As the knowledge of genetics and
genomics rapidly expand, a personalized approach to health care is
becoming increasingly important. India is fast becoming a promising
contender in the global healthcare arena
The majority of the global healthcare industry is ready to offer
solutions for the masses. The rapidly advancing field of
pharmacogenomics enables diagnostics and subsequent treatment to be
‘tailor-made’ for each individual, taking into account their
The current healthcare scenario is distinctly more of
‘trial-and-error’; which subjects the patients and their physicians to
a larger uncertainty of outcome. In the patient’s case it often entails
greater cost — both physical and financial.
The lessons from several spectacular drug withdrawals including
Fen-phen, Rezulin and Baycol have improved the ways to test prospective
drugs, for toxicity. The role of customized therapy is becoming more
important in healthcare and diagnostic industry. Pharmacogenomics
redefines the way drugs are developed, and the way in which drugs are
chosen for patients; based on their individual genetic make-up.
Understanding the underlying genetics behind a patient’s response to
therapy, is said to allow therapeutic companies develop safer and more
effective drugs. In addition, understanding how individuals are
genetically predisposed to risk of disease, may result in new drug
targets, thereby leading to new classes of drugs designed to delay, or
prevent disease onset.
Pharmacogenomics in India
The existence of a large and diverse population, coupled with a high
incidence of genetic disorders makes India, an ideal setting for
pharmacogenomics research. Growing interest in individualized therapy
to improve drug efficacy has attracted huge investments in
pharmacogenomics research. India’s growing capabilities in research,
clinical development and bio-manufacturing, give it a decisive edge in
the development of personalized medicine.
An offshoot of personalized medicine is the emergence of new age
diagnostics, based on genetic and protein markers, as well as other
metabolite-based bio-markers. Today’s diagnostic techniques track
disease progression, drug response; and are designed to customize
therapy in a differentiated manner.
Many pharmaceutical companies have made significant investments in
pharmacogenomics, with the expectation that it will help to eliminate
the unpredictable nature of drug development, bring new products to
market, aimed at preventing common diseases, and create premium pricing
for their products. It is estimated that by using
pharmacogenomics-enhanced drugs and diagnostics, pharmaceutical
companies could benefit up to
crore ($200-$500 million) in extra revenue for each drug.
Indian scientists are eagerly undertaking pharmacogenomic studies, and
many companies are also shifting their focus towards this field. The
notable players include Avesthagen, OncQuest Laboratories, Acton
Biotech, TCG Life Sciences, Advinus Therapeutics and Jubilant Biosys.
Currently, Mumbai-based diagnostic company Acton Biotech, offers
pharmacogenomics tests, to identify effective treatment for
chemotherapy patients who can benefit from anti-cancer drugs like
Cetuximab, Gefitinib, 5 Fluorouracil, Capecitabine, Tamoxifen,
Cisplatin and Oxaliplatin. This test makes sure that patients recover
effectively. Acton has tested 2,000 cancer samples for 30 genes and 10
drugs. The company is currently working on cardio-pharmacogenomics drug
section; and plans to increase its range of pharmacogenomic test as the
Oncquest Laboratories, another important company in pharmacogenomics
field brought to the market, Imatinib Resistance Mutation Analysis
(IRMA) for chronic myeloid leukemia (CML). “The success of IRMA has
been resounding. Many of the prescribing physicians are showing
confidence and acceptance of our experience with the assay; and have
hence, helped many patients get appropriate therapy for their disease,”
says Aditya C Burman, managing director of Oncquest Laboratories, New
“The many years of Oncquest’s experience in the field of molecular
diagnostics in oncology, has allowed the company to foray into
pharmacogenomics, several years ago. With the launch of IRMA, the
company has an in-depth look at the potential of the pharmacogenomics
market in India,” adds Burman.
The company has subsequently launched several pharmacogenetic tests
including Irinotecan toxicity, Warfarin dosing, Clopidogrel dosing, and
have many more in the pipeline. Oncquest is currently working with
several companies in this area, and sees many avenues for collaborative
work in the future. Burman believes that pharmacogenomics is the future
of medicine; and India, which is fast becoming a serious contender in
the global healthcare arena, could well be at the epicentre of future
Apart from private companies, public research institutions too, are
actively involved in pharmacogenomic research. The Department of
Biotechnology (DBT) has been receiving many proposals for funding such
The recent completion of the first-ever human genome sequencing as part
of Human Genome (HUGO) project in India, by scientists at the Institute
of Genomics and Integrative Biology (IGIB), New Delhi, is being seen as
a step closer towards personalized medicine. The Council of Scientific
and Industrial Research (CSIR)-led Indian Genome Variation (IGV)
project, studied 1,000 biomedically important and pharmaco-genetically
relevant genes, in populations representing the genetic spectrum of
India. The IGV database has information on over 1,000 genes which are
involved in diseases such as asthma, diabetes, neuropsychiatric
disorders, cancer, coronary artery disease, clotting disorders, high
altitude disorders, retinitis pigmentosa, predisposition to malaria and
A team of researchers at IGIB is studying the pharmacogenomics of
anti-psychotics, anti-depressant and anti-epileptic drugs, including
their pharmacokinetics and pharmacodynamics. The functional consequence
of genetic polymorphisms involved in drug response is also being
studied by the IGIB team.
