The DCGI instructs state and Union Territory drug controllers to expedite the approval process for drugs treating rare diseases: It ensures that all the applications that have been raised, either for clinical trial or importing purposes, have to go through the same process by completion within 90 days, focused on patient access as well as the need of treatment for the patient.

Main Points

Quick Approval Rules:
The DCGI asked state and UT drug controllers to dispose of applications for rare disease drugs in 90 days.
This directive also includes expedited approval for post-approval changes and import permissions.

High Court Order Sparks Action:
It was on 4 October when a Delhi High Court made an order regarding the ease of making drugs available and importing those for the patients suffering from rare diseases.
Registration certificates or RCs were to be issued in time and testing of rare disease drugs in government laboratories was emphasized on first priority.

Clinical Trial Rules:
Divisional heads are told to watch global and local clinical trials for rare diseases and make sure they are approved quickly.

Clinical trial waivers will be reviewed for:

• Gene and cell therapy products

• Drugs used in pandemic situations

• Medications for specific defense needs

Check out Rare Disease Imports:
The DCGI has made regulations to speed up rare disease drugs for patients who need them. Regulatory authorities are directed to focus on issuance of registration certificates and testing samples for drugs treating rare diseases.

Current Rules for Waivers:
Rules are already there under New Drugs and Clinical Trials Rules, 2019, and Medical Device Rules, 2017, that enable the drugs and devices intended for rare diseases to skip the clinical trials at local levels. These rules will be used to accelerate approvals more. Monitoring and State and UT drug controllers have the task of ensuring that these new timelines are followed as well as making sure drug applications for rare diseases move swiftly.
This move by the DCGI, in streamlining the process for approval of rare disease drugs, is the proactive way to address the patient's needs. By streamlining approvals and allowing imports, it is ensuring that life-saving treatments for rare diseases are made accessible to the people.