The Central Drugs Standard Control Organization (CDSCO), which launched the process to expand the pool of independent medical experts under the advisory committees, has stressed on including only the experts 'with no conflict of interests' in the panels.
The move by the CDSCO comes in the wake of allegations that the experts in different panels were the same and had vested interests in pharma companies. The parliamentary standing committee on health also had raised the issue in its recent report that shook the Indian regulatory system.
Presently, 12 New Drug Advisory Committees (NDACs) and six Medical Advisory Committees (MACs) of various medical specialties are advising CDSCO in the process of regulatory approvals of new drugs, new medical devices and clinical trials.
“In order to bring more transparency, consistency and accountability in the approval process and to have wider representation of experts of various disciplines from across the country, CDSCO is in the process of expanding the pool of such experts in the areas of oncology, haematology, ophthalmology, immunology, cardiology, nephrology, gastroenterology, hepatology, gynaecology and obstetrics, pulmonology, neurology, psychiatry, urology, paediatrics, rheumatology, microbiology, pharmacology, medicine, anaesthesiology, vaccines, dermatology, radio diagnostics and dentistry,” a notice by the DCGI said.
The panels will advise DCGI in the matters related to regulatory approval of new drugs, global clinical trials, fixed dose combinations and medical devices. They will prepare guidelines for clinical research industry in evolving acceptance criteria for marketing approval of new drugs of different therapeutic categories. The panels will define roadmap for research industry for appropriate development of new drugs relevant to Indian population, the notice said.
“Interested experts having experience in the relevant fields working in government medical colleges/institutions and having no conflict of interest may please send their curriculum vitae and conflict of interest dully filled,” the noticed added.