Legal issues in regulating the Clinical Drug Trials on human beings in India- Balancing economic opportunities with public health

Mohd. Humaid comments on the legal issues regulating clinical drug trials on human beings in India and makes an attempt to balance economic oppurtunites with public health in this regard.

INTRODUCTION

For many years, the debate on clinical drug trial is going on in different parts of the world. Clinical research is a crucial part of drug discovery and development process. In a simple term, drug trials can be defined as a practice or any investigation on human subject taken out the whole process by pharmaceuticals in order to discover the effect of any medicinal molecule on human beings or the reaction of medical product before reaching the adverse market. The research examines the relation on how the rights and feelings of the human being and their health are bargains to stabilize the industrial clinical market of the developing nation. Yet, it is certainly not the West that is introducing clinical research in India. Two ancient scripts, Charaka Samhita (a textbook of medicine) and Sushruta Samhita (a textbook of surgery), compiled as early as 200 B.C. and 200 A. D. respectively, show India's age-old proficiency in medical research.¹ The main debate is associated with the clinical trials on human beings that have been evolved during the past few years and have been over the headlines.

Current situation

Clinical drug trials in India have grown enormously over the past decades. India was the second most preferred country to conduct clinical trials outside US in 2009. Various organizations have issued a number of special guidelines related to the safe clinical trial and to strengthen the clinical trial in India. An Organization like “The Central Drugs Standard Control Organization’’ (CDSCO) is one of them that help in strengthening the safe clinical drug trials. Various drug companies are attracted to India, there are several reasons for the same including the work force, low cost and friendly drug-control system and one more that is the large number of patients available. According to the associated chambers of commerce

and industry, and influential national industry association, India is to grab clinical trials business valued at approx. US$ 1 billion by 2010, up from US$ 200 million last year. Many major steps have been taken by the government of India to ensure safe participation in trails and it is now mandatory to register all the clinical trials with Clinical Trial Registry of India (CTRI). Government data show that 2600 patients participating in clinical trials died between2005-2012 and 1200 patients suffered serious adverse effects of these, 80 deaths and more than 500 serious diverse effects were directly attributed to the drug being tested.² Number of applications to conduct clinical trials in India has fallen from 480 (with 253 approved) in 2012 to 2007 (with 73 approved) in 2013.³

Global Perspective

Experimenting drugs in the developing world

The whole purpose of testing the drugs is to find out what or which drug works wonders for the illness. In spite of getting the bad news about the clinical trials, many reports say that a positive increment or change is taking place gradually over the years. There were various trials in many countries for example; one the trial was carried out to test the new method for preventing the transmission of HIV infection from the pregnant women to the new born babies or even before giving the birth especially in the developing countries like Africa, Asia and Caribbean. Similarly unethical trials continued to be conducted. The World Health Organization (WHO) estimated approx 450000 children died from Rota-virus infection globally. Not surprisingly, 90% of these deaths occurred in countries in Africa and Asia. The big and ranked major pharmaceutical companies have major attraction of drug trial nothing else but the lower costs and availability of the neediest patients who have been previously exposed to drug trails. So it is likely more to be cheaper in countries like India, China, Vietnam, Brazil, etc. So with the gradual shift towards the globalization, India has become go-to-location for the big pharmaceutical houses to conduct the trails.

India a hot spot for clinical trial

Clinical drug research has grown exponentially over the phases in India because of many major advantages, easily available cost advantage, qualified doctors' treatment naïve patients, etc. India is the second most preferred destination to conduct clinical trials by the big pharmaceutical companies. In India, Drug Controller General of India (DCG) is the main authoritative body for approving clinical trials as well as marketing and manufacturing of the drug. The clinical trial industry in India is pegged at over rupees 3500crore and is growing at 10-12% annually.⁴ India is the only country with the genetic diversity of the population where the clinical trials are on the easier track. One major advantage of getting involved in the world clinical trials is that it places us in the benchmark position to negotiate for a cheaper price tag when such drugs are sold in India; the regulatory framework is quite weak as there is a need of specific regulatory framework that should take the proper monitoring mechanism and a rigid administration. A major thrill that country faces is the problem in the area of low literacy level which always kept regulation suspicious about the possibility of the participants being not informed about the risk involved under which they are undertaking. Though the consent of the participant is a necessary factor, an initiative from the part of the Ministry of Health and Family Welfare in its decision to thrust nearby rupees 250Crore in an e-governance initiative for the CDSCO to operate efficiently and transparently. Therefore, an unethical trail, falsified data, fraud in trials, non-compliance with GCP and the over execution of trials without the approval of DCGI are few kinds of risk involved.

