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NMRA to go for foolproof digi system
View(s):The National Medicines Regulatory Authority (NMRA) has started discussions with service providers to introduce a foolproof digitalisation system for medicine and device registration after its last initiative collapsed in the mysterious loss of nearly two terabytes of data without backup.
The regulator is now looking at systems adopted by other regulatory authorities worldwide, especially a system that is operational in 16 countries, official sources said. The pharmaceutical industry has long pushed for a digital system in favour of increasing transparency, cutting corruption—typically, a solicitation to speed up files—and boosting efficiency. The NMRA has also decided to enlist an expert panel complete with cybersecurity professionals to oversee the process and to have a secondary backup hosted by another provider. The possibility of securing World Health Organisation (WHO) funding for the project is being explored.
The process is at its initial stage, the sources said. Meanwhile, the Criminal Investigation Department’s (CID) investigation into the disappearance of data as far back as mid-2021 is continuing without prosecution.
A software engineer from the relevant local IT firm spent a spell in remand prison over the disappearance of an estimated two terabytes of data, or 2,000 gigabytes, of classified information from the Lanka Government Cloud (LGC). These were registration applications that pharmaceutical companies had uploaded via the NMRA and contained sensitive information on drug formulations along with other supporting documents. They had not been backed up.
Meanwhile, the NMRA—which has stopped issuing waivers of registration (WoR) under a controversial “special pathway” introduced in 2022—has extended for six months a large number of expired licences for drugs and devices to clear a massive backlog, including essential medicines, at ports of entry. The regulator is also attempting to process outstanding applications within six months.
The issuance of WoRs is overseen by a committee that the previous NMRA board had rendered useless. Numbers are “minimal” but donations are still expedited through Customs outside the usual stringent drugs and devices registration process.
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