Mumbai (Maharashtra) [India], July 12 (ANI): In a major crackdown under the “Safe Food, Safe Medicines, Safe Maharashtra” campaign, the Food and Drug Administration (FDA) of Maharashtra has seized stocks of Aciloc 150+ and Aciloc 300+ worth approximately Rs 2.45 crore and ordered a total market recall of the brand over deceptive labelling and branding concerns.
According to an official press note on Saturday, the action follows a routine inspection in Amravati, where it was observed that Cadila Pharmaceuticals Ltd., Ahmedabad, had long been licensed to manufacture and market Aciloc 150 and Aciloc 300, which contain Ranitidine as their Active Pharmaceutical Ingredient (API).
However, the company recently introduced Aciloc 150+ and Aciloc 300+, in which Ranitidine has been replaced with Famotidine, an entirely different active pharmaceutical ingredient. Despite this major change, the company retained nearly identical branding and label artwork, merely adding a “+” (Plus) sign to the product name before marketing the medicines.
The investigation further revealed that both the older Ranitidine-based Aciloc products and the newer Famotidine-based Aciloc Plus products were simultaneously available in the market. Such similarity in brand names could create confusion among doctors, pharmacists, and patients, increasing the risk of dispensing or consuming the wrong medicine.
Regulatory guidelines clearly state that when the active ingredient or composition of a branded medicine is changed, the revised product should not be marketed under the same or deceptively similar brand name.
Accordingly, the FDA immediately inspected 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 has taken this preventive action, considering that deceptively similar brand names could result in patients receiving incorrect medication.
The company has also been directed to immediately recall from the market the stocks of Aciloc 150, Aciloc 150 Plus, Aciloc 300, and Aciloc 300 Plus. Further investigation is underway, and appropriate legal action will be initiated under the Drugs and Cosmetics Act, 1940, and the rules framed thereunder, based on the findings.
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.”
The administration has also issued an advisory for citizens and medical professionals, urging them to verify both the brand name and the active pharmaceutical ingredient before prescribing, dispensing or consuming any medicine. Patients have been advised to exercise special caution when medicines have similar or deceptively similar brand names and to consult pharmacists if any uncertainty arises.
The administration has also urged citizens to immediately inform the Food and Drug Administration if any confusion arises due to similar medicine names or if any suspicious medicines are encountered. (ANI)
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