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

livemint.com:

Mint. 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 The brand names of other manufacturers shall be withdrawn by the state licensing authority, it said.

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. 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. Also Read | Govt frames draft rules for compounding of offences under Drugs & Cosmetics Act 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.