CDSCO apex committee streamlines drug approval process post clinical trial

New Delhi: In a move to oversee clinical trials on new chemical entities, the Central Drug Standard Control Organisation’s (CDSCO) apex committee has recommended norms to be observed to establish the predictability for conduct of clinical trials.

The matter was discussed in a meeting held earlier this month under the chairmanship of CK Mishra, Secretary Department of Health and Family Welfare, Ministry of Health and Family Welfare & Chairman, Apex Committee. The committee deliberated upon various agenda items and recommendations were given thereafter.

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Looking into the agenda to establish the predictability for conduct of clinical trials, the committee came up with a set of rules to channelise the procedure.

“The committee was apprised that the system of examination of proposals in CDSCO has since reached a maturity and, therefore, it will be appropriate that the approval processes should be streamlined,” quotes the committee report.

Subsequently, it was decided that:

• the proposals relating to GCT should be placed before the SEC and where these are accepted/rejected by the SEC, no further approval of the Technical Committee or Apex Committee will be required;


• in cases, where DCGI is not in agreement with the recommendations of SECs in case of clinical trial application, the matter may be placed before the Technical Committee for a final decision within a month of the recommendations of the SEC;


• the cases rejected by the SEC shall, in case the applicant feels aggrieved, be placed before the Technical Committee for its consideration. Where the Technical Committee decides, for reasons to be re-coded in writing, to overrule the SEC, the decision of the Technical Committee shall be final;


• IND Clinical trial applications shall be placed before the IND Committee and the decision taken by the IND Committee shall be final. DGHS or Spl DGHS may be invited to the meetings of IND Committee. In rare cases, where the IND Committee, considers it necessary to keep the Apex Committee informed, the matter may be placed before the Apex Committee for guidance; and


• a brief summary of the applications received, proposals pending, proposals rejected, clarifications sought, and approved at different levels shall be submitted for perusal of the Apex Committee every month. CDSCO will, in consultation with C-DAC, examine whether the report can be generated through SUGAM.

The meeting was attended by Dr Soumya Swaminathan, Secretary, DHR & DG ICMR; Dr Jagdish Prasad DGHS; K L Sharma, Joint Secretary Department of Health and Family Welfare and other special invitees.

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