FROM ACCEPTANCE TO ATTRACTION
Early pharmaceutical pioneers in India faced a daunting task in operating in a regulatory and ethics environment that was
overtly unfriendly for quality clinical trials. To make matters worse there was a dearth of experienced investigators and
clinical research professionals. However, with patience and persistence, these organizations and their supporters brought
about a change in the quality of research professionals, increased awareness of good clinical practice (GCP) compliance, and
made efforts to improve ethical aspects of clinical trial operations.
A decade ago, India had little in the way of clearcut regulatory guidelines for clinical trials, but it slowly progressed
toward GCP clinical trial standards.4 Because of pressure from the industry and proactive initiatives of the regulators, the Central Ethics Committee on Human
Research (CECHR) of the Indian Council of Medical Research (ICMR), New Delhi, issued Ethical Guidelines for Biomedical Research
on Human Subjects in 2000. Subsequently in 2001, a central expert committee was set up by the Central Drugs Standard Control
Organization (CDSCO) to develop Indian GCP guidelines in line with the latest WHO, ICH, FDA, and MHRA guidelines. A continuation
of this regulatory revolution has been revision of Schedule Y. Schedule Y deals with regulations relating to clinical trial
requirements for the import, manufacture, and of obtaining marketing approval for a new drug in India. The procedure for applying
for marketing approval depends on the status of the new drug. When the revised Schedule Y fully comes into force, it will
confirm India's image as a reliable clinical research destination.
In the early 1990s, sponsors often posed the question "Are Indian clinical trials acceptable globally?" and this remained
difficult to answer. Yet, it has become much easier to convince sponsors to consider India for their major clinical research
plans. In a similar way to how other emerging markets developed, India has now shown that quality data can be generated to
satisfy major regulatory agencies. Most major pharmaceutical companies have overcome the psychological hurdle concerning data
quality and routinely include India in their plans. This is why FDA's recent visit to the country generated such media interest.
ENSURING AN ETHICAL EVOLUTION
With so much attention focused on the financial aspects of the clinical trials market in India, it is important that issues
such as ethics do not take second place. There have been occasional allegations that poor and illiterate patients in India
are being used, often unknowingly, by some CROs in India as "human guinea pigs" to test new drugs.6 This, of course, is unacceptable and the industry must send a clear message to its staff about the high standards it expects
for the conduct of clinical trials. All those involved in drug development must ensure that they adhere to international and
local regulations in order to protect patients.
Sponsors must verify, and not just assume, that investigators completely understand and respect ICH–GCP, the consent process
and the need for documentation of the consent process, and the ethics process. There should also be a formal training of clinical
trials staff so that the required standards can be upheld. For example, according to Dr. Umakanta Sahoo, managing director
of Chiltern International, Mumbai, in 2006, his organization set up a dedicated network of investigators in India (CINISTA),
to serve as the preferred primary contact for the company and function as principal or coordinating investigators.6 In addition, the CINISTA participants provide trial sponsors with their views and advice for areas such as trial design,
study conduct, and interim analysis. Through this system the sponsors also learn about domestic clinical trial requirements
from Indian clinical trials professionals.
India is clearly on course to become a major center for clinical trials, and is routinely considered by international sponsors
for their global trials. The involvement of regulatory agencies, such as the FDA, should be seen as a beneficial step to ensure
that the clinical trials environment evolves in an appropriate fashion and that standards used to protect patients in other
markets are also applied in India. Although companies face continuing pressure to reduce clinical development timelines and
costs, it is important that these factors do not encourage staff to let standards slip in particular markets. It is in the
pharmaceutical industry's interest to fully engage with Indian patients in their work. Patient participation is essential
if future drugs are to be developed successfully in India. If the public has confidence in the industry, then rapid patient
recruitment will be enhanced.
Faiz Kermani, PhD, is a clinical trials consultant at BioPlan Associates, Inc.
Eric Langer is president and managing partner at BioPlan Associates, Inc., Rockville, MD. He is also the editor of Advances in Biopharmaceutical Technology in India, 301.921.9074. firstname.lastname@example.org