DCGI Expedites Approval Process for Rare Disease Drugs in India
Key Insights
The DCGI (search) is fast-tracking approvals for rare disease drugs, aiming to improve patient access and comply with a Delhi High Court order.
State and Union Territory drug controllers are directed to adhere to a 90-day timeline for processing rare disease drug applications.
Clinical trial waivers will be considered for gene and cellular therapies, pandemic-related drugs, and those for special defense purposes.
The Drug Controller General of India (DCGI (search)) is accelerating the approval process for drugs targeting rare diseases (search), prioritizing patient access in response to a Delhi High Court order issued on October 4. This order clarified that the import of rare disease drugs should be facilitated in the interest of patients.
Implementation Directives
In a letter dated December 9, 2024, DCGI (search) Rajeev Singh Raghuvanshi urged all state and Union Territory drug controllers to ensure compliance with a 90-day timeline for the approval of rare disease drugs and devices. The directive emphasizes the expeditious disposal of registration certificate (RC) issuance and import processes for these critical medications.
"State drug controllers are requested to monitor compliance with the directions regarding the timeline for the approval of all applications for rare disease drugs which should be processed within 90 days from the date of receiving," the letter stated.
The DCGI (search) has also instructed divisional heads to proactively monitor global and local clinical trials for rare diseases (search), ensuring that these files are processed swiftly. This includes fast-tracking approvals for clinical trial applications, including post-approval changes such as increasing the number of subjects to facilitate early enrollment.
Clinical Trial Waivers and Special Provisions
To further expedite the availability of treatments, the DCGI (search) will consider clinical trial waivers for gene and cellular therapy products (search), new drugs used in pandemic situations, and new drugs intended for special defense purposes. These measures aim to reduce regulatory hurdles and accelerate the introduction of innovative therapies.
The regulatory body is also streamlining the import process for rare disease drugs to address urgent patient needs. This includes prioritizing the testing of rare disease drug samples at government laboratories and expediting the issuance of registration certificates.
Existing Regulatory Framework
The DCGI (search) reminded states and UTs that the New Drugs and Clinical Trials Rules, 2019, and Medical Device Rules, 2017, already include provisions under Chapter X for waiving local clinical trials for new drugs and medical devices, particularly those targeting rare diseases (search). The letter emphasized that these provisions should be actively considered to expedite approvals.