ContentsAcknowledgment...................................................................................................................................2

Title of the Research Paper....................................................................................................................3

Abstract of the Research Paper.............................................................................................................3

I- Introduction.......................................................................................................................................4

II- International Guidelines on Clinical Trials.........................................................................................5

III- The Regulation of Trials in the India.................................................................................................7

IV- Critical Analysis of Regulation of Clinical Trials in India....................................................................8

Entry of Contract/Clinical Research Organisations-...........................................................................8

Functioning of Institutional Ethics Committee-.................................................................................9

Lack of Informed Consent-...............................................................................................................11

Responsibility of Compensation-.....................................................................................................12

V-Balancing economic opportunity with the public health context.....................................................13

VI- Conclusion......................................................................................................................................15

BIBLIOGRAPHY.....................................................................................................................................17

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AcknowledgmentI would like to thank Dr S. Surya Prakash for giving me wonderful opportunity to work on this assignment. I have learned many new things during this assignment and I am grateful to him for his guidance. I would to thank University administration for providing us with excellent library and internet facilities.

Archit Gupta

2011 B.A.LLB 51

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Title of the Research Paper- Legal issues in regulating Clinical Drug Trials on

human beings in India – Balancing economic opportunities with public health

Abstract of the Research Paper- The only way to develop a new drug molecule is

through clinical trials. While clinical trials can work a boom for patients, it can also destroy

lives of those who are subjected to such trials. Developing countries like India seems to have

become favourite destinations for pharmaceutical companies looking for cheap human

resources and lack of regulations related to human trials. But these multi-national companies

whose aim is solely driven by profit-motive have been accused of causing large scale deaths

and injuries during these trials. With scant respect to ethical guidelines and human lives, the

clinical trials in India have become a nightmare. The rising investment of pharmaceutical

companies in India seems to have overlooked the public health requirements. The author has

laid down the perspectives of various stakeholders and also tried to highlight the important

role played by each of them. The various issues involved in conducting clinical trials have

been discussed in this paper. Apart from that, economic context of conducting clinical trials

have also been discussed in the paper. The paper concludes with the proposition that the

clinical trials cannot be done away with, but with proper enforcement of mandatory

guidelines, interest of various stakeholders can be taken care of.

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I- Introduction

A clinical trial is defined as any research study that prospectively assigns human participants

or group of humans to one or more health related interventions to evaluate the effects on

health outcomes.1

A clinical trial goes back to ancient India. Two ancient scripts, Charaka Samhita (a textbook

of medicine) and Sushruta Samhita (a textbook of surgery), which were compiled as early as

200 B.C. and 200 A. D. respectively, shows India's age-old proficiency in medical research.2

Developing countries like India, China and Africa have become an attractive destination for

clinical trial activities with India having as high as 30% share of the global market.3

One of the classic examples, which show the importance of conducting clinical trials, is the

pandemic of HIV/AIDS in Africa.4 In the wake of the HIV/AIDS pandemic, there was a huge

influx of foreign medical research fund, medical devices and investigators in many parts of

Africa. This not only helped in improving research, but also improved access to antiretroviral

therapies for many patients.

Research related to healthcare carried out in developing countries which are often sponsored

by developed countries has made many outstanding contributions to the understanding,

prevention and treatment of diseases such as malaria, yellow fever and sleeping sickness.5

Till 1990s, clinical trials were conducted by the government, but with increasing

globalisation and a booming pharmaceutical industry, commercial interests have overtaken

ethical and medical concerns.6 India has allowed 100% Foreign Direct Investment in the

1 WHO | Clinical trials, http://www.who.int/topics/clinical_trials/en/ (last visited Nov 5, 2015)2 P. Sreesudha, How ethical are clinical trials in India?, 2 India Law Journal (2012), http://indialawjournal.com/volume2/issue_3/article_by_sreesudha.html (last visited Nov 5, 2015)3 FDA Seeks New Approach to Global Challenges Appliedclinicaltrialsonline.com, http://www.appliedclinicaltrialsonline.com/fda-seeks-new-approach-global-challenges (last visited Nov 5, 2015)4 Remigius N Nwabueze, Legal and ethical regulation of biomedical research in developing countries , at 2, (Ashgate) (2013),5 Nuffield Council on Bioethics, The ethics of research related to healthcare in developing countries (Nuffield Council on Bioethics),at 6, http://nuffieldbioethics.org/wp-content/uploads/2014/07/Ethics-of-research-related-to-healthcare-in-developing-countries-I.pdf (last visited Nov 5, 2015)6 India: deadly drug trials Global Post, http://www.globalpost.com/dispatch/news/regions/asia-pacific/india/110618/india-health-drug-trials (last visited Nov 5, 2015)

