The Drug Regulatory Authority of Pakistan has allowed the import and manufacturing of antiviral Remdesivir for severely ill COVID-19 patients, Radio Pakistan reported on Monday.
Registration letters were issued to two importers and 14 local manufacturers.
Remdesivir is an experimental antiviral drug that was invented as a potential treatment for Ebola. It has been approved for emergency use in Pakistan, according to the spokesperson of the Ministry of National Health Services.
DRAP’s registration board in its meeting held from June 8 to 11 had allowed the emergency use of Remdesivir.
The US Food and Drug Administration granted emergency use authorisation of the drug on May 1.
DRAP has only permitted health facilities treating COVID-19 patients to use the drug “in order to avoid the hoarding, profiteering and the distribution of Remdesivir through the black market, and its irrational use by healthcare professionals through private clinics.”
In an advisory for the use of Remdesivir, the regulatory body said unauthorised use by anyone other than designated public and private hospitals can be reported to the Quality Assurance and Lab Testing Division of DRAP and the provincial chief drug inspector.
Pharmaceutical companies and health facilities need to maintain a record of their Remdesivir inventory. Additionally, hospitals have to record patient information such as their biodata, disease severity and amount of Remdesivir administered to them.
The potential COVID-19 drug can only be used in children and adults if the following criteria are met: suspected or laboratory confirmed COVID-19, oxygen levels below 94% and requirement of supplemental oxygen, mechanical ventilation or extracorporeal membrane oxygenation.
Remdesivir should be given to hospitalised patients through an IV line by a healthcare provider under strict supervision of a qualified specialist, DRAP has instructed.
Serious side effects can be reported to the Pakistan National Pharmacovigilance Centre, through DRAP Med Vigilance e-reporting system: https://primaryreporting.whoumc.org/Reporting/Reporter?OrganizationID=PK, or via email to firstname.lastname@example.org.
DRAP has listed the following side effects: increased levels of liver enzymes due to inflammation in the liver and infusion-related reactions including low blood pressure, nausea, vomiting, sweating and shivering.