According to government auditors, an evaluation committee led by former Health Secretary Janaka Chandraguptha not only approved counterfeit immunoglobulin and rituximab injections from Seeduwa-based Isolez Biotech Pharma AG, but also cleared the purchase of four other drugs without raising concerns about glaring discrepancies in the company’s “bid” documents.
The ministry paid Isolez Rs. 144,293,355 for 3,985 vials of immunoglobulin and 2,200 vials of rituximab (the total order was for 22,500 vials at Rs. 168.8 million).
But the evaluation committee also approved orders for 1,500 units of irinotecan hydrochloride trihydrate 100 mg/5ml; 1,333 vials of docetaxel 80mg; 750 vials of fluorescein sodium 10%; and 33,333 vials of dried factor VII fraction 1,000 micrograms/2,500 micrograms, authoritative sources reported auditors as having found.
The Sunday Times first reported on December 31, 2023, that these anti-cancer medications were also contracted, although the full list or quantities were not immediately available. The irinotecan was ordered but not supplied. The expressions of interest submitted by Isolez for the other three drugs had been cleared, but orders had not been placed.
Together, the agreements ran into billions of rupees and were only disrupted because the counterfeit “human immunoglobulin” caused serious adverse reactions in patients, causing health authorities to panic, thereby triggering the collapse of the whole deal.
These drugs are predominantly administered to cancer and immunocompromised patients, who are often in serious health conditions. Waivers of registration were requested by the Health Ministry from the National Medicines Regulatory Authority (NMRA) for each of the medicines. They were designated as “emergency purchases” that allowed the drugs to be procured through the NMRA’s controversial “special pathway”—evading any form of regulation or vetting. The evaluation committee did not have any subject experts.
The invoices and “bid” documents presented to the TEC by Isolez in each of these instances claimed the medicines would be Indian, that the manufacturer would be the Indian Livealth Bio Pharmaceutical Company, and that the drugs could be delivered within one to five working days.
However, the same documents conflictingly said that the raw materials for the medicines would be from Livealth and that the products would be formulated, manufactured and marketed by Isolez in Sri Lanka. Auditors have observed that the EOI evaluation committee did not comment on any of these disparities. Livealth has categorically denied involvement in these tenders.
In the case of docetaxel and fluorescein sodium, Isolez even submitted certificates of analysis purportedly from the Indian manufacturer, sources reported the auditors as having found.
This week, the Health Ministry Medical Supplies Division’s Deputy Director, who became the seventh suspect arrested by the Criminal Investigation Department (CID) over the counterfeit immunoglobulin scandal, was remanded till January 10 after being produced before Maligakanda Magistrate Lochana Abeywickrama.
The suspect, Herath Mudiyanselage Dharmasiri Rathna Kumara, was remanded after the Magistrate considered the evidence presented by Deputy Solicitor General Lakmini Girhagama, who argued he had committed an offence under the Public Property Act.
Source: Sunday Times