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pharmaceutical industry and as a result, this industry has been booming post-1990s economic

reforms.7

Most of the patients are referred to these trials in India through their primary physician and

doctor patient relationship is such that patient would blindly follow the advice of his doctor

especially if it concerns his health.8 There is a need to examine the wrongs in the clinical

trials industry in India and the author has tried to do so in this essay. Part II deals with

international guidelines for conducting clinical trials. Part III lays down how the regulation of

such trials is done in India while Part IV points out flaws in the regulatory process in India. In

the end, the author has highlighted the economic aspect of these trials in detail in Part V and

concluded the essay in Part VI.

II- International Guidelines on Clinical TrialsThe first cases to reveal the importance of the establishing guidelines in research ethics were

the abuses committed by Nazi researchers and doctors during World War 2. It included

forcible administration of salt water and throwing prisoners into icy waters. Hundreds of

people died in these experiments and many were forced to live with physical and

physiological scars for the rest of their life.9 . This resulted in the creation of the Nuremberg

Code in 1947, which clearly stated voluntary consent is an absolute requirement for the

research involving human subjects. As a result, it became almost impossible to conduct any

clinical research with mentally impaired and other vulnerable groups. 

This was followed in 1964, by the World Medical Association’s Declaration of Helenski,

which basically deals with the issues of medical research in a lengthier and more systematic

fashion. It sets out the basic principles for all forms of medical research and it lays separate

part for medical research where medical care is also involved.10 Three things dominate entire

declaration- the research must be scientifically sound, it must satisfy the proportionality test

and integrity of the test subjects should be respected all the time.11This Declaration has acted 7 Swadhin Mondal & Dinesh Abrol, CLINICAL TRIALS INDUSTRY IN INDIA: A Systematic Review (Institute for Studies in Industrial Development) (2015), http://isidev.nic.in/pdf/WP179.pdf (last visited Nov 5, 2015)8 Sandhya Srinivasan & Sachin Nikarge, Ethical concerns in clinical trials in India: an investigation (Centre for Studies in Ethics and Rights) (2009), http://environmentportal.in/files/Ethical_concerns_in_clinical_trials_in_India_An_investigation.pdf (last visited Nov 5, 2015)9 Florencia Luna, The Oxford Handbook of Ethics ,at 622,(Oxford University Press 3) (2009), 10 Marc Stauch et al., Text, cases and materials on medical law and ethics, at 469, (Routledge) (2012)11 Id

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as a template for the various domestic codes, which have subsequently been drafted in respect

of particular areas of research practice worldwide.

The European Clinical Trials Directive 2001/20 EC governs the regulation of clinical trials of

medicines and has been transported into UK law by the Medicines for Human Use (Clinical

Trials) Regulations 2004 which replace the clinical trial provisions of the Medicines Act,

1968 and regulation made there under. The Medicines and Healthcare Products Regulatory

Agency is the regulatory body in the UK that oversee the enforcement of these regulations.12

Besides the regulation of medical research, it also deals with the manufacturing of medical

devices.

The United States FDA approved clinical trials procedure is followed worldwide.13 Under

this, trials are conducted in a number of stages and contribute to immense time, risk and

expenditure. First two stages involve the toxicological study of a potential new drug molecule

on animals. This is done to ensure that molecule is safe enough to be tested on a living

organism. If the drug is too toxic when tried on animals, the trial will not proceed any further,

but if acceptable dose ranges can be determined, then the third stage is a three-phase trial in

humans.

