The Hindu Business Line : Worth a trial

THE IDEA OF permitting clinical trials for new drugs in India at the same time as they are carried out elsewhere, is in accord with the `product' patent regime that the Government is committed to enforcing from January 2005. The `process' patent regime, that is currently in force, provided little incentive for domestic research, relying as it did on the local industry's ability to clone a drug molecule using a process different from the one identified and validated by the global patent. In other words, the local industry not only did not have to undertake any research of its own, but even the time taken from `proof of concept' to `market' was almost identical with that of the original innovator who also had taken the trouble to patent it. Any restrictions on sequencing of domestic clinical trials are only of academic importance. But the prospect of being denied such a privilege after January 2005 is bound to alter the current favourable climate for these players. In the event, the liberalised framework for undertaking clinical research should not only open a new revenue stream but also make overseas firms with deeper pockets feel more secure about sharing with domestic players their new research initiatives while jointly developing a new drug.

That India holds enormous potential for undertaking successful research in drug discovery at an affordable cost is now widely recognised. A vast pool of patients with a diverse and rich genetic background is available for clinical trials. Then there are specialty hospitals with state-of-the-art infrastructure, a vast network of private healthcare and medical research institutions with trained personnel. And, above all, an English-speaking population that has contributed to making India a force to reckon with in the software and IT-enabled services. No wonder the clinical trial industry is confident of India capturing a chunk of this multi billion-dollar business. The proposed legislative change would eliminate a significant hurdle in exploiting this potential.

But between promise and performance vast ground has to be covered. The clinical trials industry in the country has not been free from controversies. There have been allegations of volunteers being kept in the dark or not fully informed of the nature and the scope of trials. The controversy over cancer drug trials that surfaced some time ago and, more recently, the manner in which some fertility trials were conducted on women without their consent are just two cases in point. There have also been concerns that Indian industry does not uphold the highest standards of research methodology in evaluating the efficacy of the drugs being tested. That the Government has not allowed trials to be commissioned before being tried out elsewhere is in itself a tacit admission of the fact that the administrative mechanism is not quite up to meeting the inherent regulatory challenges. Lax regulation can hurt both ways: global players can lose confidence which would undermine whatever potential this nascent industry offers or expose innocent patients to dubious experiments.

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