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
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.
Join in Network for Rational Use of Medicines (NetRUM) E-discussions at
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.