers and corporations benefitting
it is important to choose that which is from this transformation. Having reaped the benefits of Bt cotton over the
right and suitable to individual cases. It is last decade, it is now time to extend this further to cover other aspects of
also important to base the decision mak- agriculture and crops where this technology can be used to solve emerging
ing process on a well-informed and well- problems such as climate variations impacting food production. For instance,
discussed process. crops that require lesser water can be evolved using this technology which
would have a positive impact on Indian agriculture.
Q. What is your expectation from the
Biotechnology Regulatory Authority Q. What strategy would you sugest to take agri-biotechnology forward?
Bill? Primarily, all stakeholders need to come together and align, such as people
The bill is important from the point of who have concerns about the technology, those who have the technology, those
view of every stakeholder. If the inter- actually working on the field and finally the planning authorities. Further,
nal regulatory mechanism evolves and the industry, academicians, politicians and policy makers need to engage and
becomes mature through the policy or increase their footprint, educate both rural and urban consumers. Information
the bill that the Parliament enacts, it will about facts need to be passed to the people involved. Given our abundant
definitely bring in the much needed di- sunlight, agricultural land, scientists, technologies as well as enterprising
rections. farmers who have enabled a food deficient country to become food sufficient,
changing the country into a food surplus state is certainly a possible task. What
is required is appropriate harnessing and application of this technology.

LIFESCIENCE INDIA | October-November 2012 41

LSI
INTERVIEW

Agri-biotechnology o ers
ninety per cent solution

There is no report of health hazards faced due to consumption
of GM foods from any country that permit GM products, says
Mr. P. Chengal Reddy, Secretary General of Consortium of Indian
Farmers Association (CIFA) in a chat with Jiggyasa Srivastava
on how agri-biotechnology can provide solutions to the critical
problems a ecting agriculture.

Q. Do you think India should adopt biotech provides value addition to been reached. New kinds of biotech-
GM technology? crop yield. Conventional farming un- nology like GM technology are the
Certainly. Agri-biotechnology pro- fortunately cannot offer solution to all need of the hour.
vides answers to most of the present- these problems. Remarkable progress
day agricultural challenges. was seen over the last two decades in Given the large middle class consum-
two segments, Bt cotton and Maize ers of 400 million who are looking for
Q. What are the options for India to with the prospect of India becoming high-quality food, the huge invest-
ensure sustainable food security? number one in Bt cotton production ment base that is available coupled
It’s not just food security but meet- next year. with a very capable managerial class,
ing food needs. Our consumption has the time is ripe for bringing in a sec-
increased consistently over the years Q. Do you consider GM crops to be ond revolution.
including milk, fruits, vegetables and hazardous for humans and the envi-
other value-added products. ronment? Fortunately, the country also has ex-
So far, there has been no report of tremely good agro climatic conditions
The solution is to increase per hect- health hazards faced due to consump- and highly adaptable farmers.
are productivity, besides addressing tion of GM foods from any of the
resistance to pests and diseases. Food countries that permit GM products. Training of Indian farmers is however
wastage too needs to be curtailed. The US has allowed the consumption vitally important to bring about criti-
Biotechnology along with irrigation of GM foods for the last decade and cal changes.
facility and agriculture will change a half, where over 300 million Ameri-
the face of India over the next 5 years. cans along with 60 million European Q. How can farming practices in In-
tourists and about 0.3 million Indian dia be scaled up to match world-class
Q. Do you think agri-biotechnology tourists have been consumers. Like- standards?
can solve this problem? wise, about 300 million Chinese con- The asset of Indian farmer is his adapt-
Agri-biotechnology will solve 90 per sume GM food. ability. Indian farmers have adapted to
cent of farmers’ problems. The basic every technology and market condi-
challenges to crops are pests, water The global GM crop areas increased tions.
stress, variable climatic conditions, al- from 4.3 million hectares in 1996 to
kalinity/salinity of soil, for which bio- 148 million hectares by 2010 without The last several years have also seen
technology provides solution. Besides, a single incidence of hazard to human enormous competitiveness amongst
health. the farmers. With FDI, long-term pol-
icies, invention of better technology,
Q. If India needs a second green assured yield is certain but to achieve
revolution, how can that be brought this, liberalization of the farms is re-
about? quired. India's 600 million small farm-
Without prioritising agricultural de- ers should be in a position to compete
velopment, India cannot achieve all- with farmers in the US, Brazil, and
round development. The limits of the China. For that, GM crops are an ab-
green revolution technology have solute must.

