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Only 3,016 clinical studies being done in India out of 2,36,329 clinical studies globally
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Shardul Nautiyal, Mumbai
February 10 , 2017
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Out of 2,36,329 clinical studies being done globally, only 3,016 studies
are being done in India. It is much behind countries like the US,
Europe, Japan, China, Malayasia and Taiwan and ranks 5th in Asia. South
Asia contributes 3,642 studies, Afghanistan contributes 18, Bangladesh
248 with 2 in Bhutan, 71 in Nepal, 348 in Pakistan and 51 in Sri Lanka.
Even
as more rational guidelines in 2015 were poised to strengthen clinical
research in India, out of the 107 clinical studies reviewed and approved
to be conducted in the country, 43 were global clinical trials till the
period ending August 2015. This is much below as compared to the year
2014 where 150 clinical studies were reviewed and approved out of which
87 were global clinical trials.
This is however contrary to the
fact that the government is considering to rationalise and has revised
certain guidelines related to providing ancillary care to the clinical
trial participant to giving no fault compensation for any serious
adverse event during the clinical trial. Among other such issues which
have been streamlined were related to capping the number of studies an
investigator can undertake and also number of beds a hospital need to
have for conducting the trial.
In the year 2013, just 17 Global
Clinical Trials (GCT) were approved to be conducted in India due to
hard-hitting revisions in compensation guidelines in January, 2013 which
negatively impacted the growth of clinical research in India.
A
clinical study involves research using human volunteers also called
participants that is intended to add to medical knowledge. There are two
main types of clinical studies called interventional studies and
observational studies.
India is lagging behind smaller countries
like Korea, Taiwan and Japan due to regulations framed following a
public interest litigation (PIL) in the Supreme Court a couple of years
ago. The regulations were enforced based on the recommendations of the
professor Ranjit Roy Choudhury expert committee appointed by the
ministry of health and family welfare.
In a clinical trial,
participants receive specific interventions according to the research
plan or protocol created by the investigators. These interventions may
be medical products, such as drugs or devices; procedures; or changes to
participants' behavior, such as diet. Clinical trials may compare a new
medical approach to a standard one that is already available, to a
placebo that contains no active ingredients, or to no intervention.
Some
people who are not eligible to participate in a clinical trial may be
able to get experimental drugs or devices outside of a clinical trial
through expanded access.
In an observational study,
investigators assess health outcomes in groups of participants according
to a research plan or protocol. Participants may receive interventions
which can include medical products such as drugs or devices or
procedures as part of their routine medical care, but participants are
not assigned to specific interventions by the investigator as in a
clinical trial. For example, investigators may observe a group of older
adults to learn more about the effects of different lifestyles on
cardiac health.
Although home to a sixth of the world’s
population, less than 1.4 per cent of global clinical trials is done in
India, a country which also has a fifth of the global disease burden.
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