1 hr ago
Maharashtra FDA Cancels Three Cadila Warehouse Licences Over Acilloc Concerns
The Maharashtra FDA has cancelled licences for three warehouses that distribute Cadila medicines.
The warehouses are in Thane, Pune and Nagpur.
The medicines were all called Acilloc, but some contained different ingredients from others.
The FDA said their similar names and packaging could cause confusion.
That could lead to someone getting the wrong medicine.
Cadila had challenged the FDA’s earlier orders in court.
The Bombay High Court said the regulator needed to follow a fresh process and hear the company first.
The latest licence cancellations came after that process.
Cadila had not commented by the time the report was published.
Maharashtra FDA cancelled sale and distribution licences for Cadila Pharmaceuticals’ CFA warehouses in Thane, Pune and Nagpur.
The regulator found products branded Acilloc 150 and 300 contained ranitidine, while Acilloc 150+ and 300+ contained famotidine.
The FDA said similar names and packaging could confuse doctors, pharmacists and patients when the products were available simultaneously.
The action followed a Bombay High Court directive in August requiring fresh notices, an opportunity for Cadila to respond and hearings.
The FDA’s July action covered stock valued at about Rs 2.45 crore; the company had not responded to a request for comment by publication.
- Who
- The Maharashtra Food and Drug Administration and Cadila Pharmaceuticals Ltd.
- What
- The FDA cancelled sale and distribution licences for three Cadila CFA warehouses over concerns about similarly branded Acilloc products with different active ingredients.
- Where
- Bhiwandi in Thane, Wadki in Pune and Nimji in Nagpur, Maharashtra.
- When
- The latest cancellations followed a fresh regulatory process after an August Bombay High Court directive; the FDA’s inspections took place in July.
- Why
- The FDA said similar product names and artwork could confuse doctors, pharmacists and patients because the products contained different active ingredients.
FDA’s safety concerns
Cadila’s challenge and procedural concerns
Similar branding for different ingredients
FDA’s safety concerns
The FDA said the similar names and artwork could confuse doctors, pharmacists and patients and lead to the wrong medicine being prescribed, dispensed or consumed.
Cadila’s challenge and procedural concerns
Cadila challenged the FDA’s earlier stop-sale and distribution orders. The articles do not state the company’s specific position on the branding concern.
Regulatory process
FDA’s safety concerns
After the court directive, the FDA withdrew its earlier proceedings and conducted a fresh process, including notices and an opportunity for Cadila to be heard, before the licence cancellations.
Cadila’s challenge and procedural concerns
The Bombay High Court questioned how the original orders had been issued and said statutory procedure, including notice and a hearing, had to be followed before imposing restrictions.
Key facts
- Regulator
- Maharashtra Food and Drug Administration
- Company
- Cadila Pharmaceuticals Ltd
- Affected facilities
- CFA warehouses at Bhiwandi in Thane, Wadki in Pune and Nimji in Nagpur
- Products cited
- Acilloc 150, Acilloc 150+, Acilloc 300 and Acilloc 300+
- Ingredients identified
- Acilloc 150 and 300 contain ranitidine; the “+” variants contain famotidine.
- Stock value
- About Rs 2.45 crore was covered during the July action.
- Court directive
- In August, the Bombay High Court directed the FDA to follow due process, including fresh notices and hearings.
Sources
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