Drug Regulator Tells States, UTs To Fast-Track Clearances, Boost Medicine Access For Patients With Rare Diseases
Fast-track clearances, waivers from clinical trials and faster access to drugs — the Union government has decided to prioritise arranging medicines and medical devices for patients in need via both global and local sourcing.
The country’s apex health regulatory authority, Central Drugs Standard Control Organisation (CDSCO), has directed drug regulators across India to approve all applications for medicines and medical devices for rare diseases within three months, in a move that will provide relief to patients suffering from a rare disease and their families.
The authority has instructed divisional heads to “monitor compliance”.
According to a letter sent by the head of CDSCO, Drug Controller General of India (DCGI) Rajeev Singh Raghuvanshi, “all state and Union Territories’ drug controllers are requested to monitor compliance with the directions regarding the timeline for the approval of all applications for rare disease drugs and devices which should be processed within 90 days from the date of receiving”.
In the letter, seen by News18, the top officers have been asked to “monitor and proactively keep a watch on global clinical trials and local clinical trials for rare diseases and to process such files expeditiously”.
According to World Health Organization (WHO) estimates, a rare disease is defined as one with an exceptionally low prevalence, affecting fewer than one in 1,000 people.
The health ministry estimated last year that India may have between eight crore and 19 crore individuals affected by rare diseases.
What triggered the move?
The move is in line with compliance with the directions issued by the Delhi High Court 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”.