parth gandhi, ronak gandhi, Shakti Shekhawat, Jimit Shah, Mahaveer Kabara, M. P. Khinchi


The larger context of clinical trials in India is poverty and the absence of affordable healthcare. For more than a decade, government policy has been to reduce public support for healthcare services, and these services are under-resourced. Health economists have pointed out that only 15 per cent of the Rs 1,500 billion spent in the health sector in India comes from the government. Clinical trials (also called medical research studies) are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people. If the drug successfully passes through Phases I, II, and III, it will usually be approved by the national regulatory authority for use in the general population. Phase IV are 'post-approval' studies. The level of concern about the impact of the CTD on clinical research activities is intense and widespread overall stakeholder groups. Opinions and quantitative survey results draw a picture of increased bureaucracy and costs, reduction of important research without creating benefits for patients. However, concrete, comprehensive figures about the clinical trial activities are only available from competent authorities. Figures on the CTD’s impact on organisation, staffing, costs and processes of the different stakeholders are missing.These trials violated the the Indian Council of Medical Research’s Ethical guidelines for biomedical research on human subjects and the World Medical Association Declaration of Helsinki: Ethical principles for medical research involving human subjects. The trial designs do not seem to have violated regulations for the conduct of clinical research in India. The existing regulatory apparatus therefore permits unethical trials of no benefit to Indians. Clearly, trials are being conducted in India that could not be conducted in developed countries, taking advantage of people’s lack of access to affordable, good quality care.


The benefits of research do not reach the community as drugs found effective following these trials may not be affordable to the community in which they were tested. Such practices are in violation of the Declaration of Helsinki as well as the general principles laid down in the Indian Council of Medical Research’s ethical guidelines for biomedical research.The infrastructure for regulation, ethics review and monitoring is insufficient. The government’s priority seems to be ensuring that clinical research in India produces good quality data according to Good Clinical Practice standards. Ethical guidelines – including its own ethical guidelines – seem to be of secondary importance. The ethical concerns raised by these clinical trials; the weak regulatory apparatus to protect trial participants, government policy to encourage international clinical trials without taking active steps to put in place a system to protect participants from harm; people’s desperation for affordable health care – all this will only worsen the harm being done to trial participants in India.t

| PDF |


Avorn J. (2004). Powerful Medicines, pp. 129-133.

Van Spall HG, Toren A, Kiss A, Fowler RA (March 2007). "Eligibility criteria of randomized controlled trials published in high-impact general medical journals: a systematic sampling review". JAMA 297 (11): 1233–40

The regulatory authority in the USA is the [[Food and Drug Administration (United States)|]]; in Canada, Health Canada; in the European Union, the European Medicines Agency; and in Japan, the Ministry of Health, Labour and Welfare.

"Clinical trials in oncology". Stephanie Green, Jacqueline Benedetti, John Crowley (2003). CRC Press. p.1. ISBN 1-58488-302-2

"Clinical Trials Handbook". Shayne Cox Gad (2009). John Wiley and Sons. p.118. ISBN 0-471-21388-8

Curtis L. Meinert, Susan Tonascia (1986). Clinical trials: design, conduct, and analysis. Oxford University Press, USA. p. 3.

Toby E. Huff (2003), The Rise of Early Modern Science: Islam, China, and the West, p. 218. Cambridge University Press, ISBN 0-521-52994-8.

Tschanz, David W. (May/June 1997). "The Arab Roots of European Medicine". Saudi Aramco World 48 (3): 20–31.

D. Craig Brater and Walter J. Daly (2000), "Clinical pharmacology in the Middle Ages: Principles that presage the 21st century", Clinical Pharmacology & Therapeutics 67 (5), p. 447-450 [448].

"James Lind: A Treatise of the Scurvy (1754)". 2001.

O'Rourke, Michael F. (1992). "Frederick Akbar Mahomed". Hypertension (American Heart Association) 19: 212–217 [213]

O'Rourke, Michael F. (1992). "Frederick Akbar Mahomed". Hypertension (American Heart Association) 19: 212–217 [212]

Bhardwaj S, Fleischer A. 2004. Statistical Significance and Clinical Relevance: The Importance of Power in Clinical Trials in Dermatology. Arch Dermatol 2004; 140:1520-1523, S. 1521

"Guidance for Industry, Investigators, and Reviewers". Food and Drug Administration. 2010-06-15.

