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Human Drug Testing Clinical Trials, Unethical Practices by Soma Hegdekatte

The Author: Soma Hegdekatte is a Law Student Studying at Gujarat National Law University, Gandhinagar

Venkatamma’s eyes fill with tears when she remembers the fateful day of 21th Jan 2010. The vivid memory of finding her daughter’s motionless body still haunts her. The doctors stated ‘suicide’ as the reason of death on the death certificate. But Venkatamma knew otherwise.

Her daughter had been in excruciating pain for the past few days and had suffered constant epileptic seizures. Venkatamma’s daughter wasn’t the only one in the district of Khammam, Andhra Pradesh, who had suddenly committed ‘suicide’. 4 other girls from nearby villages died in similar circumstances and 120 other girls faced severe complications like allergies and dizziness. What linked all these girls was the fact that they all studied in the nearby Lakshminagaram Residential Hostel, a hostel made for young poor tribal girls, and that they had been administered a vaccine for the Human Papilloma Virus (HPV), as part of an observational study of the effects of this drug on prevention for cervical cancer[i].

What was Venkatamma’s daughter’s fault? Was her life of lesser worth because she came from a poor and vulnerable background?


Human drug testing trails are very important for research in medicine. A clinical trial is defined as ‘’any research study that prospectively assigns human participants to one or more health related interventions to evaluate the effects on health outcome’[ii]. Mere animal testing cannot always be accurate and precise. Without these trials, a pharmaceutical company would never know the effects a medicine could have on people after its release in the market. Nevertheless due to the perilous nature of such tests, due care and precaution is a sine qua non to clinical trials. Only after laborious research and experimentation, are human trials allowed.


In India[iii], new drugs can be administered to humans for experimentation only after obtaining the permission of the New Drug Advisory Committee (NDAC)[iv] and of an ethics committee.   Approvals have to be taken by the DCGI (Drugs Controller General of India). In case the trial is of special nature the NDAC can consult specialized agencies like the Genetic Engineering Approval Committee, Department of Biotechnology etc. After accomplishment of the approval, the new norm is to register through the CTRI (The Clinical Trials Registry- India)[v].  This free online forum for registration of trials is maintained by National Institute of Medical Statistics (NIMS) [vi]and funded by the World Health Organization[vii] and Indian Council of Medical Research (ICMR). The CTRI was launched on 20th July 2005 and was made mandatory by the DCGI on 15th June 2009[viii][1].

CTRI is designated under the WHO’s International Clinical Trials Registry Platform, thus all CTRI registrations are exhibited on the ICRTP site[ix].

Clinical trials, by and large, are divided into 4 phases:

  • Phase 1: This phase is primarily concerned with the aspect of safety of a medicine. The number and quantity of dosages that should be administered is also evaluated. Also this phase studies how the body reacts to the body in terms of absorption, metabolism and excretion.
  • Phase 2: This phase is primarily related to the efficiency of a drug. A common practice during this phase is to divide the subjects into two groups; wherein one group is administered with the new drug and the other group (controlled group) is administered with a placebo or the standard drug used.

‘Placebo’ is a stimulant which is administered to a person or a group wherein the person or group perceives the medicine as a cure but which is in actuality is ineffectual as a medicine.

  • Phase 3: In this phase, the drug is tested on a large number of people from diverse groups. This is to test if the drug is consumable by a larger population.
  • Phase 4: This phase is usually conducted after the drug has been given market clearance. This phase studies the long term effects on the drug, its cost effectiveness and the comparison with other drugs.

Besides the Drug and Cosmetics Act, drug testing in India is also governed by two main guidelines, namely the Medical Council of India Act (MCI), 1956 and The Indian Council of Medical Research (ICMR) (2006) guidelines. The MCI act governs the conduct of a doctor. Thus if a doctor is found guilty for unethical practices, the MCI act can take punitive actions against him or disbar him from practicing again[x]. The ICMR guideline[xi] is a comprehensive document comprising of guidelines which have to be followed for medical testing. The ICMR governs a committee called Central Ethics Committee on Human Research (CECHR) which looks into the working of the Institutional Ethics Committees (IEC). An IEC is an independent body which monitors proposals and research on human experimentation and give their approval to proposals based on ethical standards.

