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‘Emergency’ drug imports: ‘NMRA Director Board empowered to import sans expert approval’

‘Emergency’ drug imports: ‘NMRA Director Board empowered to import sans expert approval’

20 Jul 2023

  • Health Secy. cites NMRA Act in response to snr. doc.'s claim that NMRA Director Board permits imports sans expert comms. approval
  • Dr. Ananda Wijewickrama alleges that Director Board Chair says that approval must be granted if Health Ministry has made decision

Following senior consultant physician Dr. Ananda Wijewickrama claiming that the importation of certain drugs is sometimes approved by the Director Board of the National Medicines Regulatory Authority (NMRA), even in the absence of such approval from the relevant expert committees, the Health Ministry said that there are provisions under the NMRA Act to import drugs without the approval of expert committees, in cases of emergencies.

Speaking during Ada Derana’s ‘Big Focus’ programme with regard to the importation of drugs, Dr. Wijewickrama made the claim that certain unregistered drugs are also being imported to the country.

When inquired as to who made these decisions, Dr. Wijewickrama stated that the said decisions are made by the Board of Directors of the NMRA, albeit in the absence of the approval of the expert committee, whose purpose is to grant the said ‘emergency’ approval of certain drugs.

“They import drugs that are being rejected by the expert committee. The Chairman of the Board of Directors claims that approval for these drugs needs to be given if the Health Ministry has made the decision,” he stated in this regard.

When contacted by The Daily Morning to inquire about the allegation, the Secretary to the Health Ministry, Janaka Sri Chandraguptha said that there are provisions under the NMRA Act for importing drugs without the approval of expert committees, in cases of emergencies. "The Board of Directors of the NMRA has the authority to grant permission for the importation of drugs that are not approved by expert committees, but they do so only after studying all the facts such as if the relevant drugs are registered in other countries, are there registrations with the relevant organisations such as the World Health Organisation, and are there any cases of patients suffering any complications due to the use of such drugs."



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