Rs 2.45 crore worth of Aciloc 150+, 300+ seized in Maharashtra; FDA orders recall | Mumbai News


Rs 2.45 crore worth of Aciloc 150+, 300+ seized in Maharashtra; FDA orders recall
Maharashtra FDA seized Aciloc drugs valued at Rs 2.45 crore (in pic: FDA Commissioner Tukaram Mundhe)

MUMBAI: In a major crackdown under the “Safe Food, Safe Medicines, Safe Maharashtra” campaign, the Maharashtra Food and Drug Administration (FDA) has seized stocks of Aciloc 150+ and Aciloc 300+ worth around Rs 2.45 crore.Following the crackdown, the department has ordered a complete market recall of the brand over concerns related to deceptive labelling and branding, news agency ANI reported.The action was initiated after a routine inspection in Amravati revealed that Cadila Pharmaceuticals Ltd., Ahmedabad, had been licensed for several years to manufacture.The company was licensed to market Aciloc 150 and Aciloc 300 containing Ranitidine as their Active Pharmaceutical Ingredient (API).However, the company recently launched Aciloc 150+ and Aciloc 300+, replacing Ranitidine with Famotidine, a completely different active pharmaceutical ingredient.Despite this significant change, the company continued with almost identical branding and label artwork, making only the addition of a “+” (Plus) sign to the product name before introducing the medicines into the market, ANI reported.The probe also found that the older Ranitidine-based Aciloc products and the newer Famotidine-based Aciloc Plus products were being sold simultaneously.Such similarity in the brand names could cause confusion among doctors, pharmacists and patients, increasing the possibility of the wrong medicine being dispensed or consumed.Regulatory guidelines clearly state that when the active ingredient or composition of a branded medicine is changed, the modified product should not be marketed under the same or a deceptively similar brand name.Following this, the FDA conducted inspections at the company’s Carrying & Forwarding Agent (CFA) warehouses in Pune, Nagpur and Bhiwandi (Thane).On July 9 and 10, 2026, the entire available stock of Aciloc 150+ and Aciloc 300+, valued at Rs 2,45,37,490, was prohibited from sale and distribution.Giving top priority to public health and patient safety, the FDA initiated this preventive action, observing that deceptively similar brand names could result in patients receiving the wrong medication.The company has also been instructed to immediately recall from the market the stocks of Aciloc 150, Aciloc 150 Plus, Aciloc 300 and Aciloc 300 Plus.Commenting on the action, FDA commissioner Tukaram Mundhe said, “Any confusion caused by a medicine’s brand name among patients, doctors, or pharmacists, leading to the dispensing of the wrong medicine, is a matter of grave public health concern.”“Compliance with regulations governing drug branding, labelling, and marketing, while ensuring patient safety, must remain paramount. Safe medicines are a fundamental right of every citizen, and safeguarding that right is our highest responsibility,” he added.The administration has also issued an advisory asking citizens and medical professionals to verify both the brand name and the active pharmaceutical ingredient before prescribing, dispensing or consuming any medicine.The administration has further appealed to citizens to immediately inform the FDA if they face any confusion because of similar medicine names or come across any suspicious medicines.Further investigation is underway, and suitable legal action will be initiated under the Drugs and Cosmetics Act, 1940, and the rules framed thereunder based on the findings, officials said.(With agency inputs)



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