The ICMR states that ‘research participants who suffer a physical injury as a result of their participation, are entitled to financial or other assistance to compensate them equitably for any temporary or permanent impairment or disability. Nevertheless this statement is vague and doesn’t precisely state the remuneration for various degrees of injury.

Hence, due to growing agitation over deaths due to trials, in 2011, ICMR came up with a framework to compensate victims of clinical trials. The proposal holds that all victims have to be compensated, irrespective of whether the injury was foreseeable or the victim had given consent with full awareness of the side effects[xii].

The most important feature of human drug testing is ‘informed consent’[xiii] of the subjects. Mere consent without adequate knowledge of the consequences, side effects, and for what the testing is being done cannot be considered as consent. Also the consent cannot be given by a third party. The consent has to come from a legal guardian or the person in concern.

In this particular case, 23,000 girls between the ages 10 to 14 from Andhra Pradesh and Gujarat were vaccinated with this drug named Gardasil[xiv], which was produced by US based pharmaceutical giants Merck and Co Inc and GlaxoSmith Kline. Merck had donated these vaccines to PATH (Programme for Appropriate Technology in Health), the largest healthcare NGO in USA, which was leading this initiative in India[xv].

 In the case of the girls from Lakshminagaram hostel, where 278 girls were vaccinated, the consent was mostly given by the principal of the school[xvi]. Venkatamma didn’t even know that her daughter was being used for observational studies until she died. Another family, who lost two of their daughters to the same cause, claimed they signed the documents because the doctors told them it would be helpful. Neither parents could read or write, and had no idea what they were signing.

This controversy brought to light the fault lines of the trial. Firstly, the programme was ‘advertised’ as a government initiative. On the brochure for the vaccine, a logo of National Rural Health Mission was printed without official approval from the government[xvii]. Secondly, the most marginalized and vulnerable groups were used for these observational studies[xviii]. All these girls were from marginalized tribal illiterate families with little access to parental guidance as they were living in a hostel.

Further PATH also violated the ICMR 2006 guidelines[xix] which states that trials can be administered on children only after a Phase 3 trial on adults for the same drug. But the Phase 3 trials for Gardasil were held on 110 Indian girls between the ages 9-15 during the period of 2007 -2008. Moreover, the motive of the whole initiative is highly debatable[xx]. Was the trial held to help these girls as claimed by PATH or was it being tried on these girls before it could safely hit the US markets?

What followed the deaths of these girls was an Interim investigation by a committee led by three scientists from the All India Institute of Medical Sciences (AIIMS). The report concluded that none of the girls died due to the vaccine. The families of the victims were not even interviewed before it was concluded that ‘drowning’, ‘malaria’, and ‘suicide’ were the reasons for their deaths[xxi].

This case led to a sea of change in the awareness of unethical trials in India. In 2013, the 72nd standing committee report[xxii] was presented in the Rajya Sabha. This report was based on an enquiry made on the incident. It clearly holds PATH, Gujarat State Government, State Government of Andhra Pradesh, ICMR, and the Drug controller General of India liable for the whole fiasco and chides the AIIMS report. The blatant violations of laws and rules have been criticized in the report and necessary action was requested.

With this incident splashing all through the media, awareness grew that this is not the only case of unethical human drug testing trials in India. India’s vast vulnerable population attracts big, global pharmaceutical giants for drug testing. The Indian drug testing market is estimated to be about 400 million dollars[xxiii].  In most cases, patients aren’t even aware that they have been given experimental drugs. Most of the time, these drugs don’t have relevance to the illness the patient is being treated for. Approximately 1730 Indians lost their lives in drug testing during the period of 2007-2010[xxiv]. Since 2005, the number of participants in these trials in India has increased to 1.5 lakhs in around 1600 trials[xxv]. Outsourcing of clinical trials is not only limited to India, with more than 1.2 lakhs of trials being held in 178 different countries, mostly developing countries[xxvi].

