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Reliance launches a clinical research arm - PHARMACEUTICALS

COMPANIES ASIA-PACIFIC
Reliance launches a clinical research arm - PHARMACEUTICALS.

By RAY MARCELO
378 words
12 May 2004
Financial Times
USA Ed1
Page 22
English
(c) 2004 The Financial Times Limited. All rights reserved

Reliance Industries, India's largest private-sector company, has launched a clinical research arm to serve multinational pharmaceutical groups hoping to slash drug development costs by outsourcing trials to the subcontinent.

Mukesh Ambani, Reliance's chairman and managing director, said the launch of the new unit, Reliance Clinical Research Services, was part of the group's "transformation from a manufacturing organisation to a knowledge and services-driven enterprise".

Several of the world's largest contract research organisations, such as Quintiles Transnational, Covance and Clinpharm, have already set up operations in India, lured by the country's large base of patients.

Contract research organisations say drug development costs, which currently can be worth up to Dollars 800m and can take 20 years, can be cut by up to 30 per cent by outsourcing clinical trials to India.

Indian medical researchers, nurses and IT staff can be hired at less than a third of western salaries and patients can be enrolled in trials more quickly.

Investment bank Rabobank estimates that the average cost of a clinical trial, which can involve hundreds of thousands of patients taking experimental drugs, is 50-60 per cent cheaper in India than in the US.

According to the Confederation of Indian Industry, a business lobby, around 80 hospitals around India are participating in international clinical trials.

The CII has been lobbying the government to grant automatic approvals for all phases of clinical trials to speed up the enrolment of patients, and in effect, accelerate the marketing of new drugs.

India last year upgraded its regulations surrounding drug testing to conform with international norms. But CII says faster drug testing is being held back by the involvement of several government agencies which each must approve trials.

Critics say, however, that patient rights are being compromised by the push to accelerate drug testing. Chandra Gulhati, editor of Monthly Index of Medical Specialities, a medical journal, said Indian patients are not as well informed as their counterparts in the US or the UK.

Dr Gulhati said the Drug Controller of India, the country's equivalent of the US Food and Drug Administration, was "not very effective" at monitoring the safety and ethics of clinical trials.
 

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