e-drug
[Top] [All Lists]

[e-drug] Should INN stems be used in brand names?

E-DRUG: Should INN stems be used in brand names? 
----------------------------------------------

The 46th WHO Assembly in 1993 requested member States to "develop policy 
guidelines on the use and protection of international nonproprietary names 
(INN), and to discourage names derived from INNs, and particularly names 
including established INN stems as trade marks" (resolution WHA 46.19) as such 
use can frustrate the rational selection of further INNs for related 
substances, and it will ultimately compromise the safety of patients by 
promoting confusion in drug nomenclature (WHO. Marketing authorization of 
pharmaceutical products with special reference to multisource (generic) 
products: A manual for drug regulatory authority. Regulatory support series, 
No.5. WHO Geneva; 1999). The Drug Regulatory Authorities (DRAs) or Member 
States have the authority to disallow a trade name if it is misleading. 

The INNs are a public property (Essential Drug Monitor, WHO; 30:2001:P24) but 
that does not mean that pharma companies can use the stems for coining their 
brand names.  The stems are meant to guide selection of new generic names for 
substances that belong to an established series of related compounds. The list 
of common stems for INN for pharmaceutical substances, for which chemical or 
pharmaceutical categories have been established, is available. The list aims to 
encourage consistency in designation of generic names (WHO. The use of common 
stems in the selection of international nonproprietary names (INN) for 
pharmaceutical substances, WHO/EDM/QSM/99.6,2000,137 p) and certainly is not 
meant for the industry to misuse the popularized and well known stems.
 
To explain the misuse of stem and its resultant impact, here is an example 
where ORS has been wrongly used in brand naming entirely a different product in 
India. We have been  witnessing   promotion of ORS-LTM an electrolyte energy 
drink with vitamin C in ready to serve tetra packs, which the manufacturer 
(http://www.jagdale.com/juggat.html) recommends for many conditions other than 
diarrhea (Advertisement in Cumulative Index of Medical Specialities (CIMS) of 
M/s Juggat Pharma Bangalore,India. 2007 ; Jan-Apr: 523). During a recent home 
survey I encountered a literate, multimillionaire respondent administering this 
product to his grandchild suffering from diarrhea. On questioning, he explained 
it was a ready to drink ORS which was more palatable and convenient to store in 
refrigerator in tetra pack! Trade mark of a brand name based on INN and 
particularly that based on established stem, defeats the very basic purpose of 
INN nomenclature. 

The question is why DRAs are not using the authority of disallowing such brand 
names? Either they are so dumb that they do not understand the importance and 
implications of this? In that case they have no business to be in the chairs. 
Or their myopic eyes are intentionally under ptosis to let the industry fool 
around with the publics. Either way, the state of affairs are indicative of 
affairs of such States. 

Dr Vijay Thawani, Nagpur, India.
vijaythawani@rediffmail.com

------------------------------------------------
Join in Network for Rational Use of Medicines (NetRUM) E-discussions at 
http://health.groups.yahoo.com/group/netrum

11-20 July : Problems in choice of brand names.
Moderator - Dr Anupama Sukhlecha
 
21-30 July : How to succeed with National Pharmacovigilance Programme? 
Moderator - Dr Manoj Swaminathan.


<Prev in Thread] Current Thread [Next in Thread>
  • [e-drug] Should INN stems be used in brand names?, Vijay Thawani <=