Outsourcing Clinical Trials to India

chillibreeze writer —Natasha Das

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Global clinical research is exploring India. Yet, it is certainly not the West that is introducing clinical research to 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.

However, a lot has changed in the clinical research scenario since then (1). Today, clinical trials are conducted through a regulated approach following certain guidelines laid down by the International Conference on Harmonization (ICH), which is spearheaded by U.S.A., Europe and Japan.

The clinical research industry in India has been growing rapidly. During the last 3 years it has increased from Rs. 20 crores to Rs. 100 crores. According to a recent McKinsey report, by the year 2010 the industry is expected to grow up to Rs. 5,000 crores.

What makes India so special?

India has become the preferred destination for global clinical trials today. The unique criteria that make India so attractive (2-4) are:

1. India has a huge population base of more than 1 billion (Indians represent about 15% of the global population)
2. This population is genetically, culturally and socio-economically diverse
3. Asians have been seen to react differently to drugs as compared to their Caucasian counterparts
4. India has the largest pool of patients (e.g. the highest number of cancer and diabetes patients are found in India)
5. It is home to a wide variety of diseases ranging from tropical infections to degenerative diseases
6. The patient population in India is mostly treatment naïve
7. Patient: doctor ratio is high
8. There is no dearth of professionals trained in the field of medicine
9. India has a large pool of highly qualified and dedicated scientists and clinical research professionals
10. The country is renowned for it’s prowess in information technology
11. English is a primary language of education and communication among Indians

Are Indians being ‘USED’ for the benefit of the Western world?

The use of Indians ‘for the benefit of the Western world’ has extensively been criticized. Before jumping into any ill-informed conclusions, it would be worthwhile to understand the benefits of clinical research (5).

1 Patients /study subjects who participate in clinical trials

• Have access to the latest medication or treatment modalities
• Get free medical care, which includes costs of investigations and medicine
• Enter into the trial voluntarily after signing an informed consent
• Are not bound to continue to participate in the trial (The consent can be withdrawn at any time)
• Receive more frequent and focused consultations leading to an improvement in the quality of healthcare

2 Investigators /physicians who conduct clinical trials

• Get first hand experience with the most recent drugs
• Get global recognition working on the same platform as other international experts on the project
• Get extensive training in the internationally accepted Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) guidelines
• Get an opportunity for publication
• Have access to the latest medicines for their patients

3 Sites / Hospitals where the research is conducted

• Get infrastructural development
• Get global recognition

So is India prepared for global clinical trials?

An article in Nature Medicine suggests that outsourcing clinical trials to India may be ‘rash and risky’ (6). This conclusion is drawn on the basis of concerns about timelines for regulatory approvals, deficiencies in the functioning of the ethics committees, and an unethical approach to the recruitment of subjects in Indian clinical trials. What then is the actual scenario of clinical trials in India?

Regulatory affairs in India

The Drugs Controller General of India (DCGI) is responsible for regulatory approvals of clinical trials in India (7). The DCGI’s office depends on external experts and other government agencies for advice. Additional permissions are required for the export of blood samples to foreign central laboratories.

All this usually takes about 3 months in India. The US FDA gives an approval in an average of 30 days. However, most US trials are delayed because of the time taken for patient recruitment. The potential for a fast patient recruitment in India may partly make up for the delay in regulatory approvals.

Certain recent changes in regulatory affairs encourage clinical trials in India. In 2005, the Schedule Y of the Drugs and Cosmetics Act was amended. Earlier, foreign drugs trials could be conducted only at one phase below the highest phase of testing abroad. Now, parallel global clinical trials are possible in India. Permission is granted for concomitant phase 2 and phase 3 trials.

The Institutional Ethics Committee (IEC) and its role

Though ethics is an important part of medical research, it is very often neglected. The Indian Council of Medical Research (ICMR) guidelines for clinical trials insist on the setting up of ethics committees at the institutional levels. The IEC’s responsibility is to scrutinize and approve the clinical trial before the study begins and also to conduct periodic reviews of the progress of the trial.

