www.checkbiotech.org ; www.raupp.info ; www.czu.cz

The year 2006 will go down as a landmark year for Indian biotechnology.
Ernst & Young ranked India third in the region based on the number of
biotech companies after Japan and Korea, January 2007 by Kiran
Mazumdar-Shaw.

The year saw a number of key developments. Indian mega corporate Reliance
Industries invested in excess of $100 million in building both manufacturing
and clinical development capabilities in Reliance Life Sciences and ended
the year by acquiring a 74% stake in a UK biotech company GenMedix. Earlier,
Nicholas Piramal acquired another UK-based biotech company, Avecia to
strengthen its innovation and contract research base.

In November, Advinus, a Tata-backed life sciences company, announced a $150
million drug discovery deal with Merck. In mid-September, Indian biotech
major, Biocon, launched its anti-EGFR monoclonal antibody BIOMAb-EGFR,
heralding the first proprietary, biotech drug with a ?Made in India? label.
Another landmark investment deal saw French Biotech major Merieux Alliancve
pick up a 60% controlling stake in Shantha Biotechnics, catapulting Shantha?
s vaccine capabilities onto the world stage.

Pune-based Serum Institute continued to dominate vaccine production in the
country and announced plans for an IPO in 2007. The prospects for research
services continued to show excellent promise with Syngene, GVK Bio and
Jubilant Biosys registering exponential growth.

Whilst the investor community remained skeptical of the Indian biotech
sector, Avesthagen successfully attracted a 20 million euro investment from
a leading European fund. On the regulatory and policy front, the biotech
sector witnessed the implementation of a new regulatory regime proposed by
the Mashelkar Committee for recombinant drugs and the MS Swaminathan
Committee for GM crops.

The department of biotechnology rolled out the strategy document for the
sector that included the launch of the SBIRI (Small Business Innovation
Research Initiative) scheme to assist start up enterprises in the incubation
phase. The agri-biotech sector saw a significant increase in acreage for Bt
cotton whilst the volatility in oil prices raised the profile of bio-fuels
with companies like Praaj Industries and enzyme producers Novozymes and
Biocon being the main beneficiaries.

The prime impetus for growth of the Indian biotech sector emanates from our
large reservoir of scientific talent pool, a wide network of research
laboratories, a vibrant pharma industry and fast-growing clinical
capabilities.

India?s ecological and population diversity is an advantage from a research
and discovery standpoint. Bioinformatics and Bio-IT have a key role to play
in personalised medicine both with respect to diagnostics and therapies.
Biometrics is another emerging opportunity where India's computational
software skills and proven cost competitiveness can be strong levers. Stem
cells and regenerative medicine have been identified as areas of strategic
importance with enabling policies backing it where companies like Reliance
Life Sciences have taken the lead.

Another important area for India is biogenerics or biosimilars as a number
of biological drugs are slated to go off patent in the coming years. India's
competitive edge derives from strong bio-manufacturing skills coupled with a
regulatory framework in place for approving generic versions of biologicals
like Insulin, GCSF, Hep B vaccine, Streptokinase etc.

The recent guidelines released for select biosimilars by EMEA and the
likelihood of USFDA doing the same will see several Indian companies
positioning themselves to be global players in this segment.

The Indian biotech sector has certainly gathered momentum over the last two
decades and has finally arrived on the global scene. The sector has crossed
many hurdles in reaching this point. The challenges ahead are enormous in
terms of building specialised human capital, creating internationally
benchmarked regulatory and IP infrastructure and the timely implementation
of the National Biotechnology Strategy.

The ultimate hallmark of success will lie in India bringing to world markets
novel and proprietary biotech products. This will largely depend on bridging
the existing gaps that exist in discovery and pre-clinical development.
Perhaps the largest gap that needs to be bridged is one that involves the
innovation interface between academia and industry. Without this, there is a
danger of knowledge being restricted and not shared which will be
detrimental to the innovation-led mindset in the country.

There are promising signs on the horizon: skeptical investors are slowly but
surely beginning to value the biotech sector more confidently. This has
catalysed a number of trans-national alliances as well as M&A activity. The
presence of large Indian conglomerates has introduced an air of seriousness
to the sector. The ministry of science and technology along with DBT are
ascribing large budgetary allocations for biotechnology. 2007 augers well
for Indian biotechnology and I am confident that we will see some globally
significant happenings in the near future that will catapult India into a
dominant leadership position.

[www.financialexpress.com]

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