A shocking revelation has surfaced: the Ondansetron Injection, later found to contain a harmful bacterial toxin, was initially cleared for import into Sri Lanka. This news, shared by Dr. Chamal Sanjeewa, Chairman of the Doctors' Trade Union Alliance for Medical and Civil Rights, raises serious questions about the integrity of the country's healthcare system. But here's where it gets controversial... the drug had already passed lab tests!
Dr. Sanjeewa revealed that the controversial injections underwent testing before being allowed into the country. The test reports, issued before importation, apparently showed no signs of bacterial toxicity. The importing company confirmed that the drug was imported on four separate occasions.
According to the information, the injections were manufactured in India during November 2024, May 2025, and August 2025. The four batches, which were temporarily pulled from use, were imported into Sri Lanka in February, July, and September 2025. Each import consisted of 67,600 vials. The relevant institution has confirmed that all batches were tested in Indian laboratories before shipment. Dr. Sanjeewa stated that the medicines were tested against ten different criteria, and the company informed the Drug Regulatory Authority that all tests were passed successfully.
Dr. Sanjeewa warns that if the medicine is cleared again based on Indian test results, it would severely damage the credibility of Sri Lanka's health system. He strongly believes that legal action should be taken against the politicians and government officials responsible for this incident, as it has eroded public trust due to poor health administration.
He explained that the regulatory process includes testing for basic quality standards such as pH value, appearance, composition, volume of medicine per vial, antimicrobial activity, presence of additional substances, bacterial toxicity, and spectrum changes. All these parameters are tested during the approval process.
He has officially informed Maan Pharmaceuticals Ltd. with relevant documentation, citing a letter issued by the institution, which confirms that the drug met all required standards in tests conducted in India.
According to European standards, bacterial toxin levels must be below 9.9 international units per milligram. Dr. Sanjeewa said the company’s letters to the Drug Regulatory Authority indicate that the toxin levels in the tested batches were within accepted limits.
And this is the part most people miss... He also pointed out that the Quality Control Laboratory of the Drug Regulatory Authority is not accredited by the Sri Lanka Accreditation Body (SLAB). Establishing a fully equipped, internationally accredited laboratory would cost around Rs. 5 billion, which he described as a relatively small amount compared to allocations made to the Presidential Fund. Dr. Sanjeewa warned that failing to establish such a facility urgently would continue to put lives at risk due to substandard medicines and lead to significant losses of public funds, as the state would be unable to recover payments made to pharmaceutical companies.
What do you think about this situation? Do you believe that the initial testing process was flawed, or are there other factors at play? Share your thoughts in the comments below!
