European Journal of Biomedical and Pharmaceutical Sciences

REVIEW ON CLINICAL TRIAL PHASES IN INDIA & NEW CHANGES

V. N. Raje, S. J. Patil, Alisha Hamidulla Mujawar and D. M. Nirmale*

ABSTRACT

Any investigation in human subject intended to discover or verify the clinical pharmacological & other pharmacodynemic effects of an investigational product. Clinical research is an organised research & systemic study conducted on human being to generate data for discovering or verifying the clinical pharmacological adverse effects with the objective of determining safety & efficacy of new drug. It is based upon development of new drugs & also new formulations, drug delivery systems, dosage regimen, surgical & diagnostic techniques, devices & therapies. It is important to check the drug quality & to see whether it works better than other drug. For this purpose India has announced a new rule for clinical trials that will speed up drug approvals & remove the requirement of large studies to test the efficacy of the drugs that have already been approved in other nations. It is observed that nearly 20-30% of clinical trial activity is being conducted in developing countries. In 20-21 the clinical trial industry will continue to focus its attention in value based outcome & getting more real world evidences. Leaders will develop outcome driven strategies emphasising the importance of medications to providers, enabling the strong payer partnership & enhancing patient relationship. New plans have been made to improve clinical trial in India. Clinical trials are link between advances in medical research technology & improved health care. New rules are applicable to new drugs, investigational new drugs for human use, clinical trials, bio equivalence studies and bioavailability studies & ethics committee.

Keywords: clinical trial, New drug Discovery, Clinical trial phases.