• Chair says situ. not unique to SL or to med. imports from a particular country, majority meds used in US and UK sourced from India with 150 quality failures of Indian drugs reported in US in 2024   
• Notes that in most cases, post-mkt. testing is done following complaints/neg. drug reactions
• NMQAL testing increased to some extent following new recruitments

The National Medicines Regulatory Authority (NMRA) stated that incidents involving substandard medicines are reported across many countries and are not unique to Sri Lanka or to medicines imported from a particular country.

Speaking to The Daily Morning, the NMRA Chairperson, Dr. Ananda Wijewickrama said that Sri Lanka follows a structured regulatory process before granting market authorisation for medicines. "Laboratory test reports are obtained for imported drugs, and inspections of manufacturing plants are carried out when required. That is how registrations are granted. Even after registration, medicines are tested from time to time once they are imported,” he said.

He explained that post-market testing is, in most cases, driven by complaints and reported adverse reactions. "In recent years, testing capacity was limited due to staff shortages at the National Medicines Quality Assurance Laboratory (NMQAL). Because of the shortage of Laboratory staff, only a limited number of tests could be conducted. In the past few months, we have recruited new staff, and testing has increased to some extent,” he said.

Speaking further, Dr. Wijewickrama said that Sri Lanka relies heavily on imports, with around 80 per cent of medicines brought in from India. He noted this is not unusual, pointing out that about 60% of the medicines used in the US and approximately 75% of those used in the UK are also sourced from India. “Quality failures are reported even in those countries. Last year (2024) alone, around 150 quality failures were reported in the US. That is precisely why medicines are tested periodically. This is not an issue that is unique to Sri Lanka or with regard to medicines imported from a particular country,” he said.

The NMRA recently ordered the immediate withholding of 10 injectable medicines used in hospital settings, following reports of adverse drug reactions and concerns about product quality. In a directive issued to the relevant local market authorisation holder, the NMRA instructed that all parenteral products manufactured by the relevant Indian company be withheld as a precautionary measure, pending further investigations. The NMRA has initiated testing at the NMQAL and directed that the listed products be withdrawn from the private sector. The medicines ordered to be withheld include: the Ondansetron Injection United States  Pharmacopeia (USP) eight mg per four ml, commonly used to prevent nausea and vomiting; the Cefotaxime Sodium for Injection British Pharmacopeia (BP) 1,000 mg, a broad-spectrum antibiotic; Co-amoxiclav for Injection BP 1.2 grams (g) and 600 mg, used to treat bacterial infections; the Haloperidol Injection BP five mg/ml, prescribed for psychiatric and acute agitation-related conditions; Imipenem/Cilastatin for Injection one g (500 mg/500 mg), a high-end antibiotic used for severe infections; the Iron Sucrose Injection USP 100 mg/five ml, used in the treatment of iron deficiency anaemia; Meropenem for Injection USP one g, another critical-care antibiotic; Piperacillin and Tazobactam for Injection USP 4.5 g, used for serious bacterial infections; and Cefoperazone/Sulbactam for Injection one g, also an antibiotic combination.