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The Drugs Consultative Committee (DCC), the advisory committee that advises the Central and state governments on matters that require uniform implementation of drug laws across the country, has opined that a stakeholder consultation should be carried out by considering various matters in connection with addressing the issues related to use of same brand name with extensions for multiple drug formulations.
The move is the latest in connection with the ongoing issue of multiple drugs being sold under the same brand name with extensions in the market, creating confusion and chances for medication errors.
The Committee, in its latest meeting held in November, was considering a representation received alleging that a pharmaceutical company is marketing multiple drug formulations under the same established brand name with different extensions.
"Concerns have been raised that the use of the same brand name for drugs with different active ingredients may mislead consumers and create confusion regarding their therapeutic use," said the Committee.
Deliberating the topic, the Committee opined to carry out a stakeholder consultation in the matter considering various aspects, said the minutes of the meeting.
It may be noted that the Committee, in a meeting last year, recommended making the Sugam portal database of all the products with brand names accessible to the general public, to address the issue of different drug formulations of different therapeutic categories being sold in the country in same or similar brand name that creates confusion in the market.
“The database of all the products with brand names in Sugam portal may be made accessible to the general public, so that when application for endorsement of brand name in Form 51 is submitted to SLA, they can search the existing brand names from this data base of CDSCO along with the trade mark registry, literature and reference books on details of Drug Formulation in India and Internet, such or similar brand names or trade name is not already in existence with respect to any drug in the country and the proposed brand names or trade names shall not lead to any confusion or deception in the market,” said the Committee in its meeting in 2024.
“Cases of existing same, similar, sound alike, look alike brands, if any available in the market should also be addressed by the concerned State Licensing Authorities with the help of such databases etc.,” it added during the time.
In case of existing brands with the same name available in the market, whoever has first submitted Form 51 under Drugs Rules, 1945 shall be allowed to continue the marketing and brand names of other manufacturers shall be withdrawn by the SLAs, it opined.
In other cases where Form 51 does not apply, the claim of being “First” shall be evaluated by the concerned SLAs on the basis of approval history and take appropriate decisions. In order to strengthen the database available with the drug regulator, all the manufacturers should be directed to upload the formulation details along with the brand names on the Sugam portal (as per Rule 84AB), added the Committee.
The discussions on the issue gained momentum after a news article referring to cases such as use of brand name Linamac 5 for a cancer drug, while the name Linamac is used to treat diabetes, surfaced early last year and the National Human Rights Commission (NHRC), India, took Suo motu cognisance in February, 2024, regarding the issue. The Commission observed that if the issue is true, it amounts to a serious issue of human rights.
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