The TGA has tested a range of human insulin products. All of the products tested met the applicable quality standards.
Human insulin preparations made from yeast and bacterial cells into which the human gene has been inserted, are some of the most widely used medicines for management of Type 1 and 2 diabetes.
Following a consumer enquiry quoting a report[1] from the USA that human insulins were found to have inadequate insulin content when sourced from local pharmacies, the TGA has undertaken a survey of some human insulin products marketed in Australia to assess the quality and content of the locally available human insulins.
Samples from the same batch were obtained from the product sponsors, and from pharmacies in the Canberra and Capital region, for each of three products, and then tested in parallel. Matching batches were not available for the fourth product, but different batches from the sponsor and pharmacy were tested together. The products were tested using methods described in the British and European Pharmacopoeias, and their labels were checked for compliance against Australian requirements.
The survey test results showed that all the samples contained the correct amount of active insulin, and all impurities tested for were well below the allowable limits. All samples were appropriately labelled.
Conclusion
Samples of insulin products purchased from the pharmacy were highly comparable to those from the sponsor's warehouse, indicating that there had been no deterioration in the quality of the products during distribution.
| Product name | Sponsor | Source of sample | Tests performed | Results |
|---|---|---|---|---|
Humulin 30/70 100 IU/mL cartridge | Eli Lilly Australia Pty Ltd | Sponsor's warehouse | Purity Content Label Checks | PASS Meets quality standards |
| Pharmacy | PASS Meets quality standards | |||
Humulin R 100 IU/mL cartridge | Sponsor's warehouse | PASS Meets quality standards | ||
| Pharmacy | PASS Meets quality standards | |||
Mixtard 30/70 100 IU/mL cartridge | Novo Nordisk Pharmaceuticals Pty Ltd | Sponsor's warehouse | PASS Meets quality standards | |
| Pharmacy | PASS Meets quality standards | |||
Actrapid Penfill 100 IU/mL cartridge | Sponsor's warehouse | PASS Meets quality standards | ||
| Pharmacy | PASS Meets quality standards |
The products tested were Humulin 30/70 and Humulin R from the sponsor Eli Lilly Australia, and Mixtard 30/70 and Actrapid from the sponsor Novo Nordisk Pharmaceuticals. Samples of each product were sourced from both the sponsor's warehouse and a pharmacy. Each sample was tested for purity, content, and label compliance. All samples from both the sponsor's warehouse and pharmacy passed all tests and checks, and so meet the required quality standards.
Footnotes
| [1] | Carter A.W. & Heinemann L. Insulin concentration in vials randomly purchased in pharmacies in the United States: Considerable loss in the cold supply chain. J Diabetes Sci Technol. 2018;12(4):839-841 with response to letters to the Editor: Carter AW; Heinemann L. Journal of Diabetes Science & Technology. 2018;12(5):1072-1077. |
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