“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 date of receiving,” DCGI said in a letter dated December 9.
To make sure that drugs for rare diseases are available in India, he has asked all division 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 said.
“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,” the letter further said.
The drug regulator has also instructed that all imports of rare diseases drugs should also be facilitated in the interest of patients.
Similarly, it has also been directed that issuance of registration certificate and import of rare disease drugs be expedited. “Samples of rare disease drugs should be tested with priority at government laboratories in the interest of patients,” Rajeev Singh Raghuvanshi said in the letter.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. Earlier in August, the government had waived off the requirement of clinical investigation of those new drugs having significant therapeutic advance over the current standard care and has already got approval in the USA, UK, Japan, Australia, Canada and the EU.
