Indian clinical trials market to grow at 30% to touch $

600m in 3 years
All the major pharmaceutical and biotech players as well as major CROs are
making India their base for conducting global clinical trials

Clinical trial outsourcing market in India is forecasted to grow at a CAGR of over 30%
during 2010-2012 to around US$ 600 million by 2012, says new report by RNCOS.

India will become one of the highest growing clinical trial destinations in the world, with
this kind of growth, according to the study titled “Booming Clinical Trials Market in
India”.

India is becoming a major hub for clinical studies because all the major pharmaceutical
and biotech players as well as major CROs are making India their base for conducting
global clinical trials.

Finding and recruiting patients – the most crucial part of the clinical research — who can
qualify for a clinical trial, is relatively much easier in India as compared to the Western
countries.

Increasing prevalence of diseases and low cost of clinical trials are other factors
promoting this market. Syngene and Quintiles are right on top in terms of market share in
a market which are rather crowd with more than 100 firms working in India in the clinical
trial market.

However, weak IPR protection, lack of trained staff, etc., which are blocking the proper
growth of the market. So, in order to ensure proper growth of the industry, these issues
need to be addressed efficiently.

The Indian government needs to take several iniatives to ensure an easy approval system
for promoting foreign investments, the report said.

In June, Indian government has made registration of all clinical trials conducted in the
country mandatory from 15th June 2009. The new registration norm will be applicable to
the clinical trials started after 15th June 2009, stated the notification from the Central
Drugs Standard Control Organisation (CDSCO) –the DCGI’s office.

Registration of clinical trials in the registry has not been held compulsory in India so far,
even though India has become a sought-after destination for outsourcing clinical studies
for drug makers across the world.

Currently, a total 987 clinical studies are being run at various centers in India, according
to ClinicalTrials.gov, a service by US National Institutes of Health. As of now, only less
than 25 of the nearly thousand ongoing clinical studies are registered in India with the
Clinical Trials Registry because such registration formalities were voluntary for the
companies.

Dr Surinder Singh, DCGI, has been reiterating the need for making the registration of
clinical studies mandatory for sometime now. Recently, Dr Singh announced in press
gathering that clinical trials registration, along with their auditing, would be made
compulsory in India, as part of his efforts to bring in more accountability and
transparency into the controversial clinical trail industry. “

Registration of clinical trials in a publicly accessible registry is very important as it

improves the accountability of the stake-holders and also ensures that key information is
made available to the public,’’ stated the notification dated 1st of June, 2009.

The Clinical Trials Registry- India (CTRI) has been set up by the ICMR’s National
Institute of Medical Statistics (NIMS) and is funded by the Department of Science and
Technology (DST) through the Indian Council of Medical Research (ICMR).

The idea behind setting up of the Clinical Trials Registry-India (CTRI) is to encourage all
clinical trials conducted in India to be prospectively registered before the enrollment of
the first participant and to disclose details of the 20 mandatory items of the WHO
International Clinical Trials Registry Platform (ICTRP) dataset.

The CTRI dataset is meant to: 1) improve transparency and accountability, 2) improve
the internal validity (details of the methods of the trial that produce reliable results,
primarily the method of random sequence generation, concealment of allocation, blinding
of participants and investigators, and inclusion of all participants results) of trials right
from the design,through conduct and reporting, 3) conform to accepted ethical standards
and 4) lead to reporting of all relevant results of all clinical trials in India and the region.

Clinical trial registration made compulsory in India from

15th June
Trial registration is now mandatory before the enrollment of the
first patient

Indian government has made registration of all clinical trials conducted in the country
mandatory from 15th June 2009.

The Drug Controller General of India (DCGI) has brought out a notification to this effect
informing the applicants to register the clinical trial in ICMR Clinical Trial Registry
before initiating the trial process.
The new registration norm will be applicable to the clinical trials started after 15th June
2009, stated the notification from the Central Drugs Standard Control Organisation
(CDSCO) –the DCGI’s office.

Registration of clinical trials in the registry has not been held compulsory in India so far,
even though India has become a sought-after destination for outsourcing clinical studies
for drug makers across the world.

Currently, a total 987 clinical studies are being run at various centers in India, according
to ClinicalTrials.gov, a service by US National Institutes of Health.

As of now, only less than 25 of the nearly thousand ongoing clinical studies are registered
in India with the Clinical Trials Registry because such registration formalities were
voluntary for the companies.

Dr Surinder Singh, DCGI, has been reiterating the need for making the registration of
clinical studies mandatory for sometime now. Recently, Dr Singh announced in press
gathering that clinical trials registration, along with their auditing, would be made
compulsory in India, as part of his efforts to bring in more accountability and
transparency into the controversial clinical trail industry.

“Registration of clinical trials in a publicly accessible registry is very important as it

improves the accountability of the stake-holders and also ensures that key information is
made available to the public,’’ stated the notification dated 1st of June, 2009.

The Clinical Trials Registry- India (CTRI) has been set up by the ICMR’s National
Institute of Medical Statistics (NIMS) and is funded by the Department of Science and
Technology (DST) through the Indian Council of Medical Research (ICMR).

The idea behind setting up of the Clinical Trials Registry-India (CTRI) is to encourage all
clinical trials conducted in India to be prospectively registered before the enrollment of
the first participant and to disclose details of the 20 mandatory items of the WHO
International Clinical Trials Registry Platform (ICTRP) dataset.

The CTRI dataset is meant to: 1) improve transparency and accountability, 2) improve
the internal validity (details of the methods of the trial that produce reliable results,
primarily the method of random sequence generation, concealment of allocation, blinding
of participants and investigators, and inclusion of all participants results) of trials right
from the design,through conduct and reporting, 3) conform to accepted ethical standards
and 4) lead to reporting of all relevant results of all clinical trials in India and the region.

The CTRI is an online register of clinical trials being conducted in India.

Any researcher who plans to conduct a trial involving human participants, of any
intervention (drug, surgical procedure, preventive measures, lifestyle modifications,
devices, educational or behavioral treatment, rehabilitation strategies and complementary
therapies) are expected to register the trial in CTRI before enrollment of the first
participant.

Registration of trials in the CTRI is free. All registered trials will be made publicly
available. The CTRI will be searchable by anyone free of charge.

The World Medical Association (WMA) has developed the Declaration of Helsinki as a
statement of ethical principles for medical research involving human subjects, including
research on identifiable human material and data.

The Declaration of Helsinki, revised by the World Medical Association in October 2008,
now calls for mandatory prospective clincial trial registration in a publicly accessible
database.