Phase 1 trials are conducted on a very small number of healthy volunteers to ensure that

proposed molecule is not harmful for humans. Phase 2 is an intermediary stage where almost

hundred patients or volunteers to check efficacy and safety of drugs. Phase 3 involves large-

scale randomized trials on several people who are suffering from the same ailment for which

the drug has been created for. The sponsors for trials are generally biotechnology or

pharmaceutical companies since drug development in the US and most other parts of the

world is undertaken largely by the private sector. Although universities and publicly funded

laboratories play a major role in the early stages of discovery-the identification of potential

lead molecules and the conduct of pre-clinical tests but the institutional structure of drug

development is such that the corporations have a major influence in determining the

procedures for conducting clinical trials for the development of new drugs.

12 Id, at 47913 Vikas Bajpai, Rise of Clinical Trials Industry in India: An Analysis, 2013 ISRN Public Health 1-17 (2013), http://www.hindawi.com/journals/isrn/2013/167059/ (last visited Nov 5, 2015)

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We can see how international community has laid down guidelines to enforce ethical practice

in these trials. These guidelines should be strictly followed and any violation of these could

even cause death of research subjects.

III- The Regulation of Trials in the IndiaLike any research or commercial activity in India, clinical trials are also supposed to go

through a very lengthy procedure before they can be conducted. The clinical trials are put

under Schedule Y to the Drug and Cosmetics Rules of 1945, which were amended keeping in

mind the increasing number of foreign pharmaceutical companies who are using India as

their research base.14 Earlier Phase 2 trials were allowed to be conducted in India only if a

Phase 3 study was going on somewhere else.15 Phase Apart from this, various professional

guidelines has been released. The Indian Council of Medical Research (ICMR) issued the

Ethical Guidelines for Biomedical Research on Human Subjects in 200016 and CDSCO

released Indian Good Clinical Practice (GCP) guidelines in 2001.17

A Clinical Trials can only be initiated after obtaining written permission from institutional

ethics committee (IEC) and Drugs Controller General (I). The application utilizes form 44

accompanied by the requirement as per schedule Y, such as documents pertaining chemical,

pharmaceutical information, animal pharmacology, toxicology and clinical pharmacology

data.

Some other documents are also required to be submitted with the application such as trial

protocol, case report form, informed consent sample form and investigator’s undertaking as

to the liability. There are additional requirements for conducting trials on vulnerable and

special groups such as pregnant women and elderly patients. The protocol must be reviewed

and approved by an institutional ethics committee, at a minimum, seven members, including

a medical scientist, a clinician, a statistician, a legal expert, a social scientist and a common

person from the community.

14 Amended Schedule Y [Drug and Cosmetic act (2nd amendment) rules]15 Samiran Nundy & Chandra M. Gulhati, A New Colonialism? — Conducting Clinical Trials in India, 352 New England Journal of Medicine 1633-1636 (2005)16 Ethical Guidelines for Biomedical Research on Human Participants (Indian Council of Medical Research) (2006), http://www.icmr.nic.in/ethical_guidelines.pdf (last visited Nov 5, 2015)17 Good Clinical Practices for Clinical Research in India, Schedule Y (Amended Version – 2005) (CDSCO) (2005), http://cdsco.nic.in/html/GCP1.html (last visited Nov 5, 2015)

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In the applicant wishes to import the biological samples that have been developed as a result

of these trial, he needs a separate license called T-License. This license is valid for multiple

shipments for one year and issued simultaneously with that of the clinical trial approval. A

separate No Objection Certificate (NOC) through separate application is required for

shipping biological samples collected from the trial subjects out of India.18

In 2008 the CDSCO started inspection of clinical trials in India19 but the full fledge onsite

inspection started in 2010 by the US-FDA trained Indian Inspectors and regulatory experts to

uphold the quality of the trials.

IV- Critical Analysis of Regulation of Clinical Trials in India

Entry of Contract/Clinical Research Organisations-

The increase in CROs or the contract /clinical research organisations can be attributed to

changing scenario behind clinical trials. Earlier, the clinical trials were mainly conducted in

academic medical institutions, with faculty providing all the necessary resources. However,

the growth of the pharmaceutical industry and a large number of molecules being discovered

required a large number of patients, who are available at low costs to consent for these trials.

