• Responds to reports of adverse drug reactions including fatalities and quality concerns, NMQAL commences testing  
• Drugs in question include Ondansetron, Cefotaxime Sodium, Co-amoxiclav, Haloperidol, Imipenem/Cilastatin, Iron Sucrose, Meropenem, Piperacillin and Tazobactam, Cefoperazone/Sulbactam

The National Medicines Regulatory Authority (NMRA) has informed the local market authorisation holder to immediately withhold a total of 10 injectable medicines used in hospital settings, following reports of adverse drug reactions and concerns over product quality.

In a letter dated Tuesday (16), marked very urgent, which was seen by The Daily Morning, the NMRA instructed that all parenteral products manufactured by the relevant Indian manufacturer be withheld from use as a precautionary measure, pending further investigations. The decision was said to be taken based on continuous adverse drug reaction reports received by the NMRA, including fatal reactions, and recommendations made in preliminary investigation reports by a consultant microbiologist attached to the Kandy National Hospital.

The NMRA stated that relevant product testing at the National Medicines Quality Assurance Laboratory (NMQAL) has been initiated to assess the safety, quality, and efficacy of the medicines. The NMRA further directed that all listed products be withdrawn immediately from the entire private sector.

The medicines ordered to be withheld include: the Ondansetron Injection US  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 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.

Commenting on the Ondansetron Injection withdrawal on an earlier occasion, the Government Medical Officers’ Association (GMOA) Media Committee Member, Dr. Chamil Wijesinghe said the withdrawal follows a preliminary inquiry after a number of patients developed adverse reactions following the administration of one of the drugs. He also said that such withdrawals are not unusual, noting that around 80 to 100 incidents involving drug-related concerns are reported annually, with medicines being withdrawn for various reasons. However, he stressed the importance of determining whether any quality issue originated during the manufacturing process or whether storage and transportation conditions may have affected the drug. “Normally, when a drug is imported, it undergoes laboratory testing by the NMRA. If that process was followed, it is important to know if these issues were not detected at that point,” he said. Commenting on reports that two patients who received the drug later died, Dr. Wijesinghe said that this has not been confirmed. “It has not yet been established whether the deaths were caused by the drug. A conclusion can only be reached after post-mortem reports are reviewed,” he said, and added that more than 250,000 doses of the drug in question were imported, and that over 220,000 doses have already been used, with the vast majority of patients showing no adverse effects. As such, he urged the public not to panic.

He also renewed the GMOA's call for the establishment of a national quality regulatory laboratory in line with World Health Organisation standards, noting that no meaningful steps have been taken in that direction so far. It further urged the authorities to provide accurate and timely information to the public rather than withholding details, warning that transparency is key to maintaining public trust.

Meanwhile, the Medical and Civil Rights Professional Association of Doctors organisation’s President, consultant/specialist Dr. Chamal Sanjeewa said that the decision to withdraw 10 injectable medicines with immediate effect was unprecedented in Sri Lanka. He said that the NMRA’s directive followed concerns over substandard quality and suspected allergic reactions linked to the drugs. Dr. Sanjeewa also pointed out that more than 100 batches of medicines imported from the same company have been temporarily or permanently withdrawn over the past two years due to quality issues. He accused the health authorities, including the Health Ministry, the drug regulatory system, and the State Pharmaceuticals Corporation, of failing to properly manage and regulate the country’s medicine supply.

Attempts to contact the Deputy Health Minister Dr. Hansaka Wijemuni, the Health Ministry Secretary Dr. Anil Jasinghe, and the NMRA Chairperson Dr. Ananda Wijewickrama were unsuccessful.