Cadila Pharmaceuticals stated that Aciloc 150+ and Aciloc 300+ products continue to be supplied to pharmacies without any restrictions on production or sale.
On Wednesday, the company confirmed that there are no directives prohibiting the manufacturing, sale, or distribution of its Aciloc 150+ and Aciloc 300+ products. It was clarified that both medications comply with all current national regulatory requirements and remain available on the market.
Cadila provided clarifications regarding the composition of Aciloc 150+ and Aciloc 300+, noting that they contain famotidine—a histamine H2 receptor antagonist used to treat acid-related diseases. The company emphasized that the active pharmaceutical ingredient has always been clearly indicated on the packaging and labels of all Aciloc products in accordance with labeling requirements.
Company representatives reported that scientific and regulatory teams are actively interacting with relevant authorities and thoroughly examining this issue. Arani Chatterjee, President of Cadila Pharmaceuticals, stated: 'Patient safety remains our highest priority. The active pharmaceutical ingredient is clearly indicated on every Aciloc package in accordance with applicable regulatory requirements. We are working closely with the relevant authorities and providing them with full support while carefully reviewing this matter.'
He also added that the company remains committed to ensuring trust in the quality, safety, and proper use of its medicines while maintaining uninterrupted product availability. Cadila Pharmaceuticals reiterated its readiness to work with the relevant authorities, affirming its commitment to quality, patient safety, and regulatory compliance.
The Food and Drug Administration (FDA) of Maharashtra has banned the sale and distribution of several medications manufactured by Cadila Pharmaceuticals Ltd. Furthermore, approximately 2.45 crore rupees worth of stock across the state was confiscated due to similar branding, despite the use of different active pharmaceutical ingredients (APIs).
The ban affects drugs such as Aciloc 150, Aciloc 150 Plus, Aciloc 300, and Aciloc 300 Plus, which contain Ranitidine and Famotidine as APIs. The FDA required the company to immediately recall all existing stocks of these four names on the market because there is a concern that such branding could lead to medication errors.
FDA Chairman Tukaram Mundhe stated in a declaration that any confusion caused by a drug's brand name that could result in doctors, pharmacists, or patients receiving the wrong medication constitutes a serious public health issue. He emphasized that adherence to regulations governing drug labeling, packaging, and marketing must remain paramount to ensuring patient safety.
During inspections conducted on July 9 and 10 at the company's transporter and distributor agent warehouses in Pune, Nagpur, and Bhiwandi district in Thane, the FDA prohibited the sale and distribution of stock for two medications. The total value of the affected stock amounted to 24.53 million rupees. According to the FDA, the company had previously received approval to manufacture and sell Aciloc 150 and Aciloc 300 with the active ingredient Ranitidine. However, a version Aciloc 150+ and Aciloc 300+ containing Famotidine was later introduced, while maintaining almost identical branding and artistic design, except for the addition of the '+' sign.
In the opinion of the FDA, having both older Ranitidine-based drugs and new Famotidine-based variants on the market simultaneously created a possibility of confusion among healthcare professionals and patients, thereby increasing the risk of incorrect prescription or intake of medication. The regulator noted that current guidelines prohibit the promotion of drugs with altered compositions under substantially the same brand name. Preventive measures were taken to protect public health due to the misleading similarity of the names and the potential for patients to receive incorrect treatment. The FDA reported that further investigation is ongoing, and legal action will be taken based on the findings in accordance with the Drugs and Cosmetics Act of 1940 and related rules.
