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CROs call for better regulatory environment to attract more business
Our Bureau, New Delhi | Wednesday, April 1, 2009, 08:00 Hrs  [IST]

The contract research organisations in the country have called for better regulatory environment including permission for phase-1 clinical trials to attract more foreign companies to the land as the country has huge potential to improve its share in the global market.

The Association of Indian Contract Research Organisations (ACRO) said the business was shifting largely from the developed countries to the countries like India and China. "We have now a share of 24 per cent while China has 33.3 per cent of the global business. We have the potential to surpass China, if we have better regulatory environment and other factors," ACRO chairman Dr S P Vasireddi said.

The foreign companies, increasingly under pressure to cut down the cost in research due to global recession, were shifting their business to this part of the world and they were looking for long term ties with Indian companies. But permission for phase zero and phase-I trials must be given, he said, adding that there existed 'no regulatory system' at present in the country to attract the MNCs.

Timezone advantage, lower labour costs, edge in IT and availability of human resources helped India to gain more but as of now the going was not good and India cannot reach the set target by 2010, he said at the recent roundtable conference. The event was jointly organised by ACRO and the Pharmaceutical Export Promotion Council (Pharmexcil) on the theme - 'Destination India - Contract Research in Pharma & Health Care'.

ACRO secretary A K Dasgupta said the country should now pay attention to improving regulatory aspects, grooming more trained persons and the functioning of ethics committees if it wanted to grab a better share. "CROs are now targeting the tier-II cities and smaller towns as metros are saturated. At present we have just 600 GCP-trained investigators. We need at least 5000 more investigators to gain business. Working of ethics committees also warrant attention," he said.

Senior health ministry officials including joint secretary Debasish Panda and DCGI Dr Surinder Singh briefed on the measures being initiated by the government to help the sector and responded to the issues raised by the members. A good number of CEOs of CROs were among those attended the conference which focussed on issues related to contract/clinical research services, regulatory issues of contract research & manufacturing including those relating to DGFT, R&D projects and funding requirements by Indian CROs.

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