Drug regulator to set up task force to simplify norms

The Central Drugs Standard Control Organisation (CDSCO) is looking to change its procedures for various activities, including the process of granting licences. The drug regulator has decided to constitute a task force to propose changes in the structure.

According to an order, existing processes, procedures, forms and licences will be reviewed with the aim to “simplify and make them user-friendly, as also shorten them.”

The task force, which will have several former members of the Food and Drug Administration, a deputy drugs controller of CDSCO and representatives of industry associations, would be required to submit its recommendations within two months. Industry associations are waiting for more clarity on the task force by the Government, according to sources.

‘More clarity’

A member of an industry association said, “This has been a long-pending demand from the industry. The licensing regime is too time-consuming and convoluted. While change is needed, we also need more clarity on the task force’s purpose. Further, the time given for submitting recommendations, is too short.” According to the order, “The recommendations in respect of first five forms will be submitted to the Drugs Controller General of India within 15 days and next forms within the next 15 days.” Business Line