ri Lanka, a deceptively small country of 22 million people, has an impressive record of health indicators complemented by a high literacy rate. However, its pharmaceutical sector had been lagging behind.

The country has about 15 drug manufacturers including one multinational company. About 90% of its medicines are imported, mainly from India. University education in pharmacy was established only in the early 1990’s, and the annual output of pharmacy graduates is currently around 140.

Since gaining independence from the British in 1948, Sri Lanka has implemented important periodic changes in drug policies. In 1958, selection of drugs for the government sector based on an essential drug concept was initiated. From 1971 to 1977, as a closed economy, the State became the sole importer of medicines. When the economy was liberalized in 1977, numerous pharmaceutical products began to flood the market. The government realized the need for regulations, which resulted in the enactment of the Cosmetics Devices and Drugs Act of 1980. The head of the Department of Health was designated as the Authority. Yet, there was no marketing authorization procedure for medicines until 1984.

In 2015, the National Medicines Regulatory Authority (NMRA) was established through an Act of Parliament. The NMRA is a semi-autonomous institution governed by a Board. The Chief Executive Officer is the institutional head and the licensing authority. The Act has mandated the NMRA with regulatory oversight over functions related to medicines, medical devices, borderline products, and conducting clinical trials.

Regulation of Pharmaceutical Products

The Act proposed several Divisions, with the Medicine Regulatory Division responsible for regulation and control of medicines licensing. The criteria for selection are quality, safety, efficacy, need, and cost-effectiveness. The Medicines Evaluation Committee (MEC), which consists of experts in medical and pharmaceutical disciplines, advises the NMRA on matters pertaining to medicines. In particular, the MEC gets involved in deciding the need when an application is made for a new molecule.

If a foreign manufacturer intends to apply for marketing authorizations, they must first appoint a local entity as their authorized agent. The NMRA will review the site master file and will conduct a risk-based GMP inspection of the facility, if necessary, according to WHO GMP guidelines.

NMRA currently uses its own application format for marketing authorization. But with new regulations currently being drafted, NMRA intends to move to the CTD (Common Technical Document) format. Sri Lanka does not entertain applications for first time drugs. New molecules must be approved by a “reference” authority first, and have a minimum of two years post-marketing experience. This requirement can be waived for medicines of national importance (e.g., dengue vaccine). NMRA currently considers the following authorities as “reference” authorities for new molecules: US FDA; Health Canada; EMA; MHRA, United Kingdom; MPA, Sweden; CBG-MEB, The Netherlands; TGA, Australia; and Medsafe, New Zealand.

Clinical and non-clinical data are required for new molecules and biologicals; the review process involves expert evaluation. Usually, these are summary reports since a stringent reference Authority has already vetted the full data. For similar biotherapeutics, or biosimilars, head-to-head comparison of trial data with the innovator is required to establish biosimilarity. For generics, quality data are sufficient. Bioequivalence data are currently required for oral antibiotics, sustained release products, and for medicines with a narrow therapeutic index.

Product registration can be provisional (valid for one or two years) or full (five years). Approved products are categorized into Schedules, such as general sales (Schedule I), OTC (IIA), prescription only (IIB), or narcotics (III).

Local manufacturers, warehouses, and pharmacies are inspected and licensed. Pharmacovigilance and post-marketing surveillance are areas that need further strengthening.

The previous Act did not provide for price regulation. At present, prices are declared with applications, and NMRA may negotiate the intended retail price. The NMRA recently imposed price controls based on a maximum retail price model of 48 essential medicines, intraocular lenses, and cardiac stents. This has significantly benefited patients in Sri Lanka.

Drug Development Activities

New drug discovery and development activities happen at two opposite ends of a continuum, but none go through the full length of the development cycle in Sri Lanka. There is a particular interest in phytochemicals, as the country has a rich biodiversity in flora and a traditional system of herbal medicines. Potential chemicals are identified, structures elucidated, and some non-clinical studies are conducted. The Departments of Chemistry and Molecular Biology of the University of Colombo have taken the lead role in these activities.

At the other end, developed molecules are evaluated for safety and efficacy through collaborative clinical trials. Data generated are used by sponsors to support new drug applications submitted to stringent reference authorities. The NMRA regulates trials on new molecules and on products for unlicensed indications, which include local investigator-initiated studies for new indications and new dosage regimens of existing molecules. Approval from a recognized Ethics Review committee is mandatory for these studies. At present, applications for first-in-human trials are not entertained. International, multicenter phase 2 studies require approval by a reference authority. All trials must be prospectively registered in the Sri Lanka Clinical Trials Registry.