The National Medicines Regulatory Authority (NMRA) is exploring the possibility of having a consignment of 160,000 Filgrastim injections tested locally after the stock was rejected for arriving in Sri Lanka without the required printed labels.
The injections, imported for the treatment of cancer patients, arrived in Julu under a previously placed order. NMRA Chairman Dr. Ananda Wijewickrama said that the NMRA could not accept the consignment because the injections did not carry mandatory information, including the generic name, dosage, method of administration, batch number, expiry date and manufacturer.
The importing company subsequently sought permission to have the injections labelled locally. However, the NMRA said it could not approve the request without independently verifying the contents of the medicine.
The company has also requested laboratory testing of the stock to establish its quality. The NMRA said it is exploring options for such testing but noted that testing the product is complex and cannot be conducted by an ordinary laboratory.
The regulator said it was aware that suitable testing facilities were not available in India and had sought assistance from the World Health Organization to identify laboratories capable of conducting the tests.
The NMRA said administering inadequately labelled medicine could raise patient safety and accountability concerns. (Newswire)