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

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."

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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.