KUALA LUMPUR, August 21 — An insulin shortage crisis has hit Ministry of Health (MOH) facilities nationwide, due to reported supply issues with local manufacturer Biocon Malaysia that’s owned by India’s Biocon Biologics Limited.
CodeBlue understands that the supply of human insulin – a lifesaving medication for millions of Malaysians with diabetes – is especially dire in Selangor; there are also reports of shortages in Kuala Lumpur and at least three other states: Johor, Melaka, and Kedah.
After patients began receiving reduced insulin supplies in some government health clinics as early as three months ago in May, the shortage of the crucial diabetes treatment has now reached critical levels, with certain public health care facilities now expected to completely run out of insulin stocks this week.
“Medical officers and pharmacists in clinics have been told to stop increasing or starting insulin for patients who need it. They’ve also been instructed to stop insulin if patients are not complying with the treatment,” a government doctor named Dr Jackie (pseudonym) told CodeBlue last Sunday.
“The availability of alternative options like SGLT2 inhibitors and insulin analog is very limited and wouldn’t meet the insulin needs of these patients. If this isn’t resolved in the next few days, we’ll run out of insulin stocks, leaving patients without their necessary supply. These patients are at a very high risk of a hyperglycemic crisis, like DKA and HHS.”
DKA (diabetic ketoacidosis) and HHS (hyperosmolar hyperglycemic state) are both life-threatening diabetes complications related to high blood sugar (hyperglycemia).
Dr Jackie said patients have been asked to get their human insulin every two to three days or are given one vial of insulin (300 units or 3ml) at the most.
In Melaka, some public health clinics have been giving patients an insulin bottle (1,000 units or 10ml) instead, which, according to Dr Jackie, can risk overdose.
Unlike insulin vials or cartridges that are used with pens dispensing pre-set doses, patients need to calculate insulin dosage and manually draw the product from insulin bottles using a 1ml syringe (unless they use insulin syringes with units labelled).
“Patients have to figure out exactly how much to put in the syringe, which is dangerous because every 1 unit of Actrapid, for example, is equivalent to 0.01 ml of Actrapid, which is difficult to measure and syringe out. The patient could easily syringe out 0.1 ml, or worse, 1 ml, and overdose on Actrapid,” said the doctor.
“Although technically, patients given a bottle have larger amounts of insulin, practically, it is actually more dangerous because of the small margin of error when calculating the dose and injecting it.”
A government pharmacist similarly said some MOH centres, like Sungai Buloh Hospital, are currently restricted to providing patients one vial of insulin per visit, forcing them to return weekly to maintain their treatment regimen.
“This situation is not new; it seems to be a yearly crisis, yet no effective long-term solution has been implemented,” the pharmacist named Blair (pseudonym) told CodeBlue, noting that an insulin supply disruption with Biocon was previously reported in 2020.
“The current supplier, Biocon, has consistently struggled to meet the demand, leaving patients and health care providers in a challenging position. Despite this being a recurring problem, there appears to be no clear backup plan in place by the Pharmacy Programme Management.
“The lack of action and foresight is deeply concerning, especially considering the critical nature of insulin in managing diabetes.”
Patient Complains About Biocon’s Insulin Quality with Higher Blood Sugar Levels
A 42-year-old patient named Nizam (pseudonym) received just one vial of insulin from a Klinik Kesihatan in the Petaling district in Selangor last June 21, when he was told that he would have to return an empty vial to the pharmacy after one week in order to get fresh insulin supplies.
Nizam, however, has been getting insulin every month from Universiti Malaya Medical Centre (UMMC) since May, when he underwent a heart bypass surgery at the university hospital.
The patient complained about the quality of Biocon’s biosimilar insulin that his MOH health clinic switched to last April from originator insulin by Novo Nordisk, a Danish multinational pharmaceutical company. UMMC provides Nizam with Novo Nordisk’s insulin.
“My blood sugar levels went up – despite injecting insulin with the same dosage – from an average of 5 to 6 to 8 to 9 before breakfast,” he said, referring to Biocon’s insulin.
One vial has 300 units (3 ml) of insulin. Nizam’s prescription from his Klinik Kesihatan was for 40 units of insulin a day (280 units a week), based on his doctor’s instructions, after an initial 48 units daily (336 units a week). But when his blood sugar didn’t go down, Nizam increased his insulin injections back up to 48 units a day.
