Global Drugs & Biologics Update

Asia/Pacific

CDSCO – Central Drugs Standard Control Organization

CDSCO soliciting feedback on regulatory system upgrade plan

The CDSCO is soliciting feedback on a Ministry of Health and Welfare plan to upgrade the country’s regulatory system at both national and state levels over the next three years. The goal of the upgrade is to “facilitate expeditious consideration and faster decision making and testing of medical products wherever required and serve the objective of the quality, safety and efficacy of drugs and other medical and cosmetics products.”

On both state and national levels, the plan calls for setting up new drug testing laboratories and upgrading those already running; creation of new lab and regulatory positions, with appropriate training for new hires; and strengthening enforcement mechanisms. The plan also proposes the establishment of a Training Academy and implementation of an e-Governance mechanism and networking of CDSCO and State Drugs Control Departments.

Comments on the proposed plan can be submitted until December 22, 2014.