India’s top drug regulator cracks the whip on similar sounding brand names

The Central Drugs Standard Control Organization (CDSCO)'s plan involves asking State Licensing Authorities (SLAs) to check the database before granting approval for a brand name.

Confusion in the names of the drugs is a common cause of medication and sale errors among patients and pharmacists.

The agenda was discussed in length and after the detailed deliberation at the DCGI's (Drugs Controller General of India) expert committee held earlier this month.

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“The data base 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 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 minutes reviewed by Mint.

Existing similar brand names

In case of existing similar brand names available in the market, the first manufacturer which submitted an application for it under the Drugs Rule, 1945 shall be allowed to continue marketing. The brand names of other manufacturers shall be withdrawn by the state licensing authority, it said.

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The regulator is also planning to make this database open to the public. The problem has assumed alarming proportions, with confusion in the names of drugs being a common cause of medication error among patients and pharmacists.

What led to the development? 

This move comes after the order of the Delhi High Court in 2022 on an issue related to a medication error where two different drugs got approval under same brand name. 

For instance, a drug used for female health got permission for acidity control in some states. 

This created a major medication error on which the High Court directed the top drug regulator to constitute a Central Drug database which should be accessible to all the state drug controllers. Only after verifying the brand name, the state authorities should give permission for drugs, it said.

The Drugs Rule, 1945 states that in case an applicant intends to market a drug under a brand name or trade name, the applicant shall furnish an undertaking to the licensing authority a similar brand name or trade name does not already exist.

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Mint earlier reported about health ministry’ plan to create a central online registry of drugs to ensure that different drugs are not marketed under the same name, or names that sound similar.

Queries sent to the health ministry remained unanswered till press time.