“I’m lucky because after my heart surgery at UMMC, they supplied me with better quality insulin than MOH.”
Nizam, who runs a food business from home, said the university hospital charges more for insulin at RM22 for a month’s supply, compared to RM1 for six months’ supply from the MOH. “That’s why I go to MOH to get my insulin.”
Gombak PKD’s Insulin Stock Below Minimum Levels, Johor Klinik Kesihatan’s Insulin Stock Still Insufficient
A pharmacist at a Klinik Kesihatan in Johor said their clinic can only provide patients at least two vials or about one week’s supply per visit for all three types of human insulin products: Insugen-R (Actrapid brand name), Insugen-N (Insulatard brand name), and Insugen-30/70 (Mixtard brand name).
“I’m rather concerned because we can’t even give one month’s supply of insulin,” the pharmacist named Ali (pseudonym) told CodeBlue last week, adding that this reduced supply began sometime around last May.
“Even if we get new insulin stocks, our current stocks are still insufficient.”
A July 31 email from a health pharmacy officer at the Gombak district health office (PKD) in Selangor, as sighted by CodeBlue, announced a restriction on insulin supplies to patients at all public health clinics in the district.
“For your information, as we have yet to receive the status of insulin stocks from the supplier and the remaining available stocks are below the minimum stock levels, the Pharmacy Units in all Klinik Kesihatan in Gombak PKD are forced to limit supply quantities to patients as follows.”
Insugen-N was limited to one week’s supply per patient, and Insugen-R and Insugen-30/70 to one cartridge (100 units of insulin) per patient. If a patient like Nizam injects 40 to 48 units of insulin a day, getting one cartridge would last for only two days.
Back In February, MOH Estimated 21% Shortfall In Human Insulin Supply For This Year
From early 2024, the MOH had already forecast a 21 per cent shortfall in the overall supply of recombinant synthetic human insulin for the year: Biocon’s biosimilar insulin (Insugen-30/70, Insugen-R, and Insugen-N) supplied by Biocon Sdn Bhd and Duopharma Sdn Bhd, and Novo Nordisk’s originator insulin (Mixtard, Actrapid, and Insulatard) supplied by Pharmaniaga Logistics Sdn Bhd.
Through Biocon Sdn Bhd, Biocon Biologics under Biocon Limited, India’s biggest biopharmaceutical company, set up a US$350 million (RM1.5 billion) insulin facility in Johor in 2016. Biocon’s website describes the 562,000 sq ft facility as Asia’s largest integrated insulin manufacturing and R&D facility.
“As the only insulin manufacturer in Malaysia, Biocon Sdn Bhd has been able to ensure insulin self-sufficiency for Malaysia and improve insulin access while providing savings to its partner, Ministry of Health (MOH), Malaysia,” according to Biocon’s website.
The MOH’s contracts for Biocon and Novo Nordisk insulins – from April 29, 2022 to April 28, 2025 – set the procurement ratio at 80:20 respectively.
“Based on Biocon’s planning for 2024, the company is able to make supplies exceeding the average monthly orders received in 2023,” Wan Noraimi Wan Ibrahim, director of MOH’s Pharmacy Practice & Development Division, wrote in a February 16 letter, as sighted by CodeBlue.
For Novo Nordisk insulin, the first additional quantity for the contract was implemented in April 2023, fulfilled 100 per cent in early January 2024.
The MOH then requested a second additional quantity of 800,000 boxes of 5s, equivalent to three months’ demand in 2023 for Novo Nordisk insulin. But the company would not supply 800,000 boxes of 5s in one go, instead setting supply as low as 56,000 boxes of 5s per month, equivalent to 0.2 month’s demand.
“Seeing that this quantity is rather limited, distribution will be made only to identified facilities,” said the Pharmacy Practice & Development Division in its February letter.
“Based on several engagement sessions with Pharmaniaga Logistics Sdn Bhd (PLSB) and Novo Nordisk Sdn Bhd (Novo Nordisk), the principal cannot give any guarantee of making offers if the Ministry advertises a new tender, due to supply issues at the global level.”
As MOH’s February letter indicated no expected problems with Biocon insulin supply for the year, it is unclear how “production problems” with the local manufacturer, as characterised by MOH internal communications this month, later cropped up.
