Govt prescribes faster access to medicines for rare diseases
rare diseases to speed up their availability. India's drug regulator has asked the state drug regulators that a fast-track approval process be adopted, including post approval changes in the application while approving the sale of such drugs. The drug regulator has also asked state drug regulators to facilitate import of rare drugs in the interest of patients.
«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.
Entrepreneurship
Building Your Winning Startup Team: Key Strategies for Success
By — Dr. Anu Khanchandani, Startup Coach with more than 25
