Sri Lanka's National Medicines Regulatory Authority says it did not permit a disputed stock of cancer-support injections to be used because the medicines lacked required labelling, amid renewed questions over how the consignment was released through Customs.

The medicines are reported to be G-CSF/Filgrastim injections, which are used to stimulate white-blood-cell production, including in patients whose treatment has reduced their ability to produce sufficient infection-fighting cells.

A doctors' group has questioned how the consignment was released through Customs despite the labelling problem.

NMRA Chairman Dr Ananda Wijewickrama said the regulator had not permitted the stock to be used because the required labels were absent.

He also said the NMRA did not know the circumstances under which Customs had released the consignment.

Conflicting quantity figures

An important discrepancy remains unresolved.

Current reporting concerning the Customs controversy refers to around 190,000 injections, reportedly worth approximately Rs.250 million.

However, earlier reporting based on statements from the NMRA concerned a stock of 160,000 Filgrastim injections rejected because the required printed labels were absent.

The earlier NMRA account said mandatory information including the generic name, dosage, administration method, batch number, expiry date and manufacturer was missing.

The regulator was exploring whether the stock could undergo appropriate laboratory testing before any further decision was made.

It is not presently established from the available information whether the 190,000 figure and 160,000 figure describe precisely the same stock, different counting methods, or different consignments/components.

Sineth News therefore does not reconcile the figures without authoritative clarification.

Customs questions remain unresolved

The NMRA's statement establishes that the regulator did not approve use of the stock because of the labelling issue.

It does not by itself establish that the Customs release was unlawful or that the medicines were imported illegally.

Questions about:

  • who authorised the Customs release;
  • the legal basis for that release;
  • whether all reports concern exactly the same consignment; and
  • the final regulatory disposition of the medicines

remain unresolved in the information currently available.

Claims that the drugs were imported “without approval” should therefore remain clearly attributed rather than presented as an established fact.