Health ministry affirms 157 controversial trial proposals re-evaluated on risks, safety parameters

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The Union health ministry has affirmed that the 157 controversial clinical trials, whose review was ordered by the Supreme Court, were reexamined and cleared by the high-level apex and technical committees in accordance with the procedures and direction by the court.

The apex committee, headed by the health secretary to monitor the clinical trials sector, has also decided that the existing system would continue with regard to the procedure of clearing proposals of clinical trials of new chemical entities.

A meeting of the apex committee, held recently, deliberated on the issue based on the recommendations of the technical committee and opined to `maintain status-quo’ in this regard of new chemical entities. The technical committee had recommended that proposals for new chemical entities `shall only be placed for the technical committee,’ whereas the present practice is to route them through the New Drug Advisory Committees (NDACs.)

The apex panel also ratified the observation by the technical committee that the 157 global clinical trials were evaluated with respect to risk versus benefit to the patients, innovation vis-à-vis existing therapeutic option and unmet medical need in the country.

During the hearing of the case filed by Swasthya Adhikar Manch in the Supreme Court, the petitioner had pointed out that the parameters like risk and innovations were not followed while reviewing the cases as ordered by the apex court in its earlier verdict.

The technical committee opined that these 157 proposals were earlier evaluated and deliberated by NDACs based on which the permissions were granted by the DCGI. As per the order of the court in October 2013, the proposals were forwarded to the technical committee as per the prescribed format decided by the committee.

“The format contained the name of the drug including chemical name, name of the applicant, therapeutic category, brief of pre-clinical information, brief of clinical information, adverse effect if any known to be associated with the drug, study title, study design, sample size, investigators and study sites details, study duration, key inclusion/exclusion criteria,, major efficacy and safety parameters to be evaluated, name of participating countries in the case of global clinical trial, NDAC recommendations and NDAC members,” the technical committee said.

“The members after having appropriate preliminary review of the proposals forwarded to them were called for further discussion in the technical committee meetings. The technical committee meetings were held on November 28, 2013 and January 15, 2014. The technical committee evaluated these proposals keeping in view all relevant aspects of safety and efficacy particularly in terms of assessment of risk versus benefit to the patients, innovation vis-à-vis existing therapeutic option and unmet medical need in the country,” the minutes of the apex committee meeting said.

The recommendations by the technical committee were placed before the apex committee which after deliberations on the proposals also agreed to the recommendations, said the minutes

Source: PharmaBiz

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