Confederation of Indian Industry (CII) is organizing a conference on "Clinical Research: Road Map for India" in New Delhi on September 24 and 25, 2003. The programme, to be attended by decision makers from the Government, Industry leaders, International delegates, key people from pharmaceuticals industry, CROs and other service providers, is to come out with suitable recommendations to enhance the prospects of Indian clinical research.
The topics of discussion include evolution of clinical trials and its impact on clinical practice, clinical research and regulatory control, clinical research and skill base-Gap Analysis & challenges in the Indian context. Ethics in Clinical Research and a GCP QA System for the software of medicinal products are also to be part of the discussions.
Clinical Trial Research, which constitutes about 70 per cent of time and money spent on developing a new drug, is an area of extreme importance for all companies. Contract Research Organizations (CROs) are fast gaining importance, as they are able to conduct Clinical Trials at a lower cost with higher level of expertise and specialization.
India has the potential to build internal capability and grow exponentially in the area of Clinical Trials and bring forth interest from a range of global pharmaceutical companies and CROs. A large and diverse patient population, networks of academic and medical centers/hospitals, well preserved genetically distinct population groups and a pool of qualified scientists, technicians and doctors are the distinct advantages that India offers.
The rapid advances in this area are set to place India on the global platform in the realm of Clinical Research & Trials. There is an increased focus on upgradation of hospital infrastructure to meet GCP standards, regulatory guidelines and establishment of GCP complaint ethics committees. At present, a large number of bio-equivalence trials of approved products and bioavailability studies of generic products which are under formulation development, are being conducted in India.
India stands at the threshold of global development with the potential to emerge as the new lexicon for R&D and Clinical Research & Trials. The conference is expected to provide the necessary interface and capability.
Union Health Minister Sushma Swaraj is to inaugurate the conference.