- NMRA unaware of circumstances behind Customs release
- Chair says use not permitted due to missing labels
The National Medicines Regulatory Authority (NMRA) has come under scrutiny over the Customs release of a consignment of around 190,000 cancer drug injections reportedly worth Rs 250 million, despite the drugs allegedly lacking the required labels and subsequently not being approved for use.
The Medical and Civil Rights Professional Association of Doctors (MCPA) has called on the NMRA to explain how the consignment was released from Customs and who was responsible for clearing it.
The drug in question is a granulocyte colony-stimulating factor (G-CSF) injection, which is administered to cancer patients, including children, following radiotherapy to help accelerate the recovery of the immune system.
Speaking to The Daily Morning, MCPA President Dr Chamal Sanjeewa said the consignment had not been used since it was imported into Sri Lanka after it was found that the injections did not carry the required standard labelling.
“If this is a questionable or unfit drug, the NMRA must reveal to the country who took steps to release this consignment from Customs,” he said.
He said the NMRA is responsible for examining and approving relevant clearance reports, analytical reports and other documentation before medicines imported into Sri Lanka are released by Customs.
“A system has been established under which a medicine cannot be brought into Sri Lanka without the NMRA approving its registration certificate, quality certificates, certificates of analysis, import control certificates, price certificates, labels and packaging certificates. The NMRA and the State Pharmaceuticals Corporation, which imported this medicine, must take responsibility for the importation of this consignment,” he said.
Dr Sanjeewa alleged that responsible officials had so far failed to provide answers on the matter, leaving cancer patients facing uncertainty over the availability of medicines.
“Ministers responsible for the subject have remained silent on the issue. As a result, doctors working at hospitals treating cancer patients have been posting on social media about difficulties in continuing to provide cancer patients with their required medicines and prescribed doses,” he said.
When contacted by The Daily Morning, NMRA Chairperson Dr Ananda Wijewickrama said that the Authority was not aware of the circumstances under which the consignment had been released from Customs.
“We don't know about the release from Customs. Our responsibility is to test medicines for quality and take appropriate action based on the results. In the same way, we found that these drugs did not have labels. We don't know what is in them, so we did not permit their use,” he said.