the only GM crop in India so far, Bt cotton has been a success story
The approval of Bt cotton for
commercial release by the GEAC at its 32nd meeting in 2002 marked
India's entry into GM club. It also led to a great deal of
hope, curiosity and expectations for the future success of agri-biotech
sector in India.
Initially frowned upon, GM cotton was a runaway success in India. The
area under this crop and the number of farmers who adopted this
technology increased significantly. The transgenic hybrids were
developed by Monsanto's Indian partner- MAHYCO
(Maharashtra Hybrid Seed Company). The introduction of Bt Cotton
significantly brought down the annual losses caused by bollworms,
estimated at about $300 million (Rs 1,384 crore). Also, it has helped
in cutting down the repeated spraying of insecticides valued at $700
million (Rs 3,229 crore), 50 percent of which is sprayed on cotton crop
Despite the continued opposition by a small section, the Indian cotton
farmers have accepted this technology in a big way and derived social
and economic benefits.
clinical trial for stem cells
approval of clinical trials of stem cell-based drugs by the Drug
Controller General of India (DCGI) has created immense interest among
global stem cell players to conduct their clinical trials in India
efficient and speedy processes for approving clinical trials by
regulatory bodies and availability of vast patient pool makes India a
good destination for conducting clinical trials. ICMR and DCGI have
drafted guidelines to conduct clinical trials in India in an ethical
and scientific manner. ICMR has formed an expert stem cell committee to
validate and recommend trials in India. DCGI recently made registry of
all clinical trials mandatory with Clinical Trials
Registry-India (CTRI) registry-so that all trials
can be monitored for proper conduct as per international norms.
Availability of skilled manpower and initiatives taken by the
government in creating good infrastructure for stem cell research are
attracting foreign institutes and private companies for collaborative
research with Indian institutes and private companies. The initiative
taken by the DBT in creating a world-class stem cell research center in
Bangalore is another positive step in nurturing value-added stem cell
research in India. India has the opportunity to be a global force in
biotechnology and stem cell research can be an important constituent of
this aspect of global leadership in this frontier technology area.
recombinant insulin and a vaccine
two indigenously developed recombinant products were real technology
breakthrough not only for the companies who developed it but also for
In 1997, Shantha became the
first Indian company to develop, manufacture and market
India's first recombinant vaccine, Shanvac-B, a vaccine for
hepatitis B. Shantha's entry into market with its hepatitis B
vaccine (Shanvac-B) drastically brought down the prices of imported
vaccine from Rs 780 to Rs 50 in 1997 and to Rs 25 in 2003.
Wockhardt, a hospitals-to-drugs chain produced India's first
recombinant human insulin- Wosulin-in 2002, making
India the first Asian country to develop, manufacture and market the
product. Those days, there were only three manufacturers of recombinant
human insulin. With Wosulin, India gained reputation on the global map.
With this indigenously developed insulin in the market, multinational
companies had to cut their insulin prices in India by 35-40 percent in
Biotech Regulatory Authority
drafting of a bill for the establishment of a National Biotech
Regulatory Authority has been a major landmark in the history of
biotech industry of the country
In 2004, a single-window
system for promotion and regulation in the form of National
Biotechnology RegulatoryAuthority (NBRA) was proposed by a task force
headed by famous agricultural scientist, Dr MS Swaminathan.
This was seen as a major step towards generating the necessary public,
political, professional and commercial confidence in the science-based
regulatory mechanism in place in the country.
Although awaited eagerly by the industry, the bill is yet to come up
before the cabinet for approval. But now the recent announcements
suggest that government is expected to push the bill through to the end
of this year.
An independent authority like NBRA will help regulate the large number
of biotech related activities in the country. These activities include
the vaccines, seeds, and biological products that require genetic
engineering. The authority is expected to ensure that the biotechnology
policies are strictly based on scientific assessment of risk. The need
for a credible biotech regulator has been felt since last decade due to
the lack of consensus on various issues related to GM technology.
has been growth in Bt parks in the country providing infrastructure to
fuel the growth
Establishment of Bt parks is
an attempt both by the central and the respective state governments to
bolster the R&D work and the infrastructure availability for
the biotech industry. Over the past seven years, many states have taken
up the biotech park initiative-especially the states of
Gujarat and Andhra Pradesh.
