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NMRA to grant blanket renewal for registered drugs after data disappearance from Lanka Government Cloud
View(s):The National Medicines Regulatory Authority (NMRA) is likely to grant blanket renewal for registered drugs that were awaiting fresh licences following the “disappearance” of thousands of terabytes of classified pharmaceutical information from the Lanka Government Cloud (LGC), industry sources said.
At a meeting this week with NMRA, drugs companies were told this was being considered as an interim measure. There is no solution yet for applications to register new drugs. “At present, registrations have come to a grinding halt,” the sources said. “With regards to the new drugs, they will have to take a decision.”
The NMRA does not typically grant blanket registration to drugs. Each gets either a provisional two-year registration or a five-year full one. Applications for renewals and approvals must be lodged at least six months before the licences lapse. It was vital that the pending registration are activated, companies sources pointed out, or, “We would, by regulation, not be able to import these drugs.”
The information had been uploaded by pharmaceutical companies along with their applications for registration and licensing of medication. The case has been handed over to the Criminal Investigation Department. Epic Technology Group which secured the contract from NMRA to digitalise drugs registration has maintained that an employee deleted the data. The circumstances remain unclear.
However, it is evident now that there has been no backup. According to the agreement between NMRA and Epic Lanka, the company is contractually obligated to provide a data-backup.
Meanwhile, pharmaceutical companies have conveyed to their principals that the information has gone missing and, “It was quite a shock to them, as well.”