Reality of Clinical Trials in India
India has the second largest population in the world and carries the highest burden of diseases, but carries out less than 1.2% of the clinical trials conducted globally.
The number of clinical trials being conducted saw a drop since 2013. Only 17 trials were approved as compared to 260 in 2012 and 500 in 2010.
India has the second largest population in the world and carries the highest burden of diseases, but carries out less than 1.2% of the clinical trials conducted globally.
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The number of clinical trials being conducted saw a drop since 2013. Only 17 trials were approved as compared to 260 in 2012 and 500 in 2010.
According to the Health
Ministry, there were 436 serious adverse events of death in clinical trials in
2012, 590 in 2013 and 443 in 2014. Of these, 16, 46 and 22 respectively were established
to be related to clinical trials.
In 2015 there were 162 deaths but data on those established due to clinical trials was unavailable.
Government data shows that many people were given compensation. But the name or addresses of person are hidden. There are no drug inspectors for regular checks on trials and private hospitals don’t come under the Right to information RTI Act. No one knows what is exactly happened on the ground level.
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In 2015 there were 162 deaths but data on those established due to clinical trials was unavailable.
Government data shows that many people were given compensation. But the name or addresses of person are hidden. There are no drug inspectors for regular checks on trials and private hospitals don’t come under the Right to information RTI Act. No one knows what is exactly happened on the ground level.
This is because court
intervened in this matter and court noticed as many as 2,262 people died in India
in the clinical trials during the past five years. Consequently court ordered
to regulate the clinical trials stringently and ensure safety of the patients.
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What are clinical trials and
why are they needed?
Clinical trials refer to a set
of practices and procedures performed on living organisms to test the safety and
adverse affects of new drugs.
Trials are needed to compare existing treatments and determine which is better. Also to study different ways to use already existing treatment to make them more effective and easier to use, and/or to decrease side effects. Trials are mandatory to learn how best to use a treatment in a different population, such as patients in whom the treatment was not tested previously.
Trials are needed to compare existing treatments and determine which is better. Also to study different ways to use already existing treatment to make them more effective and easier to use, and/or to decrease side effects. Trials are mandatory to learn how best to use a treatment in a different population, such as patients in whom the treatment was not tested previously.
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Ethical Concerns
One of the most important
problems is that consent of the participants in the clinical trials of not
taken. It is due to a large proportion of participants in India is illiterate and
lured into trials by offers of free healthcare but they are not informed of the
difference between treatment and research.
The big problem plaguing clinical research is
an over-representation of low-income groups among trial subjects.
Sometimes clinical research organizations recruit them selectively, exploiting financial need and medical ignorance. Such deception is a risk not only to volunteer health but also to society, because it can throw off the trial’s results.
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Sometimes clinical research organizations recruit them selectively, exploiting financial need and medical ignorance. Such deception is a risk not only to volunteer health but also to society, because it can throw off the trial’s results.
For instance- 2004, Bhopal gas leak survivors
getting treated at Bhopal memorial Hospital Research Centre, were recruited for
clinical trials without theory knowledge and few of them died while conducting
the trials.
Laws and regulations of
clinical trials in India
There are few laws governing clinical
trials-drugs and cosmetic Act, 1940, Medical Council of India Act 1956, Central
Council for Indian Medicine Act, 1970.
There is also a three tier
review process before final approval. First, the application is reviewed by the
subject expert committees. In second stage they are monitored by technical
committee and finally by the Apex Committee. Once this mechanism is completed
then final approval is given by Drugs Controller General of India whose
approval is mandatory. India council of medical research, the apex regulatory
body for clinical trials, was set up to promoted research culture in India and develop
infrastructure for clinical trials.
Need of clinical trials in India
70 million populations in India
suffer from rare disorders and incurable diseases many of which still do not have
any cure. There is an urgent need to do more ethical clinical trials. India is
more skewed towards non-communicable diseases like cancer etc. less focus is
done on communicable diseases like – TB, malaria etc. so clinical trials in
this area brings a balance in over all research.
What initiatives government has
taken to bring more transparency in clinical trials rules 2019?
Ministry of Health and Family
Welfare brought new clinical trial rules 2019 with an aim to promote clinical research
in country.
The new rules will ensure patient
safety, as they would be enlisted for trials with informed consent and the ethics committee will
monitor the trials and decide on the amount of compensation in cases if adverse
events. It mandates that in case if injury to the clinical trial subject,
medical management will be provided as long as required as per the opinion of
the investigator or till such it is estimated that injury is not related to the
clinical trials.
Compensation in cases of death
and permanently disability or other injuries to a trial subject will be decided
by the Drug Controller General. According
to new rules time has reduces for
approving applications to 30 days for drug manufactured in India and 90 days
for those developed outside the country.
In case of no communication
from drug controller general of India, the application will be deemed to have
been approved. The rules included waive off the requirement of a local clinical
trial if the drug is approved and marketed in countries specified by the Drug
Controller General with the approval of government from time to time.
The aim of the new rules for
clinical trials is to promote clinical research in India by providing for
predictable, transparent and effective regulations for clinical trials and
ensuring faster accessibility of new drugs to the Indian population.
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