Reality of Clinical Trials in India - Seeker's Thoughts

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Reality of Clinical Trials in India

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.
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.
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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.

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.
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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.
 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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