Criminal Cases Filed Against Drug Regulatory Authority for Importing Substandard Drugs and Causing Deaths

Strict legal action and investigations have been initiated against the National Medicines Regulatory Authority (NMRA) and health authorities, stemming from alleged deaths caused by the use of substandard drugs and ongoing failures in drug regulation. These issues have arisen concerning drugs imported by an Indian company over the past two years, and Dr. Chamal Sanjeewa, President of the Alliance of Health Professionals for Medical and Civil Rights, emphasizes that steps must be taken to blacklist or ban the company in question.

Dr. Sanjeewa states that the Ministry of Health and the Minister must take full responsibility for these incidents, and accountable officials should be removed from their positions. He also urged the public to obtain medicines only on medical advice.

Dr. Chamal Sanjeewa's complaint to the Criminal Investigation Department (CID) states that the negligence of the former Chief Executive Officer of the Drug Regulatory Authority during the tenure of former Health Minister Keheliya Rambukwella, the current Authority, and the State Pharmaceuticals Corporation has led to this situation. Serious allegations include importing drugs without proper registration, failing to conduct random sample tests before and after distribution to hospitals, and not conducting formal investigations into how bacteria entered vaccines. The complaint also reveals issues such as continuously purchasing drugs from companies that failed quality tests, weaknesses in technical evaluation committees, and advising the reuse of drugs that had been withdrawn from use.

Dr. Sanjeewa points out that an expired antibiotic, previously completely withdrawn from use due to containing glass particles, was advised for reuse, and such actions have severely eroded public trust in the National Medicines Regulatory Authority. He demands that the law be enforced against those responsible for this incident, similar to the legal actions taken against the former Health Minister and others, as negligence regarding health system failures and loss of life is a criminal offense. Furthermore, a complaint has been filed with the Commission to Investigate Allegations of Bribery or Corruption, requesting an investigation into potential financial irregularities and corruption stemming from these incidents.

Meanwhile, the National Medicines Regulatory Authority has issued an urgent circular to 'PTC Medical (Pvt) Ltd', its local agent, instructing an immediate halt to the distribution of vaccine types manufactured by India's 'Maan Pharmaceuticals'. Dr. Ananda Wijewickrama, Chairman of the Authority, confirmed that hospitals have been ordered to temporarily suspend the use of ten types of drugs until their safety is confirmed. This decision was made based on the recommendations of the Risk Assessment Subcommittee, considering preliminary investigations by a microbiologist at the Kandy National Hospital, as well as reports of adverse drug reactions and deaths.

The suspended drugs include Ondansetron, Cefotaxime, Co-amoxiclav, Haloperidol, Imipenem with Cilastatin, Iron Sucrose, Meropenem, Piperacillin with Tazobactam, and Sulbactam with Cefoperazone. The relevant company has confirmed that these drugs have been withdrawn from the private sector, and further tests are being conducted by the National Medicines Quality Assurance Laboratory (NMQAL).