The Lancet (2009). "Phase 0 trials: a platform for drug development?". Lancet 374 (9685): 176

Silvia Camporesi (October 2008). "Phase 0 workshop at the 20th EORT-NCI-AARC symposium, Geneva". ecancermedicalscience.

^ "Guidance for Institutional Review Boards and Clinical Investigators". Food and Drug Administration. 1999-03-16..

"Periapproval Services (Phase IIIb and IV programs)". Covance Inc.. 2005..

Arcangelo, Virginia Poole; Andrew M. Peterson (2005). Pharmacotherapeutics for Advanced Practice: A Practical Approach. Lippincott Williams & Wilkins. ISBN 0781757843.

Web Site Editor; Crossley, MJ; Turner, P; Thordarson, P (2007). "Clinical Trials - What Your Need to Know". American Cancer Society 129 (22): 7155.

Yamin Khan and Sarah Tilly. "Seasonality: The Clinical Trial Manager's Logistical Challenge". Pharm-Olam International (POI). Yamin Khan and Sarah Tilly. "Flu, Season, Diseases Affect Trials". Applied Clinical Trials.

Expert Group on Phase One Clinical Trials (Chairman: Professor Gordon W. Duff) (2006-12-07). "Expert Group on Phase One Clinical Trials: Final report". The Stationery Office.

"Tax Credit for Testing Expenses for Drugs for Rare Diseases or Conditions". Food and Drug Administration. 2001-04-17.

Paul, J.; Seib, R.; Prescott, T. (Mar 2005). "The Internet and clinical trials: background, online resources, examples and issues" (Free full text). Journal of medical Internet research.

Life on a Trial - What to Expect.

Life Sciences Strategy Group, "Clinical Trial Technology Utilization, Purchasing Preferences & Growth Outlook" Syndicated Publication, May, 2009

Angell, Marcia (2009), "Drug Companies & Doctors: A Story of Corruption", New York Review of Books, Vol 56, No 1; 15 January 2009.

Angell M. (2004). The Truth About Drug Companies, p. 30.

Sox HC, Rennie D (August 2008). "Seeding trials: just say "no"". Ann. Intern. Med. 149 (4): 279–80

Rang HP, Dale MM, Ritter JM, Moore PK (2003). Pharmacology 5 ed. Edinburgh: Churchill Livingstone. ISBN 0-443-07145-4

Finn R, (1999). Cancer Clinical Trials: Experimental Treatments and How They Can Help You., Sebastopol: O'Reilly & Associates. ISBN 1-56592-566-1

Chow S-C and Liu JP (2004). Design and Analysis of Clinical Trials : Concepts and Methodologies, ISBN 0-471-24985-8

Pocock SJ (2004), Clinical Trials: A Practical Approach, John Wiley & Sons, ISBN 0-471-90155-5

SOMO, “Ethics for Drug Testing in Low and Middle Income Countries: Considerations for European Market Authorisation,” Feb 2008,.

VBDO, “CSR voting advice: Discharge of executive board members,” Akzo Nobel case, (Jan 2008), p. 20-21.

SOMO, “Ethics for Drug Testing in Low and Middle Income CountrieConsiderations for European Market Authorisation,” Feb 2008,

Basu, “India's clinical trials and tribulations,” Asia Times, 23 Jul 2004.

C.M. Gulhati, “Needed: closer scrutiny of clinical trials,” Indian Journal of Medical Ethics, Vol.12(1), Jan-Mar 2004,

C.M. Gulhati, “Needed: closer scrutiny of clinical trials,” Indian Journal of Medical Ethics, Vol.12(1), Jan-Mar 2004,

G. Mudur, “Researchers question ethics of diabetes drug trial,” BMJ, Vol. 325, 17 Aug 2002, p. 223, (Jan 2008)

Basu, “India's clinical trials and tribulations,” Asia Times, 23 Jul 2004

About this article





Additional Links

Manuscript Submission


Innovare Journal of Medical Sciences
Vol 1 Issue 1 2013 (April-June) Page: 19-32

Online ISSN



366 Views | 367 Downloads

Authors & Affiliations

parth gandhi

ronak gandhi

Shakti Shekhawat

Jimit Shah

Mahaveer Kabara

M. P. Khinchi


  • There are currently no refbacks.