Current Regulatory Challenges for the Registration of Generic Medicines in Sri Lanka.

Abstract

Background: Generic medicines play a crucial role in ensuring the affordability of pharmaceuticals in the market. Nevertheless, stringent regulatory authorization is indispensable for upholding the quality of these generics. However, overly complex or inefficient regulations can lead to delays and increased costs in generic medicine registration, ultimately limiting patient access to affordable treatments in Sri Lanka. Objective: To determine the challenges encountered by regulatory pharmacists in generic medicine registration in Sri Lanka Methods: A qualitative study was conducted using an interviewer-administered structured questionnaire using a convenient sample of 20 regulatory managers employed at private pharmaceutical companies that manufacture/import generic medicines to Sri Lanka. A manual thematic analysis was used for the data analysis by generating initial codes, themes, and sub themes to write descriptions for the research objectives. Results: About 80% of pharmaceutical companies have been involved in generic medicine registration process for less than 20 years. Four main themes emerged: regulatory requirements for registering generic medicines, challenges faced by regulatory pharmacists, areas for improvement in the registration process, and opportunities for regulatory officers. The main challenges include poor interaction with the National Medicines Regulatory Authority (NMRA) and outdated guidelines (75%), registration restrictions and lengthy documentation (85%), and the need for better follow-up and communication with the NMRA (80%). Opportunities involve increased contact with regulatory authorities (90%) and direct exposure to the regulatory system (50%). These findings highlight the issues and potential improvements in the registration process for generic medicines in Sri Lanka. Conclusions: Regulatory pharmacists face daily challenges due to the complex and lengthy registration process. To improve efficiency, there is a pressing need to digitalize the registration process and refine the dossier submission and evaluation steps. Digitalizing the registration process for generic medicines could enhance access, speed, and transparency of services from the NMRA