The Health ministry is expanding its experts list, who are to be included in the expert panels and Subject Experts Committees (SECs) to advise on matters relating to approval of new drugs including biological, medical devices and clinical trials and other related issues for the Drugs Controller General of India (DCGI).
The evaluation will be made for the 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 from the opinion of ministry of health and family welfare or DCGI which requires expert advise. Further, the expert panels/SECs advise the DCGI for preparing guidelines for clinical trial industry in India evolving acceptance criteria for marketing approval of new drugs of different therapeutic categories, and building roadmap for research industry for appropriate development of new drugs relevant to Indian population.
The essentiality and desirability of new drugs in terms of assessment of risk versus benefit to the patient will be examined by SECs. The Central Drugs Standard Control Organization (CDSCO) has invited applications from experts and professionals for their inclusion in these expert panels/subject expert committees.
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