The Central Drugs Standard Control Organisation (CDSCO) will give the first priority to giving approval of new drugs having direct impact on public health and of special relevance to Indian health scenario, according to Drugs Controller General of India (DCGI) Dr G N Singh.
Dr Singh has prepared a priority chart to address the regulatory issues requiring greater attention in a time-frame manner for safeguarding and enhancing the public health by assuring safety efficacy and quality of drugs, cosmetics and medical devices. The approval of new drugs has been placed at the top of the functioning chart.
Monitoring the quality of drugs marketed in the country in coordination with the State drug control authorities will be the next on the priority list. “Examination of safety issues of marketed drug reported in the country or outside the country or through pharmacovigilance programme for taking decision on prohibition/ restriction on use of such drugs,” will be the other top task.
Registration of ethics committees, monitoring of clinical trials in the country, examination of reports of serious adverse events occurring during the clinical trials and protecting rights, safety and well-being of the participant subjects in the clinical trials are the other important responsibilities to be carried out on priority basis, according to a notice by the DCGI.
In another order, the DCGI also constituted an 'international cell' in the CDSCO headquarters with immediate effect to handle the works relating to international treaties, cooperation and other such matters. Dr S Eswara Reddy (DDC), Dr I S Hura (ADC) and Siddharth Sahai Malhotra will be the members of the cell.