The Union health ministry has formed 12 New Drug Advisory Committees (NDAC), comprising experts in the respective fields, to advise the Drugs Controller General of India (DCGI) in matters for review of applications of new drugs and clinical trials.
Each of the panels set up to advise in matters related to review and regulatory approval of clinical trials and new drugs, except for Investigational New Drugs (INDs), relating to different therapeutic areas, has ten members. The panels were formed on reproductive and urology, cardiovascular and renal, ophthalmology, vaccines, dermatology and allergy, anaesthetics and rheumatology, neurology and psychiatry, pulmonary, oncology and haematology, gastroenterology and hepatology, metabolism and endocrinology, and antimicrobial-antiparasitic-antifungal-antiviral areas.
“The committee will advise DCGI in matters to undertake in-depth evaluation of non-clinical data including pharmacological toxicological data, clinical trial data (phase I, II, III, and IV) furnished by the applicant for approval of new drug substances of chemical and biological origin to be introduced first time in the country including vaccines and r-DNA derived products,” according to an official note by the health ministry.
The panels will also evaluate data being submitted by the applicants on global clinical trials, fixed dose combinations of two or more drugs to be introduced for the first time in the country. It will help preparing guidelines for clinical research industry in evolving acceptance criteria for marketing approval of new drugs of different therapeutic categories. The panel will also define roadmap for research industry for appropriate development of new drugs relevant to Indian population.
“While considering cases of new drugs, the committee will examine essentiality and desirability of new drugs in terms of assessment of risk versus benefit to the patient, innovation vis-à-vis existing therapeutic option and unmet medical need in India,” the note said.
Application for new drugs and global clinical trials will be evaluated by the committee either through meetings or by circulation of the applications. The term of the committees is for three years. Office of the DCGI will initially examine the applications and if any data is lacking the same will be informed to the applicant within 45 working days or else the data will be forwarded to the members of the committee in the respective areas.