The World Health Organization (WHO) has objected to the practice of Indian pharmaceutical companies misusing international non-proprietary names (INN)as trademark protected brand names.
The WHO feels that the practice is not only against international ethics, but also increases the risk of wrong medication.
INNs are names that help to identify the chemical composition of a pharmaceutical substance without having to use long and unwieldy chemical names.
These are internationally recognised names that can be used by all without claiming any proprietary rights. They help in easy identification of a drug thereby reducing confusion in drug nomenclature, which is an essential element of drug safety.
In a recent letter to the Drugs Controller General of India (DCGI), the WHO has expressed concern over a trademark application filed by Cadila Pharmaceuticals for “platin”, a common name that is used for at least 18 medicines. Cadilla officials were not available for comment.
“The registration of platin as trademark is particularly harmful, since it is identical to the INN stem (a portion of INN) ‘-platin’ used for antineoplastic agents, platinum derivates. Moreover, there are already 18 INNs ending with ‘-platin’. It is therefore important that such well-established INN stems should not be allowed to be used in or as trade-marks,” Raffaella Balocco Mattavelli, manager of the INN Programme, Quality Assurance and Safety Medicines, WHO, said in the letter.
Cisplatin, Oxaliplatin and Carboplatin are some of the commonly used varieties of cancer medicines. The WHO wants the DCGI to prevent Cadila’s attempt to secure brandname protection for “-platin”.
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This is not the first time the WHO is bringing the issue of misuse of INNs before the notice of the DCGI. During the current year, it has objected to the use of three other names, Docetax for being similar to the INN docetaxel, Prazole for being an INN by itself and Nanotaxel for including the INN stem ‘-taxel’, and had wanted the Indian drug regulatory authorities to take remedial measures.
According to WHO sources, most of the developed countries and several developing countries refuse to provide trademark protection to INNs or its stems as they are generic names that can be used by everyone.
“Sri Lanka refuses to register a brand name that carries INN stem as it will cause confusion and also prescription error,” a WHO official said.
Though WHO resolution calling for non-use of INN as brand names is not binding on member countries, Indian Trade Marks Act prohibits registration of words that are INNs or that are deceptively similar to such names, sources said.
According to a study on India’s use of INNs conducted by the Centre for Trade and Development (Centad), the use of INNs as trademarks can dilute the INN system by creating confusion in drug nomenclature. Since trade marks enjoy legal protection unlike INNs, the use of INN stems may thwart the coining of new INNs by WHO,” the study noted.
The study has listed 80 instances of such INN violations by Indian companies in the last seven years. In all these cases, WHO complaints had evoked little response.