The Hindu Business Line : Doors may open for MNCs to do Phase I trials

Testing phase
Phase I clinical trials involve the first ever exposure of a prospective drug to humans.
The new drug is tested for the first time on a group of 50-100 human volunteers to evaluate safety, dosage etc.
A McKinsey report projects that the domestic clinical trials market would touch $1.5 billion by 2010.
There are about 70-80 clinical research organisations in the country.

A leg-up to R&D drug companies.

P.T. Jyothi Datta

Mumbai, Jan. 1 The regulatory environment that has kept the doors firmly shut on multinational companies (MNC) looking to conduct Phase I clinical trials in India, may be set for a change this year.

High-level recommendations from different quarters, including the Drug Technical Advisory Board, are adding up in favour of allowing MNCs to conduct Phase I clinical trials in the country. And this year could see a decision from the Union Health Ministry, a ministry source told Business Line.

Criteria

Overseas companies may be allowed to undertake a Phase I trial, if they are able to provide all documentation required by the regulator, the official said. Another scenario where Phase I clearance could be given to an MNC is, if it were doing multiple-centre studies, the official said.

More than 95 per cent of drugs that come into the country have had their Phase I trials done overseas. It is time that India too showed some “global responsibility,” said a ministry official.

As the pressure builds to open up Phase I trials for overseas companies, the environment has been primed further with a registry for locally-done clinical trials up and running this year, besides a Central Drug Authority also being set up.

Phase I clinical trials involve the first ever exposure of a prospective drug to humans, where the new drug is tested for the first time on a group of 50-100 human volunteers to evaluate safety, dosage etc.

Indian companies are given regulatory clearances for Phase I trials of their prospective drug molecules. But, regulatory authorities have kept overseas companies at bay from Phase I trials, given the sensitivities of exposing the local population to a new drug, besides the inherent risks it involves.

Pharmaceutical industry representatives point out that domestic drug makers get regulatory approval to do phase I trials on their prospective drug molecules in other countries such as the United Kingdom, the US or Canada. Similar clearances should be possible for overseas companies in India too, a pharma representative said.

Clinical research cos

A McKinsey report projects that the domestic clinical trials market would touch $1.5 billion by 2010. There are about 70-80 clincial research organisations (CRO) in the country, an industry representative said.

Despite the upbeat projection, a CRO official cautions, that Phase I should be opened up for overseas companies only when the regulatory, monitoring, hospital and emergency infrastructure is equipped to handle the challenges it poses.

In early 2006, the United Kingdom was rocked by a clinical trial gone awry — when volunteers who were exposed to a new drug for cancer and auto-immune diseases, developed multi-organ failure. All volunteers survived, thanks to the quick and intensive care that they got, the CRO representative points out.

The Centre has to tread with caution in India. But in India, where patient-safety norms such as ‘The Biomedical Research on Human Subjects (Regulation, Control and Safeguards) Bill’, is still pending, the Centre will have to tread with caution, another Health Ministry official said.

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