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Putting
molecular equations right...
The
crucial issue in R&D hovers around changing the mindset and ensuring
global level commitment to innovation, says Jayashree Padmini
THE
Indian pharma industry has passed through the second level of maturity
when it recently swallowed the failure of the anti-diabetic molecule
of Dr Reddy’s Laboratories in late phase II trials. This molecule
christened Ragaglitazar is one of the first innovative drugs from
India and has been licensed out to Novo Nordisk. The industry took
its first test when it, foreseeing the product patent regime, gulped
down the pep pill and plunged into innovative R&D.
The
buck stops here..
The
OPPI estimates suggest a 45 per cent jump in annual R&D expenditure
by domestic pharma companies during the 1997-2000 period where the
figure for fiscal 1999 is at Rs 320 crore. Only a part of it goes
into innovative research. Is this a tangible amount? Could we compare
this with the R&D-spend of Pfizer that stands at $5.3 billion
for the year 2002? Leave apart the tussle with statistics. What
do we have to work out the molecular equations right? ‘‘Years
of scuffle in reverse engineering has fortified skills in chemistry,’’
boast industry stalwarts, ‘‘now we are leveraging this
expertise to innovative R&D". Another claim, we have a
vast scientific pool that could be mobilized to original research.
Up to this point, it looks fine. The crucial issue hovers around
changing the mindset and ensuring global level commitment to innovation.
Working
out synergies..
India
emerges as an attractive R&D origin and destination owing to
the fact that, drug development costs could be as low as Rs 100
crore, an 80 per cent cut.
However,
while charting out strategic plans to explore the Indian capabilities,
we need to analyze whether the right atmosphere for research prevails
in the country. Dilip Sanghvi, CMD, Sun Pharma puts it, ‘‘We
need to brush up our pharmacogenomics and stimulate skills in target
based drug discovery.’’ Moreover, Indian skills are limited
to a few therapeutic areas. A glance at the therapeutic focus indicates
that the research pattern is tilted towards lifestyle diseases.
Apart
from the pharma companies, our institutes are equally well poised
in R&D. Despite the low level of accountability and lethargy,
our scientific fraternity has given results, especially under the
CSIR umbrella. CSIR, under its programme on bio-active molecules
is covering 21 odd disease areas where so far 44 leads have been
identified and 25 patents have been filed. The enthusiasm in industry
academia collaboration is also moving in the right direction paving
way for accelerated research and subsequent commercialization efforts.
India has 2000 odd research institutes flooding with scientific
talent, which could be strategically mobilized to take on R&D
with ease, points out Dr Swati Piramal, director, Nicholas Piramal.
The
model of RRL Jammu proves that Dr Swati’s vision for future
is quite undistorted. RRL has a focussed vision on drug discovery
and its two anti-diabetic molecules have been taken up by Lupin
Laboratories recently.
Policy
Issues
States
Dilip Sanghvi, ‘‘Industry requires government support
and sector friendly policies as it builds up the infrastructure,
commits resources and upgrades skillsets to partake in the global
opportunity.’’ Dr Swati Piramal while quite optimistic
on the future R&D prospects stresses on the need for a proactive
approach from the government.
Next
is the most contentious issue - animal experimentation. Take the
recent examples of Dr Reddy’s and Ranbaxy which state that
they have been compelled to undertake studies on new molecules abroad
owing to delays and lack of infrastructure in the country. Overseas
studies not only add to cost but also call for more time, as they
have to fall in the waiting list. In this context how would domestic
companies take into R&D with ease? Ranbaxy is said to have incurred
about Rs 2.3 core for undertaking studies overseas for its two molecules.
Dr
J M Khanna, former president, R&D, Ranbaxy, who spearheaded
Ranbaxy’s research programme and took it through five molecules
and more, echoes the same sentiment and says, ‘‘We need
to upgrade our capability in biological sciences and government
should, on a priority basis, invigorate a set of institutes across
the country to equip them with expertise in pre-clinical studies.’’
Dr Swati also stresses on fast clearance on clinical studies. The
Drug Controller General, Ashwini Kumar says that due to lack of
infrastructure, his department is unable to meet the targets of
clearing the applications to match industry expectations. He mentioned
about one of his recent interactions with Dr N Dave Venayak, scientist
and a senior evaluator with Canadian drug control authority.
The
DCGI feels that once the World Bank funded project of upgradation
of the drug control machinery in the country is through, the authority
would be able to improve the situation.
Biotechnology,
is it a big bet?
Biotechnology
has emerged as the buzz word in pharma industry with each and every
company charting out plans for biotech forays. The notable names
in the list include Ranbaxy, Dr Reddy’s, Dabur, Morepen and
a few institutions in the list - CSIR labs like IGIB and RRL. Prof
Samir Brahmachari, director, IGIB (Institute of Genomics & Integrative
Biology) wants to give a message to the Indian industry which is
eager to take a plunge into the biotech, ‘‘All investments
in biotechnology should be of low burning rate, meaning moderate
but sustained.’’ The tools of biotechnology are expected
to, apart from drastically cut down the time and cost involved in
identifying drug targets, open up the molecular route to better
therapies.
However,
Dr Khanna quips, ‘‘Biotech route is more complex than
the conventional drug discovery methodologies. The future research
model in India would be a balanced combination of the biotech as
well as conventional methods.’’ Supports Dilip Sanghvi,
‘‘I think companies are directing enough funds to acquire
biotech tools and to develop a better understanding of its utilization
as a part of the drug discovery process.’’
Where
are we heading?
The
indications are that we are heading in the right direction, but
with much of hiccups and apprehensions. There need to be concerted
efforts from the government, industry and institutions to work out
innovative collaboration models.
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