CDSCO cracks down on duplicate drug brand names to prevent medication errors

Drug regulators have introduced stricter rules to eliminate duplicate and deceptively similar medicine brand names. The new First-to-Register policy and mandatory Sugam portal verification aim to prevent medication errors, improve patient safety and ensure unique brand names across the pharmaceutical industry.

Hyderabad: Imagine swallowing a routine antacid, Medzol, before breakfast for a minor gastric irritation, only to have your central nervous system shut down because you were given an identical box of Medzol, which was manufactured in another Indian State and is a potent hospital-grade sedative. Such potentially fatal medical mishaps can happen to anyone due to the practice of adopting a ‘brand extension’ strategy by pharma companies.

By launching a drug with a name resembling or rhyming with an already well-established drug, meant for some other disease, pharma companies try to exploit the situation by taking a marketing shortcut. So, instead of spending resources to build a brand, pharma companies tend to ride on the brand reputation of existing well-known drugs, at the patient’s expense.

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Clamping down on such deceptive practices, a few days ago, the drug regulatory authorities, including Central Drugs Standard Control Organisation (CDSCO) and the Drugs Controller General of India (DCGI), issued an urgent public notice on brand-name extensions. The aim of the notice is to eventually phase out duplicate naming conventions.

As part of the clampdown to eliminate such strategies, the state-level drug regulators, including Telangana Drug Control Administration (TGDCA), have been directed to implement the ‘First-to-Register’ rule. For any identical/deceptively similar brand names currently operating for different medical treatments, the pharma company that has first submitted Form 51 under Drugs Rules to TGDCA will retain exclusive, absolute rights to that brand name.

The CDSCO and DGCI have also directed TGDCA to summarily withdraw the brand approvals of all subsequent manufacturers using that same name, which will force late-entering pharma majors to quickly recall, rename, and repackage their inventory or face immediate criminal prosecution for marketing misbranded and spurious drugs under Section 17-B of the Drugs and Cosmetics Act.

The TGDCA has also been directed to utilise the Sugam Portal to address the issue. “Whenever we catch a pharma company using duplicated names, they give the excuse that they did not know another company somewhere in India is already using a similar brand name,” DCA officials here said.

Under the new rule, all pharma manufacturers are legally mandated to upload their ingredient formulations along with their intended commercial brand names on the Sugam portal. When a state drug controller like TGDCA processes a new manufacturing application, the software automatically cross-checks the name phonetically and visually against both the Sugam database and the national Trademark Registry. If the software flags a potential clash, the license for the duplicate brand name is blocked at the entry point.