New Delhi, July 11 (IANS) The Maharashtra Food and Drug Administration (FDA) has barred the sale and distribution of certain medicines manufactured by Cadila Pharmaceuticals Ltd and seized stock worth around Rs 2.45 crore over concerns that similar branding could lead to medication errors, as per multiple reports.
It also directed the company to recall select products from the market, it added.
The action relates to Aciloc 150, Aciloc 150 Plus, Aciloc 300 and Aciloc 300 Plus, which contain different active pharmaceutical ingredients (APIs) despite having nearly identical branding.
According to the FDA, Aciloc 150 and Aciloc 300 were originally approved with Ranitidine as the active ingredient.
The company later introduced Aciloc 150 Plus and Aciloc 300 Plus containing Famotidine while retaining almost identical branding and artwork, except for the addition of the ‘+’ symbol.
The regulator said the simultaneous availability of the Ranitidine- and Famotidine-based medicines in the market could create confusion among doctors, pharmacists and patients, increasing the risk of dispensing or consuming the wrong medicine.
FDA Commissioner Tukaram Mundhe said any confusion caused by a medicine’s brand name that could result in doctors, pharmacists or patients receiving the wrong drug was a serious public health concern.
The FDA said it prohibited the sale and distribution of the available stock of the medicines during inspections carried out on July 9 and 10 at the company’s carrying and forwarding agent warehouses in Pune, Nagpur and Bhiwandi in Thane district.
The action covered medicine stock valued at Rs 2,45,37,490.
Existing guidelines prohibit marketing medicines with a changed composition under substantially the same brand name and added that the preventive action was initiated to safeguard public health, the regulator said.
The FDA said further investigation is underway and legal action will be taken under the Drugs and Cosmetics Act, 1940, and the rules framed thereunder based on the findings.
–IANS
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