President Bidya Devi Bhandari has issued an ordinance to amend the Drugs Act (1978) for the third time to facilitate the use of emergency medicine and vaccines that have been tested and approved in other countries.
The Ministry of Health and Population (MoHP) on Thursday had proposed a draft of the ordinance to the Cabinet in advance to cover legal issues related to a potential vaccine roll-out and to avoid legal complications (such as the ones faced during the roll-out of antiviral medicine remdesivir).
The Department of Drug Administration in September authorised the import and usage of remdesivir for treatment of Covid-19 patients as a study drug only after much pressure to do so from frontline doctors treating infected patients.
“The Government of Nepal may allow the organization or company developing the vaccine in clinical trials as per the permission of the government of any foreign country or the concerned regulatory body to conduct clinical trial of such vaccine in Nepal,” the ordinance reads.
Director General of the Department of Drug Management, Bharat Bhattarai said, “Clinical trial means testing any medicine or vaccine with the consent of a patient or other person to determine whether it is an appropriate cure or not.”
The ordinance also has provision to stop the use of any drug or vaccine if any dire effect is seen. In addition, the drugs banned by World Health Organization (WHO) and other countries will be banned for use in Nepal as well.
The Ministry hasn’t yet decided the company that will supply the vaccines, some of which are either in their third phase of trial and a few that have completed all trials.