Since companies can’t have direct access to patient or doctors, they need an intermediary and

CROs function as specialized organisations to fill the void. 20

A research report has estimated that 40 to 50 % drug applications which are submitted in the

EU and US are tested in Latin America, India, China and other developing countries with the

help of contract research organisations.21 Clinical trials are increasingly being outsourced to

these CROs in the off shoring countries.22About 90 % of all clinical trials in India are

18 Mohammed Imran et al., Clinical research regulation in India-history, development, initiatives, challenges and controversies: Still long way to go, 5 Journal of Pharmacy and Bioallied Sciences 2 (2013), http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3612334/ (last visited Nov 5, 2015)19 Joseph Alexander, On-site inspection of clinical trials to be intensified by CDSCO teams soon, PharmaBiz, 2009, http://pharmabiz.com/NewsDetails.aspx?aid=51551&sid=2. (last visited Nov 5, 2015)20 Marcia Angell, The truth about the drug companies, at 21-36, (Random House) (2004)21 SOMO Submitter et al., Putting Contract Research Organisations on the Radar: An Exploratory Study on Outsourcing of Clinical Trials by Pharmaceutical Companies To Contract Research Organisations in Non-Traditional Trial Regions, at 12,SSRN Electronic Journal22 Supra note 4, at 2

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conducted by CROs.23 No audit of individual death is conducted in our countries, although

autopsies are conducted, but the personnel conducting don’t have specialised knowledge.24

The ties between these organisations and pharmaceutical industries include not only grant

support but also a host of other arrangements. Researchers serve as consultants to companies

whose products there are studying, enter into royalty arrangement and also receive company-

sponsored trips.25

Functioning of Institutional Ethics Committee-The role of institutional ethics committee is to save the research subject from the illegality of

research, and especially if the legal rights of the subject are violated by it.26These committees

must assess the research protocols and check where the ethical requirements have been

thoroughly fulfilled. This practice began in the United States with the so called institutional

review boards (IRBs) and is currently accepted worldwide.27

Surprisingly the responsibility of these committees is substantial and yet, they don’t have

resources that are available with regulatory agencies and pharmaceutical companies. A

common problem with many developing countries including India is that of poor training of

some of the members as well as lack of resources for the infrastructure and the administrative

backup, which undermines the efficacy of these committees.28

These committees lack an adequate number of non-technical personnel and they tend to be

biased in the favour of the clinical study. Many institutes don’t have standard operating

procedure for these committees and are a violation of the ICMR guidelines. 29 An ICMR

survey conducted in 2005 found that only a few institutional ethical committees follow the

prescribed legal provisions and function as per various ethical guidelines30

23 Supra note 5, at 424 'People keep falling sick': How poor Indians are recruited for clinical drug trials NBC News, http://investigations.nbcnews.com/_news/2012/03/02/10561824-people-keep-falling-sick-how-poor-indians-are-recruited-for-clinical-drug-trials (last visited Nov 5, 2015)25 Supra note 9 at 62826 C. Roy-Toole, Illegality in the Research Protocol: The Duty of Research Ethics Committees under the 2001 Clinical Trials Directive, 4 Research Ethics 111-116 (2008)27 Supra note 9, at 62428 Supra note 9, at 63129 Anvita Pandiya, Quality of independent review board/ethics committee oversight in clinical trials in India, 2 Perspect Clin Res 45 (2011)

30 Sunil Kumar et al., Regulation of Drug and Clinical Trials in India :Why Rights Matter (Jananeethi) (2011), http://www.jananeethi.org/jananeethi/project_reg/regulationdrugtrialindia.pdf (last visited Nov 5, 2015)

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In a study conducted by Jawaharlal Nehru University, following discrepancies were found in

IECs constituted in Delhi hospitals-31

(i)The main job of the ethics committees was with procedural requirements like informed

consent and insurance coverage for the trial subjects, but there was no will towards ensuring

that ethical guidelines are not violated which is reflected in the fact that none of the IECs that

were studied actually made any field visits to actually monitor ongoing clinical trials.

(ii)The ethics committee members had little understanding of the various ethical guidelines

that were required to be implemented. For example, ensuring that the interests of the

sponsors and the institutions did not conflict with those of the patients is the main function of

the legal fraternity member on IEC and he was not even aware about his duties.

(iii)There was a clear conflict of interests in the procedures followed for the investigation of a

trial related death.