The numbers might be appalling, but India does have something to gain from these trials. The Drugs and Cosmetics Act 1940[xxvii], one of the foremost laws governing drug testing in India, was amended in 2005. Before this amendment, all the phases for the trial had to be retested in India if the trial was previously done in some other country. Presently there is no such requirement. By this amendment India can become a part of global clinical trials, thus making India also entitled to availability of these drugs. But as of now, this amendment has merely made India more susceptible to exploitation.

Nevertheless, India does have a ray of hope. In 2013, The Supreme court passed a judgment[xxviii] based on a public interest litigation wherein it  criticized the use of Indian citizens as ‘guinea pigs’ and directed chief secretaries from all states to look into all facets of clinical trials and make effective regulations regarding the same. In fact, 162 trials have been put on hold indefinitely. While it is true that the awareness of unethical trials is increasing by the day and this judgment will have positive ripples to that effect, this fight against unethical testing has not been completely suborn. Putting trials on hold in fact has a negative effect on foreign investment and the pursuit for making useful drugs available in India. What is actually needed is stringent implementation of the existing rules and any new laws rather than complete cynicism towards clinical trials.

India is not alone and isn’t the biggest victim. There are countries which have no voice and where there are no laws to tackle any misconduct that are being exploited at this current moment. 80% of trial patients[xxix] in developing countries aren’t aware that they are being tested. In most countries, like India, the illiteracy of poor people is exploited. They are promised treatment for their illness, but in reality the medicine being testing has nothing to do with their illness. Sometimes these drugs are not for the market of that country, and are only tested there so that they can be sold in developed countries. In cases where the drug has relevance to the subject’s illness, the subject is coerced into drug testing under the promise that it would treat their illness. The subject is obliquely coerced, as he has no option but to take the medicine in order to get cured.  There have been instances where the regular drug for an illness has been replaced by the experimental drug under the claim that the previous medicine is unavailable.

The mathematics is simple. Conducting trials in developed countries like USA is extremely expensive and cumbersome. In India and other developing countries, the amount to be paid to a consenting subject is lesser than half that has to be paid to a subject in USA. Also the process of conducting the trials is cheaper. The number of approvals needed in a developing country in much lesser than what is needed in a developed country.

One more reason why trials are held in developing countries is because it is easier to find ‘treatment naive’ patients in developing countries. Treatment naive patients are those who have not been exposed to many medicines. This helps because it creates lesser chances of side effects due to other medications being taken by the patient and the body has an authentic reaction to the experimental drug.[xxx] Further, a country like India holds a diverse group of communities. Therefore, testing drugs in India will give companies a diverse genetic experimentation ground to test the efficiency of these medicines. In addition, most developing countries have either lax or nonexistent punitive laws in case of death due to clinical trials. Rampant corruption and lax rules in most developing country stand as crutches for these companies in cases of death or injury. The compensation also, is much lesser than what has to be paid in developed countries.

Discussing the Food and Drug authority (FDA) of America becomes pertinent at this point, as most clinical trials are for US based companies and FDA monitors the drugs entering US markets. Results from clinical trials concluded outside USA are allowed by the FDA. In USA, once a New Drug Application has been registered, the results of Phase 2 and Phase 3 have to be submitted and are subject to review[xxxi]. Nevertheless in 2008 only in 0.7 %[xxxii] of clinical trials done outside USA were reviewed. FDA’s justification for this is that clinical trials done abroad are outside their jurisdiction and procuring documents is cumbersome as they might be confidential.

Boon or Bane in disguise?

The small town of Tudun Wada, Kano district, Nigeria, saw one of its worst nightmares in 1996.The whole town was plagued by an epidemic of Bacterial (meningococcal) meningitis. The epidemic had already engulfed 12,000 lives when an American research- based Drug Company named Pfizer decided to take up the role of a messiah by introducing a drug called Trovan (trovafloxacin)[xxxiii].

But hope soon turned into despair. Trovan was tested on 200 children, in order to see its effects and side effects. As a result of these tests, 11 children died and innumerable children were left with disabilities ranging from brain damage, deafness, blindness to various other cognitive injuries. It was only after the tests, that various flaws in the conduct of the tests were found. Pfizer was then sued by the victims of these tests in the US courts (Abdullahi v. Pfizer, Inc[xxxiv] and Adamu vs Pfizer[xxxv]). The Trovan case even today stands as a benchmark illustration of Human drug-testing in third world countries by big pharmaceutical companies.

