Not all clinical and drug trials and illegal and there are legal provisions for ethical and legal clinical and drug trials both at the International and National level, but still there are quite a few cases that India has seen over the period of the last couple of decades. This puts a question mark on the effectiveness of these legal provisions as the main objective of these provisions is to ensure the protection of the volunteers.
What are the Illegal Clinical and Drug Trials?
Clinical and Drug trials primarily aim at curing or treating a specific disease by introducing the drug into the human body carrying such disease. This test gives an opportunity to the organization to record the various results which the drug shows on a living body. But the issue with Illegal Clinical and Drug trials is that they do not work under the framework of legislation that governs such trials. These lead to the potential threat against the health of volunteers and also towards spreading harmful diseases amongst the public when the drug backfires or instead of curing it enhances the disease.
The patients are sometimes never told about the clinical trial they are subjected to i.e. they are not given a proper briefing of the trial, type of drug being used, potential side effects and precautions which again are against the rights of the patients and can cause fatal injuries to the human body.
India as a favorable state for Drug Trials:
Drug trials are often done on poor patients who are in need of money and easily volunteer for the clinical trials because of the monetary compensation which is paid by the pharmaceutical organizations. Also, it often happens that the patients volunteer for more than one clinical trial at a time which leads to improper results, results on which the organizations base their research. Due to lower cost of drug development, a pool of patients and highly skilled medical investigators, India has become one of the most favorite for most of the global clinical trial organizations which is shown by the fact that India hosts nearly a fifth of all global clinical trials with a huge potential for financial and scientific gains.
Regulations in India:
The Central Drugs Standard Control Organization (CDSCO) is the National Regulatory Authority in India. Department of Health and Family Welfare also appointed an expert committee to give guidelines on clinical trials, the committee then published the guidelines in 2013 in which it stated that clinical trials shall be closely monitored and only take place at accredited centers. Both the principal investigator of the trial and the ethics committee of the institute should be accredited. Only those trials conducted at such centers should be accepted by the Drugs Controller General of India (DCGI). Each patient must give written consent for any such clinical trial.
The Drugs and Cosmetics Act 1940:
The Drug and Cosmetics act 1940 and its Rule of 1945 is one of such documents which governs the import, manufacture, and distribution of the drugs in the county. The Schedule Y of the act governs the clinical trials and ensures that clinical trials falling under the ambit of schedule Y of the Act complies with the necessary requirements. It has 12 appendices, formats for clinical trial protocols, informed consent forms, Ethics Committee (EC) approval templates and a format for Serious Adverse Event (SAE) reporting.
Ethical Guidelines for Biomedical Research on Human Participants:
Recently, the Indian Council of Medical Research (ICMR) released the revised guidelines called the ‘Ethical Guidelines for Biomedical Research on Human Participants’ in the year 2017. This guideline covers two broad aspects of clinical research – the general principles that need to be followed and guidance regarding special areas of research, e.g., research in children or herbal research. Researchers are expected to be familiar with both these documents and abide by the requirements in the former and the guidance in the latter.
The review concludes that the clinical trial industry in India has great potential to become the most favorable destination in the world because of the low cost of doing business, the availability of skilled professionals, and, the availability of a large and diverse patient pool. But to achieve all that, India still needs to work on some serious issues. There is a need to create a regulatory environment capable of ensuring the conduct of clinical trials without violation of humanitarian ethics and other social norms.
Another major issue that promotes Illegal drug trials is poverty. Potential volunteers for these types of drug trials are mostly poor and illiterate who consent to whatever the organizations ask for just to get compensations without taking into account the types of risk involved, the complexities and side effects that may arise due to such trials