Another CSIR-led institute, Center for Drug and Research Institute
(CDRI) has been leading the pharmacogenomics studies in various areas
of research, including the cancer biology.
The Indian Council of Medical
Research (ICMR) has recently set up a new task force on
pharmocogenomics to focus on specific research topics in the field of
pharmacogenomics. The task force will focus on various topics of
research, including identification of genes and pathways involved in
pharmacokinetics and pharmacodynamics of common drugs, and validation
of human single nucleotide polymorphisms (SNP) haplotypes of
short-listed genes in Indian population. The task force is also
intending to conduct research on the development of an ‘Indian
The ICMR center in Puducherry, an Advanced Center for Pharmacogenomics
at the Department of Pharmacology in Jawaharlal Institute of
PostGraduate Medical Research (JIPMER) is doing research in this field,
and a team of researchers are studying the influence of genetic
variation on drug response in patients.
The majority of pharmocogenomic work being conducted in India and
globally, are very basic in nature; and so are the end results. Yet,
this lays a foundation for many future revelations to come.
Burman adds, “Pharmacogenomics is a combination of various scientific
disciplines that gives a clear picture of individual and general
population trends. Such a deep understanding of any subject would throw
light on problems its practitioners face; and that holds true for
healthcare as well.”
“As more work is done in pharmacogenomics, the industry is able to
introduce newer and better pharmaceuticals and companion diagnostic
products. The governing bodies have acknowledged the utility of such
products; and have, in many cases, guided industry to follow this path
in specific instances. Globally, the pharmacogenomics-driven
diagnostics and therapies have gained acceptance at a much faster rate,
than its predecessors,” says Burman.
Aravind K Tripathi, senior researcher, Cancer Profiling &
Pharmacogenomics Division, Acton Biotech, says, “The field of
pharmacogenomics is not immature, and it involves complex processes.
Complexity in finding gene variations that affect drug response is
tough, because of our limited knowledge of single nucleotide
polymorphisms (SNPs). Finding the variations that occur when a single
nucleotide in the genome sequence is altered, is more complex, when the
three-billion-base human genome can give the possibility of finding
such SNPs in millions, which plays a direct role in drug response.”
Tripathi, however, agrees that the field of pharmacogenomics has not
gained enough popularity. He attributes it to the lack of exposure of
molecular biology among doctors; high costs of these tests compared to
cost of treatment; longer turnaround times and lack of bedside
technologies; lack of skilled manpower and smaller market size; and
hence lack of investment in marketing these tests.
Introducing multiple pharmacogenomics products to treat the same
condition for different population subsets, is undoubtedly, a
complicated process, in terms of prescribing and dispensing drugs.
Apart from these, inherent problems regarding the time and cost
associated with the development of diagnostic tests, remain a major
restraint for market growth. Moreover, obtaining intellectual property
for pharmacogenomic tests pose significant challenges for companies.
Therefore, it is essential that the Indian governments’ patent systems
offer protection for innovations related to personalized medicine.
Among different countries, the European pharmacogenomics market is the
largest revenue generator, primarily due to the high level of awareness
about pharmacogenomics among medical professionals as well as the
public. Following the European market is the US, which has radically
changed the emphasis on disease management uniformity; focusing more on
individual patient management and personalized medicine.
Burman of OncQuest believes that there are two main driving factors for
this industry. The first is the aforementioned R&D being conducted
by pharmaceutical and molecular diagnostic companies. He says, “This is
imperative to set the groundwork for a robust pipeline of products that
will target several disease segments. In addition to this, efforts need
to be given to reducing costs for such tests and treatments, without
which it would remain out of the majority of the global population.”
The second, and perhaps the most important driver, he mentions, is
educating the healthcare providers to the proper use of these products;
and to facilitate them in formulating appropriate treatment plans for
their patients. Without the explicit involvement of treating
physicians, these products would stay primarily in the research
laboratories, and would rarely make it to the mainstream.
Sandeep Saxena, founder & CEO of Acton Biotech, Mumbai, says, “The
driving forces for the Indian pharmacogenomics market will be the
development of cost-effective and rapid methods, equipment, and kits
for the diagnostic tests. With prices coming down, pharmacogenomic
tests will find a larger market, and hence attract investments.
Significant investments are needed in educating doctors about the
basics of molecular biology, clinical significance of these tests; and
publish papers relating to drug response and Indian patient genetics.”
According to Sandeep Saxena, extending partnerships with pharmaceutical
companies, medical device companies, large hospital chains and teaching
hospitals is vital for growing pharmacogenomics market in India.
from Rahul Koul)