The cracks in Pfizer’s conduct were scrutinized after the controversy. The staff of Pfizer could not prove that they had taken the consent of the parents of the children. Most parents later alleged that they weren’t aware of that the children were taking part in a trial[xxxvi]. During the trial, half of the children (the control group) were purposely given low doses of ceftriaxone, the FDA-approved drug being used at that point. Pfizer also did not revert to the regular medicine in cases where Trovan had failed to show improvement[xxxvii]. It was also alleged that animal testing of Trovan had demonstrated hazardous side effects like the ones faced by some of the children. Also, there was no follow up after the trial, to ensure post trial care, with Pfizer’s personnel leaving the country abruptly after the 2 week trial.[xxxviii]

The Abdullahi case is important as it brought out the connection between human drug testing and public international law. The victims sued Pfizer in the US court under the Alien Tort statute under the claim that the international customary law that prohibits human experimentation on non-consenting individuals was violated.

The Alien Tort Statute  is a section of the United States Code which states: “The district courts shall have original jurisdiction of any civil action by an alien for a tort only, committed in violation of the law of nations or a treaty of the United States.”[xxxix] This law was made to help non-American citizens in cases of human rights violation against violations committed by states outside America. The relevance of this law to America has been questioned in recent times, however (Kiobel v. Royal Dutch Petroleum)[xl].

The case was taken to the second circuit of appeals after it was dismissed in the District court over subject matter jurisdiction. In the second circuit, Pfizer contended that the case was not applicable because they were a private party and there was no ‘law of nations’ regarding non consensual human experimentation. Nevertheless the court took up the case since there was sufficient evidence regarding the Nigerian government’s involvement and that non-consensual human experimentation violated international customary law, which has been stated in various codes and declarations like the Helsinki declaration, Nuremburg code and the International Covenant on Civil and Political Rights. The court held that international customary law was indeed violated in this case. This decision was questioned by Pfizer through a writ of certiorari, asking the Supreme Court[xli] to review the Circuit Court’s verdict; on the basis that the Nigerian government’s involvement in anything which violates international law has not been established[2]. This writ was dismissed, but eventually the case was dismissed in the US courts under the grounds of forum non conveniens[xlii]. The doctrine of forum non conveniens states that a court can refuse jurisdiction in case it deems another country’s jurisdiction more appropriate for the case. Thus the case was then transferred to the Nigerian jurisdiction. Eventually an out of court settlement of 75 million dollars was agreed upon by Pfizer and the representatives of the Nigerian government[xliii].
The Trovan case for the first time highlighted human drug testing in third world countries by multinational companies and the various international laws related to it.
International Law on Human Drug Testing
Nuremberg Code
 Anybody who has read about the Holocaust would have definitely come across the name Josef Mengele, or ‘the angel of death’. His experiments on children in concentration camps still leaves people appalled and horrified even years after the Holocaust. Josef Mengele managed to flee without a trial after the Second World War, but the rest didn’t. During the subsequent Nuremberg trials, a doctor trial was held, where 20 out of 23 doctors were found guilty for human experimentation. Thus the Nuremberg code was adopted in 1947. The Nuremberg code deals with 10 pointer code of ethics related to human experimentation. Issues like voluntary and informed consent, precaution before experimentation, liberty for termination of experimentation by the subject et al, are dealt with in this code. It is the first ever code on human experimentation and forms the basis for future international ethics.
Universal Declaration of Human Rights[xliv]
Though the declaration does not specifically deliberate on human experimentation, the topic does come under the purview of human rights. Human experimentation mainly comes under the purview of two articles in the declaration;
Article 3
Everyone has the right to life, liberty and security of person.
Article 5
No one shall be subjected to torture or to cruel, inhuman or degrading treatment or punishment
International Covenant on Civil and Political Rights
This covenant was adopted in 1966 General Assembly through a resolution. Article 7 of this covenant specifically deals with human experimentation and states;
‘’No one shall be subjected to torture or to cruel, inhuman or degrading treatment or punishment. In particular, no one shall be subjected without his free consent to medical or scientific experimentation.’’[xlv]
Helsinki Declaration [xlvi]
This declaration was first adopted in 1964 and was subsequently revised six times. The Helsinki declaration is the most important document monitoring medical ethics around the world. It was developed by the World Medical Association[xlvii]. While referring to human experimentation ethics in international law, this declaration is the apex document.
The declaration lays importance on informed consent and covers the topic comprehensively. The declaration, after heavy debates and several revisions, now gives a complex overview on when placebos can be used and when regular medicine has to be used for the controlled group during experimentation. Nevertheless the declaration doesn’t delve into the role and liability of sponsors of clinical trials, which is much needed in today’s times.
Human drug testing is essential for further growth in medicine. Also involving third world countries in this experimentation is mutually beneficial. While the pharmaceutical companies get to cut down on their expenses and hold trials on a diverse range of people, citizens of third world countries have a lot to gain too. A country can be entitled to the use of a drug testing in that country. Further the money and medicinal treatment offered can be beneficial to various segments of their society.
What have hindered this mutual beneficial contract are the unethical practices used in these drug testing trials. While India’s recent steps to combat misconducts is inspirational, there are still many countries which lag far behind. Many developing countries still don’t have laws in regard to human drug testing. Every country should be encouraged to formulate taut laws for drug trials to protect their citizens. After the formulation, it must been be seen to that there is efficient implementation of these laws.  Corruption and red-tapism ; which are the common problems affecting developing countries, should be curtailed first, in order to smoothen the path of this cause. Further stringent punitive action in cases of violations must be taken. No giant pharmaceutical company should be able to ‘bully’ a country or take a country or its citizens for granted. Moreover testing should be allowed in a country only if that medicine will be sold in that country later and is beneficial for its citizens. International forums, while addressing human drug testing, should encourage transparency, equality and an environment which is mutually beneficial.
Every man has the right to live and die with full dignity. Using a man as a ‘guinea pig’ goes against the very principle of human dignity. Controlling the malaise of unethical human drug testing is one step forward in achieving the ultimate goal; upholding universal human dignity.