Gujarat is rapidly growing as far as Bt parks are concerned. The aim is
not just to attract big players to the park but also to promote local
companies. This includes The Akruti Gujarat Biotech Park which is a
joint venture between the Gujarat government, The Chatterjee Group
(TCG), and Akruti City Limited. It is also in the process of setting up
an Agri-Biotech Park. Maharashtra is coming up with an International
Biotech Park at Hinjawadi in Pune, a joint venture between Maharashtra
Industrial Development Corporation (MIDC) and The TCG Real Estate and
the Agri-Biotech Park in Jalna.
Andhra Pradesh is one of the first states in the country to kickstart
the BT parks strategy. Other states include, Tamil Nadu, Karnataka,
Himachal Pradesh, Rajasthan, Uttar Pradesh and Chattisgarh. Recently,
the Orissa Government commissioned a state-of-the-art Biotech Pharma IT
Park, spread over 64.86 acres, at Mouza-Andharua, Bhubaneswar on a
public-private partnership (PPP) mode.
The park, the first-of-its-kind in Orissa envisages promotion of
biotech, pharmaceuticals and IT industries in the state. The state
government has recently selected Bharat Biotech International as the
'developer' for this prestigious project.
industry gradually moved towards consolidation with an upswing in mega
mergers, alliances and acquisitions
The industry witnessed
landmark convergence between pharmaceutical and biotech companies, not
just globally, but even in India, thus paving the way for consolidation
in the domain. A convergence between the pharma and biotech sector will
gradually see both parties leveraging their strengths in drug
development, commercialization, discovery and manufacturing
capabilities thus delivering innovation and changing the whole
landscape of M&A deals.
Globally, Big pharma's acquisition spree started making big
news since 2008. In January 2009, Pfizer acquired biotech big-wig Wyeth
for $68 billion (Rs 3.12 lakh crore), followed by Roche ending its long
drawn hostile battle with Genentech by buying the remaining 44 percent
stake, thus acquiring the latter for $46.8 billion. This was followed
by Merck's announcement in March 2009 to acquire Schering
Plough for $41.1 billion (Rs 1.88 lakh crore). Other big deals include:
Eli Lilly's purchase of ImClone Systems last year, Japanese
giant, Takeda Pharmaceutical's acquisition of Millennium
Pharmaceuticals and Cephalon's takeover of
Australia's Arana Therapeutics.
But the highlight was big pharma's growing interest in Indian
companies. The landmark pharma-biotech deal being Sanofi-Shantha
Biotechnics deal last year. Sanofi's vaccine's
division, Sanofi-Pasteur, announced that it will pay €550
million (Rs 3,602 crore) for the Indian company. The former acquired
ShanH, French subsidiary of Merieux Alliance, which holds a majority
stake in Hyderabad-based Shantha. Similarly, Pfizer entered into an
agreement with Aurobindo Pharma wherein the former acquired rights to
39 generic solid oral dose products in the US and 20 in Europe, plus an
additional 11 in France. In a similar way, Pfizer also inked alliance
deals with Ahemdabad-based Claris Life Sciences and Kolkata-based TCG
Life Sciences. In a similar way, GSK and Dr Reddys' Labs
entered into a marketing deal.
human genome sequencing in India
unique achievement in the field of science, the breakthrough paves the
way for affordable healthcare and predictive medicine
In December 2009, The Council of Scientific and Industrial Research
(CSIR), India completed first ever human genome sequencing in India.
With this achievement, the nation entered the league of select few
countries like the US, China, Canada, UK, and Korea that have
demonstrated the capability to sequence and assemble complete human
genomes. This feat was unique in the sense that it was by a team of
very young scientists. They finished the complete sequencing and
assembling in much shorter time when compared to similar efforts
The sequencing of the first human genome in India in conjunction with
Indian Genome Variation program opens newer vistas for low-cost
affordable healthcare and predictive medicine in future for the masses.
This also opens up newer possibilities in disease diagnostics,
treatment and sustaining low-cost drugs in the market.