Applying for CDSCO license for your drug? Make Sure your formulation does not have similar brand name

New Delhi: In a bid to curb the irrational practice of using similar names for different drugs that results in utter confusion, the Union Health Minister has recently laid conditions of seeking a licence for undertaking on brand or trade names of drugs under Drugs Rules, 1945, wherein, the drug makers will have to furnish an undertaking to the licensing authority to the effect that a similar brand name is not in existence and it would not lead to any confusion or deception in the market.

In this regard, the Health Ministry had issued a draft notification proposing to amend the Drugs and Cosmetics Rules, 1945 to incorporate a provision for regulating brand names by the central licensing authority. The authority had invited objections and suggestions from stakeholders before the expiry of a period of forty-five days, which was made available to the public on February 27 2019.

Suggestions were received and considered by the Central Government and now in exercise of the powers conferred under sections 12 and 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government, after consultation with the Drugs Technical Advisory Board (DTAB), hereby makes the following rules further to amend the Drugs and Cosmetics Rules, 1945, namely;

In the Drugs and Cosmetics Rules, 1945 (hereinafter referred to as said rules), in rule 71, after subrule (8), the following sub-rule shall be inserted, namely;

"(9) In case the applicant intends to market the drug under a brand name or trade name, the applicant shall furnish an undertaking in Form 51 to the licensing authority to the effect that to the best of his knowledge based on search in trade marks registry, central data base for brand name or trade name of drugs maintained by Central Drugs Standard Control Organisation (CDSCO), literature and reference books on details of drug formulations in India, and internet, such or similar brand name or trade name is not already in existence with respect to any drug in the country and the proposed brand name or trade name shall not lead to any confusion or deception in the market.".

In the said rules, in rule 71A, after sub-rule (4), before the proviso, the following sub-rule shall be inserted, namely:―

"(5) In case the applicant intends to market the drug under a brand name or trade name, the applicant shall furnish an undertaking in Form 51 to the licensing authority to the effect that to the best of his knowledge based on search in trade-marks registry, central data-base for brand name or trade name of drugs maintained by Central Drugs Standard Control Organisation (CDSCO), literature and reference books on details of drug formulations in India, and internet, such or similar brand name or trade name is not already in existence with respect to any drug in the country and the proposed brand name or trade name shall not lead to any confusion or deception in the market.".

In the said rules, in rule 71B, after clause (iv), before the proviso, the following clause shall be inserted, namely:―

"(v) in case the applicant intends to market the drug under a brand name or trade name, the applicant shall furnish an undertaking in Form 51 to the licensing authority to the effect that to the best of his knowledge based on search in trade marks registry, central data base for brand name or trade name of drugs maintained by Central Drugs Standard Control Organisation (CDSCO), literature and reference books on details of drug formulations in India, and internet, such or similar brand name or trade name is not already in existence with respect to any drug in the country and the proposed brand name or trade name shall not lead to any confusion or deception in the market:".

In the said rules, in rule 76, after sub-rule (10), the following sub-rule shall be inserted, namely:―

"(11) In case the applicant intends to market the drug under a brand name or trade name, the applicant shall furnish an undertaking in Form 51 to the licensing authority to the effect that to the best of his knowledge based on search in trade marks registry, central data base for brand name or trade name of drugs maintained by Central Drugs Standard Control Organisation (CDSCO), literature and reference books on details of drug formulations in India, and internet, such or similar brand name or trade name is not already in existence with respect to any drug in the country and the proposed brand name or trade name shall not lead to any confusion or deception in the market.".

In the said rules, in rule 76A, after clause (iv), before the proviso, the following clause shall be inserted, namely:―

"(v) in case the applicant intends to market the drug under a brand name or trade name, the applicant shall furnish an undertaking in Form 51 to the licensing authority to the effect that to the best of his knowledge based on search in trade marks registry, central data base for brand name or trade name of drugs maintained by Central Drugs Standard Control Organisation (CDSCO), literature and reference books on details of drug formulations in India, and internet, such or similar brand name or trade name is not already in existence with respect to any drug in the country and the proposed brand name or trade name shall not lead to any confusion or deception in the market:".

In the said rules, in Schedule A, after Form 50, the following Form shall be inserted, namely:―

"FORM 51
[See rules 71(9), 71A(5), 71B(v), 76(11) and 76A(v)]
Form of undertaking to the licensing authority for marketing a drug under a brand name or trade name

(1) I .............................. of............................. intend to market the drug specified below under a brand name or trade name - ……………………………
(i) Name of the drug :
(ii) Dosage form :
(iii) Composition :

(2) I hereby give this undertaking that to the best of my knowledge based on search in trade-marks registry, central data-base for brand name or trade name of drugs maintained by Central Drugs Standard Control Organisation, literature and reference books on details of drug formulations in India, and internet, such or similar brand name or trade name is not already in existence with respect to any drug in the country and the proposed brand name or trade name shall not lead to any confusion or deception in the market.
Place………………..
Date ………..............

[Signature, Name, Designation Seal/Stamp of the manufacturer or on behalf of the manufacturer].".

Also Read: ZENTEL VERSUS FENTEL: HC restrains manufacture, sale of medicine for violation of trademark