Abstract:
Background: The current pharmaceutical industry in Sri Lanka heavily relies on imports. In
today’s rapidly changing economic environment, pharmaceutical manufacturing companies are
experiencing many challenges. Encouraging local pharmaceutical production is imperative to
supply medicines for affordable prices fulfilling market needs.
Objective: To explore the regulatory challenges that curtail the optimum production capacity of
local pharmaceutical manufacturers (LPM) in Sri Lanka
Methods: A comprehensive approach was employed targeting regulatory affairs managers from
all 19 local pharmaceutical companies listed on the National Medicines Regulatory Authority
(NMRA) website. Regulatory challenges faced by LPM were targeted. A quantitative-qualitative
mixed study was performed using a semi-structured questionnaire. Quantitative data were
subjected to descriptive statistical analysis and for qualitative data, the thematic analysis method
was employed.
Results: Six professionals provided data revealing notable insights. Significant themes identified
were pharmaceutical site approval delays, challenges in the product registration process,
evaluation timeframe for document response, and requirement for user-friendly policies. Under the
theme of site approval delays, subthemes were identified such as unavailability of a dedicated
division for LPM at NMRA, low system efficiency, and absence of thorough local good
manufacturing practices. Additionally, difficulties related to site visits, audits, and shortage of
evaluators were noted. Significant findings for product registration were stringent price controls
and limitations on the number of products registering to one particular generic, which have led to
monopolies within the industry. Many respondents mentioned the delay of the overall process of
product registration due to the inefficiency of NMRA. Moreover, participants expressed the need
for user-friendly government policies for LPM. Further, emerging interest of foreign investors in
establishing pharmaceutical manufacturing facilities in Sri Lanka was revealed. However, the
absence of formal education and procedures for foreign investors could be challenging for the
industry.
Conclusions: Pharmaceutical manufacturing companies face many challenges due to regulatory
complexities, and delays which could affect to optimum production capacity of local
pharmaceutical manufacturers. By addressing current issues, the growth of the local
pharmaceutical manufacturing industry can be foreseeable in the future.
