Pharmaceutical companies will be required to carry the National Medicines Regulatory Authority (NMRA) registration number alongside the bar or QR code of the respective drug manufacturer on each pack of medication to ensure authenticity after a series of recent scandals in the health sector, according to NMRA Chairman Dr. Ananda Wijewickrema.
The changes to the labelling requirements have been decided upon by the NMRA board. Accordingly, a sticker must be placed on each commercial pack with the words “NMRA approved” and the number of the NMRA registration certificate. The sticker is to be implemented for all consignments released to the market from August 1.
The product must also have a QR or bar code of the manufacturer to let consumers know the product name, generic name and strength, batch number, and dates of manufacture and expiry. These measures are being taken after shocking incidents of document falsification and the provision of counterfeit drugs to government hospitals.
The NMRA has also introduced waivers of registration (WoRs)—where drugs and devices are allowed into the country bypassing the usual registration process—with security features, again to prevent the type of forgeries that took place during the past two years.
WoRs will also now be issued through the Health Ministry’s “Swastha” digital database, which integrates, among others, the State Pharmaceutical Corporation, the Medical Supplies Division and the NMRA. The regulator will release the WoR after the Health Ministry initiates the process. The certificate will contain security features and also be available in six colours, one for every institution that is entitled to a copy.
These measures were announced this week by NMRA Chairman Dr. Wijewickrama at a BMICH event to commemorate the 9th anniversary of the regulatory body.
WoRs are now strictly vetted by a specialist committee, with the fast-tracked “special pathway” introduced under the previous NMRA dispensation being abolished. Laboratory renovation has also started, and vacancies have been advertised. The World Health Organisation (WHO) has committed to lab improvement, and there will be collaboration with labs in universities and other institutions.
The digitalisation process, which also ended in a scandal in 2021 with the erasure of the new NMRA database, is also restarting. The WHO has called for applications from consultants in this regard. There are moves to increase post-market surveillance or the monitoring of the safety of drugs and devices after they are released to the market.
(sundaytimes.lk)
(Except for the headline, this story, originally published by sundaytimes.lk has not been edited by SLM staff)
