WHO's there? Pharmaceutical branding in India
Patents are portrayed and envisioned as the indispensable reward to compensate pharmaceutical firms for the large cost, risk and years of research that are put into drug discovery and development. However, this monopoly right comes with an expiration period. Brand loyalty towards a trademark of an off-patent drug can enable the manufacturer to enjoy indefinite benefits from a patent beyond its expiration.
However, brand loyalty and extensive marketing may lead to market monopolisation, a barrier that is very difficult for generic drug manufacturers to overcome. From a public health perspective this has numerous downsides.
For instance, it may lead to physicians prescribing brand-name drugs instead of generic substitutes. It can result not only in suppression of competition and reduction in consumer choice, but also in an increase in the price of drug to make up for the pharma company’s investment in aggressive brand promotion.
The International Nonproprietary Names (INN) programme was established by the World Health Organization (WHO) to assign non-proprietary names to pharmaceutical substances so that each substance would be recognised by a unique name.
The World Health Assembly endorsed resolution WHA 46.19 which states that trademarks should not be derived from INNs, and INN stems should not be used in trademarks. The assembly reasoned that such practice could frustrate the rational selection of INNs and ultimately compromise the safety of patients by promoting confusion in drug nomenclature.
Regulation of INN in India
The Drugs and Cosmetics Act 1940 and the Drugs and Cosmetics Rules 1945 regulate the marketing approval, manufacture and distribution and sale of drugs in India. As per the rules, the proper name of the drug is required to be printed in a more conspicuous manner than the trade name, which must appear immediately aft er or under the proper name.
However, it is pertinent to point out here that INNs are considered to be the proper name of the drug only where the concerned drug does not have any name under Schedule F, the official pharmacopoeia, or the National Formulary of India.
