The Maharashtra Food and Drug Administration (FDA) has barred the sale and distribution of select medicines manufactured by Cadila Pharmaceuticals Ltd, after finding that near identical branding across two different drug formulations could lead to dangerous mix-ups. Stock worth approximately Rs 2.45 crore has been seized across the state.
The Action that includes four products: Aciloc 150, Aciloc300, Aciloc 150 Plus, and Aciloc 300 Plus. Cadila originally received approval to manufacture and sell Aciloc 150 and Aciloc 300, both containing the active pharmaceutical ingredient (API) Ranitidine, a drug used to reduce stomach acid. The company later introduced “Plus” versions — Aciloc150 Plus and Aciloc 300 Plus — containing a different API, Famotidine, which serves a similar purpose but is a distinct compound. Crucially, the Plus variants retained almost the same brand name, packaging, and artwork as the originals, with the only visible difference being the addition of a “+” symbol. Because both the Ranitidine-based and Famotidine based versions were being sold in the market at the same time under nearly identical branding, the FDA found there was a real risk that doctors, pharmacists, or patients could confuse the two and dispense or consume the wrong medicine.
The Regulatory Response Following inspections conducted on July 9 and 10 at Cadila’s carrying and forwarding agent (CFA) warehouses in Pune, Nagpur, and Bhiwandi (Thane district), the FDA: Banned the sale and distribution of Aciloc 150 Plus and Aciloc 300 Plus. Ordered an immediate recall of all four products —Aciloc 150, Aciloc 150 Plus, Aciloc 300, and Aciloc 300 Plus — from the market. Seized existing stock valued at roughly Rs 2.45 crore from the inspected warehouses. The FDA stated that existing regulatory guidelines prohibit marketing a medicine with a changed composition under a brand name that remains substantially the same.
The move is described as a preventive step taken to safeguard public health, given the deceptive similarity in branding and the potential for patients to receive the wrong medication. Investigation into this matter is still underway. Depending on the findings, the regulator indicated that legal action could be taken against Cadila Pharmaceuticals under the Drugs and Cosmetics Act, 1940, and the rules framed under it.
Written by: Pramit Hazra
Graphics by: Pramit Hazra
