Last Updated on October 6, 2024 by The Health Master
Brand Name
In a bid to protect patient safety and prevent confusion in the Indian pharmaceutical market, the government’s advisory body, the Drugs Consultative Committee (DCC), has proposed making the Sugam portal database of brand name of drugs accessible to the public.
This move comes in response to concerns raised by the National Human Rights Commission (NHRC) about the widespread practice of selling different drug formulations under the same or similar brand names for treating various medical conditions.
The Problem of Brand Name Confusion
The DCC has highlighted the significant risks posed by brand name confusion in the Indian pharmaceutical market.
Identical or similar brand names for different drug formulations can lead to medication errors, jeopardizing patient health.
Examples cited by the NHRC include the use of “Linamac 5” for a cancer drug while “Linamac” is used to treat diabetes, and the multiple companies selling different active ingredients under the brand name “Medzole.”
DCC’s Recommendations
To address this issue, the DCC has made several recommendations:
- Public Access to Sugam Portal: The database on the Sugam portal, which lists all drug brand names, should be made accessible to the general public. This will enable individuals and healthcare professionals to verify the authenticity of drug brands and avoid potential errors.
- Stricter Brand Name Approval: State Licensing Authorities (SLAs) should carefully scrutinize brand name applications to ensure that they do not conflict with existing brands or create confusion in the market.
- Prioritization of Existing Brands: In cases where multiple brands share the same name, the manufacturer who first submitted Form 51 under the Drugs Rules, 1945, should be allowed to continue using the brand name.
- Evaluation of “First” Claims: For brands where Form 51 does not apply, SLAs should evaluate claims of being “first” based on approval history and take appropriate decisions.
- Enhanced Database Maintenance: Drug manufacturers should be required to upload formulation details along with brand names on the Sugam portal, as per rule 84AB, to strengthen the database available with the drug regulator.
Support from Other Regulatory Bodies
The Drugs Technical Advisory Board (DTAB) has also expressed concerns about brand name confusion and has recommended that the DCC address this issue to ensure patient safety.
The DTAB has suggested that the country consider having a single licensing/approving authority and has urged the DGHS to write to the trademark authority for stricter enforcement of brand name regulations.
NHRC’s Intervention
The National Human Rights Commission (NHRC) has taken suo motu cognizance of the issue of brand name confusion in India.
The Commission has observed that this practice poses serious risks to human rights and has issued notices to the Union health ministry and the Drugs Controller General of India to address the matter.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
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