FDA Maharashtra Cracks Down on Deceptive Drug Branding

In a bold move, Maharashtra's FDA has seized Aciloc 150+ and Aciloc 300+ worth Rs 2.45 crore, due to deceptive branding by Cadila Pharmaceuticals. The FDA ordered a total market recall over concerns of consumer confusion and patient safety. Legal action under the Drugs and Cosmetics Act is pending.

In a significant enforcement action under the 'Safe Food, Safe Medicines, Safe Maharashtra' campaign, the Food and Drug Administration (FDA) of Maharashtra has seized stocks of Aciloc 150+ and Aciloc 300+. Valued at approximately Rs 2.45 crore, these drugs have been subject to a total market recall due to concerns over deceptive labelling and branding.

An official announcement on Saturday revealed that the crackdown followed a routine inspection in Amravati. It was discovered that Cadila Pharmaceuticals Ltd., Ahmedabad, had been producing and marketing Aciloc 150 and Aciloc 300, containing Ranitidine as their active ingredient. The company recently launched Aciloc 150+ and Aciloc 300+ with Famotidine as the new active ingredient, retaining nearly identical branding and raising potential confusion.

The investigation unveiled simultaneous availability of both old and new Aciloc products, posing risks of misadministration. Guided by regulatory norms, the FDA stressed that brand names must change when ingredients do, prompting seizures from warehouses in Pune, Nagpur, and Bhiwandi. With public health as the priority, Commissioner Tukaram Mundhe emphasized stringent compliance with drug laws and urged public caution.