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Govt accepts Ranjit Roy panel report on approval of new drugs, clinical trials & banning of drugs

Ramesh Shankar, Mumbai
Friday, November 8, 2013, 08:00 Hrs  [IST]

The Union health ministry has accepted the recommendations of the Prof. Ranjit Roy Chaudhury expert committee which had recently submitted its report to the ministry.  The committee was constituted by the ministry in February this year to formulate policy and guidelines for approval of new drugs, clinical trials and banning of drugs.

According to senior officials in the ministry, the recommendations of the expert committee were discussed in a meeting with its members recently. During the meeting, clarifications on certain recommendations were obtained from the committee.   After the meeting, the ministry in-principle accepted the recommendations of the committee.

Accepting the recommendations of the expert panel for accreditation of ethics committees, investigators and the clinical trial sites, the ministry decided that in order to strengthen the clinical evaluation of new drugs, the clinical trials should be conducted in accredited sites by accredited investigators with the oversight of accredited ethics committees (Ecs). As this is a long term measure, in the meantime, Quality Council of India (QCI) will be considered for creating a system for accreditation of investigators, ethics committee and clinical trial sites. Although, the Drugs & Cosmetics Rules, 1945 already provide for registration of ethics committee, accreditation of such committees will be undertaken following a specific procedure.

As this requires amendments in the Drugs & Cosmetics Rules, as an immediate measure, CDSCO would initiate steps relating to the process of accreditation by constituting an expert body of 20-25 experts. The names of experts will be finalized by CDSCO in consultation with Dr. Ranjit Roy Chaudhury, Dr. Y. K. Gupta, Prof. & Head, Dept. of Pharmacology, AIIMS, New Delhi and Dr. Arun Aggarwal, Prof. of ENT, Maulana Azad Medical College, New Delhi, senior officials in the ministry said.

Accepting the recommendations of the committee on the procedure for review of applications of clinical trials and new drugs, officials said that the New Drug Advisory Committees (NDACs) will be renamed as Subject Expert Committees. The members for their meetings will be drawn randomly from a large pool of experts. Applications of clinical trials and new drugs will initially be evaluated by the Subject Expert Committees and their recommendations will be reviewed by the Technical Review Committee (TRC). The TRC will be constituted under DGHS and consisting of experts from each areas i.e. clinical pharmacology, regulatory clinical toxicology/ pathology, medicinal/ pharmaceutical chemistry, pharmacy and immunology including clinicians, basic scientists involved in drug development and subjects specialists (drug indication wise). CDSCO will grant approval of clinical trial and new drugs based on the recommendations of TRC.


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