The Union health ministry has approved 25 panels of experts of various therapeutic areas for evaluation of various categories of applications of clinical trials, new drugs and new medical devices. Subject Expert Committees (SECs), comprising eight medical experts (one pharmacologist and 7 medical specialists) have to be constituted drawing the names of the experts from the respective panels approved by the ministry. In case any of the experts fail to attend the SEC meeting, another from the same panel will be invited to attend the meeting.
These SECs will advise the DCGI for the in-depth evaluation of non-clinical data including pharmacological toxicological data, clinical trial data (phase I, II, III, and IV) etc. furnished by the applicants for approval of new drug substance of chemical and biological origin and new medical device to be introduced for the first time in the country including vaccines & r-DNA derived products; Subsequent approval of biological products including vaccines & r-DNA derived products already approved in the country; Global clinical trials; Fixed dose combinations of two or more drugs to be introduced for the first time in the country; and Causality analysis, safety of drugs or any other technical matter in the opinion of ministry of health and family welfare or DCGI which requires expert advice.
The SECs will advise the DCGI for the preparation of guidelines for clinical research industry in evolving criteria for acceptance for marketing approval of new drugs of different therapeutic categories; and for defining roadmap for research industry for appropriate development of new drugs relevant to Indian population. While considering approval of new drugs and clinical trial of NCEs/GCTs, the committees will examine the essentiality and desirability of new drugs in terms of Assessment of risk versus benefit to the patient; Innovation vis-a-vis existing therapeutic option; and Unmet medical need in India.
Applications for new drugs and global clinical trials shall be evaluated by the experts through meetings or through video conferencing.
The members of the committee shall hold office for a period of three years but shall be eligible for re-nomination provided that the persons nominated continue to hold their offices in their respective organisation by virtue of which they are nominated. In case any expert from the panel retires from his institute/organisation, subject expert from the same institute/organisation may be included in the panel.
The members of these committees shall give their expert comments in writing after evaluating the proposal within a period of 6 weeks from the receipt of such proposal even if they fail to attend the meeting. The committee shall evaluate the proposals of new drugs and clinical trials keeping in view the requirements as prescribed in the regulatory framework. The expert committees will review the proposal and give their recommendations in a composite manner as far as practical.