Clinically correct

Clinical research, as a distinct business model, is a relatively new phenomenon in India. The term, which would have meant merely bio-equivalence studies (experiments conducted to test if a generic drug is equally effective as the original patented drug) a decade ago, is today considered the most critical, time-consuming, risky and expensive component of new drug development.

India is fast turning into an important centre for global clinical research "" a fact that is reflected in the presence of multinational drug majors like Pfizer, Johnson and Johnson, GSK, Merck, Eli Lilly, and Novartis.

All big companies today either own clinical research facilities (such as Pfizer and Eli Lilly), or outsource clinical research services from contract research organisations (CROs) in the country.

The shift in MNC interest towards India for clinical development was not momentous. The rising costs of clinical development in advanced countries, and the dwindling numbers of money-spinning drugs (resulting in reduced profits) has prompted them to go in for outsourcing.

India's revised patent laws (that provide protection for products), introduction of good clinical practices, rich patient pool, talented medical faculty, and the data processing infrastructure for bioinformatics has helped India make the most out of the outsourcing opportunities.

According to industry estimates, India can attract between 5-10 per cent of the global contract research outsource market over the next five years.

This includes chemistry services, toxicology services and clinical research activities. This translates into a business worth $0.8-1.7 billion by 2008, and $1-2 billion by 2010. Approximately, 40-50 per cent of this would come from clinical research.

An Ernst & Young study, commissioned by industry body FICCI, says that India will contribute 1,00,000 patients towards clinical research, and will need not less than 3,000 clinical trial sites, over 50,000 clinical research professionals and a regulatory body that can handle over 400 clinical trial applications.

However, all is not well with this emerging business opportunity. The Drugs Controller General of India (DCGI) is concerned over the mushrooming of CROs in the country. The ministry of health and family welfare, under whose administrative control the DCGIfunctions, has hinted at formulating an accreditation system for CROs.

Concerns have also been raised about the delay in regulatory approvals, deficiencies in the functioning of the ethics committees, and the overall quality of clinical trials.

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SNIPPETS

On fast track
The Drugs Controller General of India (DCGI) is likely to put an end soon to the delay in sanctions of global clinical trials.

The DCGI has announced a checklist for submission of applications for global clinical trials, and has assured that those applications which comply with the specifications in the checklist will get a fast track clearance.

The attempt is the first among a series of measures planned by the ministry of health and family welfare to promote clinical research activities in the country.

The ministry is in the process of framing a law that would ensure proper regulatory control over experimentation on human subjects.

The law, which is at the drafting stage, is aimed at allaying fears among the public about making them "guinea pigs" through human trials. It will also protect the interests of human subjects, and also make sure that the benefits of clinical research reach the common man at a reasonable cost.

The clinical research community feels that proper government regulation is essential for the sustained growth of the industry.

They have demanded the setting up of a central committee of experienced researchers for policy implementation, comprehensive policy guidelines for clinical trials, rules and regulations for toxicology studies and a host of fiscal incentives.

Grooming centre
The Centre for Translational Research in Health Sciences, the first-of-its-kind institution, will soon be a reality in India. The institution, being set up under the joint patronisation of the department of biotechnology and the department of health, will be India's hub for training clinical research scholars.

Training in apparently unrelated topics like medicine, information technology and statistics, among others, would enable students to take up multi-tasking.

The central government has already sanctioned Rs 100 crore for setting up of the facility at Faridabad, near Delhi.

Though the thrust area would be capacity building in clinical research, the centre will also develop new vaccines, futuristic diagnostics and biological drugs, and establish an incubator for the development of products.

The centre will run academic programmes such as Masters in translational research and clinical sciences besides granting MD/PhD degrees to physician scientists.