Challenges for the Importation of Biopharmaceutical Products in Sri Lanka.

Abstract

Biopharmaceuticals, which are derived from biological sources such as humans, animals, or microorganisms, include sugars, proteins, nucleic acids, and living cells or tissues. These products are highly specific and target only certain molecules in the body, making side effects less frequent compared to conventional synthetic drugs. Biopharmaceuticals are seen as breakthrough solutions for serious health issues and represent the future of the pharmaceutical industry. However, Sri Lanka is still in the early stages of adopting biopharmaceuticals, relying solely on imports. In fact, 45% of pharmaceutical imports include biopharmaceuticals in Sri Lanka. The aim of this study was to explore the background of the pharmaceutical companies importing biopharmaceutical products in Sri Lanka and to examine the regulatory challenges they face. A mixed-method survey was conducted using an interviewer-administered questionnaire with mostly open-ended questions. Eight of the 25 market authorization holders participated in the study. Quantitative data were analyzed using SPSS, and qualitative data underwent manual thematic analysis. The findings revealed that most (62.5%) companies were sole proprietorships, and half had been operating for over 10 years. Half of the companies also reported annual revenues exceeding 10 billion LKR, though 87.5% of importers had no subsidiaries beyond one location. Two main categories of challenges were identified. First, regulatory issues specific to the National Medicines Regulatory Authority included outdated and poorly implemented policies, lack of transparency, lengthy dossier evaluation times, high evaluation fees compared to general products, inefficiency, inexperienced assessors, and even dossier misplacement during external evaluations. Secondly, company-specific challenges, that are involved with inadequate infrastructure for cold chain maintenance and difficulties in product recalls.