A civil activist claims he was summoned and threatened with arrest for speaking out against a repeatedly flagged substandard medicine, as serious questions resurface over drug safety, patient deaths, and regulatory accountability in Sri Lanka’s healthcare system.
The Medical Supply Database confirms that the current Medicines Regulatory Authority has revoked the approval of the Sri Lankan manufactured drug “Co-Amoxiclav Injection” after it was found to be substandard in multiple batches on nearly 23 occasions over the past few years, according to Sanjaya Mahawatta, the convener of the Magen Rata civil movement.
Speaking at a media briefing held in Colombo, Mahawatta stated that he had repeatedly submitted documented evidence regarding the drug to both the Medicines Regulatory Authority and the Criminal Investigation Department. Despite this, he said he was summoned to the Criminal Investigation Department and warned that he would be arrested if he continued to speak publicly about the drug in question.
He further noted that audit reports issued during the tenure of former Health Minister Keheliya Rambukwella had raised concerns over patient deaths linked to the administration of this injection. Within this context, Mahawatta revealed that several batches of the drug that had been temporarily withdrawn were later recalled and reintroduced by the current Drug Regulatory Authority, raising concerns about consistency and transparency in regulatory decisions.
Mahawatta also highlighted suspicions that the drug may have been directly linked to the recent death of a mother at the Huruluwewa Hospital in Anuradhapura, as well as complications reported at the Colombo National Hospital. Addressing the media, the husband of the deceased woman stated that his wife’s condition deteriorated rapidly after she was administered a specific drug at the Huruluwewa Regional Hospital. She later died after being transferred to the Anuradhapura Hospital. He stressed that a fair and impartial investigation must be conducted into her death.
According to Mahawatta, despite repeated reports of adverse reactions and ongoing complications associated with this medicine, the decision by the current Chairman of the Drug Regulatory Authority to continue its use remains questionable. He argued that authorities must explain to the public why such drugs are not permanently withdrawn and warned that suppressing civil activists will not suppress the truth.
Recently, one batch of the drug was temporarily removed from use at the Colombo National Hospital. It has been reported that the medicine is manufactured at a pharmaceutical production facility located in the Horana area.
