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

ASSESSMENT OF COMPLIANCE OF DRUG LABELS IN INDIA WITH ‘THE DRUGS AND COSMETIC ACT AND RULES’ GUIDELINES

Ashok Kumar Sharma and Amol Khanapure*

ABSTRACT

Background: Information mentioned on innermost container of a drug is most important for the dispenser as well as consumer. The Drugs and Cosmetic Act and Rules mention guidelines for labelling of innermost container of drugs but it has been observed that the compliance to these is often low. Since there are only few studies available to assess the compliance with these guidelines, the present study was planned. Materials and Methods: A total of 100 dosage forms from various categories were randomly collected from drug selling / dispensing units or physicians and included in the study for assessment of compliance of their labels with the guidelines mentioned in „The Drugs and Cosmetic Act and Rules‟. Results: Proper name was more conspicuous than trade name in 14.82% non-generic preparations; while trade name was under and after proper name in 96.3% in these preparations. Pharmacopoeia name was present in 88% preparations; while correct statement of net contents was mentioned in 69% preparations. Red vertical line was observed in 97.40% preparations. Preparations containing Schedule G drug had compliance for „Caution‟ as 100%. Preparations containing Schedule H drug had compliance for symbol „Rx‟ as 77.65% and for warning as 98.82%. Preparations containing Schedule H1 drug had compliance for „Rx‟ in red and warning in red box as 100%. Other particulars with 100% compliance were content of active ingredients, name and address of the manufacturer, batch number, manufacturing licence number, date of manufacture and expiry, „Physician‟s sample- Not to be sold‟ on preparations which were Physician‟s sample and „FOR EXTERNAL USE ONLY‟ on preparations meant for external application. Conclusion: From the above findings, it may be concluded that majority of drug labels were not compliant with the guidelines given by The Drugs and Cosmetic Act and Rules. Strict adherence is necessary to ensure safe, effective and rational use of medicines.

Keywords: Drug labels, The Drugs and Cosmetic Act and Rules, Compliance.


[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 )