Maharashtra FDA Cancels Cadila CFA Warehouse Licences In Thane, Pune & Nagpur Over ‘Acilloc’ Brand Concerns

Mumbai: The Maharashtra Food and Drug Administration (FDA) has cancelled the sale and distribution licences of Cadila Pharmaceuticals Ltd’s carrying and forwarding agent (CFA) warehouses at Bhiwandi in Thane, Wadki in Pune and Nimji in Nagpur, following concerns over deceptively similar “Acilloc” brands containing different active ingredients.

High Court Directed Fresh Process

The action follows a Bombay High Court directive in August, after Cadila challenged the FDA’s earlier stop-sale and distribution orders. The court directed the FDA to follow due process, including issuing fresh notices, giving the company an opportunity to respond and conducting hearings before passing any fresh orders.

The FDA’s original action followed inspections at the three CFA warehouses in July, when it found Acilloc 150, Acilloc 150+, Acilloc 300 and Acilloc 300+. According to the regulator, Acilloc 150 and 300 contain Ranitidine, while the “+” variants contain Famotidine. Despite the change in active ingredient, the products carried substantially similar brand names and artwork, with the “+” being the major distinguishing feature.

FDA Cited Confusion Risk

The FDA had earlier said the products were available simultaneously in the market, creating a potential risk of confusion among doctors, pharmacists and patients and possibly resulting in the wrong medicine being prescribed, dispensed or consumed. It had also directed recall of the affected stocks and barred the sale and distribution of the concerned “+” variants. The stock covered during the July action was valued at around Rs 2.45 crore.

Cadila subsequently approached the Bombay High Court, challenging the FDA’s action. The court questioned the manner in which the initial orders had been issued and stressed the need to follow the statutory procedure before imposing such restrictions. The FDA agreed to withdraw the earlier proceedings and undertake the process afresh, including issuing show-cause notices and providing the company an opportunity of hearing.

The latest licence cancellation therefore comes after the FDA’s fresh regulatory process rather than as a continuation of the original stop-sale orders. The action covers the three identified CFA facilities and prevents them from undertaking sale and distribution activities under the cancelled licences.

The cancellation pertains to the sale and distribution licences of the three identified CFA warehouses. Any further action against the company or the concerned products will depend on the outcome of the regulatory proceedings and compliance measures required by the FDA.

An email was sent to Cadila Pharmaceuticals seeking its response to the Maharashtra FDA’s action. However, the company had not responded until the time of going to press.

To get details on exclusive and budget-friendly property deals in Mumbai & surrounding regions, do visit: https://budgetproperties.in/