Publication:

An audit of drug package insert: a survey based study in India

Background The primary source of drug information is a Package Insert. It is a printed leaflet that contains information based on regulatory guidelines for the safe and effective use of a drug. It is also known as prescription drug label or prescribing information. Regulatory requirements for drug package inserts or leaflets vary across nations. United States-Food and Drug Administration (US-FDA) and European Medicines Agency (EMA) amend their regulations governing the content and format of labelling for drug products from time to time. US-FDA has published a revised guideline in the Federal Register of January 2006, which is being followed by pharmaceutical industry of the country.

Methods Around 192 package inserts were collected from pharmacies located at different areas. They were analyzed according to Sections 6.2 and 6.3 of Schedule D of Drugs and Cosmetics Rules, 1945.

Results Out of 192 package inserts, most available information in therapeutic indications is Posology and method of administration (97.3%) followed by Contra-indications(93.2%) in pharmaceutical information, it is Special precautions for storage (77%) followed by Shelf life in the medical product as packaged for sale (33.8%).

Conclusions Contents of the package inserts should be complete, reliable and up to date. This can be a step forward for ethical and effective dissemination of healthcare services in our growing society. Therefore, recommended to update the existing package inserts based on criteria mentioned in the Schedule D of Drug and Cosmetic Act, 1945.