KUALA LUMPUR, August 22 — The Ministry of Health (MOH) today minimised the role of human insulin in treating diabetes, amid a severe shortage crisis without the ministry estimating when supplies would recover.
Instead, the MOH said there are 41 diabetes medications in its formulary, with “only human insulin facing supply issues.”
“Therefore, as a whole, the MOH wishes to stress that diabetes management for MOH patients is not affected,” the MOH said in a statement posted on X by Health Minister Dzulkefly Ahmad.
“The recent disruption of supply of human insulin in MOH facilities was caused by manufacturing issues with the local supplier’s facility.
“To ensure continuity of treatment for patients, the MOH has taken several measures, including increasing the use of insulin analogs and oral therapies, based on clinical assessments by the treating doctor for each patient.”
Type 2 diabetes mellitus (T2DM) is a progressive condition, where over time, oral glucose-lowering drugs may lose their effectiveness. As a result, most patients eventually require combination therapy to achieve optimal glycaemic control.
This approach is also recommended by the Malaysian Clinical Practice Guidelines (CPG) for Type 2 diabetes. Insulin is commonly used in combination with oral agents due to its suitability across all age groups, flexibility in dosing regimens, and its cost-effectiveness compared to other treatment options.
Insulin analogs are significantly more expensive than human insulin. MOH’s statement today did not project the cost implications of switching patients from human insulin to insulin analogs.
CodeBlue previously reported Health director-general Dr Muhammad Radzi Abu Hassan’s circular issued yesterday on the MOH’s plans to switch 45 per cent of eligible diabetes patients currently on human insulin treatment to insulin analog or SGLT2 inhibitors; 55 per cent can remain on human insulin treatment, if there is enough supply.
SGLT2 inhibitors – which improve glycaemic control by causing the kidneys to remove sugar from the body through urine – are also much more costly than human insulin.
The Health DG’s circular further listed priority groups for insulin naive patients to begin insulin treatment: Type 1 diabetes patients, pregnant women, and patients with serious kidney failure.
The MOH today also cited its previous August 12 press statement on planned changes to its pharmaceutical procurement process that included an ability to review existing contracts in certain circumstances, such as the right to renegotiate prices and cheaper alternative product supplies compared to the contract product.
“For the medium- and long-term, the MOH is confident that insulin supply will be at an optimum level,” the ministry said in its statement, without specifying when that would be.
Far from attracting bids from drugmakers, the MOH’s August 12 statement proposing the government’s “right” to revise existing contracts is more likely to deter pharmaceutical companies, especially since Malaysia is a small market that might not be worth the risk of unexpected changes in contract terms.
The MOH cited ongoing efforts to diversify sources of insulin supply, urging interested local and foreign manufacturers and suppliers to register their insulin products with the National Pharmaceutical Regulatory Agency (NPRA) that would be prioritised in evaluations.
“NPRA shall expedite dossier assessment,” Dzulkefly added.
The only local manufacturer of human insulin in Malaysia is India’s biosimilars company Biocon Biologics that operates an insulin manufacturing facility in Johor. Eighty per cent of the MOH’s human insulin supply is from Biocon Biologics, while the remaining 20 per cent is supplied by Denmark’s pharmaceutical giant Novo Nordisk.
It is unclear if Novo Nordisk has opted not to renew or bid for a new contract to continue supplying insulin to Malaysia.
Following CodeBlue’s report yesterday on Malaysia’s severe insulin shortage, complaints by MOH staff have emerged online, as well as to CodeBlue directly, about how some public health care facilities, including Klinik Kesihatan, have already completely run out of the lifesaving diabetes drug.
MOH’s Pharmacy Services Programme also held a virtual emergency meeting last night with nearly 500 ministry staff nationwide to discuss the insulin shortage crisis.
“To ensure public welfare, the MOH will not compromise on issues that threaten the supply of medicines that are an important aspect of health care,” said the MOH.
