The order is linked to Aciloc 150, Aciloc 150 Plus, Aciloc 300 and Aciloc 300 Plus, which have Ranitidine and Famotidine as APIs, they said.
The FDA has directed the company to immediately recall all available stocks of Aciloc 150, Aciloc 150 Plus, Aciloc 300 and Aciloc 300 Plus from the market over concerns that such branding could lead to medication errors. It has also barred the sale of Aciloc 150 Plus and Aciloc 300 Plus.
“Any confusion caused by a medicine’s brand name that could result in doctors, pharmacists or patients receiving the wrong drug is a serious public health concern,” FDA Commissioner Tukaram Mundhe said in a statement.
He said compliance with norms governing branding, labelling and marketing of medicines must remain paramount to ensure patient safety.
In the statement, the FDA said it prohibited the sale and distribution of the available stock of the two medicines during inspections carried out on July 9 and 10 at the company’s carrying and forwarding agent (CFA) warehouses in Pune, Nagpur as well as Bhiwandi in Thane district.
The action covered medicine stock valued at Rs 2,45,37,490, it said.”The company had earlier received approval to manufacture and market Aciloc 150 and Aciloc 300 containing active pharmaceutical ingredient Ranitidine. However, it later introduced Aciloc 150+ and Aciloc 300+, which contain Famotidine as active ingredient, while retaining almost identical branding and artwork except for the addition of the ‘+’ symbol,” it said.
According to the FDA, both the older Ranitidine-based medicines and the newer Famotidine-based variants were found to be available simultaneously in the market, creating the possibility of confusion among doctors, pharmacists and patients, and increasing the risk of dispensing or consuming the wrong medicine.
“Existing guidelines prohibit marketing medicines with a changed composition under substantially the same brand name. The preventive action was initiated to safeguard public health due to deceptive similarity in the brand names and the potential for patients to receive incorrect medication,” it said.
The FDA said further investigation is underway and legal action will be taken under Drugs and Cosmetics Act 1940 and the rules framed under it based on the findings.