Biocon Biologics: Second Phase Of Manufacturing Facility Underway
Biocon Biologics did not specifically answer CodeBlue’s questions about the scale of the company’s insulin supply disruption for the MOH, the cause of the disruption, or when supply could recover.
Instead, the Indian global biosimilars company simply said it has provided the MOH over 87 million insulin cartridges and served the needs of nearly 300,000 people with diabetes in Malaysia, since the opening of its Johor insulin manufacturing facility in 2016.
“In anticipation of the increase in demand for insulins, we had started expanding our capacity in Malaysia last year with an additional investment of US$250 million (RM1.1 billion). This second phase of the facility is underway and the Drug Product facility is currently undergoing the qualification process,” Biocon Biologics site head (Malaysia) Joe Sian told CodeBlue in a statement.
“It is expected to be ready for approvals by MOH early next year. Once ready, it will double the company’s capacity, thus enabling us to cater to the additional demands for human insulin and insulin glargine.”
Sian also said the Biocon Biologics insulin manufacturing facility in Malaysia had state-of-the-art R&D, quality assurance, quality control labs, and a “very robust” quality management system.
“As a part of its pharmacovigilance practice, the Company diligently monitors all the ADRs (adverse drug reactions) that are reported. There have been no reports of suspected adverse reactions, suggesting notable product quality related issues, regarding our insulins, in Malaysia.”
Biocon Biologics further noted that since its entry into Malaysia, prices of human insulin have dropped by over 40 per cent and insulinisation has improved by 30 per cent, according to a market study.
“Despite the capital-intensive nature of insulin production, Biocon Biologics has succeeded in expanding access to insulin therapy by pursuing an innovation strategy that is rooted in affordability. As the first and only insulins manufacturing facility in Malaysia, our commitment to the people of Malaysia is paramount.”
MOH Considers Switching Patients To Oral Medication Or Insulin Analogs
CodeBlue understands that the MOH was considering, about a fortnight ago, switching diabetes patients from human insulin to either oral antihyperglycemics or insulin analogs, amid the “urgent” situation with a risk of “failing to provide any insulin to patients” if supplies did not recover.
It is unclear if MOH Putrajaya has made a decision yet or if some public health care facilities have already begun switching patients from insulin to oral medicines. CodeBlue has requested comments from the ministry.
A clinical pharmacist named Darcy (pseudonym) raised problems with both alternatives of oral medications and insulin analogs.
Darcy explained that insulin is typically initiated in patients with poor glycemic control, either as monotherapy or in combination with oral antihyperglycemics.
“Starting insulin can be challenging because many patients find it inconvenient and are often fearful of injections, despite insulin’s effectiveness and relative safety in achieving glucose control. Switching these patients back to oral medications could negatively impact their outcomes, as oral agents may not provide the same level of control,” the clinical pharmacist told CodeBlue.
“Additionally, it can be frustrating for both patients and health care providers to reverse the decision to use insulin after significant effort has been invested in counselling and overcoming the initial resistance to insulin therapy.”
As for insulin analogs, Darcy noted significant advantages like a reduced risk of hypoglycemia (low blood sugar) and more convenient dosing schedules.
“However, its high cost is a critical factor, as insulin analogs are significantly more expensive than human insulin. Transitioning from human insulin to insulin analogs could severely impact health care budgets due to this substantial cost difference.
“Furthermore, decisions on whether to maintain or revert back to human insulin after supply issues are resolved should also be carefully considered, balancing both clinical benefits and financial constraints.”
The clinical pharmacist said most clinical guidelines recommend initiating insulin in patients with poor glycemic control that cannot be managed with oral antihyperglycemics alone.
“Patients with very poor glycemic control are at risk for serious complications, such as kidney failure, stroke, and more. These risks are key counselling points when advising patients to start insulin. Reverting this decision could cause confusion, leading patients to question the necessity of insulin.
“Moreover, requiring patients to visit the pharmacy weekly for refills would likely reduce compliance, particularly among working patients. It’s unreasonable to expect patients to adhere to their treatment when we cannot provide a convenient and consistent supply.”
According to the National Health and Morbidity Survey (NHMS) 2023, about 15.6 per cent of Malaysian adults (3.6 million people) have diabetes.
