KUALA LUMPUR, August 26 — Dzulkefly Ahmad today blamed Biocon Biologics’ failure to meet its contractual obligations over supply of human insulin to the Ministry of Health (MOH) for the current shortage.
The health minister, however, did not specify if the Indian biosimilars company – which operates an insulin manufacturing plant in Johor, touted as Asia’s largest integrated insulin manufacturing and R&D facility – has been fined, or how much it has been fined, for non-delivery under MOH procurement rules.
“We want to make sure that despite the failure to fulfil their contractual obligations, we’re now talking to them again to ensure that they will have to provide, whether from the Johor plant or from India,” Dzulkefly told reporters today at the sidelines of the Malaysia International Healthcare Megatrends 2024 conference.
“We are in communication with the Indian principal, Biocon. So they must supply it – whether locally or overseas.”
The MOH signed two contracts for human insulin supply from April 29, 2022 to April 28, 2025: Biocon’s biosimilar insulin supplied by Biocon Sdn Bhd and Duopharma Sdn Bhd, as well as Danish pharmaceutical company Novo Nordisk’s originator insulin supplied by Pharmaniaga Logistics Sdn Bhd.
The procurement ratio is 80:20 for Biocon and Novo Nordisk insulins respectively.
Biocon Biologics’ insulin manufacturing facility in Malaysia doesn’t just supply the domestic market, but also the global market. According to Biocon’s 2023-24 integrated annual report, Biocon’s Johor plant received approvals from not just Malaysia’s National Pharmaceutical Regulatory Agency (NPRA), but also the United States’ Food and Drug Administration (FDA) and the European Medicines Agency (EMA), among other regulators.
Dzulkefly today downplayed the severity of the unprecedented human insulin shortage that has forced the MOH to plan to switch 45 per cent of eligible diabetes patients currently on human insulin treatment to SGLT2 inhibitors or insulin analogs. Such a significant policy change was not previously reported with insulin shortages in past years.
The Malaysian Medical Association (MMA) has expressed concern with the sudden transition to these more expensive alternative treatments, not just over cost, but with the fact that the switch is driven by necessity and not clinical preference.
“It’s not that kind of alarmist scenario by some media,” Dzulkefly told reporters, when asked if the supply of human insulin has “totally depleted”.
“It can last until the end of the year, but meanwhile, we’ll continue to get other suppliers.”
The health minister said although there is a shortage, he has not heard of patients not being prescribed human insulin.
Doctors, pharmacists, and patients have told CodeBlue about reduced supplies of human insulin for diabetes patients for at least the past three months since May, with patients given just two to three days or one week’s supply, instead of one month’s supply like usual.
Some public health care facilities, including Klinik Kesihatan, have already completely run out of insulin stocks.
“I wouldn’t want to believe that we’ll be in a crisis situation as such because we have other alternatives and we are getting other suppliers,” Dzulkefly said, citing insulin analogs, SGLT2 inhibitors, and oral antihyperglycemics.
He, however, acknowledged that diabetes patients are put on human insulin treatment because they’re no longer responsive to oral medications.
The health minister also claimed that the MOH has already “gotten commitment” from other human insulin suppliers, but did not specify if such drug makers have already participated in any new tender.
He simply promised a fast-track evaluation process by the NPRA of 60 days for human insulin products amid the current shortage, compared to the usual few months.