42 LIFESCIENCE INDIA | October-November 2012

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holders in one of the fastest growing sector.

LSI is available in print and digital (e-zine) version

LSI reaches to over 45,000 targeted readers who drive the sector in India, spread across the country, e ectively making it
one of the rst of its kind in this space. In addition to CII Life Sciences & Healthcare members, its dedicated readers base
include key decision makers in Life Science and healthcare organizations in India and across the globe, fund managers, in-

uencers, research heads, institutional heads, ministries and government departments, state governments, Global Industry
Chambers, Trade promotion organizations of various countries, hospitals. LSI by virtue of being a CII initiative also enjoys
the reputation of a policy discussion platform and therefore, has the reach to policymakers and regulators governing the
life sciences and allied sector. Through its digital version or e-magazine it is reaching to 3,00,000 readers globally. Mapped
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LSI
COVER STORY

GM crops: Future in limbo

Research in GM -Rolly Dureha research and development on transgenics
crops faces road in agricultural crops should only be done
blocks as landmark August 2012 is a particularly signifi- in strict containment. Field trials under any
Parliamentary cant month for Indian agri-biotech- garb should be discontinued forthwith.”
Committee nology. This is the period when
decision comes out the Parliamentary Committee on Agricul- The major reasons for this outright rejec-
strongly against ture came out strongly against genetically tion of GM crops include a perceived loss
genetically modi ed modified crops, virtually blocking future of biodiversity, biosafety concerns re-
crops, virtually developments in this area. The 492 page garding human health, livestock and ani-
blocking future lengthy report on “Cultivation of Geneti- mal health, inadequacy of the regulatory
developments in cally Modified Food Crops -Prospects and mechanism, “lack of trickle-down” gain
this area. Effects” unequivocally rejected the option to farmers among many others. While not
of genetically modified food crops for the discounting any of the concerns raised by
country. Cutting across party lines, all 31 the honourable Parliamentary members, it
panel members were unanimous in their is expected that such a high level commit-
decision to veto GM crops, without a single
note of dissent. The report stated, “Further

44 LIFESCIENCE INDIA | October-November 2012

LSI
COVER STORY

tee should have gone into the mer- not caused any major influence on desirability and feasibility of field tri-
its of GM crops and looked at their plant productivity or posed hazards als for genetically modified crops. In-
prospects in totality before coming to same or alien species. Just because cidentally, the issue of GM crops have
up with such a strong decision. The the creation of GMOs is accelerated by been in the apex court since 2004 and
bigger question that needs to be ad- process in laboratories, does not make it has passed several orders. While
dressed is how to maximize R&D in the process and products dangerous. allowing field trials, the Court had
the country in agri-biotechnology, The impediments introduced on the imposed certain restrictions includ-
the different approaches available science based regulatory system will ing increase of the isolation distance
rather than focussing narrowly on Bt rob poor farmers of protection from to 200 metres between GM planted
cotton and Bt brinjal alone. The panel pests, agricultural diseases and cli- fields and other fields, besides bring-
should have also explored issues like matic changes.” ing in a protocol for testing contami-
India’s requirement for further R&D nation up to 0.01 percent of neigh-
collaboration with public sector insti- According to Garg, dependence on bouring fields.
tutions in other countries to bring out conventional breeding would fail to
new agri-products which will arrest provide food security and protec- Currently, GM crops sporting insect
the monopoly of multinationals, high tion from famine. Scientific advances resistance, disease resistance, herbi-
seed cost and IPR issues. need to be kept away from geopoliti- cide tolerance, hybrid production, im-
cal or ideological concerns, he further proved oil quality, etc. have occupied
Recommendations of policymak- added. While it is not mandatory for 148 million hectares of land across the
ers provide a roadmap for the future government to accept parliamentary globe, leading to substantial social,
and this requires a need to broaden standing committee's recommenda- economic and environmental ben-
perspectives and have foresight to fa- tions, suggestions of such panel re- efits. Even in the European Union,
cilitate technology development via ports do influence government policy. known for its cautious approach to-
improved breeding mechanisms and Besides, the report is significant as it wards GM technology, it has been
biotechnology in the agricultural are- comes at a time when Centre is trying acknowledged that biotechnology
na. Incidentally, the decision to im- to introduce a new regulatory system and in particular GMOs are per se not
port seeds of high yielding wheat va- for GM products (The Biotechnology riskier than conventional plant breed-
rieties in the 1960’s was taken against Regulatory Authority of India) which ing technologies. This was stated in a
stiff political opposition. However, it incidentally is aimed at streamlining recently released report by European
is this that turned the tide and ush- existing regulatory process. Mean- Commission on “A decade of EU-
ered in Green Revolution, making In- while, Supreme Court has sought re- funded GMO research, 2001-2010”
dia food surplus. port from an expert committee on the based on more than 130 research
projects, covering over 25 years of re-
Reacting to the recommendations of search projects that involved over 500
the Parliamentary Committee report, independent research groups.
Dr GK Garg, Director, Krishidhan
Research Foundation, said, “The hon- Back home, the Hyderabad based Na-
ourable parliamentary standing com- tional Institute of Nutrition (NIN) has
mittee has been unduly influenced by vindicated the stand of Bt Brinjal sci-
the views of Anti GMO lobby. We are entists claiming that it is safe in ev-
hopeful that the report will not get ery respect. An exhaustive report on
adopted on face value but will pass the laboratory experiments carried
through informed debate within the out on its safety has been submitted
Government and inside the Parlia- to the Review Committee on Genetic
ment.” Manipulation (RCGM) of the Depart-
ment of Biotechnology. The pre-clin-
He further added that the report ical tests conducted at the NIN show
failed to recognize that most of the that Bt Brinjal is as safe as its non Bt
genes used in GMO have natural ori- counterparts. A moratorium on com-
gin which are transferred and tested mercialisation of Bt brinjal had been
under field condition for validation to imposed in February 2010 by the then
minimize inadvertent loss of produc- Minister of Environment and Forests
tivity that happen in nature because Jairam Ramesh amidst a huge public
of various factors. “Transposons are outcry regarding its biosafety and en-
natural Genetic engineers and have vironmental concerns.

