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).
Reasons for the ban and product recall
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.
Official stance of the regulator
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.
Inspection details and violations
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.
Risks to patients and further actions
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.
