• Users Online: 160
  • Print this page
  • Email this page
ORIGINAL ARTICLE
Year : 2020  |  Volume : 7  |  Issue : 2  |  Page : 75-79

A study to evaluate ayurveda product labels for their compliance as per drug and cosmetic rules 1945, rule 161(B)


Central Ayurveda Research Institute, CCRAS, Bengaluru, Karnataka, India

Correspondence Address:
Dr. Raghavendra Naik
#12, Manavarthekaval, Kanakapura Main Road, Talaghattapura Post, Bengaluru - 560 109, Karnataka
India
Login to access the Email id

Source of Support: None, Conflict of Interest: None


DOI: 10.4103/AYUHOM.AYUHOM_21_21

Rights and Permissions

Background: Product labels are considered as clinical instruction manual which plays a vital role in providing information to the prescriber and end-user at a glance. As Ayurvedic drugs fall under the purview of the Drugs and Cosmetics Act, 1940, a set of quality criteria-based information is required to be displayed on the labels of Ayurvedic product containers marketed in India. Aim and Objective: In the present study, containers of different Ayurvedic products dispensed at Government hospitals and sold at private pharmacies in Bangalore were selected and checked for their compliance with labeling guidelines as mentioned in Drugs and Cosmetic Act 1940. Results: Among 150 selected products, 78 products were classical preparations and 72 were proprietary medicines. Among the fourteen criteria derived from labeling guidelines mentioned in drugs and cosmetic act, all the 150 products were following the standard guidelines with respect to the six basic criteria like name and address of the manufacture, net weight of the formulation, batch number, license number, date of manufacture and mentioning of the word Ayurvedic medicine. Conclusion: Even though majority of the labels of Ayurvedic drug containers fulfilled the requirements, a good number of Ayurvedic products are still not in accordance with the regulatory requirements in providing label information. Following a strict compliance in some labeling specifications like providing complete details of ingredient with their net weight in metric system, displaying the caution warning for formulations containing schedule E 1 drugs, providing the expiry date, and citing the reference from authentic texts in case of classical formulations is still lacking.


[FULL TEXT] [PDF]*
Print this article     Email this article
 Next article
 Previous article
 Table of Contents

 Similar in PUBMED
   Search Pubmed for
   Search in Google Scholar for
 Related articles
 Citation Manager
 Access Statistics
 Reader Comments
 Email Alert *
 Add to My List *
 * Requires registration (Free)
 

 Article Access Statistics
    Viewed257    
    Printed10    
    Emailed0    
    PDF Downloaded26    
    Comments [Add]    

Recommend this journal