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bates and discussions, the GoM finally
approved the national pharmaceuti-
cal pricing policy (NPPP) in the third
week of September to control the pric-
es of all 348 essential drugs and adopt-
ed the weighted average price (WAP)
mechanism to cap the prices. The aver-
age price of a formulation derived from
same molecule will be worked out by
taking into account prices of all brands
having market share of one per cent or
more. The recommendation to this ef-
fect has been forwarded to the Union
Cabinet who in turn, in a submission
to the Supreme Court, has promised
to take the final decision in the third
week of November 2012.

Thanks to Supreme Court’s intervention, the long-pending The impact of the recommendation
drug pricing policy will soon be announced by the on industry will be massive as 348 es-
government. But it will have to tackle many prickly issues sential drugs have a total sale value
before it does so. of around Rs 30,000 crore a year, ac-
counting for an estimated 60 per cent
-Dilip Maitra two opinions about the fact that the of the domestic pharmaceutical mar-
pharmaceutical industry needs to have ket. There is also a huge jump in num-
The process of economic liber- some price regulations on its products ber of drugs as at present only 74 bulk
alisation that started from the because the vast majority of poor In- drugs and their formulations are under
early 1990s has seen most indus- dians need affordable healthcare. So, the control of the government.
tries in India going out of the draco- when recently the empowered Group
nian licensed raj that almost crippled of Ministers (GoM) at the Centre rec- Announcing the decision of the GoM
the economy. But among the few in- ommended that 348 drugs should be the Union Agriculture Minister Sharad
dustries which still come under gov- brought under the price control, no one Pawar had said, "We have finalised ev-
ernment’s partial price control, an questioned the larger socio-economic erything. Now it will go to the Cabi-
important one is the drugs and phar- objective of the move. But different net and the Cabinet will take the final
maceuticals industry. While the entire constituents of the industry and the view.” Apart from Pawar the other
industrial sector has enjoyed and pros- consumers are divided on the implica- members of the G0M are Fertilisers
pered from the wave of liberalization tions on the industry and the impact and Chemicals Minister Srikant Jena,
that swept the Indian economy in the on pricing. After several years of de- Commerce Minister Anand Sharma,
last two-and-half decades, there is no Health Minister Ghulam Nabi Azad,
Minister for HRD, Communications
and IT Kapil Sibal, Law Minister Sal-
man Khurshid and Planning Com-
mission Deputy Chairman Montek
Singh Ahluwalia.The GoM was given
the task in 2009, to finalise a mecha-
nism to control the prices of 348 es-
sential drugs and their combinations,

