New Delhi: The top drug regulator is planning to direct all drug makers to upload formulation details along with brand names on its Sugam portal to check the issue of drugs having similar brand names.
The Central Drugs Standard Control Organisation (CDSCO) plan involves asking State Licensing Authorities (SLAs) to review the database before granting approval for a brand.
Confusion over drug names is a common cause of medication and dispensing errors among patients and pharmacists.
The agenda was discussed at length and after detailed deliberation at the DCGI (Drug Controller General of India) expert committee held earlier this month.
“The database of all the trademarked products on Sugam Portal may be made available to the general public so that when an application for approval of a trademark is submitted to SLA, they can search for the existing trademarks in this database of CDSCO along with the trademark registry, literature and reference books on drug formulation details in India and the internet, such trademarks or similar trade names do not already exist in respect of any drug in the country and the proposed trademarks or trade names do not create confusion or misleadingness in the market,” the minutes reviewed by Mint.
Existing similar brand names
If similar brands are available on the market, the first manufacturer to apply for them under the Drugs Rules, 1945, will be allowed to continue marketing them. State licensing authorities will withdraw the brands of other manufacturers, he said.
The regulatory body also plans to open this database to the public. The problem has taken on alarming proportions, as confusion over drug names is a common cause of medication errors among patients and pharmacists.
What led to development?
The move follows the Delhi High Court’s order in 2022 on an issue involving a medication error where two different drugs were approved under the same brand name.
For example, a drug used for women’s health has been approved to control heartburn in some states.
This led to a serious medication error, prompting the Supreme Court to order the top drug regulator to create a central database of drugs that could be accessed by all state drug controllers. State authorities should only authorise the marketing of drugs after verifying the brand, it said.
The Medicines Regulations 1945 provide that where an applicant intends to market a medicine under a trade name or brand, the applicant must provide the licensing authority with an undertaking that a similar trade name or brand does not already exist.
Mint We previously reported on the Health Ministry’s plan to create a central online registry of medicines to ensure that different drugs are not marketed under the same or similar-sounding names.
Questions sent to the Ministry of Health remained unanswered by the time this edition went to press.
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