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