(iv)There was considerable pressure from various stakeholders and this could lead to IEC

members ending up in a compromise and not doing their primary job of ensuring protection

of human rights.

(v)Most importantly, the IEC members failed to take into consideration social inequalities

that underlie the decisions regarding the kind of clinical trials that are taking place in India

today and their relevance to the public health needs of the country.

Many cases including Anticancer drug study in Kerala32, recruitment of poor family's children

at AIIMS resulting in death of around 49 kids 33points to the finger at the weaknesses of

Institutional Ethics committee.

31 Registrar General, India, Report on Causes of Death: 2001-03, Ministry of Home Affairs, New Delhi, India, 200932 Supra note 1533 Bharat Dalvi, Drug trials in children: Doubts and dilemmas, 1 Annals of Pediatric Cardiology 81 (2008)

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Lack of Informed Consent-Once the decision to use human beings is made, special problems of informed consent are

presented. This doctrine has four components- assent, competency, information and absence

of duress.34 Informed consent is one of the most fundamental factors in research ethics.

This issue was also highlighted in American journals when a study on the natural course of

syphilis involving poor African American men who did not provide consent for the study;

those men were deceived are told that they are enrolling in a treatment for their own syphilis.

There were not informed about the penicillin which was available at that point of time for the

treatment of this disease.35As part of a study of cancer immunity, live cancer cells were

injected into some 21 human subjects and they were not informed that these were cancer

cells. In all these cases, lack of consent or approval is visible are subjects were not given

requisite information to make informed choices.36

How can a patient deny access of trials when their only option of survival is through the

findings of these trials? As a result, many are coerced through the use of negotiating power of

the sponsor and CROs to participate in these trials without telling the true consequences of

it.37

The Supreme Court has also raised concerns over 162 trials were approved in a period of less

than two months, even after the court banned all the clinical trials unless there were

specifically approved by the health ministry.  The court has ordered that health ministry to

justify the quick approval of such a large number of trials.38

According to the new guidelines, a manufacturer, before requesting an individual to

participate in clinical trial of a new drug, must inform the individual all the foreseeable risks

or discomforts as well as of the possible benefits. For further regulation, the Department of

Health and Family Welfare has appointed an expert committee for setting guidelines for CTs.

The committee produced and published its report in July 2013. It suggested various measures

to ensure that clinical trials are conducted according to prescribed ethical guidelines. Both the

34 Michael H Shapiro & Roy G Spece, Cases, materials, and problems on bioethics and law, at 95,(West Pub. Co.) (1981)35 Bernard Challenor & James H. Jones, Bad Blood: The Tuskegee Syphilis Experiment, 3 Journal of Public Health Policy 231 (1982)36 Supra note 9, at 62237 Supra note 9, at 62638 Independent, ‘A heaven for clinical trials, a hell for India’: Court orders government to regulate drugs testing by international pharmaceutical companies, 2013, http://www.independent.co.uk/news/world/asia/a-heaven-for-clinical-trials-a-hell-for-india-court-orders-government-to-regulate-drugs-testing-by-8849461.html (last visited Nov 5, 2015)

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principal investigator of the trial and the ethics committee of the institute should be

accredited. Only those trials conducted at such centres should be accepted by the Drugs

Controller General of India (DCGI).

An informed consent from each participant is a prerequisite for a clinical trial. In

circumstances where informed consent has to be obtained from special groups of people who

have limited capacity to protect their interests or give consent for themselves, the consent

given by the guardian and should be witnessed by an independent person. The audio‐visual

recording of the informed consent process should be undertaken and the documents

preserved, adhering to the principles of confidentiality. The audio‐visual recording of the

informed consent process and other related documents should be safely preserved after the

completion of the study for at least a period of 5 years (Government of India, 2014). If any

adverse effect or serious adverse effect occurs during a clinical trial, the sponsor-investigator

should be responsible for providing medical treatment and care to the patient at his own cost

and also provide proper compensation for disability or death of the participant.39

Responsibility of Compensation- The research subjects in developing are vulnerable due to lack of resources and there is a

need to have special mechanism for protection of their rights.40

During clinical trial, a patient can die because of several reasons: life threatening diseases

like cancer, cardio‐vascular diseases like heart failure/stroke and other serious diseases that

the participant may have be suffering from in the past. Death can also occur due to adverse

effects of the trials. In UK, it is necessary that all clinical trials include provision for