[i] Shantanu Guha Ray and Kunal Majumdar, ‘The cervical cancer Bazaar’, Tehelka [March 20 2010]

[ii] World Health Organization, International Clinical Trials Registry Platform (ICTRP), (23rd October 2014),

Available at –

[iii]Available at-, and, (22 November 2014)

[iv] Sohini Das, ‘Delay in approvals add to clinical research firms’ woes’, Business Standard[July 4 2012]

[v] Pandey A, Aggarwal AR, Seth SD, Maulik, M, Bano R. Juneja A. ‘Clinical Trials Registry India: Redefining the conduct of clinical trials’. [2008] J Cancer 45 (3): 79-82.

[vi] Pandey A, Aggarwal A, Maulik, M, Seth SD. Clinical trial registration gains momentum in India. Indian J Med [2009],Res [Letter to Editor] ; 130: 85-86.

[vii] China and India join WHO clinical trial registry platform, news release of World Health Organization, July 25, 2007. Available at-

[viii] Ibid

[ix] World Health Organization, International Clinical Trials Registry Platform (ICTRP)

List of Registers

[x] P. Shree sudha, How ethical are clinical trials in India?, [2007], India Law Journal, (23 November 2014) Available at-

[xi] supra

[xii] Joe C Mathew, ICMR to frame clinical trial compensation guidelines, Business standard, [ Dec 04, 2011], New Delhi, (30 November 2014), Available at –

[xiii] World Medical Association, ‘Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects’, art. 20, 22, G.A. Res. (adopted 1964, amended 1975, 1983, 1989, 1996, and 2000). Available at-

[xiv] Ibid

[xv] Sanchita Sharma, ‘Cancer vaccine study in a spot’, Hindustan Times [11 April 2010 ] New Delhi

[xvi] Priya Shetty,‘Vaccine trial’s ethics criticized’ Nature,[22 June 2011], Available at – (19 November 2014)