46 LIFESCIENCE INDIA | October-November 2012

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based on the draft proposal and sug- as 60 per cent of the pharma market large market share will certainly see
gestions from various stakeholders. comes under price control. Experts be- margin erosion. In this context, Tapan
The purpose was to make medicines lieve that within the industry different Ray, Director General Organisation
and healthcare affordable. The previ- segments will be affected differently. of Pharmaceutical Producers in India
ous GoM on pharma, set up in Janu- While the large and dominant players OPPI – a body representing multina-
ary 2007, was also headed by Pawar. will take bigger hits smaller compa- tional drug companies in India, said
However no rrecommendations were nies may benefit. Multinational com- that the key objective of the Drug Price
made in 2007 and 2008. panies who have large domestic sales Control in India is to ensure adequate
may also be more affected than those access to essential medicines for the
The legal angle who have large exports. common man. To achieve this objec-
tive meaningfully, the process that
Currently, under the Drug Price Impact on industry price regulator should follow must al-
Control Order (DPCO) 1995 only 74 ways ensure that such medicines are
molecules come under price control. Thus MNC drug makers like Novar- adequate and reasonably affordable.
Since the government failed to come tis, Pfizer, GlaxoSmithkline (GSK),
out with a revised list of National List Abbott, Ranbaxy etc will see a large Ray wrote that the DPCO of 1995 did
of Essential Medicine (NLEM) and a erosion in profits as their domestic not achieve this as production of many
new price control mechanism, All In- sales account for the highest chunk of drugs stopped due to non-remunera-
dia Drug Action Network (AIDAN), revenue and profit. GSK, for example, tive prices. Further more, “The pre-
a NGO, and others filed a public in- derives 98 per cent of sales from do- vailing price control mechanism has
terest litigation in Supreme Court in mestic market and the SBI Capital failed to meet the above two critical
2003 seeking a quick decision. Market in a study said its revenue criteria. This is mainly because 26 out
may drop by 20 per cent. Similarly, of 74 bulk drugs featuring in DPCO
Earlier another government body, Pfizer is likely to see a revenue ero- 95, though still very important, are
Department of Pharmaceuticals sion of 15 per cent. As the weighted not currently manufactured in India
(DoP) had suggested that pricing of average price (WAP) mechanism will due to non-remunerative pricing.”
348 essential drugs specified in the bring down the average price, com- He insisted that if all the essential
draft policy should be based on the panies with strong brand pull and
weighted average prices of the three
best-selling brands of any product The industry’s concern is understandable as 60 per cent of the
having same strength or combina- pharma market comes under price control. Experts believe
tion. By proposing this, the policy that within the industry di erent segments will be a ected
sought to discard cost-based pricing di erently. While the large and dominant players will take
of formulations. But the Union health bigger hits smaller companies are likely to bene t
ministry and the Planning Commis-
sion had taken objection to this posi-
tion on the ground that such a pricing
policy can defeat the very purpose of
making available the essential medi-
cines at reasonable prices to the com-
mon man. An expert group under
the Planning Commission was of the
view that the prices of essential drugs
should be capped with reference to the
lowest formulation sold in the market.
While the government remained un-
decided, the Supreme Court recently
set a deadline to the Government to
finalise the long pending pharma pol-
icy by September 27, forcing the GoM
to make final recommendation on the
proposal, which was opposed largely
by the industry players who viewed
that further control would impact the
industry in a negative manner. The
industry’s concern is understandable

