union government's recent amendment to Schedule Y of the Drugs and Cosmetics
Act has given a fillip to clinical trials by multinational drug companies
operating in India, reports Nisha Das.
Eli Lilly, GlaxoSmithKline, Sanofi-Aventis and Roche are already doing it.
Others are scrambling to get started. We are talking about clinical trials
of new drugs. A number of the world's top pharma MNCs have already kick-started
simultaneous and standalone clinical trials on various therapeutic segments
in India. The reason? The union government's recent move to amend Schedule
Y of the Drugs and Cosmetics Act, allowing MNCs to conduct simultaneous clinical
trials, both overseas and in India. However, the government has not yet given
permission for MNCs to conduct phase-I trials in India so far.
isn't just big pharma that's looking in. Many new contract research organisations
(CROs) have also outlined plans to tap India's large pool of patients suffering
from cancer, diabetes and other maladies, for various drug indications.
gaint Pfizer has already picked a city in one of the north-eastern states
of India to conduct clinical trials on 300 patients for a new malaria cocktail
drug that combines chloroquine (to which several Indian malarial strains have
developed resistance) and azithromycin, an antibiotic. Pfizer is also carrying
out clinical trials for drugs to treat osteoporosis, breast cancer and schizophrenia.
According to industry sources, Pfizer's cumulative investment on clinical
research in India is believed to be $13 million.
C N Potkar, Pfizer's director of clinical research told this reporter, "We
have gradually increased our activity spectrum across a range of therapeutic
areas. A group of about 40 clinical research professionals is engaged in conducting
phase-II, III and IV studies. The volume of work done in India is gradually
rising, but still insignificant when compared to the developed countries."
At present, Pfizer is conducting around 20 clinical trials. It has independently
conducted more than 40 good clinical practices (GCP) workshops and has trained
more than 2,000 investigators and other professionals.
company has also contributed to research infrastructure development at various
institutes through clinical trials that have already been conducted. For instance,
it has contributed dual energy X-ray absorptiometry (DeXA) machines
costing over $600,000 to develop osteoporosis centres at leading hospitals
in the country.
CRO Trainor and Partners (T&P) has decided to launch its Indian operations.
Speaking to domain-b, T&P's clinical quality management
consultant Susan Trainor said, "We are extremely bullish on India. We
are scouting for partners to start a franchise. India is the right destination
to carry out clinical trials in many therapeutic segments."
consultancy McKinsey & Co estimates that by 2010, global pharma majors
would spend up to $1.5 billion just for drug trials in the country. A Rabobank
India report says that India has the largest pool of patients in many diseases,
including cancer and diabetes. The Rabo study pinpoints that India's biggest
advantage is its low cost. For instance, trials for a standard drug in the
US can cost up to $150 million. A similar drug could be tested in India for
less than half of that amount.
to industry sources, the pace at which drug trials are being instituted in
the country is so fast that the Clinical Data Interchange Standards Consortium
(CDISC), USA, a non-profit organisation committed to the development of clinical
research organisations' standards the world over, is looking at setting up
a chapter in India.
Lilly India managing director Rajeev Gulathi said, "We were among the
first pharma firms to start good clinical practices in India. With a favourable
policy supporting us, our clinical trials practice in India will accelerate."
Eli Lilly has over 17 large and small clinical research projects running in
40 hospitals across India. Many of them are simultaneous clinical trials.
The company has already held clinical trials involving more than 600 patients
for human insulin and insulin lispro. It is also conducting trials on oncology,
as well as developing a new molecule for lung cancer.
Plc (GSK) has started seven simultaneous clinical trials of its vaccine and
pharma molecules. The company has also tied up with a series of hospitals
to do the trials. Speaking to domain-b, a GSK spokesperson said,
"We have identified clinical trials in India as a significant area of
activity. Data from Indian trials is extremely important for us." He
was reluctant, however, to divulge any more details about the company's activities.
Pharma's director of medical research and regulatory affairs Dr Dhananjay
Bakhle is very positive about developments. "The Schedule Y amendment
will give a boost to clinical trials by pharma MNCs in India. Now, MNCs can
do simultanous trials across the globe," he said. However, Dr Bakhle
was reluctant to give details on what Aventis is doing in India. Company sources
say that Aventis is conducting clinical trials in the cardiovascular, diabetics
and oncology segments. The company is presently in the process of setting
up its clinical trials infrastructure in the country.
sources say Roche, the Swiss pharma major, has set up clinical trial sites
in India as part of its global trials for treatment of a new drug for a particular
variant of lung cancer. One of the reasons for including India is that it
has a vast patient population afflicted by this type of lung cancer, which
is primarily triggered by use of tobacco products. The company is also considering
India as a prospective site for Roche's future clinical trials involving new
drugs and therapies for treatment of different variants of blood cancer and
the picture in perspective, the secretary general of the European Forum of
Good Clinical Practices, Francis Crawely, explains: "Though, China, Singapore
and east European countries are the principal focus areas for MNCs to conduct
clinical trials, India
is a favourite destination because it offers a vast variety of population,
high educational standards and has a number of emerging small biotech firms."