DRAP streamlines availability of Covid-19 drug

Islamabad: The Drug Regulatory Authority of Pakistan (DRAP) has issued registration letters for import and local manufacturing of Remdesivir after fixation of its price by the Cabinet to enable emergency use of the drug. It has also authorized two importers and 14 local manufacturers to meet the demands of institutions and hospitals treating critically ill COVID-19 patients.

“Remdesivir was recently approved by US FDA for emergency/compassionate use. Soon after the regulatory authorities of US, Japan, UK and Europe authorized its compassionate use, DRAP started to issue NOCs for import of Remdesivir on need basis. Such approval is issued immediately. However, to ensure availability of Remdesivir injection in sufficient quantity, DRAP held an emergency Registration Board Meeting for grant of registration. After that, the Drug Pricing Committee meeting was convened to recommend maximum price to Cabinet for final approval as a statutory requirement under Drug Pricing Policy 2018,” a spokesman of DRAP communicated through a press release.

Registration letters have been issued to importers and local manufacturers, instructing them to make the drug available in sufficient quantities by a couple of weeks. The permission is granted on the conditions that Remdesivir injection will not be placed in the open market and would be given to institutions and hospitals only. Local manufacturers having registration of Remdesivir will strictly monitor the clinical usage of this emergency use drug and immediately report any unwanted effect to DRAP.

Remdesivir is a new antiviral medicine recommended for use in moderate to severe disease by Pakistan’s National Management Guidelines and has been shown to shorten the duration of illness. Its use is limited to seriously ill Covid-19 patients; physicians may opt for the use of this emergency drug after thorough evaluation of a patient’s condition and chances of survival.