Unless the norms of Good Clinical Practices in India are harmonized with International Council of Harmonization (ICH), Indian companies would find it difficult to cope with demands of future global markets, according to Jayanthi Swanimathan, Spectra Clinical Research Centre associated with Apollo Hospitals Enterprises Ltd., Chennai.

India needs improvement in areas like study of epidemiological database, basic infrastructure, regulatory approvals, GCP training, functioning of ethics committee etc., considering our population and disease profile. Indian guidelines have significant difference in some of the areas with ICH - GCP, making the task of compliance difficult for CROs and pharma companies, investigators and ethics committee, and delaying the registration of new drugs in the market.

She noted that currently the average cost of a drug development in US is about $ 800 million, and out of 5000 compounds, only 250 enter testing, and only one out five molecules entering trials get approval. The whole process takes 10-15 years. If the Indian companies were not able to come up with new launches by 2007 - 08, they might get hit although they have the choice of manufacturing pure generics or contract manufacturing, said the expert while participating in a national workshop on Intellectual Property Rights organized by the Sri Ramachandra College of Management, Chennai.

She also noted that while India have strengths in factors like patients and speed of recruitment, medical and pharmaceutical expertise, language and communications, cost leadership, infrastructure facility, information technology development etc., clinical research in India were hampered by low commercial potential, underdeveloped regulatory framework, poor basic medical documentation, data confidentiality etc. At present in India, about 50 GCP trials are going on and there are about 250 GCP trained investigators, with a total spending of about $ 30 million. This is likely to grow to $ 30 million by 2010. Some of the major issues to be considered in the case of clinical trials are investigator qualifications, sponsorship, investigator responsibility for data analysis, powers and essential documents for IEC, compensation, drug label, monitor's responsibility etc.

The expert said in the new IPR regime, India would have advantages by way of product patent availability, more money flow and labour possibilities, more knowledge based skill development, lower cost, consistent clinical trials in any part of the globe, manufacture of off label drugs by Indian companies etc. India is considered a hot destination for any clinical research, due to factors like out a total of 1.2 billion people, India have 80 million cardiac patients, 60 million diabetics, 50 million asthmatics, 50 million hepatitis B cases, one in three Indians infected latent TB, 35 million HIV positive cases by 2010 etc. India formulated its GCP guidelines in 2001, and the new Schedule Y recommended by Dr. Mashelkar links provisions to Indian GCP guidelines. Once enacted as law, it would become the norms for following clinical trials in India, said the expert.