Clinical Trial in India “Are we really are the Guinea Pigs”, and Current Indian Scenario
What we perceive from Clinical Trials is testing of a drug on human beings who are treated as experimental “guinea pigs”.
Clinical research is part of developing a new drug molecule or testing the generic copies of the more costly and unavailable drug. Yes, it looks as we humans are guinea pigs and companies are testing their drugs on us like Guinea pigs, but there are two sides of a coin.
Drug manufacturing companies and Doctors use clinical research studies data to compare current treatments or drugs available with potentially better ones, in this way they can keep improving the care offered to the patients. As with the increasing resistance power of new strains of disease causing microbes and viruses, the more effective and cheap treatment is the need of the hour. Also the increasing population demands for cost effective treatment which can reach the poor as well.
Clinical research provides the evidence, without which medicine would never progress. How a drug can be made available to humans, before testing in humans??
But clinical trials aren’t just about testing new drugs. Clinical trials also involve using existing medicines in new ways, or in new combinations, to make them more effective. These molecules called as generic drugs or copies of the original drug are low priced, easily available and can reach to far population. That’s why we have same drug under different names and brands, as per the company doing the manufacturing.
So one question arises here – is it is safe to be a part of a Clinical Trial?
We can say that no treatment or medicine is 100% risk free. But all clinical research studies have to go through very strict ethical and regulatory rules and regulations before making them available to the patients.
These rules and regulations can be briefed as below. In 2010, the National Institute of Justice in the United States published recommended rights of human subjects:
- Voluntary, informed consent
- Respect for persons: treated as autonomous agents
- The right to end participation in research at any time
- Right to safeguard integrity
- Benefits should outweigh cost
- Protection from physical, mental and emotional harm
- Access to information regarding research
- Protection of privacy and well-being
These rules are very much followed in India too and the patient should give informed consent before being part of any trial.
Many steps have been taken by the government of India to ensure participant safety by introducing more stringent changes in regulatory bodies of clinical research, in India. Some such changes are as follows.
Registration of all clinical trials with Clinical Trial Registry India (CTRI) is mandatory. All trial documents and final report also need to be uploaded at the registry. This aimed at putting trial related information in the public domain.
From the year 2014 the Audio-visual recording of the informed consent process is now mandatory with each patient taking part in the trial this will make the process more transparent and maintain confidentiality.
The Institutional ethics committees (IECs) are empowered and their registration is now mandatory. They independently, without any influence review and monitor the ongoing trial at the site or hospital and any serious Adverse Events happening to the patients, taking part in the trial.
Compensation is awarded in case there is harm & injury that happens to the patient or any rule is violated.
Violation of rules cans also lead to imprisonment of up to one year. In addition, trial participants have to be provided ancillary care if they suffer from for any other illness during the trial.
Principal investigators (PIs), IECs and the trial sites accreditation has been recommended to ensure competence of investigators.
The patient’s who take part in the study are closely monitored, explained about the study, and in fact are provided with the best treatment and care available.
Current status of clinical research in India: The clinical trial industry in India is pegged at over Rs 3,500 Crores and is growing at 10-12% annually.
Companies have started taking more interest in India because of the genetic diversity of the population and also the liberal rules after the amendment in year 2005. However, trials in the country have been plagued by scandal. Government data shows that more than 2,600 patients participating in clinical trials in India died between 2005 and 2012, and nearly 12,000 suffered serious adverse effects. Of these, 80 deaths and more than 500 serious adverse effects were directly attributed to the drug being tested.
In 2013, India’s Supreme Court stepped in, to setup the rules to monitor clinical trials.
Immediate consequence of these actions was that the number of new clinical trials dropped dramatically. Number of applications to conduct clinical trials in India fell from 480 (with 253 approved) in 2012 to 207 (with 73 approved) in 2013. The new rules are aimed at ensuring that patients are not kept in dark and also greater compensation will be paid to them.
The leading domestic pharmaceutical companies, says that the increasing reluctance of India’s drugs and devices regulator to grant approvals for new drugs, even if they are approved in developed countries, has severely hampered the industry. The hub appears to have shifted to China, where a lot of government support has come to the aid of the industry.
Stringent regulatory rules and regulations has also made outside pharma companies apprehensive and skeptical about doing trials in India.
Clinical research is not only for testing costly drugs also for finding safer and better medicines for deep-rooted diseases such as HIV, malaria, diabetes, hypertension etc. India, with its large patient population, limited health needs, costly medicines and limited resources, needs to make newer and better treatment options available to its population in a quick, economical and dependable manner. For this, India must take proactive part in clinical research and assume leadership role globally.
The health ministry proposed pre-submission meetings to enable technical discussions and sorting of issues between Drug companies and the drug regulator.
However, some doctors say that clinical research in India is of a high standard and that deaths during clinical trials are to be expected.
Once the grey areas and contentious issues are addressed, that clinical research in our country will quickly scale up in a much safer, regulated and enabling environment.
The scientific community is extremely thankful, to those volunteers who participate in trials, through them they are learning more all the time about how to deal with a whole range of medical conditions – and make some real breakthroughs that will affect thousands of lives.
- http://timesofindia.indiatimes.com/india/370-die-in-clinical-trials-in-2-years-kin-of-only-21-get-compensation/articleshow, by Sushmi Dey
- The Pharmaceutical Journal, Vol. 275, p658
- http://www.financialexpress.com; Current Status of Clinical Trials in India: By De Y K Gupta
Author :Anushri Pawar
Anushri has a masters degree in Biotechnology and has worked in clinical research field for a while.She is now a freelance HR professional.She is enthusiastic, about science and loves to express her thoughts through writing.