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  • DCGI Pushes Fast-Track...

DCGI Pushes Fast-Track Approval for Rare Disease Drugs, Prioritizes Patient Access

Farhat NasimWritten by Farhat Nasim Published On 2024-12-13T18:28:45+05:30  |  Updated On 13 Dec 2024 6:28 PM IST
DCGI Pushes Fast-Track Approval for Rare Disease Drugs, Prioritizes Patient Access
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New Delhi: The Drug Controller General of India (DCGI) has instructed state and Union Territory drug controllers to fast-track the approval process for rare disease drugs, ensuring all applications are processed within 90 days. The directive includes accommodating post-approval changes in applications and facilitating the import of these essential drugs to guarantee timely access for patients in need.

This comes in response to a Delhi High Court order on October 4. The order clarified that all import of rare drugs “may also be facilitated in the interest of patients". Also, as per the directions given by the court, the drug regulator has asked states and UTs for “the expeditious disposal" in issuance of registration certificate (RC) and import of rare disease drugs. Not only drugs, but the order also said that the sample of rare disease drugs should be tested with “priority" at government laboratories “in the interest of patients".

According to a recent media report in The Economic Times, a letter sent by Drug Controller General of India (DCGI), Rajeev Singh Raghuvanshi, on December 9, 2024, calls for all state and Union Territory drug controllers to monitor compliance with a 90-day timeline for approving rare disease drugs and devices.

"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 read.

The DCGI also instructed divisional heads to "monitor and proactively keep a watch on global clinical trials and local clinical trials for rare diseases and to process such files expeditiously."

It further directed states and UTs that whenever any clinical trial for rare diseases, whether global or local, comes to attention, or consideration, "a fast-track approval process shall be adopted in the approval process including any post approval changes in the application like the increase in number of subjects to facilitate early enrolment of subjects in the trial."

Also Read: Delhi HC asks Center to release Rs 10 crore to AIIMS for treatment of rare diseases

Clinical trial waiver will also be considered for gene and cellular therapy products, new drugs used in pandemic situations, and new drugs used for special defence purposes, reports ET.

The apex drug regulatory body has also made provisions for facilitating the import of rare disease drugs to meet the urgent needs of patients. Furthermore, the issuance of registration certificates for such drugs and their subsequent imports should be expedited.

"Samples of rare disease drugs should be tested with priority at government laboratories in the interest of patients," Rajeev Singh Raghuvanshi mentioned in the letter.

Furthermore, the central regulatory agency reminded states and UTs that under the New Drugs and Clinical Trials Rules, 2019, and Medical Device Rules, 2017, provisions already exist under Chapter X for considering a waiver of local clinical trials for the approval of new drugs and medical devices, including those intended for rare diseases. “This provision may be considered for rare diseases drugs and devices," the letter added.

fast track approvalrare disease drugscdscoclinical trials waiverstate drug regulatorsdelhi high court orderrare disease treatmentsrajiv singh raghuvanshidcgi lettermedical device rulesnew drugs and clinical trials rulesglobal clinical trialslocal clinical trialsdrug importsgovernment laboratoriesdrug approvalrare diseases drug
Source : with inputs
Farhat Nasim
Farhat Nasim

    Farhat Nasim joined Medical Dialogue an Editor for the Business Section in 2017. She Covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She is a graduate of St.Xavier’s College Ranchi. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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