Maharashtra FDA Bans Aciloc 150+ And 300+, Orders Recall Over Medication Confusion Concerns

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 Dispensing

FDA 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.

The 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 Names

The 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.

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