A survey by ICMR shows that there are ethics committees in only about 200 institutions. Most research institutions in India, however, either do not have an IEC or there is inadequate representation in it by persons other than those of the medical fraternity. Without a representation of persons from a non-scientific background, the opinion of the IEC is likely to be biased in favor of the study. The clinical research guidelines clearly specify the need for such personnel.

Some IEC’s do not have a regular schedule of meetings, lack standard operatingprocedures (SOPs) or do not have a proper member representation according to the guidelines.

However, things are changing for the better. The ICMR has a Central Ethics Committee on Human Research (CECHR). This committee audits the functioning of these IECs. The recently amended Schedule Y of Drugs and Cosmetic Rules orders the composition of the IEC as per the ICMR guidelines. The DCGI’s office, in collaboration with WHO, ICMR and many committed research professionals, has been conducting training programs for members of the Ethics Committees across the country.

Ethical recruitment of participants

To protect the interests of the study participants, a written informed consent is usually required before the recruitment. Low literacy levels and poverty in India when added to the pressure from the sponsors for early completion of patient enrollment do at times lead to unethical recruitment.

An increase in the literacy and socioeconomic levels is expected to increase the awareness of patients regarding the consent they give for clinical trial studies. The GCP guidelines stress the need for the implementation and documentation of the informed consent process. A strict adherence to the study protocol by the investigators and the study team members at the sites, as emphasized by the GCP guidelines, will help protect the rights of the study participants.

GCP and GLP training

Certain uniform guidelines for GCP and GLP need to be followed while conducting clinical trials and generating clinical trial data. This increases the credibility of Indian data and makes it acceptable by global regulatory authorities. Out of the tens of thousands of doctors in India, only a handful of around 400 to 500 are GCP trained and experienced in conducting clinical trials. A major investment is required at the beginning of the trial to train medical professionals in the basics of GCP.

Each year the number of GCP trained personnel is steadily increasing in India. Sponsors, Contract Research Organizations (CROs) and Site Management Organizations (SMOs) are making efforts to train more and more numbers of investigators and ethics committee members on the principles and practice of GCP.

Effective monitoring of clinical trials

The DCGI gives the approval for conducting clinical trials in India. How is the trial being conducted? Is anybody tampering with the data at any point? At present, there is no central monitoring mechanism in place to answer these questions.

However, things are going to change from 2006. The DCGI is already training a group of people to act as clinical trial monitors. Whenever permission for a clinical trial is granted by the DCGI’s office, these study monitors will oversee them. Proposals for a central clinical trials registry in India are also being considered.

At present monitoring of clinical trials is done by the representatives of the sponsors or the CROs.

A bright future for clinical research in India

In spite of all the present pitfalls, the country is certainly gearing up to attract more and more researchers from around the world to conduct their clinical trial studies in India. The regulatory system is being polished. Laws are being amended to facilitate the entry of global clinical trials. Massive and concerted efforts are on to train research professionals and increase the base of investigators and supporting staff. These initiatives are certain to improve the current situation. In brief, India is already off the starting blocks and gearing up for an inundation of clinical research trials. This will ensure the timely conduct and completion of the clinical trials and at the same time generate high quality data for international submission.

Reference:

1. Nundy S. and Gulhati CM. A New Colonialism? — Conducting Clinical Trials in India. NEJM. April 21, 2005. No. 16, Volume 352: 1633-1636.
2. Sinha G. Outsourcing drug work: pharmaceuticals ship R&D and clinical trials to India. Scientific American Online, August 16, 2004. (http://www.sciam.com/article.cfm?articleID=00033282-DBF5-10F9-975883414B7F0000) Last Assessed December 21, 2005.
3. Lamberti MJ, Space S, Gammbrill S. Going global. Appl Clin Trials 2004; 13:84-92.  
4. Borfitz D. Lifting India's barriers to clinical trials. Center Watch 2003; 10(8): 1-9. 
5. Anaokar S. Clinical Research in India. www.pharmabiz.com
6. Jayaraman KS. Outsourcing clinical trials to India rash and risky, critics warn. Nat Med 2004; 10:440.
7. Bhatt A. Clinical trials in India: Pangs of globalization. Indian J Pharmacol 2004; 36:207-208

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