Local Pharmaceutical Industry in Sri Lanka: Regulatory Challenges

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.