Summary
India is R&D hub for pharmaceuticals
Analysis
With a steep growth in
the economy, urbanization,
and more affl uent
lifestyles for some, Western-type
diseases have begun to emerge in
India. Th e increasing prevalence of
oncologic, cardiovascular, respiratory,
and diabetic disorders, central
nervous system degenerative
diseases, and psychiatric conditions
among some parts of the
population, alongside the tropical
and infectious diseases, provide an
opportunity for the pharmaceutical
industry to work with clinicians in
India to improve health care both
within India and globally
Th e rationale for running clinical
trials in India is a much-debated
topic in both local and national
media within India. Th e benefi ts of
participating in clinical research are
always considered on behalf of the
patient who could receive, free of
charge, a potentially eff ective treatment
and/or medical attention that
may not otherwise be given or available.
Th e investigator benefi ts by
learning new clinical research skills
and by being in contact with a global
medical research community with
the possibility of contributing to a
new medical therapy. Th e benefi t for
India is in social, public health, and
economic development terms, while
the potential benefi ts for the global
pharmaceutical industry in terms of
medical advances are clear
It is expected that investment by
pharmaceutical companies in clinical
trials in India will rise from its
current levels of approximately $100
million to $1.5 - $2 billion by 2010.
Many of the trials conducted in India
will be run as part of global studies,
bringing together patient data
across a number of countries. Th e
FDA, EMEA, and other regulatory
agencies are already prepared to
consider clinical data generated in
India for the purpose of regulatory
submissions. Th e foundations for
clinical research clearly exist in India,
and the regulatory agency, having
issued the Indian GCP guidelines in
December 2001 and the Schedule Y
in January 2005 (requirements and
guidelines for conducting a Clinical
Trial in India), is determined,
under the leadership of the new
Drug Controller General of India
(DCGI), to enhance the operations
of the agency and deliver timely,
robust, and quality medical advice
and decisions. In addition, the Indian
Council of Medical Research (ICMR)
issued the Ethical Guidelines for
Biomedical Research on Human
Subjects in 2000 and works with the
DCGI to improve the processes and
procedures for clinical research and
development in India. A Clinical
Trial Registry is already operational
in conformity with the suggestions of
the World Health Organization, and
guidelines for research and therapy
are being placed on the website
Successful applications to the
DCGI for a new trial are those
that focus on patient safety and
the potential overall benefi t and
those that have all documentation
correctly submitted. Th e new Drug
Controller General of India has
continued the two-track system
(eff ective from December 2006) for
regulatory approval of clinical trials
such that those clinical trials
that have already gained
approval by the regulatory
bodies in the US, Germany,
UK, Switzerland, Australia,
Japan, South Africa, Europe,
or Canada (Category
A) are likely to be approved
within a timeframe of approximately
three months,
whereas applications for
trials that are not already
approved by another
recognized regulatory
agency (Category B) go
through the normal review
process and may take up
to six months for approval. Ethics
committees can be approached in
parallel to the submission to the
DCGI at most sites. In the granting
of a license from the Director
General of Foreign Trade (DGFT)
for the import and/or export of
blood samples/investigational
products or bi-products, delays
are inevitable if partial, or inaccurate,
documentation is submitted.
Particular attention should also be
paid to the labeling of the Investigational
Medicinal Product (IMP).
Import/export licenses are issued
subsequent to approval from DCGI
and may take two to three weeks.
Understanding the bureaucracy
and working through it rather than
against it achieves greater success.
According to PAREXEL’s bio/
pharmaceutical R&D Statistical
Source Book 2008/2009, India
rose to claim the eighth spot in the
world with regard to the number
of clinical investigators signing on
to conduct FDA-regulated clinical
trials in 2007. Th e number of
clinical investigators rose by 29% to
395 in 2007 and represented 1.8%
of all investigators around the world
signing on to conduct FDA regulated
trials (up from 1.3% in 2006).
