What happened to the NMRAs Data Cloud ?

COLOMBO (News 1st); The data cloud of the National Medicines Regulatory Authority continues to malfunction.

Print media revealed on Sunday (22) that the process of renewing the registration of medical drugs and equipment has been severely affected.

Chairman of the National Medicines Regulatory Authority Dr. Rasitha Wijewantha said that steps have been taken to ensure that there is no shortage of medicine and equipment need to face the COVID-19 pandemic.

In 2018 the National Medicines Regulatory Authority began accepting online applications for registration of drugs and renewal of registration for the same.

Accordingly, the data of the NMRA were stored on the government cloud operated by Sri Lanka Telecom under the supervision of the ICTA.

The NMRA choose to hand over the management of the data cloud to a private entity through a tender process carried out by the ICTA.

With the COVID-19 outbreak in the country this date cloud was used extensively and according to a notice published on the 15th of October last year the renewal of registrations of all medical drugs and medical equipment was only done online.

Dr. Rasitha Wijewantha said the automated data system of the NMRA got deactivated on the 9th of July.

"All activities on this data system has stalled since then. I have lodged a complaint with the Criminal Investigations Department on this matter as well," he told News 1st.

"I have been informed that they had obtained a court order and are conducting investigations into the matter together with the Moratuwa University," he further added.

The Sunday Times reported that the National Medicines Regulatory Authority (NMRA) is likely to grant blanket renewal for registered drugs that were awaiting fresh licenses.

The report goes on to add that at a meeting this week with NMRA, drugs companies were told this was being considered as an interim measure.

The report goes on to note that there is no solution yet for applications to register new drugs.

Quoting Sources the Sunday Times point out that "At present, registrations have come to a grinding halt, and they will have to take a decision, with regards to the new drugs"

The NMRA does not usually grant blanket registration to drugs.

Drugs are registered provisionally for a period of 2 years or given a full registration valid for 5 years.

Applications for renewals and approvals must be lodged at least six months before the licenses lapse.

During this 6 month period the NMRA can activate a license of a drug that is on the list of drugs pending registration.

The Sunday Times quoting company sources pointed out that It was vital that the pending registration are activated, or companies would, by regulation, not be able to import those drugs.

According to the report all data on the application approved for registration and applications submitted for renewal of registration were stored on the Lanka government cloud.

The report added that the data of the NMRA on the government cloud had been erased by an employee of the private company that stored the data on behalf of the NMRA.

News 1st inquired into the progress of the investigations from the Criminal Investigations Department.

The CID said that no statements have been recorded, and that a technical investigation into the incident is being conducted together with the University of Moratuwa.

How did sensitive information stored on the country's National Data cloud disappear?

More importantly, did the companies involved not have any responsibility to maintain a backup of these highly sensitive information?

Should we allow such an important and sensitive operation to be completely destroyed as a result of being handed over to companies that do not even fulfil the minimum requirements needed to qualify to provide these services?