Abstract

HOW EXPIRED ARE THE EXPIRED DRUGS: THERAPEUTIC, REGULATORY & FINANCIAL IMPLICATIONS

Dr. M. C. Gupta* and Dr. Jyoti Sharma

ABSTRACT

Expiry date is the date until which the drug manufacturer can guarantee that the medicine is fully potent and safe to take based on scientifically-sound product testing. If the drugs are stored under optimal conditions, they may retain 90% of their potency for at least five years after the labeled expiration date. However, expiry date is important for both manufacturers as well as consumers. From the companies' perspective, any liability or safety risk is diminished by limiting the period during which a consumer might misuse or improperly store a drug. Moreover, any new warnings or indications, newer devices for drug delivery; newer strength of the drug may not be brought to the market for the benefit of consumers if the older ones will not be expired/discarded. The expiration dates are very conservative to ensure that the patients get everything they paid for. A manufacturer could extend expiration periods again and again, but to support those extensions, it would have to keep doing stability studies and keep more in storage than it would like. Stability has for long been a major problem with Indian drugs due to improper storage conditions. Whether or not an expired drug can be safely taken depends on several factors like the way the drug is stored and the stability of its active ingredients or the condition for which it is being used. Therefore, it is not advisable to take expired medicines, without fully understanding the consequences.

Keywords: Expiry date, Stability, Storage.