SLMA says must ensure Sinopharm used only if NMRA approves

The Sri Lanka Medical Association (SLMA) has written to Health Minister Pavithradevi Wanniarachchi urging her to ensure the approval of the National Medicinal Regulatory Authority (NMRA), prior to use of the Sinopharm vaccine on Sri Lankans.

The President Dr Padma Gunaratne and the Council of the Sri Lanka Medical Association (SLMA) noted the need to maintain the integrity and independence of the NMRA for a long term successful vaccination programme in Sri Lanka.

“The NMRA was established in 2015 through an Act of Parliament, and plays an essential role in protecting public health by ensuring medical products available in the country meet accepted standards of safety, quality and efficacy. In the context of COVID-19, the NMRA appointed an independent panel of experts to study all documents submitted in relation to candidate vaccines for COVID-19 and provide scientific advice for emergency use approval in Sri Lanka,” the SLMA said in the letter circulated to the media by the Health Ministry media unit.

The SLMA said that they have been made to understand the recently imported Sinopharm vaccine, to date, does not have the NMRA approval for use on Sri Lankan Nationals or the approval of the World Health Organization.

“We are aware that the NMRA appointed committee of independent panel of experts were of the opinion that the data provided so far are inadequate to arrive at a decision on the safety, efficacy and the immunogenicity of the Sinopharm vaccine,” the SLMA said.

The SLMA also said that they have been informed that attempts are being made to overturn that decision and register the said vaccine for emergency use.

“The fact that a large consignment of the questionable vaccine has already landed in the country does support this information. We believe that it is irregular for our health authorities to administer a vaccine not approved by the NMRA even to foreign nationals based in Sri Lanka,” the SLMA said.

The SLMA informed the Government of Sri Lanka the need to make decisions based only on scientific evidence for optimum control of the COVID 19 infection.

it added that assuring a background of freedom for decision making at the NMRA with no other outside influence would be of paramount importance in this regard. (Colombo Gazette)

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