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To prevent use sans NMRA approval: Rights group files FR in SC on Sinopharm  

11 Apr 2021

  • Govt., NMRA maintain no approval yet for use on locals 

  • UK has made request for vaccination of their nationals 

  The People's Movement for the Rights of Patients (PMRP) organisation filed a fundamental rights (FR) petition in Supreme Court on Friday (9), seeking an order preventing the use of the Sinopharm Chinese Covid-19 vaccine until it receives the approval of the National Medicines Regulatory Authority (NMRA).   However, the State Minister of Primary Healthcare, Epidemics, and Covid Disease Control Dr. Sudarshini Fernandopulle maintained that the NMRA has not yet approved the vaccine to be administered to Sri Lankans.   When queried about the petition, Dr. Fernandopulle said: “I saw the news reports. However, the NMRA has not yet given permission for the vaccine. The NMRA only gives approval following a thorough review.”   Meanwhile, NMRA Chief Executive Officer (CEO) Dr. Kamal Jayasinghe also said that approval has not yet been given to the vaccine to be administered to Sri Lankans.   “We don't use Sinopharm. They are not being administered under our purview. At the moment, only Chinese nationals in Sri Lanka are being vaccinated with Sinopharm in Sri Lanka through the Embassy,” he said.   Explaining on approving the acceptance of the consignment of 600,000 Sinopharm vaccines from China, Dr. Jayasinghe said that it was approved under Section 109 of the NMRA Act. “Under this Section, the NMRA has approved the acceptance of the donation and to clear it for the use of Chinese nationals in Sri Lanka based on a request made by the Chinese Embassy, since it’s a vaccine that is being administered to them in their country. We can approve it on humanitarian grounds. This is not the only such request. The UK has made a request. They make these requests with responsibility. Therefore, we have to approve them,” he said.   Meanwhile, Dr. Jayasinghe said that all vaccines and medicines are only approved after following the due procedures.   “We have not yet approved Sinopharm for the use of Sri Lankans. As we have done before, and as always, approval will only be given following a review of the vaccine. Not only Covid-19 vaccines, any medicine will be approved only after a thorough review. There is a procedure to be followed with regard to any medicine, and that's how it is being done,” he said.   When queried about allegations of favouritism in approving vaccines, Dr. Jayasinghe said: “If we did any favours, it would lead to many issues. After all, the vaccines would be administered to us at the end of the day. People with certain issues come up with various statements.”   The petition, filed by Attorney-at-Law Gowri Thavarasa on behalf of the PMRP, has named 24 persons including Health Minister Pavithra Wanniarachchi; State Minister of Production, Supply, and Regulation of Pharmaceuticals Prof. Channa Jayasumana; and officials attached to the NMRA as respondents.   The petitioners have urged the court to direct the respondents to submit the details of the expert committee appointed prior to the purported removals of members of the NMRA, to study the safety and efficacy of the Sinopharm vaccine.   They also urged the court to direct the respondents to submit details of the information sought from the manufacturer by the said expert committee appointed to study the vaccine.   


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