- Maharashtra FDA cancelled sales licences of three Cadila warehouses over violations
- Medicines with similar brand names had different active ingredients causing risk to patients
- Aciloc+ packs exceeded the prescribed 14-tablet pack size for Famotidine drugs
The Maharashtra Food and Drug Administration has cancelled the sales and distribution licences of three CFA warehouses of Cadila Pharmaceuticals Ltd. in Pune, Nagpur and Thane over regulatory violations involving medicines sold under the Aciloc and Aciloc+ brands.
The action follows inspections conducted in July 2026 at the company's CFA warehouses in Bhiwandi in Thane district, Wadki in Pune and Nimji in Nagpur district.
The inspections raised concerns that medicines containing different active pharmaceutical ingredients (APIs) were being marketed under closely similar brand names, creating a potential risk of patients receiving the wrong medicine.
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Cadila marketed Aciloc 150 and Aciloc 300 with Ranitidine as the active ingredient, while Aciloc 150+ and Aciloc 300+ contained Famotidine. The Maharashtra FDA noted that only the “+” symbol differentiated the brands despite the change in active ingredient.
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The authorities also found that Aciloc 150+ was available in 30-tablet packs and Aciloc 300+ in 20-tablet packs, despite the prescribed pack size of 14 tablets for Famotidine tablets under Schedule P-1 of the Drugs and Cosmetics Rules, 1945.
Another major concern involved supply mismatches. In some cases, wholesalers in the Pune division had ordered Ranitidine-based Aciloc 150/300 but received Famotidine-based Aciloc 150+/300+ instead.
The company had challenged the regulatory action before the Bombay High Court. In an August 11, 2026 order, the court directed authorities to issue fresh show-cause notices and provide the company an opportunity to respond.
Following written submissions and personal hearings, the licensing authorities found the explanations unsatisfactory and passed reasoned orders cancelling the licences.
The FDA also noted that Gujarat authorities had cancelled manufacturing licences for Famotidine 20 mg and 40 mg tablets with retrospective effect from June 2, 2026. Maharashtra FDA said this development had not been disclosed during the proceedings.
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FDA Commissioner Tukaram Mundhe urged consumers to check the generic name and dosage on medicine labels and advised retailers to dispense medicines strictly as prescribed.
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