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

["Vijay Thawani" <vijaythawani@rediffmail.com>]

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

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