India is an emerging market with growing number of entrepreneurs foraying into research and healthcare. Indian government is creating an effective regulatory framework. Protection of patents and IPR is now improving. India has a better place than countries like China in the clinical trials field, Dr Charles Pierce, president Global Clinical Partners, Inc. USA, said.According to IMS International, there is a surge in pipeline growth with the number of projects expected to increase from 12,700 in year 2005 to 13,465 in 2007. The US pharmaceutical companies are increasing their R & D investments and this triggers enormous scope for outsourcing a lot of research services from India.
US companies believe that Indian counterparts understand good clinical practices and value ethics. Indian capabilities are already proven. India will also soon become a key drugs market, as it has comparatively a large population than the US, which is currently the biggest market. India is likely to have three times more diabetic patients than in the US in the coming years.
Commenting on the need of having or creating clinical trials registries by countries, Dr Charles said, the decision to create a national registry is optional and should be based on suitability. No pharmaceutical company would like to share its results or any information in a clinical trials registry, which may benefit its competitor.
It may be noted Synapse Clinical Research Foundation (SCRF), a not for profit organization founded to provide easy access to information on clinical trials currently running in India, has developed an Indian Clinical Trials Registry (ICTR), claimed to be the first of its kind in India. The ICTR contains information for public on Ethics Review Board (ERB)/DCGI approved clinical trials/human volunteer studies that are currently running in India for different medical diseases. In parallel, SCRF has also launched the Indian Investigator Registry (IIR) and Indian Registry for Ethic Review Boards (IRERB). Some voluntary organizations in the US, NIH too have established clinical trials registries in the past.
Touching upon ethics in clinical trials, Dr Charles pointed, vulnerable section of population such as minors, employees, students, unemployed, homeless, ethnic minority groups, patients with incurable diseases should be used ethically in site trials. Subject recruitments should be ethical.