India to set up a registry database which will contain all datas and research results of all clinical trials which would be available in a public domain which will provide transparent results and information for patients.// The detail of the new registry database was announced by Drug Controller General of India Ashwani Kumar.
He announced the details of the registry during a two day workshop on 'Building and Managing Clinical Trial Capacity in India: Challenges in Ethics, Equity and Efficiency', which has been organized by Indian Council of Medical Research, Administrative Staff College of India and Fordham University, US. The workshop will discuss issues like prioritization of clinical trials, protection of vulnerable subjects, building ethical capacity, creating review mechanisms, reporting adverse events and accreditation and regulation.
The workshop was attended by more than 60 delegates including government officials, researchers, pharmaceutical companies' representatives, NGOs and advocacy groups are attending the workshop. It is being held in the backdrop of debates on methods employed in high-risk clinical trials by pharma firms and the concern on outsourcing of such trials to developing countries. The speakers at the inaugural session underlined the need for a strong legislative and regulatory framework for clinical trials and addressing ethical issues.
Ashwani Kumar, Drug Controller General of India said, “Multi-centric clinical trials would be allowed on the same protocol as followed in the US and Britain, presently multinational companies were conducting 100 clinical trials in India while domestic firms were engaged in some 300 trials and he said training was being imparted to officials to supervise the process of clinical trials and ensure compliance with the regulations”.
Health secretary P. Hota said, “India had the potential and a great opportunity to emerge as a global centre for cl
inical trials, we need to have the right kind of institutions, right legislation, and human skills and budgetary and other administrative support so that we don't miss the bus."
Falguni Sen, a professor at Fordham University, New York, said revenue accruing from clinical trials in India was $70 million in 2003. The Confederation of Indian Industry has estimated that this will grow to $200 million in 2007 and between $500 million and $1 billion by 2010.
The Contract Research Organizations (CROs) found India an attractive destination, more than five CROs conducted 70 percent of the outsourced clinical trials worldwide, have established a presence in India directly or through partnerships. Though, we may be happy lot of clinical trials being conduced in India, but we should also be aware that clinical trials involving humans may be dangerous and it should not lead to exploring the poverty and ignorance of Indians involved in these clinical trials. So, a registry containing datas and results of clinical trials would be available to patients as well to committee monitoring it will help to avoid
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