“insurance or indemnity to cover the liability of the investigator and sponsor which may arise

in relation to a clinical trial.41

The main reasons low cost of drug development are cheap human resources, low recruitment

cost and lower rate of compensation for any injury sustained or death during the research

process. Sometimes CROs even recruit patients without any formal assurance of

compensation. A large proportion of participants in India are illiterate and lured into trials by

offers of free healthcare and financial inducements. However, they are often not aware of the

39 Supra note 740 Supra note 9 ,at 62741 Hazel Biggs, Healthcare research ethics and law (Routledge-Cavendish) (2010)

12

benefits and risks of taking part in such trials, and many may not even be able to distinguish

between a clinical treatment and a clinical trial.42

The duration of the patent granted for a new molecule is for a period of 20 years; but before

the company can get the license to commercially exploit a new drug the molecule, it has to

complete the phase of clinical trials to prove its efficacy. It takes anywhere between 2 and 10

years to complete the clinical testing phase for drug development process. This means that of

the total duration of 20 years for a patent, a substantial period may actually be lost in clinical

trials, thus reducing the duration within which the company can make its profits from the

molecule without facing any competition. The companies are terribly anxious to get the

clinical trials out of the way as early as possible to get the drug on the market.43

With almost 25 per cent of the Indian population living below poverty line, it is unlikely that

these drugs will be “affordable”. Another important issue in this context is compensation for

clinical trial related injury or death. Over the past five years, more than two thousand people

have died because of clinical drug trials and amongst them, only a few have received

compensation.44

V-Balancing economic opportunity with the public health contextThere is a school of thought that says there is an obligation to carry out research, for the

advancement of society generally, or if even there is no such positive obligation, there is a

right not to be unduly fettered in pursuing any form of scientific enquiry.45

Clinical trials in developing countries might be conducted to achieve some marketing

objectives. For instance, drugs approved by regulatory agencies in developed countries might

not be approved by the regulatory authority of the developing country. Thus trials might be

conducted just to secure the marketing rights in developing countries.46 It has also been

observed that sponsors are able to recruit subjects more quickly in developing countries and

bring medicines faster into the market.47 The faster the drug company can obtain the 42 Supra note 743 T. Ross, “An Overview of the Drug Development Process,” May-June 2005, The Physician Executive, 48–52 (2005)44 Supra note 745 Supra note 10, at 46146 Supra note 4, at 347 Department of Health and Human Services :Office of Inspector General, The Globalization of Clinical Trials: A Growing Challenge in Protecting Human Subjects, at 8, (2001)

13

necessary information for the drug’s approval, the greater the financial gains. Certain steps in

final phases of trials can be accelerated by recruiting subjects in least possible time. 48All this

means that some developing countries have deliberately set out to encourage and attract

international research as a means of improving their economy and furthering their

development agenda.

India participates in 7 % of global Phase 3 clinical trials, and the growth rate of the Indian

clinical trial sector is more than twice that of the global market.49

It might difficult for the poor to say no to risky projects if incentives offered to them are

substantial and they make take their decision without regard to their health.50They may be

denied the very benefits of these trials if proper regulation is not available. A controversial

research was conducted in 1991 with a hepatitis A vaccine in northern Thailand. Forty

thousand children between the ages of 1 and 16 participated and they were given access to

this for only one year. Later it was found that the medicine was meant for only tourists who

are visiting and patent helped the company to earn millions.51

There can be various models to distribute the benefits of research among the members of host

population: Under the first model, the researchers would be required to obtain pre-trial

assurances that the fruits of successful research programs would be made reasonably

available to members of host population. The second model rejects this narrow approach and

adopts ‘fair benefits approach’. Under this model, benefits would include but not limited to

economic services and healthcare services to the members of host community. It would also

include providing educational and employment opportunities.52

The public health situation in India is far from optimal, with a disproportionately high disease

burden and a health system that is not effective in providing preventive and curative services

to a large section of India’s poor population, for which there are several reasons.53

It would be undesirable if further distortions were caused by clinical trials research driven by

multinational pharmaceutical companies without concurrent benefits to the health of Indians.

