The database will enable pharmaceutical companies to search for existing brand names before submitting registration applications. (Representative Image/Getty)
Confusion among many of these drugs could have serious consequences for patients because doctors prescribe them and sell them under the same brand names to treat vastly different conditions, according to government documents
India's drug regulator, the Central Drugs Standard Control Organization (CDSCO), is exploring a proposal to allow public access to a comprehensive database of all drugs sold in India to address the issue of the same name.
The database will enable pharmaceutical companies to search for existing brand names before submitting registration applications. If an identical, similar, similar-sounding or similar-looking brand already exists on the market, the regulator will consider the first approved brand name for marketing, the proposal said.
naming name
For example, a drug called Linamac 5 is used to treat cancer, while another drug called Linamac is used to treat diabetes. Likewise, the drug Oxetol is used to treat bipolar disorder and epilepsy, while the similar-sounding Exitol is used to treat constipation. Additionally, the drug Istamet is used to treat diabetes, while another drug, Indamet, is used to treat asthma. Mixing up these medications in the pharmacy can have serious consequences for patients.
“It has been noticed that a large number of drugs with the same brand name, treating completely different conditions, are being marketed in India,” said a document prepared by the CDSCO, accessed by News18. “The database of all brand products in Sugam Portal is available to the public…”
The government is aware, according to the document, that confusion between these drugs could have serious consequences for patients because doctors market them under the same brand names to treat different conditions.
To address the issue of identical brand names, the regulator is considering a proposal to open the Sugam Portal's repository of branded products to the public. This will allow applicants to search for existing brand names before submitting an application for recognition, ensuring that the proposed name will not cause confusion or deception in the market.
Sugam is an electronic government portal launched by the government to strengthen the regulatory framework for the drug registration process.
“…applicants can search for existing brand names from this database and also search in other databases such as Trademark Registrations, literature and reference books with detailed information on pharmaceutical formulations in India and the Internet for such or similar brand names or trade name for which no medicine yet exists in the country, and the proposed brand name or trade name should not cause any confusion or deception in the market.
“…other brand names of the same, similar, similar sounding, similar looking etc. should not be sold in the market,” it said, while adding that all manufacturers should be directed to upload the formula details along with the brand name on the product. Sugam Portal.
The case ended up in court, leaving consumers confused
Several such cases involving similar brand names have been heard in Indian courts. For example, in Glenmark Pharmaceuticals v. Sun Pharma Laboratories, the appellants challenged an interim injunction prohibiting the use of the Indamet trademark. “The trademark Istament is for a drug containing the salts 'metformin hydrochloride' and 'sitagliptin phosphate monohydrate', used to treat diabetes,” explains an analysis published in Legal 500, a global publication specializing in legal affairs. . “However, the Indamet trademark is derived from the ingredient compounds, Inda from ‘indacaterol acetate’ and ‘met’ from ‘mometasone furoate’, which require a dry powder inhaler or DPI device for ingestion and are indicated for the treatment of asthma. “
According to an analysis by the authors, representing law firms Christine Chiramel and Prachi Sachar, courts cannot ignore the possibility of confusion or misunderstanding when ordinary consumers are faced with similar-looking prescription drugs, even if their therapeutic applications differ significantly.
They wrote that buyers of average intelligence could not be expected to break down product names or engage in such activities during transactions.
