• 3 Board members resign citing criticisms over IVIG scandal and admin. irregularities involving current Chair
• Health Minister to probe allegations levelled

Three members of the Board of Directors of the National Medicines Regulatory Authority (NMRA) – attorney Manoj Gamage, Dr. Priyantha Serasinghe, and Supul Wijesinghe – have resigned citing the criticisms levelled at the NMRA regarding the controversial human intravenous immunoglobulin (IVIG) deal and the irregularities allegedly committed by the current NMRA administration.

All three members – who were appointed as members of the NMRA's Board of Directors by former Health Minister Keheliya Rambukwella – who is currently in remand custody over the IVIG deal – had tendered their resignations to incumbent Health Minister Dr. Ramesh Pathirana yesterday (13).

Speaking to The Daily Morning, Gamage claimed that various parties have been accusing the NMRA regarding the IVIG deal for many months with the aim of protecting drug traffickers and diverting the related investigations. “We have always tried to explain to the people who don’t know the truth about this that the NMRA is not an organisation that carries out activities related to the selection of drug purchasers or the importation of drugs, and that it is merely an organisation that acts as a regulatory authority. The Authority, which works for the registration of drug suppliers and the maintenance of such drugs' quality, has a limited role in emergency procurement under the existing rules and regulations,” he said.

He also said that when Janaka Fernando, the Owner of the Isolez Biotech Pharma AG (Private) Limited. Company, who is also the main suspect in the IVIG deal, requested the good manufacturing practice certificate for his manufacturing plant, he (Gamage) and the Board of Directors had refused to grant it, and had, through that action, fulfilled their duty properly. 

“Nevertheless, it is a matter of surprise that by knowingly concealing these facts, those who have made the drug mafia a political battle, are accusing the NMRA and spreading false information, while the relevant authorities are silent about it,” he said.

He also made several accusations against the current NMRA Chairman (Dr. Ananda Wijewickrama) in the letter sent to the Health Minister, and explained the same to The Daily Morning. “He was very unhappy about me as I opposed him when he was trying to reverse certain decisions that had been taken by the Board of Directors earlier. I am well-aware that he even tried to remove me from the NMRA through the Health Minister,” he said. 

Gamage further claimed that the current NMRA Chairman is trying to re-hire a group of employees who were removed from the NMRA over the recent data deletion incident in the NMRA's information system and the deliberate delay in the registration process of new drug suppliers for various financial benefits. He alleged that Dr. Wijewickrama is trying to build a “crony gang” within the NMRA and that there have been many irregularities in the recruitment of the current Chief Executive Officer of the NMRA. 

“I know that it is a very dangerous situation to continue dealing with the people of the current administration based on these circumstances. I am not prepared to be a part of anti-Government conspiracies by dealing with an administration that has direct relations with the parties that launch various conspiracies against the Government led by President Ranil Wickremesinghe, and attempt to create a problematic situation in the country based on the health sector, which is sensitive to the people.”

The resignation letter of Dr. Serasinghe stated: “Since July, 2022, the Board has taken considerable steps to improve the operation of the NMRA to the best of our ability despite baseless allegations made by various parties who were affected by the steps taken by the Board. Recently, with the change in the management, I feel that there is a deliberate move to reverse some of the bold and correct decisions taken by the Board that was appointed in July, 2022. Further, it has been noticed that there is a recent attempt to drag the NMRA Directors to the controversial IVIG procurement that was done by the Medical Supplies Division (MSD) of the Health Ministry, in which the NMRA had no involvement. Considering the existing unpleasant situation, I don’t wish to continue as a member of the Board of the NMRA.”

Tendering his resignation to the Health Minister, Wijesinghe said that though the NMRA Board appointed in July 2022, took significant measures to improve the systems, processes, transparency and governance of the NMRA, the Board members were subjected to various false, baseless, and malicious allegations from 2022 onwards by various parties with vested interests. 

“Regardless of the declaration of secrecy of all affairs of the NMRA by every Board member, officers and employees of the NMRA under Section 24 of the NMRA  Act, certain information and documents including Board meeting minutes were disclosed in the public domain during the period of my Directorship,” he said.

When contacted by The Daily Morning, Dr. Pathirana said that he would look into the allegations levelled by the resigned NMRA members against the current administration in the coming days.

Dr. Wijewickrama was not available for comment.

In October, 2023, the NMRA stated that a batch of IVIG imported to Sri Lanka from India, allegedly in violation of the due procedure, was suspended from use. In a media release dated 3 October 2023, the then NMRA Chairman Prof. S.D. Jayaratne claimed that forged documents were found to have been submitted for Customs clearance when importing the said drug which later failed the relevant quality tests. The matter had come to light following reports of allergic reactions after the drug was administered to several patients under treatment at the National Hospital in Colombo and the District General Hospital in Matale in August and September, 2023. The matter led to great controversy and the arrest of Rambukwella, the former Health Ministry Secretary Janaka Sri Chandraguptha, the MSD’s Director Dr. Kapila Wickramanayake, the Assistant MSD Director Shanthi Solomon, the MSD's Accountant (Supplies) Niran Dhananjaya, and the MSD Pharmacist Sujith Kumara and the Deputy Director of Health Services Herath Kumara and them being placed in remand custody subsequently. Several parties had also accused certain officials of the NMRA, particularly those appointed during Rambukwella's tenure as the Health Minister, of aiding and abetting in the IVIG deal.