The ongoing staff shortages affecting the registration and licensing of pharmaceuticals are being addressed, with plans for resolution in 2025, according to Medical Supplies Division (MSD) Deputy Director General Dr. Garusinghe Wijesuriya.

Discussions have been held with the Finance Ministry’s Department of Management Services and the Department of Treasury Operations, leading to an agreement on approving new cadre and recruiting personnel to fill vacant positions at the MSD. 

Dr. Wijesuriya noted that the shortage of staff spanned various categories, with an estimated 40-60 vacant positions at the MSD level.

Meanwhile, State Pharmaceuticals Corporation (SPC) General Manager Dinusha Dasanayake revealed that the SPC was also operating below its required staff capacity.

The Annual Report for 2023 by the National Audit Office (NAO) has highlighted the issue, revealing that over 1,500 registration files have been left incomplete by the end of December. 

The report has also pointed out that procedures designed to extend medicine registration and grant batch release approvals are in contradiction to the regulations outlined in the National Medicines Regulatory Authority (NMRA) Act.

Additionally, the required evaluations regarding the quality, safety, and efficacy of medicines have not been conducted as mandated.

This backlog has been attributed to multiple factors, including staff shortages and delays caused by the Covid-19 pandemic. 

However, NMRA Chief Executive Officer Dr. Saveen Semage reassured that only minimal issues remained regarding the registration of medicines. 

He confirmed that the NMRA was holding ongoing discussions with local manufacturers to ensure smooth registration processes.

As per Section 3(a) of the NMRA Act No.5 of 2015, it is mandatory for the authority to ensure the quality, safety, and efficacy of medicines provided to the public. 

All medicines must be registered with the NMRA before being imported, produced, distributed, or sold in Sri Lanka.