Brar Calls For Govt Support For Clinical Research Outsourcing

New Delhi, Sept 24: | Updated: Sep 25 2003, 05:30am hrs
Ranbaxy Laboratories CEO DS Brar feels clinical research outsourcing to India will take off only when regulatory infrastructure and support systems are in place. He added that India occupies a small place in the world scheme of clinical investigation despite the fact that India has quality infrastructure, pool of talents and various ethnicity of diseases.

Mr Brar was speaking at the international conference on clinical research organised by Confederation of Indian Industry (CII) in New Delhi on Wednesday.

Minister for chemicals and fertilisers Sukhdev Singh Dhindsa said, India has the potential to become a global player in clinical research, and can attract a significant amount of outsourcing. But the quality of data generated in clinical research can be acceptable only if clinical investigators and the sponsors religiously follow the principle of good clinical practices. With possible side-effects on patients undergoing trials,investigators and industry must ensure that no iota of doubt creeps up about possible exploitation of trusting patients in developing countries. Drug controller general of India Ashwini Kumar said, The regulatory authorities face challenges, biggest being having enough trained evaluators and the issue of who would bear the cost of additional manpower. One also needs multi-disciplinary expertise requiring part of the work to be outsourced. But who would monitor this Then there are complaints about confidentiality of data, but I am not sure what this is supposed to mean. The last statement was seen as being directed to those pressing for data exclusivity in the country.

Ministry of health and family welfare secretary JVR Prasada Rao said, Clinical research in the country is bound to undergo change in the future. Companies will not be able to survive by just being dependent on generics, and will need to focus on new molecules. This will require greater financial investments as well as technological upgradations.

In the area of clinical research, India would have to focus on being more open and transparent. This will ensure people and their elected representatives all know what is going on. Members of civil society acting as watchdogs would also need to be taken along, he added.

Mr Prasada also said, Testing facilities and outdated technologies need to be upgraded for which the government has already announced an assistance package by the World Bank. The government is going through a process of accrediting laboratories not only in the government sector but also in the private sector.