GUIDELINES AND REGULATORY REQUIREMENTS FOR LABELLING AND PACKAGING OF INJECTIONS IN USA, EUROPE, INDIA AND CANADA

Reena B. S. Chaudhary*, Dr. Ronak Dedania and Dr. Vineet Jain

ABSTRACT

Labelling and packaging are beneficial description of the products which is very useful for the consumers to distinguish the products from others. Consequently, these are the unique identity of the product. Now a day, it becomes a habit of most of the population to see the product label before they go for purchase. 25% of total all medication errors are due to name confusion, and 33% due to packaging and/or labelling confusion. This article describes about various guidelines and regulatory requirements for injectable dosage forms in USA, Europe, India and Canada according to their code of regulations. In the USA, the content & format requirements of labelling and packaging comes under 21 CFR Part 211, Subpart G - Packaging and Labelling Control. In the India, Rule 97 of D & C Act, 1940 and Rules, 1945 requires specific caution statements to be present on label for the different drug schedules. Recently, updates on the amendments made on the drugs and cosmetics rule 1945 (amendment rules 2018) on labelling of medicines rules 96 & 97. In the Europe, Article 54 labelling and package leaflet of directive 2001/83/EC of Europe. In the Canada, The Canadian Consumer Packaging and Labelling Act Provide the Information Which Appears on The Package/Label of Injections. The inner label affixed to an immediate container of the drug. The outer label includes any label affixed to the drug packaging, including a pouch, card, accordion label, or other construct.

Keywords: Injection, Labelling, Packaging, Requirements, USA, Europe, India and Canada.