-By A Special Correspondent
(Lanka-e-News -19.June.2025, 11.10 PM) A Sri Lankan pharmaceutical scandal deepens as German lab confirms immunoglobulin drug was devoid of medicinal value – and dangerously contaminated
A damning report from a German chemical laboratory has shaken the Sri Lankan healthcare system to its core. Court proceedings in Colombo this week revealed that an immunoglobulin drug, procured and distributed under the oversight of the country’s former Health Minister Keheliya Rambukwella, was not only ineffective—it was lethal.
According to Deputy Solicitor General (DSG) Lakmini Girihagamage, who appeared before the Maligakanda Magistrate's Court on behalf of the Attorney General, laboratory tests conducted on approximately 200 samples of the drug found that it contained only saline and harmful bacteria, and no active immunoglobulin compounds whatsoever.
The investigation has now reached a critical turning point, with indictments against Rambukwella and nine others expected to be filed before the Colombo High Court imminently.
The drug in question—marketed as an immunoglobulin product for paediatric use—was supplied to Sri Lanka’s Ministry of Health through a little-known Indian-based entity named Ayushulem Biotech Pharma. This firm, the court heard, had no prior record of large-scale pharmaceutical manufacturing or international quality certification.
At the centre of the scandal is the former Minister of Health, Keheliya Rambukwella, a controversial figure already plagued by a political career marked by allegations of corruption and mismanagement. According to the DSG, phone records show eight calls between Rambukwella and Sugath Janaka Fernando, the owner of Ayushulem Biotech, during the procurement period. There were a further 31 calls between Rambukwella and the then Additional Secretary to the Ministry of Health, also a suspect.
These call logs are now being considered vital circumstantial evidence, raising questions about whether the procurement was driven by medical necessity—or political and financial inducement.
The German laboratory report, submitted to the court earlier this month, forms the most scientifically damning piece of evidence in the case. It states that the supposed immunoglobulin samples—used to treat vulnerable children with weakened immune systems—contained no trace of antibodies or therapeutic proteins.
Instead, the solution was composed entirely of saline and multiple strains of harmful bacteria, some of which could trigger severe immune reactions or sepsis if administered intravenously.
The revelation sent shockwaves through the courtroom and wider public. “We are not just looking at a case of substandard medicine. We are looking at a public health catastrophe,” said a senior health sector official who spoke to the Financial Times on condition of anonymity.
The court heard that the drug had been administered to hundreds of children in state hospitals between 2022 and 2023. An undisclosed number of adverse reactions were recorded, but no official mortality audit has yet been published—prompting accusations of a state-led cover-up.
The scandal is only the latest in a string of corruption-ridden public procurement schemes in Sri Lanka’s public sector. However, the immunoglobulin case stands out for its blatant disregard for pharmaceutical standards and regulatory oversight.
Insiders from the Ministry of Health claim that the approval process for the drug circumvented multiple standard operating procedures. Ayushulem Biotech Pharma had reportedly never received NMRA (National Medicines Regulatory Authority) approval under the formal fast-track process. Instead, it was listed under a "Special Procurement Arrangement" used typically during states of emergency such as pandemics—though no such declaration was active during the drug’s import.
Further scrutiny has revealed that documents attesting to the drug's origin, composition, and batch stability were forged or missing entirely from NMRA databases.
One internal NMRA memo, leaked to this newspaper, reveals that a regulatory officer who initially objected to the product’s release was transferred overnight.
In Colombo's Lady Ridgeway Hospital for Children, where some of the immunoglobulin vials were administered, doctors remain tight-lipped. But families of affected patients are demanding answers—and accountability.
“We trusted the government hospital. My child was given that drug during a fever episode,” said Thilini Perera, a mother from Ratnapura. “He was vomiting and had convulsions after the injection. They told us it was normal. Now we know it was poison.”
At least 17 civil suits have already been filed by families seeking damages. Legal observers expect a wave of litigation once indictments are formally issued and the full scope of the damage is made public.
According to DSG Girihagamage, the investigation into the immunoglobulin procurement is now complete, and the Attorney General’s Department is ready to file indictments at the High Court. Charges are expected to include criminal negligence, procurement fraud, breach of trust, and attempted murder.
The suspects list includes:
Keheliya Rambukwella, former Health Minister
Sugath Janaka Fernando, owner of Ayushulem Biotech Pharma
Dr. Ruwan Wijayamuni, former Additional Secretary
Six mid-level procurement and regulatory officers
One logistics coordinator alleged to have facilitated the delivery
Legal experts believe that Rambukwella, due to his ministerial position and direct communications with both Fernando and top health officials, could face the stiffest charges.
The Attorney General’s Department is also expected to request asset freezes and international travel bans on the suspects.
The scandal is drawing international scrutiny. German regulatory agencies, alerted to the misuse of their lab findings, have reportedly opened parallel investigations into how a dangerous counterfeit drug passed through export controls.
The World Health Organization’s South-East Asia regional office said in a statement that it was “concerned by the grave nature of the findings” and had requested a full dossier from the Sri Lankan authorities.
“This is no longer just a local corruption issue. This is a global pharmaceutical integrity failure,” said Dr. Martin Rothschild, a Munich-based healthcare regulation consultant. “It raises fundamental questions about how much of the medicine being sent to developing countries is even medicine at all.”
Despite the severity of the revelations, Sri Lanka’s ruling coalition has remained largely silent. President Anura Kumara Dissanayake, elected on an anti-corruption platform, has yet to comment directly on the immunoglobulin case.
Opposition lawmakers, however, have seized on the scandal. “This is medical murder. We warned for years that health sector procurement was rotten. Now we have bodies,” thundered MP Harsha de Silva during a parliamentary session.
Even within Rambukwella’s own political alliance, pressure is mounting. Several MPs have privately expressed dismay, with some fearing wider exposure of other irregular health tenders signed during the COVID-19 period.
Healthcare professionals warn of a deeper, more long-lasting consequence: the erosion of public trust in Sri Lanka’s already embattled public health system.
“There is a shadow now over every injection, every drip, every drug that comes from the central system,” said Dr. Anjali Jayasuriya, a consultant immunologist. “This scandal may take a decade to recover from.”
Efforts are reportedly underway to audit other drug batches procured during Rambukwella’s tenure. If further anomalies are discovered, observers fear this may be the tip of the iceberg.
As Sri Lanka braces for the formal indictment of a former Cabinet Minister over what may be one of the gravest public health failures in its history, the deeper question lingers: Was this merely a one-off deal gone wrong—or evidence of a deeply embedded culture of patronage, negligence, and impunity?
For now, the courts will adjudicate the criminality. But for the families of affected children, no verdict can undo the pain caused by injecting saline and bacteria instead of life-saving medicine.
-By A Special Correspondent
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by (2025-06-19 20:24:26)
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