The Hon. Dayasiri Jayasekara, Attorney-at-Law

¶ 01 Hon. Deputy Chairperson, before I begin, I must raise a serious issue. Hon. Nalinda Jayatissa is not in the Chamber now, but several Ministers are present. From tomorrow morning, the country will have no Auditor General. Your Government, from the beginning, pledged to strengthen the Auditor General’s Department. Yet, what has happened?

¶ 02 The former Auditor General retired on 2025.04.08. Thereafter, you appointed an Acting Auditor General for 14 days, then extended on 2025.04.23 for another 30 days. Meanwhile, you proposed to the Constitutional Council the name of H.T.P. Chandana of the University of Kelaniya—a friend of Anura Dissanayake. He has not served a single day in the public service and lacks experience in parliamentary audit work, yet arrangements were made to seat him. When that failed, you tried to extend the Acting appointment by another six months. Yesterday we learned the Constitutional Council rejected that extension. So, from tomorrow morning, Sri Lanka has no Auditor General. What are you waiting for?

¶ 03 You attempted to drag this until the 3rd of next month when Mr. Prathap Ramanathan, Ms. Anula Wijesundara and Ms. Dinesha Samararatne—the three civil society members—would leave the Council. Ultimately, the country is left without an Auditor General. I request you, Anura—please do not do this ugly thing. The people appointed you President; do not interfere like this.

¶ 04 Now to the Ministry of Health. First, the human immunoglobulin issue. The previous Government fell partly due to it. Now it has re-emerged as a massive crisis under this Government. I have with me the “Medicine Recall and Revocation Database.” Dated 2024.09.09, it refers to “Immunoglobulin for Intravenous Use BP 5%.” Under “Defects,” it states: “adverse drug reaction for the product including death.”

¶ 05 What did the SAFRESC Committee say? I quote: “SAFRESC committee met on 08.09.2024 via online recommended to withhold the product until complete the investigation.” Following an adverse reaction in Trincomalee—including a death and several complications—a letter dated 2024.09.09 was issued titled “Withholding of Product Due to Adverse Drug Reaction Pending Completion of Investigation” to the company head, signed by Dr. Saveen Semage, instructing immediate withholding in the entire private sector.

¶ 06 Then on 2024.10.01, another communication: “Failure to comply with the bacterial endotoxin test and particulate matter test, withdraw the product.” On 2024.10.18, again from Dr. Semage: “Withdrawing of Product Due to Adverse Drug Reactions and quality defects,” noting that products must meet British Pharmacopoeia standards, and instructing: “As the market authorization holder, you must ensure that the product is withdrawn in the entire private sector immediately.”

¶ 07 Subsequently, Maldives raised concerns. Still, nothing meaningful was done. On 2025.01.02, SAFRESC decided that Dr. Rajiva de Silva would review additional manufacturer documentation and that Director/NMQAL obtain quotations from WHO prequalified labs in Thailand, Bangladesh and Singapore for sample testing. Yet this was not carried out. Meanwhile, two patients died: K.D. Sujeewa (58) of Gampaha, died on 2025.06.26 at North Colombo Teaching Hospital, bed no. 78709/25; and W.G. Nandasinghe (69) of Kandy, bed no. 999/72 at Kandy Hospital.

¶ 08 Then SAFRESC observed that an independent lab report had been provided by the Central Drugs Standard Control Organization/Zonal Office—India. Because BP testing was not possible locally and tests were to be sought from Thailand, Singapore or Bangladesh, instead an Indian Pharmacopoeia (IP) report via a zonal office was obtained. SAFRESC stated: “Verify the analytical reports provided by the manufacturer with the issuing authority.”

¶ 09 Based on this, the medicine was allowed to be used again. The NMRA Chair, Specialist Dr. Ananda Wijewickrama, issued a media release saying the medicine had initially been withheld, but “subsequent investigations show the medicine meets proper standards,” and it can continue to be used. I ask the Minister: on what basis was it said to be of proper standard?

¶ 10 Hon. Minister, I know you were not involved in nefarious activities, but this is happening under your Government. You remember Keheliya Rambukwella’s matter: he went in and out of prison; his statements here are remembered. He said: “People die at hospitals; that is why there are florists outside.” People cursed that government for it and it fell. Now, under your Government, two have died and others suffered complications due to this drug. Under Keheliya, people did not die—there were complications—but now deaths have occurred, and the NMRA has permitted continued use.

¶ 11 The statement also notes the Indian Central Standards Control Organization confirmed standards. I ask: which parameters were checked in these tests? SAFRESC clearly called for testing in WHO-prequalified labs in Thailand, Bangladesh or Singapore. Instead, an Indian IP report was used for a product registered as BP 5% for IV use. Why was an IP standard used to clear a BP-labelled product? If the testing method for BP 5% is not available here, why was such a product registered by NMRA? Who registered it? On whose responsibility was withhold/withdraw reversed? Provide a list of drugs in Sri Lanka that were withheld or revoked and later reinstated—has this ever happened before?

¶ 12 Also, after these deaths and complications, the drug is still being used in hospitals, with no regulatory circulars barring use. What quantity remains, and what was the expenditure? Please clarify.

¶ 13 Next, our Minister Nalinda Jayatissa went to the UK asking doctors to return, but under your Government 1,200 doctors have left; 5,000 more are awaiting exams to leave. Make the medical profession a closed profession and ensure their facilities and retention.

¶ 14 In Kuliyapitiya Hospital, the Professorial Unit—this was raised even by the President then. Please table the promised funds. I lodged a complaint with you on the dire situation: constant clashes; police arriving daily. This cannot continue. Also, Nikaweratiya Hospital has no adequate dialysis machines—only one; please provide another. The Dialysis Unit in Kuliyapitiya is located in a corridor area; resolve this. Finally, Hettiipola Hospital needs accommodation for doctors; we have allocated small sums annually; please expedite.

¶ 15 Regarding Independent Television, previously we said Keheliya was sending teledramas. Now your Coordinating Secretary from Pelawatte, Upul Ranjin, is sending them. Only old teledramas are aired; new ones require clearance from Pelawatte. Please look into this.

¶ 16 I wish you well. I conclude.