Maharashtra FDA bars sale and orders recall of Cadila drugs over similar brand names

FDA Commissioner Tukaram Mundhe said confusion caused by similar brand names, which could lead doctors, pharmacists or patients to administer the wrong drug, amounted to a serious public health concern.

FDA Commissioner Tukaram Mundhe said confusion caused by similar brand names, which could lead doctors, pharmacists or patients to administer the wrong drug, amounted to a serious public health...

Mumbai: In a significant action aimed at preventing medication errors, the Maharashtra Food and Drug Administration (FDA) has prohibited the sale and distribution of Aciloc 150+ and Aciloc 300+ and ordered an immediate recall of the products, citing concerns that their deceptively similar brand names could lead to confusion and compromise patient safety.The action follows a routine inspection in Amravati, which found that a pharmaceutical company had introduced Aciloc 150+ and Aciloc 300+, containing Famotidine as the active pharmaceutical ingredient, while the original Aciloc 150 and Aciloc 300 contain Ranitidine. Despite the complete change in composition, the company retained nearly identical branding and packaging, merely adding a "+" sign to the product names.Similar Packaging Raises Risk Of Wrong Medicine DispensingFDA officials found that both the older Ranitidine-based products and the newer Famotidine-based variants were simultaneously available in the market, creating the possibility of confusion among doctors, pharmacists and patients and increasing the risk of dispensing the wrong medicine.Following the findings, the FDA conducted inspections at the company's carrying and forwarding agent (CFA) depots in Pune, Nagpur and Bhiwandi (Thane). On July 9 and 10, the regulator prohibited the sale and distribution of the entire available stock of Aciloc 150+ and Aciloc 300+, valued at Rs 2.45 crore.Bombay HC Enhances Compensation For Land Acquired For Kurla-Thane Railway Expansion, Grants Tenants ShareThe company has also been directed to immediately recall all stocks of Aciloc 150, Aciloc 150 Plus, Aciloc 300 and Aciloc 300 Plus from the market. Further investigations are underway, and legal action will be initiated under the Drugs and Cosmetics Act, 1940, and the rules framed thereunder based on the outcome of the probe.Action Follows CDSCO Concerns Over Similar Drug NamesThe Maharashtra FDA's action comes close on the heels of a recent move by the Central Drugs Standard Control Organisation (CDSCO), which has proposed restricting the use of brand name extensions and suffixes for medicines containing different active ingredients, amid concerns that such practices can mislead patients and lead to therapeutic confusion and medication errors. The national regulator has sought stakeholder comments on the proposal till July 17."Confusion arising from similar drug names and the possibility of patients receiving the wrong medicine is a serious public health issue. Patient safety and regulatory compliance must be paramount in drug branding and marketing," FDA Commissioner Tukaram Mundhe said.To get details on exclusive and budget-friendly property deals in Mumbai & surrounding regions, do visit: https://budgetproperties.in/

The Maharashtra Food and Drug Administration (FDA) has barred the sale and distribution of some medicines manufactured by Cadila Pharmaceuticals Ltd and seized stock worth about Rs 2.45 crore across the state over branding similarities despite having different active pharmaceutical ingredients (APIs), officials said on Saturday. The order is linked to Aciloc 150, Aciloc 150 Plus, Aciloc 300 and Aciloc 300 Plus, which have Ranitidine and Famotidine as APIs, they said. The FDA has directed the company to immediately recall all available stocks of Aciloc 150, Aciloc 150 Plus, Aciloc 300 and Aciloc 300 Plus from the market over concerns that such branding could lead to medication errors. It has also barred the sale of Aciloc 150 Plus and Aciloc 300 Plus. "Any confusion caused by a medicine's brand name that could result in doctors, pharmacists or patients receiving the wrong drug is a serious public health concern," FDA Commissioner Tukaram Mundhe said in a statement. He said complianc