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poor interaction with the National Medicines Regulatory Authority (NMRA) and outdated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
