Serious concerns over patient safety have erupted after revelations that substandard imported medicines entered Sri Lanka’s hospital system, triggering renewed fears of regulatory failure and life-threatening lapses in drug approval standards.
The decision taken by the Drug Regulatory Authority after the current government came to power to allow Indian standard medicines into Sri Lanka’s hospital system and open market, bypassing British or European standards, has been described as a short sighted and dangerous move. A strong appeal has been made to the President to immediately investigate the matter and introduce an urgent program to ensure only internationally accepted standard medicines are released to hospitals.
These concerns were raised at a media briefing addressing the deaths of patients who developed severe allergic reactions to Ondesterone Injection, a drug imported from India and widely used to control nausea, vomiting, and anesthesia related side effects. The medicine has since been temporarily withdrawn from use.
Chairman of the Drug Regulatory Authority, Dr. Ananda Wijewickrama, confirmed that laboratory investigations conducted by the Pure Biology Department of the Kandy National Hospital found bacterial toxins in vials of the drug. This revelation has intensified public alarm over drug safety and regulatory oversight.
It was recalled that similar toxins were detected in medicines imported and distributed to hospitals during the tenure of former Health Minister Keheliya Rambukwella. As a result, there is growing public distrust over the spread of substandard medicines within the national health system.
The speaker stressed that the decision to register medicines under standards of the Indian Drug Regulatory Authority is both life threatening and irresponsible. He urged the President to act swiftly to control the risk of low quality medicines entering hospitals across the country.
It was also stated that since the questionable drug was imported by the State Pharmaceuticals Corporation with approval from the Drug Regulatory Authority, a request will be made to the Criminal Investigation Department to conduct a full investigation into the procurement and approval process.
He further noted that unresolved corruption allegations against former health ministers and senior officials continue to haunt the ministry, warning that continued inaction is now directly endangering public lives.