Th e opportunity exists for universities
(over 220 medical colleges in
India), hospitals (more than 16,000
hospitals and more than 700,000
speciality hospital beds), pharmaceutical
companies, and government
agencies to work together to
provide world class, ethical clinical
research capabilities in a sustainable
economic and politically stable
environment. Th e challenge now is
to continue to train signifi cant numbers
of clinicians in semi-urban and
rural areas to become investigators,
and other study staff to ICH GCP to
consistently deliver quality during a
high-growth phase.
Th ere is an obvious advantage
that India has the second largest
English-speaking population in the
world and while informed consent
documents and patient-related
documents may need to be translated
into other languages such as
Hindi, Marathi, Telugu, Bengali,
Tamil, Urdu, the vast majority of
patient notes and source documents
are written in English. A cautionary
note should, however, be sounded
as real cultural diff erences and preferences
can be missed because of
the large English-speaking population
and particularly so because
many legal and business constructs,
due to historical legacy, seem to
be familiar. Care also needs to be
taken however, as not all corporate
constructs and processes
will translate instinctively or
immediately
Regarding the conduct of a
clinical trial, it is clear that
quality control is the key
to success. While there is a
large pool of talented and
enthusiastic graduates, there
are fewer skilled and experienced
clinical research
associates (CRAs). Sponsors
should focus on eff ective
training in worldwide standard
operating procedures
(SOPs) both in an academystyle
teaching course and through
on-the-job training, mentoring,
and follow-up testing. In such a
competitive resource market, retention
of key employees is an essential
management focal point and
requires attention to individualized
personal development plans. Regarding
SOPs, it is important to appreciate
the value of Indian innovation,
procedures, and contributions to
process improvement, understanding
that the British or the American
way is not the only way. However,
at the same time, it should be noted
that training to work with standardized
processes, clear communications,
and awareness of escalation
routes, are imperative for CRAs and
investigational site staff alike, particularly
regarding patient inclusion/
exclusion, serious adverse events
reporting, use of code breaks, etc.
Some of the challenges expressed
by clinicians in India include issues
around informed consent and
real choice for the patient, patient
compliance (although new tracking
technologies may help here),
concomitant unknown, unapproved,
local medications and
treatments, and fi nally the impact
on the eff ectiveness and safety of
the IMP based upon the underlying
nutritional status and genetic
variations within the Indian patient
population.
Technology-enabled processes and
operations are well accepted
boundaries and management focus
are logistics and vendor management.
A combination of global and
local distributors tried, tested and
tightly managed, can work well.
Likewise, local procurement managers
clearly benefi t from any global or
corporate guidelines.
Foreign companies in India need to
be aware that a western-style management
matrix structure is not
necessarily well understood and
can seem confusing within a more
familiar hierarchical structure of
governance in India. Also, there is
an expectation, which is generally
fulfi lled, that large local companies
and international companies will
manifest corporate social responsibility
through social, educational
and/or medical non-profi t making
programs in the community. At
the same time, from an industry
perspective, we should consider
India as high value, not low cost.
Labor costs in India are in fact
on the rise, spurred by growing
international demand for skilled
India-based staff ; the high value
is derived from the abundance of
highly skilled scientifi c, medical,
and technical staff in India. While
signifi cant investment in both human
resources and the infrastructure
is required, there are fi nancial
incentives in the form of either
local or national tax
benefi ts for
certain types of research or businesses.
Issues around protection
of data and intellectual property
rights are high profi le and continue
to be addressed between global
pharmaceutical companies and the
Indian government agencies.
Th e expectation is for signifi cant
growth of outsourcing of clinical
research to India, anticipating an
enhanced regulatory environment
with more resources, facilitating
faster clinical trial set-up and quality
deliverables.
This author consults with leading institutions through GLG
Analyses are solely the work of the authors and have not been edited or endorsed by GLG.
