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Contract Research and Manufacturing Services (CRAMS) in India by G Gokhale, M Antani

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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 ...

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