Letters to the Editor

May 1, 2003

Applied Clinical Trials

Applied Clinical Trials, Applied Clinical Trials-05-01-2003,

Readers respond to feature article and editorials.

Concerning India

The article Clinical Trials in India, by Radhika Bobba and Yamin Khan (

Applied Clinical Trials

, February 2003, 5256) highlighted the tremendous clinical development opportunities in India. The authors rightly attribute Indias attractiveness as a clinical trial location to her large population, with diseases of both the developing and industrialized worlds, and a well-trained medical workforce.

In spite of the opportunities for rapid recruitment of treatment-nave subjects and the potential for substantial cost savings, however, U.S. and European pharmaceutical and biotechnology companies are reluctant to use India for their clinical development requirements. The reason for this reluctance is concerns about data quality, study ethics, bureaucratic regulations, and intellectual property rights (IPR) protection. Unless these concerns are addressed, notwithstanding the numerous newly opened contract research organization offices in India, persuading the global industry to deploy India as a major contributor to their multicentric clinical trials will be difficult.

I disagree with the authors statement that concerns regarding data quality from far-flung studies has dissipated. On the contrary, concerns about data quality and acceptability by FDA and EMEA are paramount for drug developers considering a nontraditional country for clinical trials. These concerns can be allayed by selecting well-trained investigators that are conversant with International Conference on Harmonisation (ICH) good clinical practice (GCP) guidelinesalso by ensuring that the clinical research associates and study monitors are trained in GCP and supported by standard operating procedures that are compliant with GCP and GLP (good laboratory practices). Additional quality assurance may be provided by international resources with experience of auditing other nontraditional clinical trial locations, for example, Central and Eastern Europe. Preliminary experience suggests that the clinical data from India is of world-class quality, but we must make every effort to maintain this standard.

As the article points out, some debate about the ethics of performing clinical trials in developing countries exists. The almost overzealous regulations prescribed by Schedule Y of the Indian Drugs and Cosmetics Act (Schedule Y, Requirement and Guidelines on Clinical Trials for Import and Manufacture of New Drug, The Drugs and Cosmetics Rules, India, 1945) are intended to safeguard Indian subjects. More recently, the Drugs Controller General of India adopted ICH GCP guidelines, including those related to informed consent and the absence of subject payments. Inclusion of India in global clinical trial programs is not third world exploitation. It enables one-sixth of the worlds population to access the benefits of biomedical innovation.

The article comprehensively describes Indias bureaucratic clinical trials regulatory processes. An in-depth and up-to-date knowledge of the regulations, along with experience of interacting with the regulatory authorities is essential for international companies seeking to conduct their clinical trials in India.

Lastly, the global ethical pharmaceutical industry has reservations about conducting their pivotal clinical studies in India, because of Indias historic exemption from the World Trade Organization IPR regulations. India has committed to adhere to international IPR standards, however, and it will enforce all product patents registered after 1 January 1995. Indias determination to emerge as a leader in the global software industry is driving much of the recent progress in IPR protection by the Indian legal system. Hence, concerns about inadequate IPR protection for drugs undergoing clinical development in India are a hangover from a previous era. More so as physical access to the drugs has never been a requirement for successful reverse engineering by Indias generic pharmaceutical industry.

I endorse Bobba and Khans observation that India is viewed as an important global resource for clinical trials and data management services. Unless the tacit concerns of the global pharmaceutical industry are effectively addressed, however, the opportunities in India will remain underused.

Nermeen Y. Varawalla, MD, DPhil, MBAManaging Director, PerinClinical Ltd, UK.
email: nermeen.varawalla@ periclinical.c o.uk

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