The Union health ministry is expanding the list of experts included in the expert panels and Subject Experts Committees (SECs) to advise the Drugs Controller General of India (DCGI) in matters relating to approval of new drugs including biological, medical devices and clinical trials and other related issues.
Pulmonary, analgesic, anaesthetic, vaccine, hepatology, dentistry, neurology, psychiatric, pediatric, gynacology, oncology, hematology, cardiology, urology, nephrology, antiviral, antimicrobial, rheumatology, gastroenterology, radiodiagnosis, opthalmology, dermatology, endocrinology, pharmacology, bio-medical engineering, electronics/electrical engineering, biosta tistician, toxicology and orthopedic are the different panels which are used for drawing experts for evaluation of the applications of new drugs, medical devices, clinical trials. SECs are constituted by including experts from these panels.
The experts/SECs advise the DCGI in matters relating to in-depth evaluation of non-clinical data including pharmacological toxicological data, clinical trial data (Phase I, II, 111, and IV), etc. furnished by the applicant 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; and subsequent approval of biological products including vaccines & r-DNA derived products already approved in the country.
It will also evaluate 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 in 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 evolving acceptance criteria for marketing approval of new drugs of different therapeutic categories, and 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 SECs will examine 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.
The Central Drugs Standard Control Organization (CDSCO) has invited applications from experts and professionals for their inclusion in these expert panels/subject expert committees.