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medicines featuring in the NLEM mechanism. They are of the view that prices of drugs sold in retail and those
2011 are brought under DPCO 95, if the new system is imposed it will sold in bulk through tenders to insti-
solely to make them more affordable actually increase the price of essen- tutions. The price differences ranged
to patients, there is a high possibility tial drugs, making healthcare more from around 100 to 5600 per cent.”
that market factors (read low prices) expensive. This assumes added im- According to JSA there is also a wide
may make many of these important portance as 60 per cent of healthcare variance in prices of the same medi-
medicines unavailable to the patients, expenses are paid out of pocket as cine sold under different brands by
as happened in case of so many bulk against 80 per cent by insurance com- different companies. Moreover, the
drugs covered under DPCO 95. panies in developed countries. Indian more expensive brands sell much more
NGOs say that before announcing than the less expensive ones because
The MNC drug companies, there- the policy the government must first big companies are able to promote
fore, feel that drug price control alone publish a white paper giving details of their expensive brands by offering
cannot improve access to medicine post-WAP prices of each drug in the incentives to prescribers and chem-
significantly and there is a dire need NLEM list. ists, JSA added. “The WAP method is
to augment other healthcare access entirely skewed, as the ceiling price
related initiatives in tandem for a ho- All India Drug Action Network (AID- fixed would largely reflect the price
listic approach. Another drug makers’ AN), which took the government to of the brand leaders. Generally 2-3
body, India Pharmaceutical Alliance court for not announcing new drug top selling brands – usually the most
(IPA) also thinks that the proposed policy, says that in the name of im- expensive control a bulk of the mar-
policy will lead to significant drop posing price control, the government ket. So price control will do nothing
in revenue. According to IPA Secre- is actually lifting it. “This is legiti- to bring down drug prices, and in
tary General D G Shah, including 348 mizing profit maximization by com- fact will encourage cheaper brands to
drugs under the essential drugs list panies,” said AIDAN lawyer Colin start charging more and approach the
will lead to a nearly 17 per cent loss in Gonsalvez. “The whole exercise is high ceiling price. This would only
annual revenue for the pharma indus- designed to mislead nation. The gov- legitimize the rampant over-pricing
try. Shah is of the view that the WAP ernment must go by the 1995 order, of drugs by companies, prevalent to-
formula will lower revenue and prof- expand the list of drugs under control day,” said JSA.
its, but it is certainly better than the and retain the ‘cost of production’ for-
cost-based pricing approach demand- mula for pricing.” Another NGO, the To strengthen its point JSA gave a
ed by the civil society organisations. Jan Swasthya Abhiyan (JSA) claimed few examples. In case of Atorvastatin
that the weighted average pricing 10 mg, a cardiovascular drug having
Analysts believe that the impact on (WAP) mechanism will actually lead 75 brands in the market, the highest
the industry will be mixed as compa- to increase in prices as products from price is Rs 7.50 and the lowest price
nies with large exports are unlikely to large pharma companies have strong is Rs 0.92 per tablet. The WAP pricing
be affected by the new pricing regu- brand pull and are priced higher. This for this drug will be Rs 4.92, certainly
lation. Companies like Dr Reddy’s, is more so because medicine prices in lower than the highest price but 5.35
Glenmark, Lupin, Sun Pharma who India have no relation to the actual times costlier than the lowest price.
have large export market for their cost of production, packaging and A list of 17 drugs in JSA’s list reveal
products and have limited exposure marketing. “A study commissioned that the degree of price variation be-
in the regulated drugs list will have by the National Commission on Mac- tween the least price brand and the
moderate impact on revenue and roeconomics and Health showed that WAP will range between 1.72 times to
profits. The domestic industrial drug there is a very wide variation in the 12.27 times. Organisations against the
company: Indian Drug Manufactur- WAP system also point out that since
ers Association (IDMA), however, re- pricing control is based on single mol-
fused to comment on the pricing issue ecules, drug companies will produce
as the matter is not settled in court. combination drugs to circumvent the
essential drug list.
No respite
Clearly, the government will have to
While the industry players are busy strike a balance between many con-
calculating the bottom line impact tentious issues before it announces
and working out new strategies to the National Pharmaceuticals Pricing
minimize the damage, the civil so- policy in the third week of November.
ciety organisations are insisting that Right now it appears to be a difficult
the government should not accept task to arrive at a meeting point.
the GoM’s recommendations of WAP

48 LIFESCIENCE INDIA | October-November 2012

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SPOTLIGHT

Battle over
Generic Drug Trade

India’s patent rules for drug trade -Jiggyasa Srivastava
have been grabbing eyeballs the
world over, ever since it acceded India’s global presence is often associated with its flourishing IT sector.
to WTO agreement in 2005. The But for many poor countries, India is also a home for low cost generic
recent Court rulings on drugs medicines. India is the largest supplier of affordable HIV/AIDS and Tu-
manufactured by Novartis and berculosis medications and is the second leading provider of medicines dis-
Cipla have again raised a major tributed by UNICEF in the developing world.
debate on Indian rules failing
to protect intellectual property A generic drug is a drug product that is comparable to brand/reference list-
rights of original inventors. ed drug product in dosage form, strength, route of administration, quality
and performance characteristics and intended use. The country is home to a
thriving generics industry, whose imitator drugs make up about 90 per cent
of the market. India’s generic drug industry began to flourish in the 1970s