[xvii] Zeina Awad, ‘Experimenting on India’, , Dateline [31 july 2011],  Available at –, ( 23 November 2014)

[xviii]  N. B. Sarojini and Anjali Shenoi, ‘At What Price?’ Gardasil Research Targets

Girls from Vulnerable Communities, Available at –, (23 November, 2014)

[xix] ICMR, Ethical Guidelines for Biomedical Research on Human Participants, 2006, Available at-, (22 November 2014)

[xx] ibid, note xvii

[xxi] Ibid, note xvii

[xxii]  72nd standing committee report,, (21 November 2014)

[xxiii] Jason Overdorf, India deadly trials, GlobalPost, [19 june 2011],  Available at, (21 November 2014)

[xxiv] Clinical trial: India an easy target for foreign drug companies(23 November 2014), Available at,

[xxv] Daniel Cressey,India shakes up rules on clinical trials’, , Nature, [ 21 August 2012],  Available at, (23 November 2014)

[xxvi] Andrew Buncombe and Nina Lakhani, without consent: how drugs companies exploit Indian ‘guinea pigs’, The Independent [November 14 2011], Available at, (22 November 2014)

[xxvii] Available at- (21 November 2014)

[xxviii]  Swasthya Adhikar Manch and Anr. Vs union of India , 2013(13)SCALE146,

[xxix] Available at-, (22 November 2014)

[xxx] Ibid

[xxxi] Duff Wilson,’ 6,485 Overseas Clinical Trials and Counting’, the business of Health care, [2 December 2012], Available at, (21 November 2014)

[xxxii] supra

[xxxiii] Jacqui Wise, Pfizer accused of testing new drug without ethical approval, [January 21, 2001], National center for Biotechnology information, available at –, (23 November 2014)

[xxxiv] 562 F.3d 163 (2d Cir. 2009)

[xxxv] 399 F. Supp. 2d 495, 497 (S.D.N.Y. 2005)

[xxxvi] The Body Hunters’ The Washington Post in[ December 2000], Available at –  (23 November 2014)

[xxxvii] Ibid

[xxxviii] J. Stephens, “Where profit and lives hang in balance,” Washington Post [December 17, 2000]. The intravenous form of chloramphenicol used by MSF was recommended by WHO as the first line treatment for bacterial meningitis in low-income countries. World Health Organization, Meningiococcal meningitis, Fact sheet 141 (February 2010). Available at At the time, however, ceftriaxone, was regarded in the industry as standard of care for bacterial meningitis. Federal Ministry of Health of Nigeria, Report of the investigation committee on the clinical trial of trovafloxacin (Trovan) by Pfizer, Kano, 1996 (Kano, Nigeria: Federal Ministry of Health, 2001). Available at, (23 November 2014).

[xxxix] Harvard Law, Alien torts claim Act, available at, (23 November 2014)

[xl] Stacey B. Lee, J.D, ‘Harbinger of Informed Consent Parity’, Abdullahi v. Pfizer and the Alien Torts Statute, available at, (21 November 2014)

[xli] Stacey B. Lee , Informed consent: Enforcing pharmaceutical companies’ obligations abroad, [2010 volume10], Health and human rights, available at, (23 November 2014)

[xlii] Keith GibsonSupreme Court Declines To Review Corporate ATS Action Against Pfizer , [30 June 2010], Available at, (22 November 2014)

[xliii] Joe Stephens, Panel Faults Pfizer in ’96 Clinical Trial in Nigeria, [May 7 2006], Washington Post, Available at-, (21 November 2014)

[xliv] Available at, (21 November 2014)

[xlv] International Covenant on Civil and Political Rights; art. 7, Dec. 19, 1966, 999 U.N.T.S. 171, available at, (22 November 2014)

[xlvi] World Medical Association, Declaration of Helsinki. Available at, (20 November 2014)

[xlvii] Bernard Fischer, ‘A Summary of Important Documents in the Field of Research Ethics’,[2006, volume 32], pp. 69-80 ,oxford journal, Schizophrenia Bulletin, Available at, (20 November 2014)


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