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Shardul Nautiyal, Mumbai May 25 , 2019
The Indian Drug Manufacturers Association (IDMA) has urged the Drugs Controller General of India (DCGI) to revise the proposed 'Condition of Undertaking' which the pharma companies have to submit to the DCGI to ensure that the brand name used by the owner or applicant for a particular drug is not duplicated while granting licences or renewals.

A draft notification issued by the DCGI recently proposes amendment to Rules 71, 71A, 71B, 76 and 76A under Drugs and Cosmetics (D&C) Rules, 1945 to introduce a Condition Of Undertaking which says “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”.

In its submission, the IDMA stated that such an undertaking is almost impossible to guarantee as there could possibly be another company marketing a drug under the same or similar brand name in some remote part of the country. Registration of a brand name as a trademark prior to use on any product is only optional.

There are unregistered trademarks in use as brand names, which are often not possible to search and information on which is not possible to access. As such, no applicant can give a declaration as proposed. Similarly use of a Trademark prior to registration is not mandatory in India and alternatively Trademarks that are proposed to be used can also be registered in India. The trademark authorities could at best confirm ownership of the name if already registered with them, it said.

In its submission to the DCGI, IDMA has suggested to revise the proposed Condition of Undertaking and has stated, “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 the application for Trademark registration has been filed and to the best of his/her knowledge such or similar brand name or trade name is not already in existence”.

Applicants may further be directed to print the symbol of trademark after the brand name to indicate that he/she has applied for Trademark registration and/or is the owner of the brand name. If the brand name is already registered with the Office of Registrar of Trademarks then symbol of registration may be printed after the brand name.

In spite of giving such an undertaking, the manufacturers would still need to submit applications for grant of product permission only under a proper name and subsequent to grant of such permission they would be allowed to market their product under the brand name or trade name, the IDMA said.

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