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Is India Ready For Phase I Studies?

Tuesday, August 15, 2006

India has come a long way as a center for clinical drug trials, but is the country ready for Phase I studies? I think the short answer – and others would agree – is “no”. Take, for instance, recent comments by Ashwini Kumar, the Drug Controller General of India (DCGI), who spoke recently at the Drug Information Association’s (DIA) Annual Meeting in Philadelphia. Kumar, head of the Central Drug Standard Control Organization (CDSCO), India’s regulatory agency, said that India needed to create an environment for the best quality assurance before embarking on phase I studies…

As a first step, the country upgraded regulations governing clinical research – Schedule Y – last year to harmonize them with U.S. and international standards. It also eliminated “phase lag,” which mandated that India not begin a phase of a global trial program until that phase had been completed elsewhere.

The new regulations gave rise to expectations that India would begin to allow first-in-man studies. No dice. India still forbids Phase I studies unless the molecule was developed there. India basically is a Phase II/III market, and “Phase I” in the Indian context generally means bioequivalence & bioavailability studies, which are less complex to run and yield less informative data than first-in-man studies.

But biopharmaceutical companies can get around Phase I barriers by doing that portion of the study outside the country and completing the rest in India. Some contract research organizations (CROs) are already doing this. A CRO will bring an entire project management team from the West after conducting a first-in-man study outside India. That’s not the norm, though, as the logistics can be difficult.

For now, this doesn’t mean that domestic pharma has a real edge over Western pharma. But large, formerly generic, Indian pharma companies are beginning to invest in new drug development and can develop a molecule for which they are able to conduct preclinical studies through phase III in India without the kind of interruption and limitations that Western companies experience.

Discussions about creating a more FDA-like regulatory body in India are ongoing, and that would certainly be another significant step toward creating confidence in hosting first-in-man studies and also toward making the country a truly global player in the clinical research market.

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