EUROPEAN JOURNAL OF
PHARMACEUTICAL AND MEDICAL RESEARCH

( An ISO 9001:2015 Certified International Journal )

An International Peer Reviewed Journal for Pharmaceutical, Medical & Biological Sciences

An Official Publication of Society for Advance Healthcare Research (Reg. No. : 01/01/01/31674/16)

European Journal of Pharmaceutical and Medical Research (EJPMR) has indexed with various reputed international bodies like : Google Scholar , Indian Science Publications , InfoBase Index (In Process) , SOCOLAR, China , Research Bible, Fuchu, Tokyo. JAPAN , International Society for Research activity (ISRA) , Scientific Indexing Services (SIS) , Polish Scholarly Bibliography , Global Impact Factor (GIF) (Under Process) , Universal Impact Factor , International Scientific Indexing (ISI), UAE  , Index Copernicus , CAS (A Division of American Chemical Society) USA (Under Process) , Directory of Open Access Journal (DOAJ, Sweden, in process) , UDLedge Science Citation Index , CiteFactor , Directory Of Research Journal Indexing (DRJI) , Indian citation Index (ICI) , Journal Index (JI, Under Process) , Directory of abstract indexing for Journals (DAIJ) , Open Access Journals (Under Process) , Impact Factor Services For International Journals (IFSIJ) , Cosmos Impact Factor , Jour Informatics (Under Process) , Eurasian Scientific Journal Index (ESJI) , International Innovative Journal Impact Factor (IIJIF) , Science Library Index, Dubai, United Arab Emirates , Pubmed Database [NLM ID: 101669306] (Under Process) , IP Indexing (IP Value 2.40) , Web of Science Group (Under Process) , Directory of Research Journals Indexing , Scholar Article Journal Index (SAJI) , International Scientific Indexing ( ISI ) , 

 ISSN 2394-3211

Impact Factor: 6.222

 ICV - 79.57

Abstract

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.


[Full Text Article]

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Google Scholar Indian Science Publications InfoBase Index (In Process) SOCOLAR, China Research Bible, Fuchu, Tokyo. JAPAN International Society for Research activity (ISRA) Scientific Indexing Services (SIS) Polish Scholarly Bibliography Global Impact Factor (GIF) (Under Process) Universal Impact Factor International Scientific Indexing (ISI), UAE Index Copernicus CAS (A Division of American Chemical Society) USA (Under Process) Directory of Open Access Journal (DOAJ, Sweden, in process) UDLedge Science Citation Index CiteFactor Directory Of Research Journal Indexing (DRJI) Indian citation Index (ICI) Journal Index (JI, Under Process) Directory of abstract indexing for Journals (DAIJ) Open Access Journals (Under Process) Impact Factor Services For International Journals (IFSIJ) Cosmos Impact Factor Jour Informatics (Under Process) Eurasian Scientific Journal Index (ESJI) International Innovative Journal Impact Factor (IIJIF) Science Library Index, Dubai, United Arab Emirates Pubmed Database [NLM ID: 101669306] (Under Process) IP Indexing (IP Value 2.40) Web of Science Group (Under Process) Directory of Research Journals Indexing Scholar Article Journal Index (SAJI) International Scientific Indexing ( ISI )