Government, Legislations and Court directions

Clinical drug research on a human subject is regarded as an essential part of drug research and development. The main question arises that whether the participant who is taking part in the drug trial is well informed about the same? There are instances which show that the pharmaceutical companies do not follow the government regulations and specific laws which they should follow for the same. India’s highest court has given the guidelines to the government to tighten the norms and regulations for the conduct of clinical trials for new drugs. In one of the petitions filed by a famous NGO has alleged that many patients in India have been used by pharmaceutical companies as “guinea pigs” for clinical trials of new pharmaceutical compounds. Supreme Court has asked the government to set up proper norms in relation to ensure the safety of the participants who are taking part in the trials. Apart from the topic, the government has also brought in the various amendments to the clinical trial

and various other regulations are being revised in this respect to make sure the trials are carried out in the safest way. In an application filled by two Bhopal based NGO’s in the petition had alleged that the survivors of the deadly poisonous gas leak from Union Carbide factory in Bhopal 30 years ago and being used as a “guinea pigs” for the clinical trials of new drug.⁵ There were many petition that was filed regarding the clinical trials suggested that low cost, inadequate and liberal enforcement penalties have made this country an eye catching destination for the big pharmaceutical houses for the test or the clinical trial. The Hon’ble Court observed that “uncontrolled clinical trials are causing havoc to human life’s”, laid guidelines for global clinical trial (GCT), including clinical trials of New Chemical Entities (NCE’s).⁶ Clinical drug trials are of utmost importance for the development of new medicinal molecule in the country and to which India has the capacity and calibre for drug discovery and research.

Violation of Human Rights

The clinical trial involves types of practices that are required to certify a new medical molecule as safe before reaching the market. Here the consent of the participant in the clinical trial plays the crucial role which denotes that the patients who are getting involved in the respective process should be informed or be made aware of the trial being conducted on him/her, as the process involved the negative and positive side effects, etc. Many researches on human subjects in recent years have been influenced by the growing financial force and the growing effect of advances in science has led them to unethical paths which have affected the human life on a great scale. Human beings are easily exposed in various types of trials, especially people with mental disability, especially the children’s, prisoners, people suffering from several illnesses, etc. These are the few of the numerous breathtaking human rights violations that have been seen in the field of clinical trials. All these instances clearly show the loophole in our Indian legal system for penalizing the big pharmaceutical houses that violates the rules and follow an un-ethical way of conducting the trials. India is not alone the biggest prey; there are many other countries which have no specific law to tackle the misconduct that is being carried out on the patients who are not aware that they are being tested. The harsh reality is that the patients who are taking part in the trial are promised

treatment for their illnesses, but in reality the medicine being tested on them has nothing to do with their illness. Drugs are tested in developing countries and are sold in the developed countries. A clinical trial costing US$ 180 million in the US costs only US$ 100 million in India.⁷ Like in the Pfizer case, Pfizer was accused of testing new drug without ethical approval in which an official inquiry was set up into allegation that the drug manufacturer Pfizer did not obtain official approval before testing a new drug on children during a meningitis epidemic in Nigeria.⁸ The Govt, courts, legislations and the civil society still have to spend much to balance the difference and to improve the situation. There is still a need of proper drug regulations and professional research to carry on the same.

Writer’s opinion

India with a huge variety of benefits like patients, low costs, low literacy rate, etc. have led to the immense growth of the clinical trial market. However, to achieve its global goal, India will have to work a lot to supersede the major challenges like unethical trial, lack of good professionalism, trial investigators and the main one lacks of knowledge. The reason why India has become as a global hub for clinical trials are not different, but its large number of population and patients who are in need of treatment and apart from this the low cost and growing infrastructure, development in the field of medical sciences and good medical expertise. For the past few years the cost of clinical trials in India is reduced up to 60% as compared to the other developing countries of the world and so on. Investigators cannot bargain the life of innocent people by simply exposing them into the trial without their consent. The increased compensation every time that is offered to the participants of the trial is not just sufficient as it is an inhuman act to put a human life on sale with a price tag. There is no price payable to the finest masterpiece created by God. The big pharmaceutical houses to ensure their stability in the market cannot easily ignore the safety and security of the participants who are ignorantly put into the drug testing. Problems are not only prevailing in the place of trials, but there are a few more problems that are being encountered during the trials like falsified data, failure to obtain the consent from the subject, lack of ethical awareness and much more. In India as for many years there was no compulsory registration system prevailing for during trial until 2006. So what happened to all the unethical trials that took place before 2006? The whole scenario is blurred to date. The true fact is that our legal

system is not strong to maintain the transparency and accountability in the practice of clinical trial. The law should be implemented in such a way that is should govern the clinical trials and research associated with utmost diligence and transparency and if it is not sooner be done, then there will be a situation of great distress and annoyance.

Conclusion

India is certainly setting itself to attract more and more researchers from around the world to carry on their clinical trial studies in India. The new laws are being amended to facilitate and channelize the entry of the big pharmaceutical houses. There is a need to alter and implement the existing intellectual laws with high ethical standards that will lead the clinical trial of India to the next level in international market. The trials of small scale pharmaceutical companies should be stopped to an extent on illiterate human subject as it can lead to adverse affect that will be quite unbearable. Being the second largest populated country in the world, India can contribute positively in the global medical researches and drug development program, etc. In the last few years we continually see the dramatic increase in the number of clinical trials. There is a need of a proper structure for regulating the clinical trials as India lacks a proper mechanism in the clinical trial industry. With experienced clinical professionals and technological advances, India will be sure to give best as a major favourite destination for the clinical researches in the near future.