KUALA LUMPUR, August 22 — Malaysia’s current insulin shortage crisis indicates that simply having a domestic manufacturing facility does not guarantee supply, said the Galen Centre for Health and Social Policy.
Galen Centre chief executive Azrul Mohd Khalib said there must also be a predictable supply of active pharmaceutical ingredients (APIs) that are used for the production of pharmaceuticals.
He also pointed out that human insulins are manufactured using recombinant DNA technology, where the gene for human insulin is inserted into bacteria and that bacteria is then used to manufacture insulin. As it is used in humans, there are stringent quality control measures to ensure safety and efficacy.
“We need to ask three main questions: are there problems with the APIs involved in insulin production here in Malaysia; how much of the production done here in Malaysia is intended for export; and whether there are questions or concerns regarding the quality of insulin being produced for supply in this country, which may not have passed muster,” Azrul told CodeBlue in a statement yesterday.
CodeBlue yesterday reported a severe shortage of human insulin in Ministry of Health (MOH) facilities nationwide, due to reported supply issues with Biocon Sdn Bhd that runs an insulin manufacturing facility in Johor, touted to be Asia’s largest integrated insulin manufacturing and R&D facility. Biocon is owned by India-based biosimilars company, Biocon Biologics.
US-based pharmaceutical news site FiercePharma reported in August 2023 that the United States’ Federal and Drug Administration (FDA) cited Biocon’s insulin manufacturing facility in Malaysia, following a site inspection in July.
The American regulator reportedly cited the plant for eight observations, including inadequate corrective and “repeat” problems that the FDA observed on previous visits. Biocon was cited for a number of ongoing issues, such as scissors stored in non-sterile holders being used to open “bags of sterile components,” improper blockage of air filters, insufficient cleaning of sterile machinery, and numerous problems with batch testing and record-keeping.
According to FiercePharma, the US FDA also cited Biocon’s failure to lay out detailed, written guidelines for some manufacturing operations, besides reprimanding the drugmaker for a lack of employee training.
In an October 2023 statement issued from India, Biocon Biologics said it would continue to engage with the US FDA “for an expeditious resolution and approval of its biosimilar Insulin Aspart application.”
CodeBlue also reported that since last February, MOH Putrajaya had already forecast a 21 per cent shortfall in its supply of human insulin for this year. The MOH receives supply of human insulin from two providers – Biocon and Novo Nordisk – at an 80:20 ratio.
“There is a problem which needs to be addressed regarding supply and demand, but also our willingness to pay for that supply. If we are always going to ‘race to the bottom’ for the supplier providing the cheapest but inconsistent supply and quality of medicine, we will continue to be vulnerable to such situations year on year,” Azrul said.
“There are only two options moving forward: increase funding for diabetes treatment (already costing triple compared to non-diabetes diseases) or decrease the number of patients who are diabetic and need to be on insulin.”
He stressed on the need to diversify Malaysia’s insulin supply, including imports when necessary.
The Galen Centre also suggested that the MOH charge patients copayments for insulin, perhaps RM50 for one month’s supply, citing a 2022 meta-analysis of 10 Malaysian studies that found low medication adherence of 34.2 per cent among people with Type 2 diabetes.
“This is not to penalise but to improve medication adherence,” Azrul said.
“It is likely that at least three out of five insulin vials supplied to patients are actually wasted. How do we reduce this and improve adherence so that lives can be saved? Co-pay is one way.”
