4 - Issues and concerns

Abstract

Although regulations relating to clinical trials have evolved greatly to match global standards, many issues still remain. The extreme shortage of regulatory experts is a major concern. Sponsors should be aware of differences in the Indian GCP version of ICH-GCP, and of the roles and responsibilities of foreign sponsors conducting clinical trials in India. Lack of pre-Investigational New Drug meetings with the regulatory reviewers and deficiencies in the functioning of ethics committees and CROs are other concerns. The participation of human subjects in clinical trials exposes all stakeholders involved in the trial to liability. Improper disclosure, conflict of interest, violation of good clinical practice and injuries resulting from the test drug can expose the sponsor company to the risk of liability. Sponsors/CROs are required to undertake to provide complete medical care and compensation for injury to the subjects in clinical trials. It is mandatory for manufacturers to obtain a licence to manufacture or loan licence from the authorities and to comply with certain conditions. Manufacturing units must undergo periodic inspection by the authorities.