Introduction

The Indian Constitution preserves the pride of being the longest and most comprehensive Constitution to have bestowed with utmost importance and dignity to its citizens in terms of right to life and personal liberty irrespective of his/her economic strata in the society. But undoubtedly not many of us are aware that somewhere or the other this privilege is not been achieved in a holistic manner, talking in terms of the one who unfortunately happen to fall under the category of “poor” in our society and at the lure of some petty money, these vulnerable ones become subjects at the hands of some Pharmaceutical Companies, who use them for clinical trial of their drug innovation. In 2004 one of the most shocking landmark incident happened when 14 participants who were administered drug without their consent and knowledge of its adverse consequences, died during the course of the clinical trials at Bhopal Memorial Hospital and Research Centre, which was established exclusively for treating the victims of the 1984 gas leak.1 Yet another striking and recent news witnessed in a National Newspaper on 18th Aug, 2012 was the death of 211 people from January to June 2012 due to serious adverse effects of drugs administered to them during clinical trial conducted by the Drug Companies.2

Clinical Trial: A positive or negative practice?

In general prospective when analyzed, clinical trial is a positive requirement to strive towards the growing developments in the present Pharmaceutical market worldwide. Moreover now that Government has also finally given positive node to foreign pharmaceutical companies to invest in India, it is a good sign for India that global clinical research is gradually exploring India. But the biggest question is how far India can exploit this opportunities and at the same time to come up with measures to protect the rights and safety of the subjects of clinical trial, so as to make such trials both methodologically and ethnically valid is a big concern.

It is worth appreciating that very recently Government is seen to have shown positive responses towards the long controversial issue of rights and safety of research subjects after decades of debate, protest by various organizations and experiences of the vulnerable poor subjects. In this review, this article attempts to throw light on the Central Drugs Standard Control Organization’s (CDSCO) role and steps taken towards protecting and ensuring rights and safety of the subjects of clinical trial.

Present regulatory measures in India regarding clinical trials

There are number of laws governing clinical research in India. They are The Drugs and Cosmetics Act 1940, Medical Council of India Act - 1956 (amended in the year2002), Central Council for Indian Medicine Act – 1970, Guidelines for Exchange of Biological Material (MOH order, 1997, Right to Information Act – 2005, The Biomedical Research on Human Subjects (regulation, control and safeguards) Bill – 2005.

Out of all the above laws, The Drugs and Cosmetics Act – 1940 plays a significant role in terms of clinical trials. In 2002 certain important amendments were made to the Drugs and Cosmetics Rules, 1945 with regard to conducting of clinical trials for import and manufacture of new drugs. As a result, it is mandatory to obtain prior approval from the Drugs Controller General of India (DCGI) before any institution conducts clinical trials for a new drug.3Further Schedule Y of the Rule specifies that the Clinical Trial should be conducted in compliance with the protocol and Good Clinical Practice (GCP) Guidelines specified for the purpose as well as with all applicable statutory provisions.

Recent positive approaches by CDSCO with regards to safety of the subjects of clinical trial

The coming up of the remedial shield as “Draft Guidelines for determining quantum of Financial Compensation to be paid incase of clinical trial related injury or death”4 is a significant step that CDSCO has taken with the aim of protecting the rights, safety and well being of the subjects participating in the trial. Ironically, the Drug and Cosmetics Rules is silent about any specific provision for payment of compensation to victims who suffer serious adverse injuries or death as a consequence of clinical trial, however the Good Clinical Practice (GCP) Guidelines for Clinical Trials of India under Para 2.4.75 provides such compensatory measures. With the objective of incorporating specific procedures to be followed for payment of compensation in case of trial related injury or death, steps are being taken to come up with certain standards through this draft rule to determine such compensation, once it is finalized and enforced.

In assessing or deriving an amount to be called as appropriate compensation in the case of trial related injury or death, the guidelines have primarily taken the following parameters into consideration :-

  1. Age of the deceased ;
  2. Income of the deceased ;
  3. Seriousness and severity of the disease the subject was suffering at the time of his/her participation into the trial ;
  4. Percentage of permanent disability ;

Lacunas /insufficiency of the guidelines in determining compensation

  • Income Factor: The guideline determines that higher is the financial earning capacity, higher would be the compensation payable to the subject of clinical trial who suffers any injury or death. It apparently reflects that comparatively one who is financially sound would get more compensation than the poorer one. Moreover those individuals who are incapable of earning due to any physical or mental disability, old age or any other reasons would be most affected if income factor is taken into consideration to determine the amount of compensation.
  • Seriousness and severity factor: The guidelines insist on immediate nexus between the trial and the injury or death that subsequently may occur. However, the determination of compensation should not be restricted to direct short-term injury during the trial. In many cases, the injury to the research participants is not immediate but may show only after few months in a gradual process.
  • Disability factor: It may vary from individual to individual depending upon his/her physical strength, resistance power, racial characteristics, genetic make-up, individual biochemistry etc. The draft should have demarked the difference between permanent and temporary disability.

Apart from the aforesaid guidelines, another pertinent step taken by CDSCO that reflects the seriousness and strictness towards ensuring safety measures to the subjects of clinical trial is the recent order published on 16th August 2012 under the heading “Ensuring rights/ safety of clinical trials subjects in India” where strict instructions are given to the Ethics Committee involved in clinical trial to keep vigil on the clinical trials being conducted under their jurisdiction.6 Further under the same heading a notice has also been published emphasizing on written consent to be taken from the subjects of any clinical trial who is administered with any new drug after the Investigator provides all relevant information pertaining to the study to be undertaken on him (the subject) so that the subject is aware of the nature of possibilities of adverse effect of the study and that the consent given to such study should be free and in conscious mind.7

Conclusion

As India is approaching towards globalization in the recent developments in the Pharmaceutical sector occurring worldwide, based on its comparatively low cost and skill base , India portrays to be a prospective hub for many big foreign Pharmaceutical Companies for drug innovation, So as to exploit this opportunity for the betterment of the country, it is pertinent that introduction of any drug innovation in the market should be preceded by a successful clinical trial which should be both methodologically and ethically valid. Inspite of the appreciable steps taken so far, our law framers further need to put efforts to raise the standard for a more rigid and stricter vigilance mechanism on the Pharmaceutical Companies who conduct such clinical trial at the cost of the lives of some vulnerable and poor individuals who are not even aware that in our Country, there is existence of “right” to lead a safe and healthy life that the Supreme law of the land-the Constitution guarantees to each and everyone irrespective of their economical conditions, race or any other difference.