December 16, 2024

In a significant move to support patients battling rare diseases, the Central Drugs Standard Control Organization (CDSCO), India’s apex drug regulatory body, has directed drug regulators across the country to fast-track the approval process for medications and medical devices aimed at treating rare conditions. The directive, issued by the Drug Controller General of India (DCGI) via a circular dated December 9, 2024, mandates that all such applications be processed within three months.

Focus on Rare Diseases

Rare diseases, as defined by the Ministry of Health and Family Welfare, are health conditions with low prevalence, affecting a relatively small percentage of the population compared to more common illnesses. These diseases often present unique challenges due to limited treatment options and a lack of widespread research.

The DCGI’s directive emphasizes the urgency of addressing this gap. Senior officials have been instructed to closely monitor both global and local clinical trials for rare diseases and to expedite the processing of relevant files.

Streamlined Approvals and Import Facilitation

The circular underlines the need to facilitate the import of rare disease medications in the best interest of patients. States and Union Territories have been urged to ensure the swift clearance of imports and the issuance of Registration Certificates (RCs).

Furthermore, the directive prioritizes government laboratory evaluation of samples for rare disease medications. These samples will be tested on an urgent basis to ensure timely availability for patients in need.

A Positive Step for Patients

This move is expected to significantly benefit families grappling with the burden of rare diseases. By expediting approvals and fostering a more efficient regulatory process, CDSCO aims to improve access to life-saving medications and medical devices, while aligning with the courts’ directives to prioritize rare disease treatments.

This landmark decision reinforces the government’s commitment to addressing the challenges faced by rare disease patients and ensuring equitable healthcare access.

For complete order please click DCGI-circular-dt-09-12-2024-Judgement-dated-04-10-2024-90-days-Timeline-for-the-approval-of-all-applications-for-rare-disease-drugs-and-Medical-Devices.