What are rare diseases?

Rare diseases are conditions that affect a small number of people.

Why is it important to expedite the approval of rare disease drugs and Medical Devices?

Rare disease patients often face significant challenges in accessing timely and effective treatments. Expediting the approval process can significantly improve patient outcomes.

How will this directive impact patients with rare diseases?

This directive will lead to faster access to life-saving treatments, improving the quality of life for patients with rare diseases.

CDSCO directs expedited Approval of Rare Disease Drugs and Medical Devices

CDSCO divisions are instructed to prioritize and expedite the approval process for both global and local clinical trials for rare diseases.

The Health Master

December 10, 2024

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Last Updated on December 16, 2024 by The Health Master

CDSCO

In a significant move to accelerate access to life-saving treatments, the Central Drugs Standard Control Organization (CDSCO) has issued a directive vide DCGI circular dated 09-12-2024, to expedite the approval process for rare disease drugs and Medical Devices.

Download DCGI circular dated 09-12-2024

This decision is in compliance with a recent judgment by the Delhi High Court and aims to address the urgent needs of patients suffering from rare diseases.

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Key Directives

Timely Approvals for Rare Disease Drugs and Medical Devices (Class A & B):

State and UT Drug Controllers are mandated to process all applications for rare disease drugs and medical devices (Class A & B) within a strict 90-day timeframe from the date of receipt.

Expedited Approvals for Rare Disease Drugs and Medical Devices (Class C & D):

Divisional heads at CDSCO are directed to process applications for rare disease drugs and Medical Devices (Class C & D) within 90 days.

Download classification of Medical Devices

Fast-Track Approval for Clinical Trials:

CDSCO divisions are instructed to prioritize and expedite the approval process for both global and local clinical trials for rare diseases.

This includes post-approval changes like increasing the number of subjects to facilitate early patient enrollment.

Facilitated Import of Rare Drugs:

Import procedures for rare drugs will be streamlined to ensure timely access for patients.

Prioritized Testing of Rare Disease Drugs:

Government laboratories will prioritize testing samples of rare disease drugs to expedite the issuance of Registration Certificates (RCs) and import permits.

Consideration of Waiver for Local Clinical Trials:

CDSCO may consider waiving the requirement for local clinical trials for rare disease drugs and Medical Devices, leveraging existing provisions in the New Drugs and Clinical Trials Rules, 2019, and Medical Device Rules, 2017.

By implementing these measures, CDSCO aims to significantly improve the lives of patients with rare diseases by ensuring timely access to innovative therapies.

Also read following FAQs

What are rare diseases?

Rare diseases are conditions that affect a small number of people.
Why is it important to expedite the approval of rare disease drugs and Medical Devices?

Rare disease patients often face significant challenges in accessing timely and effective treatments. Expediting the approval process can significantly improve patient outcomes.
How will this directive impact patients with rare diseases?

This directive will lead to faster access to life-saving treatments, improving the quality of life for patients with rare diseases.

Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.

Disclaimer: This content, provides generic information only. It is in no way a substitute for a qualified medical opinion. Always consult a specialist or your own doctor for more information. The Health Master does not claim responsibility for this information.

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