Such distortions could occur due to various reasons. Drugs, vaccines and devices that

48 Supra note 9, at 62249 Supra note 4, at 550 P. R. Ferguson, CLINICAL TRIALS AND HEALTHY VOLUNTEERS, 16 Medical Law Review 23-51 (2008)51 Supra note 9, at 64552 Supra note 9, at 64053 R Misra et al., India health report (Oxford University Press) (2003)

14

undergo clinical trials in India may not be related to the major causes of disease burden here.

Commercial pressures may lead to more emphasis on clinical trials for expensive therapeutic

drugs than on preventive vaccines and cheap drugs.54

Outsourcing of clinical trials to India is part of a larger globalization and knowledge economy

process which, along with its potential benefits and downsides, seems set to proceed as the

dominant theme of global development over the near future.55

VI- ConclusionWith the increase of trials in developing countries, many issues may have become the focus

of international debate including obligations during and after trials and vulnerability of some

population. The issues faced during the implementation of various guidelines show that

persuasive guidelines cannot have ant deterrent effect on erring companies and doctors.

Rather, a separate statute is required which can cover all the best international practices

necessary to conduct a clinical trial and any violation of those should be made a penal

offence. The ethics committee must comprise of government representative who can take

balance views and there functioning should be made more transparent and suo moto

disclosures of their decisions should also be made mandatory.

The cost of a human life seems to be diminishing in our country and there is no single ethical

framework that can balance both research and ethical requirements of the society. Merely

issuing guidelines won’t guarantee anything. Look at how related to sex selection and human

transplantation are constantly broken by the same people who are supposed to safeguard

them. Awareness about the law is necessary apart from the strict implementation. While

encouraging clinical trials might be right thing, but without adequate safeguards, our country

can easily become a banana republic, where lives on poor and innocent citizens are available

for sale. The pharmaceutical multinational companies with the backing of their governments

are in a position to dominate the system in a developing country like ours and unless the

public opinion forces them to change their methods, all efforts could be easily undermined by

them.

54 Lalit Dandona, Clinical Trials in India: Balancing economic opportunity with the public health context, 19 THE NATIONAL MEDICAL JOURNAL OF INDIA 55 ,at 56,(2006), http://www.nmji.in/archives/Volume_19_2_March_April2006/editorial/Clinical_Trials_in_India.pdf (last visited Nov 5, 2015), 55 Thomas L Friedman, The world is flat (Farrar, Straus and Giroux) (2005)

15

It is impossible to find anyone connected with clinical trials who is not in the payroll of the

drug maker56 Dr Ambujam Nair Kapoor, a senior scientist of the Indian Council of Medical

Research (ICMR), states the problem bluntly: “Unless we put in place systems that ensure

safety of patients and good quality of trials, people will get away with whatever they can get

away with.” 57

As the author was writing this paper, the apex court has dismissed an application seeking a

stay on vaccine trials in which lakhs of children would be subjected to trials. This shows

that clinical trials are here to stay.58 After all India is practically a paradise for conducting

clinical trials.

56 Kris Hundley, The latest industry being outsourced to India: clinical drug trials, Tampa Bay Times, 2008, http://www.tampabay.com/news/business/the-latest-industry-being-outsourced-to-india-clinical-drug-trials/934677 (last visited Nov 5, 2015)57Bulletin of the World Health Organization, Clinical trials in India: ethical concerns, 2008, at 577-656, http://www.who.int/bulletin/volumes/86/8/08-010808/en/ (last visited Nov 5, 2015)58 Mohammed Iqbal, Petition on vaccine trials dismissed, The Hindu, 2015, http://www.thehindu.com/news/cities/Delhi/petition-on-vaccine-trials-dismissed/article7767755.ece (last visited Nov 5, 2015)

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BIBLIOGRAPHY Remigius N Nwabueze, Legal and ethical regulation of biomedical research in

developing countries, (Ashgate) (2013),

Hazel Biggs, Healthcare research ethics and law (Routledge-Cavendish) (2010)

Florencia Luna, The Oxford Handbook of Ethics ,(Oxford University Press 3) (2009),

Marc Stauch et al., Text, cases and materials on medical law and ethics, (Routledge)

(2012)

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