LIFESCIENCE INDIA | October-November 2012 49

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when the Indian Patent Law allowed only process patents in cheaper alternative to conventional brand name drugs.
pharmaceutical products upto a period of seven years. This Growing concerns in developing countries regarding access
was intended to keep the cost of medicines at affordable to medicines at prices that are affordable, led to consider-
levels. This protocol enabled the domestic pharma players able confabulations amongst WTO members. The outcome
to manufacture copy drugs through reverse engineering of of this process was the Ministerial Declaration adopted at
existing medicines by modifying the manufacturing pro- the conclusion of the Doha Ministerial Conference held in
cess. In 2005, India reintroduced the product patent regime 2001 on TRIPS Agreement and Public Health. The Doha
to comply with the obligations of the WTO Agreement Declaration unequivocally stated at the outset “that TRIPS
on Trade-Related Aspects of Intellectual Property Rights Agreement does not and should not prevent Members from
(TRIPS). The reintroduction of product patent brought with taking measures to protect public health” The patent policy
it uncertainties for the generic manufacturers for their abil- allowed signatories to protect the new invention in drugs
ity to reverse engineer products would be limited to a con- through patents, but at the same time gave members the
siderable extent. Furthermore, India is under pressure to right to override patents to produce generic drugs in times
introduce data exclusivity, a move that could also affect the of national emergencies. This exception rose as a bone of
future prospects of the generic manufacturers. Under the contention between the patent holding companies and the
product patent regime, a generic version of a patented drug developing nations like India. The bigger question becomes
can be introduced in the market only by having recourse to what constitutes an Emergency?
flexibilities in the patent law, viz., patent opposition, com-
pulsory licensing or parallel importation. Amidst this debate, the challenge arises how India can bal-
ance the rights of a patent holder while providing afford-
Although India shifted to the product patent regime in 2005, able health care for all. “The patent regime in this country
the capabilities developed during the past two decades be- should be so devised that utmost priority is given to secure
came a competitive advantage for the Indian pharma in- the people's right to access affordable, quality health care
dustry in the 1990s, when the rising healthcare costs in without monopoly. This can be achieved by an automatic
many developed countries forced them to seek the cheaper license of right, with a suitable royalty payment on net sales
generic drug option. Thus, the Indian pharma industry was to the innovator. Even a developed country like Canada fol-
able to exploit the enormous generic opportunity that was lowed this policy from 1969 to 1992, under the Canadian
spawned. The share of Indian pharma companies in the bill S-91”, says Y.K. Hamied, Chairman, Cipla. “We need to
total pie of approvals for generic drugs (called abbreviated take a closer look as to what is best for India. One cannot
new drug applications (ANDA) approvals in the U.S.) has have the same laws for 600 million people in the developed
risen steadily. In 2011 itself, more than a third of the ANDA world and 3 billion people in the Third World”.
approvals were by Indian firms. The Indian companies
have received 144 approvals of the total 431 ANDAs and In this context, two landmark legal decisions were made
117 tentative approvals given by US FDA during 2011. As recently which have earned their place in the history of the
a consequence, formulation exports from India, essentially pharma industry in India. In one of the most sought after
generic drugs, have grown at 21 per cent compounded an- legal battles in India, Delhi High Court ruled that Cipla,
nual growth rate (CAGR) between 2005-06 and 2010-11.

The debate

Today, Intellectual property rights (IPRs) have become syn-
onymous with the debate on generic drug production and
trade. Proponents of generic drugs point out the extremely
high prices charged for drugs by the MNCs as compared to
generics. They strongly endorse the production of generics
to address the need of the developing world for cheap drugs
against life-threatening diseases as reasons to circumvent
conventional patent law.

Opponents of generic drugs hold that the patent rights
are essential in order to encourage pharmaceutical com-
panies to develop new and better drugs and those generic
drugs are potentially harmful. Arguments thus concen-
trate around issues of the inviolability of patents, the needs
of the developing world for drugs and how best to meet
them and whether generic drugs can be a suitable and

50 LIFESCIENCE INDIA | October-November 2012