News
Revoke removal of nominee from NMRA – SLCP
The Sri Lanka College of Paediatricians (SLCP) has expressed their “greatest dismay” over the recent sacking (on April 1) of their nominee from the National Medicines Regulatory Authority (NMRA) by Health Minister Pavithra Wanniarachchi and sought a revocation of this order as well as an urgent meeting with the Minister.
In a letter sent to the Health Minister on Wednesday (April 7), the SLCP has stated that they selected their nominee, Dr. LakKumar Fernando, unanimously after careful discussion in the Council as he had suitable qualifications and credibility to represent them.
The SLCP pointed out that on February 24, they received a letter from the Secretary to the State Ministry of Production, Supply and Regulation of Pharmaceuticals, K.R. Uduwawala, requesting them to nominate three members to the NMRA Board.
“We are in the firm belief that this letter misled us to nominate two members in addition to Dr. LakKumar Fernando, although it was not according to the NMRA Act. However, two of these members declined participation and we clearly communicated that to the Secretary on March 12. The only remaining name was Dr. LakKumar Fernando, to represent the SLCP on the NMRA Board,” the SLCP said.
Terminating his service to the NMRA leads to the loss of SLCP representation there, they state, explaining that they should have a position in the NMRA as they represent the healthcare needs of children.
Requesting the revocation of the Minister’s decision to terminate the service of Dr. LakKumar Fernando, the SLCP urged immediate steps to reappoint him to the NMRA, while seeking a meeting with the Minister.
The letter signed by SLCP President Prof. Vasantha Devasiri has been copied to many including Production, Supply and Regulation of Pharmaceuticals State Minister Channa Jayasumana; Primary Health Services, Pandemics and COVID-19 Prevention State Minister Dr. Sudarshini Fernandopulle; Health Secretary Major-General Dr. Sanjeewa Munasinghe; and Director-General of Health Services, Dr. Asela Gunawardena.
Meanwhile, the ‘Students Involved in Rational Health Activities’ (SIRHA) of the Colombo Medical Faculty have raised issue with regard to the recent shake-up at the NMRA.
They state that during the past couple of weeks, there has been a turnover of posts in the Board of the NMRA, starting with Dr. Palitha Abeykoon (who is the current WHO special envoy on COVID-19 in South-East Asia), Prof. Asita de Silva (former Chairman) and eight others of the 13-member Board.
The SIRHA says: “We are reliably informed that the apparent reason for this turnover is to accelerate the procedure to get China’s Sinopharm vaccine approved through the NMRA. The new acting-Board has been favouring the Waiver of Registration (WOR) to the recently imported (donated) Sinopharm vaccine for emergency use in Sri Lanka, based on insufficient information. A proper phase III clinical trial has not been done with a larger, adequate sample. The WHO has also not approved the Sinopharm vaccine yet, probably due to lack of evidence-based information.”
Pointing out that the Association of Medical Specialists (AMS) and the Sri Lanka Medical Association (SLMA) have already expressed the “downside” of this issue, the SIRHA stresses that all vaccines that are being imported to Sri Lanka should undergo a proper secure procedure to get approved to be used here.
The NMRA is authorized to carry out that process with experts who are impartial and unbiased. In that process, sufficient evidence-based (research-based) information is analysed regarding the efficacy, potency and safety of all vaccines. The recommendations of this impartial board of experts are adhered to by the NMRA when registering a medicinal or cosmetic product. Similarly, this process should be adhered to with regard to the Sinopharm vaccine, the SIRHA adds.