Abstract
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.
Keywords
expiry - quality control - homeopathic medicines - drug stability - active pharmaceutical
ingredient
