India's CDSCO seeks comments on clinical trial accreditation standards

India's Central Drugs Standard Control Organization (CDSCO) has sought comments on accreditation standards of Ethics Committees, clinical trial investigators and trial sites designed by India's Quality Council.

A Ministry of Health's Expert Committee chaired by Ranjit Roy Chaudhury designed the standards that clinical trials should be conducted only at accredited sites by accredited investigators--with the oversight of accredited Ethics Committees.

The committee was charged with sharp changes to the drug and clinical trial approval process because of concerns over patient consent and other issues that led to a sharp drop in approvals. It was also asked to review the process for banning drugs.

- here's the CDSCO report (PDF)