The Maharashtra Food and Drug Administration has barred the sale and distribution of some medicines manufactured by Cadila Pharmaceuticals Ltd. and seized stock worth about Rs 2.45 crore across the state, citing concerns over branding similarities despite the products having different active pharmaceutical ingredients, officials said on Saturday.
Recall Ordered For Four Products
The order concerns Aciloc 150, Aciloc 150 Plus, Aciloc 300 and Aciloc 300 Plus, which use Ranitidine and Famotidine as active ingredients, officials said. The FDA has directed the company to immediately recall all available stock of the four products from the market, citing the risk of medication errors arising from the similar branding. It has also barred the sale of Aciloc 150 Plus and Aciloc 300 Plus.
Ranitidine and Famotidine both belong to a class of drugs called H2 receptor blockers, commonly used to treat acid reflux and related stomach conditions, but they are chemically distinct compounds with different dosing requirements. Regulators have flagged in the past that near-identical brand names carrying different formulations or strengths can increase the risk of a pharmacist or patient picking up the wrong variant, particularly when the packaging looks similar at first glance.
FDA Cites Public Health Risk
FDA Commissioner Tukaram Mundhe said confusion caused by similar brand names, which could lead doctors, pharmacists or patients to administer the wrong drug, amounted to a serious public health concern. He said compliance with norms governing the branding, labelling and marketing of medicines must remain a priority to safeguard patient safety.
The action forms part of the state drug regulator's ongoing surveillance of pharmaceutical products sold in Maharashtra, under which it periodically inspects manufacturing units, distribution channels and retail outlets to check for labelling violations, substandard stock and other compliance lapses. Officials said further action against the company would depend on its response to the recall directive and the outcome of the FDA's continuing review of the matter.
(With PTI inputs)
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