The New Delhi-based Centre for Trade and Development (Centad) has triggered a debate over the appropriateness of using part of International Nonproprietary Names (INNs) in the brand names of drugs. The debate comes in the wake of the resolution of World Health Assembly (WHA) to request member states to develop policy guidelines on the use and protection of INNs and to discourage the use of names derived from them, particularly names including established stems, as trade marks.
The Centad is soon to finalise a study on "Use of INNs in India" to provide more clarity into the whole issue of INNs. The draft report of the study notes the presence of several brand names derived from INNs, including use of INN stems, in the country. The draft of Centad clearly shows about 80 instances where World Health Organisation (WHO) had sent INN protection letters to the Drugs Controller General of India. All these letters have a mention of the use of INN derived brand name by domestic companies.
The companies whose brand names have come under WHO scrutiny cut across all sectors - small, medium and big - of domestic pharmaceutical industry. The letters which were sent during 2005-06 takes note of Diltiaz-30 (Plethico Pharmaceuticals), Tripride, Valsar & Amiodar (Micro Labs), Tiotrop (Sun Pharma), Zogrel, Oxiplatin, Riluzole, Rampri & Ramsartan (Rajvi Vipul Bhagat), Sefpirome (Novartis), Retinol (Psycoremedies), Cansartan (Medley Pharmaceuticals), Rampril (Protech Biosystems Pvt Ltd), Sunij Rx Ramipril Tablets RL-5 (Sunij Pharma), Betapride (Avinash Health Products), Amipride (A N Pharmacia Labs Pvt Ltd), Pride (First Care Pharma), Dipride (Divus Laboratories), Guapride & Cefotaxim (Ajanta Pahrma), Oprazole (Glenmark Labs), Gliride (Nicholas Piramal ), Grel (Shreya Life Sciences), Dogrel (Genom Biotec Pvt) and Clogrel (Cadila Healthcare Ltd).
The study calls for meaningful talks with WHO and the office of the DCGI on the use INN in drug brands. Clear and effective communication from the WHO to the national drug authorities for creating awareness about all issues pertaining to use of INNs is the suggestion made by Centad. It is also to suggest formulation of guidelines (by DCGI) on the use of INNs in accordance with requirements of WHA resolution. The study highlights the important role the Registrar of Trade Marks has to play in controlling the use of INNs in brand names. It wanted the Registrar to notify INNs recommended by the WHO in the Trade Marks Journal. "The Trade Marks Rules should specifically require an examination of new applications for determining whether they are derived from INNs," it suggested.
While the government policy is to encourage the use of generic names on drug labels, it is not very clear on the issue of acquiring trade mark rights over brand names that contains part of INNs. The industry is also divided on the issue of INNs as the domestic industry feels that any control over the use of INNs can prove beneficial to the MNCs.
Centad is an independent, not-for-profit organisation that carries out policy research and advocacy on issues around trade and development with a focus on South Asia. One of the thematic areas being addressed by Centad is the issue of the complex linkages between trade and public health.