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 ‘No connection between plasma provision-IVIG import’

‘No connection between plasma provision-IVIG import’

07 Nov 2023 | BY Buddhika Samaraweera

  • NBTS acknowledges provision of blood plasma to Isolez Biotech Pharma AG 
  • Health Secy. quizzed by CID

The National Blood Transfusion Service (NBTS), while acknowledging that it, following the due procedure, provided 150 litres of blood plasma (a light yellowish or straw coloured component which serves as the liquid base for whole blood) to the Isolez Biotech Pharma AG (Private) Limited. Company, which has allegedly supplied a batch of human intravenous immunoglobulin (IVIG) to the health sector by submitting forged documents, stated that there is however no connection between the provision of blood plasma and the procurement of any related product to the country's health sector, and the ensuring of the quality of such products.

Recent incidents of the local drug supplier named Isolez Biotech Pharma AG (Pvt.) Ltd. having imported a batch of human IVIG, and another batch of the Rituximab injection which is administered to cancer patients, led to a great controversy. It was later revealed that they had procured blood plasma from the NBTS to manufacture the IVIG batch in question.

Well-placed sources within the NBTS told The Daily Morning that out of the red blood cells, white blood cells, platelets, and blood plasma, the most rarely used component is blood plasma, so an excess of 40,000 to 45,000 litres of such is collected at the NBTS, annually. "Only about 10,000 litres of blood plasma is used for patients locally. What happened before 2015 was that we discarded the excess volume of blood plasma. However, since then, the relevant authorities granted approval to call for tenders and sell the blood plasma. As a country which has a high quality blood transfusion service, our blood plasma is of very high quality, so, there is a great demand for it."

The sources said that a Sri Lankan national, who has later been revealed to be the owner of the Isolez Biotech Pharma AG (Pvt.) Ltd., had visited the NBTS and requested for a considerably large quantity of blood plasma, 2,000 litres, claiming it to be for a research aimed at discovering new proteins in the blood plasma. "The volume that he asked for was somewhat suspicious, and his research proposal had no mention of a university or research institute. He did not say that the request for blood plasma was for a commercial purpose. However, the NBTS directed him to obtain the approval of the Director General of Health Services or the Health Ministry Secretary. Then, he came again on 27 February with a recommendation from the Health Ministry's Secretary (Janaka Sri Chandraguptha).” NBTS sources added that it is a usual practice for them to provide blood related components to certain institutions such as universities and research institutes. "When someone comes with proper documents, we provide them with blood related components for research purposes. It is something that we should do for the advancement of science. Even now there are several universities which have made such requests. It is a common practice."

When queried about the provision of such components, particularly blood plasma, for commercial purposes, the NBTS sources said that there had been foreign nationals coming to purchase them with their local representatives since 2015. However, the NBTS emphasised that there is no connection between the provision of such, and the procurement of blood plasma-based pharmaceutical products to the country's health sector. "They pay the relevant amount and purchase the blood plasma. We credit the relevant sums to the Treasury's consolidated fund. However, if any product made of blood plasma is purchased by our health sector, the relevant authorities including the National Medicines Regulatory Authority (NMRA) should ensure that they are up to the required standards and quality."

When the relevant individual came with the Health Ministry Secretary's recommendation, the NBTS sources said that it had appointed a review committee of high level officials including the NBTS Deputy Director, three medical specialists, and another medical officer to look into the request. "There is usually a standard committee to review these kinds of requests, but, we appointed a separate committee to look into this matter as there were some suspicions about the volume of blood plasma that they asked for," the sources said, and added that the relevant committee had recommended on 3 May 2023, to provide the individual with packets of blood plasma containing 200 millilitres per week for nine months."

The Daily Morning queried the NBTS sources as to whether the relevant individual, who has now been revealed to be the owner of the Isolez Biotech Pharma AG (Pvt.) Ltd., had mentioned about any university or research institute at that stage, to which the sources replied: "By this time, he had submitted the photographs and video footage of a high tech research facility located in Seeduwa. The committee had recommended that a team of officials visit it, but it did not happen."

Speaking further, NBTS sources said that it had provided a total volume of 150 litres of blood plasma to the relevant individual, following the due process which included the issuance of payment receipts. "They had purchased blood plasma only until September of this year (2023), and then they did not come. It is only with the ongoing Criminal Investigations Department (CID) proceedings that we came to know that he is the owner of this Company. However, one should not mix these matters. The provision of blood plasma to a certain party following due process is one matter, and the procurement of blood plasma based products is another. The procurement of this IVIG batch was a massive financial transaction. So, what did the relevant quality review committee do? They should have ensured its quality."

When contacted by The Daily Morning, Chandraguptha declined to comment on the matter, saying that there are judicial proceedings going on with regard to the matter. It was reported that he had been questioned on the matter by the CID yesterday (6). 

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