Terabytes of information attached by pharmaceutical companies to their applications to the National Medicines Regulatory Authority (NMRA) for registration and licensing of medication have “disappeared” from the Lanka Government Cloud (LGC), authoritative sources said.
“Pharmaceutical companies applied either for new registrations or renewals of expiring registrations via a digital system recently introduced by the NMRA,” a private sector source said, requesting anonymity. “Along with our applications, we submitted massive files of supporting documentation that ran in terabytes. We were told a few weeks ago that these have been erased from the cloud.”
“We are not sure what the status is now,” he continued. “Whose applications are being processed, whose are not. We anticipate a drugs shortage in a few months if this is not sorted out.” Official sources argued that registrations would be extended.
The Sunday Times confirmed with several sources that the data had been erased. However, it was not immediately clear how the mishap had occurred. NMRA officials are now refusing to accept digital applications citing the incident, sources also said, adding that the Criminal Investigation Department has been handed the case.
The NMRA digitisation project was implemented under the last administration in partnership with the Information and Communication Technology Agency (ICTA) of Sri Lanka. Epic Technology Group, a private sector company, was selected as the service provider after a tender process.
The system was based on Epic’s “DoxPro Enterprise Content Management Platform”, a press release said at the time. It “aims to lower the cost of operations and save thousands of labour hours spent annually on regulatory process, and thereby enable the NMRA to achieve regulatory excellence through its end-to-end Information as a service model”.
Requiring applications to be submitted electronically meant that the process by which the NMRA reviewed and granted approval for each “molecule” could be tracked online by the applicant. It also meant registration was given in order of submission. One of the objectives of digitising the system was to “stop money changing hands to expedite registration”, an industry source said.
Part of the contract was to design a backup for the information but it is not known whether this had been done. EPIC Executive Chairman Nayan Dehigama did not answer text messages or the telephone.
The LGC does not have a data service with backups, another technology source said. “Therefore, it is not impossible for such information to be erased,” he explained. “Each application must do its own backup. That’s what Epic Lanka should have done.”
Recently, several months of data gathered via a Hospital Management System introduced to the Police Hospital in Colombo were lost after “a developer made a mistake”, he continued.