Current Status of Expiry of Homeopathic Medicines in Brazil, Germany, India and the United States: A Critical ReviewFunding None.
25 October 2018
24 April 2019
29 July 2019 (eFirst)
Background Assignment of expiry date to homeopathic medicines is a subject of important concern to its pharmacists and practitioners. This study compares the regulatory framework for the expiry of homeopathic medicines in four countries: Brazil, Germany, India and the United States.
Findings Different or no expiry periods are variously followed. Whereas Germany, with some exceptions, employs a maximum expiry of 5 years for both potencies and finished products, Brazil adopts a 5-year expiry for finished products only, potencies used in manufacture being exempted from an assigned expiry date. In India, all homeopathic medicines except dilutions and back potencies have a maximum of 5 years' shelf-life, including those supplied to consumers. In the United States, homeopathic medicines are exempted from expiry dates.
Comments There is neither a rational basis nor scientific evidence for assigning a short (3–5 years) expiry period for homeopathic medicines as followed in some of the countries, particularly in light of the fact that some studies have shown homeopathic medications to be effective even after 25 years. Homeopathic ultra-dilutions seem to contain non-material activity that is maintained over time and, since these exhibit different chemical properties compared to the original starting material, it is quite possible they possess properties of longer activity than conventional medicines. Regulators should acknowledge this feature and differentiate expiry of homeopathic medicinal products from that of conventional drugs.
Keywordsexpiry - quality control - homeopathic medicines - drug stability - active pharmaceutical ingredient
• Regulatory frameworks for expiry of homeopathic medicines in Brazil, Germany, India and the United States are compared.
• A short expiry of 3 to 5 years, to exemption from expiry, is followed across these countries.
• There are differences in the physico-chemical properties and stability aspects of UHDs compared with homeopathic low potencies; scientific studies and clinical experience indicate that UHDs possess a longer shelf-life.
• Regulatory bodies should consider this aspect by differentiating UHDs from low potencies, and also from conventional medicines.
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