The problems faced by brand owners and consumers who deal with trademarks that are identical or deceptively similar are well known. In most such cases, consumers may be end up buying one product thinking its another, leading to inconvenience. However, when such confusions occur in pharmaceutical products, it may not just be a matter of inconvenience, but could have far reaching consequences. This very problem of pharmaceutical products marketed under trademarks that are confusingly similar is sought to be addressed in India by an amendment proposed to the Drugs and Cosmetics Rules, 1945.

The proposed amendment may be attributed to the directions given by the High Court of Delhi in a suit 

between Curewell Drugs & Pharmaceuticals and Ridley Life Science, although Indian courts have dealt with many cases involving drugs bearing confusingly similar names. The draft proposes to introduce the below recited rules to address the issue of drugs bearing confusingly similar names.

“In case the applicant intends to market the drug under a brand name or trade name, the applicant shall furnish an undertaking to the licensing authority that such or similar brand name or trade name is not already in existence so that the brand name or the trade name to be used by the applicant shall not lead to any confusion or deception in the market.”

It is pertinent to note that, Section 17B of the Drugs and Cosmetics Act, 1940 empowers the drug licence granting authority, Drug Controller General of India (DCGI), to raise objections in case of drugs bearing confusingly similar brand names, which is also pointed out by the Court. In view of said section, it is not clear how the proposed amendment to the Rules further empower DGCI to proactively tackle the problem.

One may argue that it is not the lack of provisions in appropriate statutes to deal with the problem, rather it is the lack of procedures and infrastructure to effectively implement the provisions, that has led to the problem not be effectively addressed. The Court in fact recognises this and has issued directions for consideration by the authorities to tackle the problem effectively. The directions are listed below.

• Creation of a secured platform, to be under the supervision of the DCGI, which is accessible to all State FDAs, both for access of data and for uploading of data.
• Creation of a “master electronic database” of all the approved brand names for manufacture and sale of drugs issued both by the DCGI and the State FDAs and making the same available to all state FDAs and Drug controllers through a secured platform. The list to be maintained and made available both brand wise and manufacturer wise, on the secured platform.
• List of registered trade marks under Class 5 for pharmaceutical and medicinal preparations be obtained from the Controller General of Patents, Trade marks and designs and be made available to the approving authorities at the Central level and State level.
• Access to the data be given to Drug Inspectors/Drug Controllers across the country;
• Drug Inspectors/Drug Controllers to conduct regular and periodic inspections as per the Act and the Rules to ensure that the drugs that are being manufactured in a particular unit are duly licensed for. The reports of the said inspections to be submitted through the secured platform;
• Periodic and regular reports of drug inspectors should be compulsorily submitted to the respective licensing authorities on the secured platform and a mechanism be set up for review of the said reports at the State level;
• Periodic meetings ought to be held at the central level, to review the status of manufacture and sale of drugs across the country, under the aegis of the DCGI;
• Strict action in accordance with law ought to be taken against those manufacturers who manufacture drugs without licences, who indulge in adulteration or contamination of drugs etc. A periodic report as to the number of actions taken, ought to be uploaded on the secured platform of the DCGI.    

Implementing procedures and developing technology platforms in line with the directions above is certainly the way forward if the authorities wish to tackle the problem proactively and effectively. We certainly hope that such long-term solutions, though time consuming and resource intensive, are implemented, given the serious consequence that may result from the problem of drugs being marked under deceptively similar trademarks.

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