Maharashtra FDA raids 18 locations, suspends licences and orders recall of Aciloc medicines

The FDA seized 530 kg/litres of basundi, raw milk and ice cream

The Maharashtra Food and Drug Administration (FDA) conducted 18 raids on July 9, launching a statewide crackdown on food safety violations. This led to the seizure of adulterated and substandard food products, suspension of four food business licences and action against multiple establishments across the state.

In Mumbai, the FDA suspended the licence of Gautam Dugdhalaya in Ghatkopar West after seizing 530 kg/litres of basundi, raw milk and ice cream worth Rs 79,120. Officials said the action followed alleged violations of labelling norms, unhygienic storage conditions and failure to maintain the required cold chain.

Elsewhere in Maharashtra, the FDA seized over 2,272 kg/litres of milk and milk products worth Rs 1.62 lakh from five locations, including dairies in Ahilyanagar, Jalgaon and Latur. It also confiscated suspected substandard spices and edible oil from Navi Mumbai and Nanded, while registering eight FIRs in gutkha and pan masala cases, arresting 13 persons and seizing prohibited products worth over Rs 41 lakh.

The department also inspected 58 hotels, restaurants and eateries across the state, issued improvement notices to 26 establishments and suspended the licences of four businesses in Mumbai, Dhule and Pune for food safety and hygiene violations.

FDA action on medicine

The Food and Drug Administration (FDA), Maharashtra, has also taken action against stocks of Cadila Pharmaceuticals' Aciloc 150+ and Aciloc 300+ worth approximately R2.45 crore and has directed the company to recall the products from the market.

During a routine inspection in Amravati, officials found that Cadila Pharmaceuticals Ltd., Ahmedabad, had existing approvals to manufacture and market Aciloc 150 and Aciloc 300 containing the active pharmaceutical ingredient (API) Ranitidine. However, the company introduced Aciloc 150+ and Aciloc 300+ containing a completely different API, Famotidine, while retaining almost identical branding, label artwork and packaging, with only a ‘+' (Plus) added to the brand name.

The investigation found that both the older Ranitidine products and the newer Famotidine Plus products were simultaneously available in the market. The similarity in branding could create confusion among doctors, pharmacists and patients, increasing the risk of dispensing or using the wrong medicine.

"The possibility of patients, doctors or pharmacists being confused by a medicine's name, resulting in the dispensing of the wrong drug, is an extremely serious public health concern. Safe medicines are a fundamental right of every citizen, and safeguarding that right is our foremost responsibility." Tukaram Mundhe, Commissioner, Maharashtra Food and Drug Administration.