Deaths due to substandard medicine; NMRA faces legal action
– The Medical and Civil Rights Professional Association of Doctors (MCPA) had initiated legal action against the National Medicines Regulatory Authority (NMRA), raising serious concerns about patient safety, an official said.The case relates to several reported deaths allegedly linked to the use of Ondansetron Injection, severe allergic reactions, and the death of a pregnant woman after antibiotics were given during a caesarean section at Galassa Maternity Hospital in Kalutara. The complaint also involves medicines imported from an Indian company that had been withdrawn during the past two years.
Speaking to the media after filing the complaint, MCPA Chairman Dr. Chamal Sanjeewa said the medicines under concern include antibiotics, Ondansetron used to control vomiting, Haloperidol prescribed for mental illnesses and febrile seizures, and Iron Sucrose used to treat iron deficiency. He said most of these medicines were imported between 2024 and 2025.Dr. Sanjeewa said that more than 100 batches of medicines imported from India have been temporarily or permanently withdrawn over the past two years due to quality issues. He criticized the Health Ministry, the Drug Regulatory Authority, and the State Pharmaceutical Corporation (SPC), saying drug regulation in the country has collapsed. He pointed to unsafe storage of imported medicines and repeated regulatory failures.
The Indian company should be banned or blacklisted over importing over the past two years. The Health Ministry and the Minister should hold the full responsibility over the incidents.
He called on responsible health officials to step down and urged the public to take medicines only under proper medical advice. He said the large number of withdrawals shows the urgent need for strong reforms in drug regulation and procurement, the MCPA chairman said.According to Dr. Sanjeewa, the complaint highlights negligence by the former Executive Director of the Drug Regulatory Authority during the former Health Minister Keheliya Rambukwella administration, the current Drug Regulatory Authority, and the State Drug Corporation. The allegations include importing medicines without proper registration, failing to test random samples before and after supplying drugs to hospitals, and not properly investigating how bacteria entered vaccine vials.
The complaint also raises concerns about buying medicines from companies linked to drug quality failures, weaknesses in technical committee evaluations, poor estimation of drug stocks, approval of such stocks by the Ministry of Health, and repeated instructions to reuse medicines that had already been withdrawn.
Dr. Sanjeewa further said the complaint points to an instruction issued to reuse an expired antibiotic that had been fully withdrawn earlier due to the presence of glass particles. He warned that such actions have damaged public trust in the Drug Regulatory Authority and the Ministry of Health, and that ignoring repeated warnings about failures in the health system, leading to loss of life, is a criminal offence.
He has asked the Criminal Investigation Department (CID) to urgently investigate the matter and take legal action against those responsible, similar to previous cases involving former Health Minister Keheliya Rambukwella and senior health officials. A separate complaint has also been filed with the Bribery Commission, calling for an investigation into possible financial gains and corruption linked to the issue.Meanwhile, the NMRA has ordered hospitals to temporarily stop using ten medicines until their manufacturing processes are confirmed to meet safety standards. NMRA Chairman Dr. Ananda Wijewickrama also told the Daily Mirror that an urgent circular has been sent to PTC Medical (Pvt) Ltd, instructing the company to stop distributing injectable medicines made by Maan Pharmaceuticals Ltd of India until further notice.
The decision was taken following recommendations by the Safety and Risk Evaluation Subcommittee on December 16, 2025, after repeated reports of adverse drug reactions, including deaths. Early investigations by a consultant microbiologist at the National Hospital in Kandy also raised safety concerns.PTC Medical, the market authorization holder, has confirmed that the affected medicines have been withdrawn from the private sector. Further testing is now being carried out at the National Medicines Quality Assurance Laboratory to check their safety, quality, and effectiveness.
The affected medicines include Ondansetron Injection, Cefotaxime, Co-amoxiclav, Haloperidol Injection, Imipenem with Cilastatin, Iron Sucrose Injection, Meropenem, Piperacillin with Tazobactam, and Sulbactam with Cefoperazone. PTC Medical said the withdrawal is a precautionary step and asked all private hospitals and distributors to comply immediately.
