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Discrepancy in ‘Aciloc’ Name; FDA Takes Action Against Cadila’s ?2.45 Crore Stock
FDA: Issue with ‘Aciloc’ Name; Tukaram Mundhe’s Department Acts Against ?2.45 Crore Stock
Nagpur: The State Food and Drug Administration (FDA) has taken significant action regarding drug safety. Restrictive measures have been imposed on a stock of Cadila Pharmaceuticals Limited’s ‘Aciloc 150+’ and ‘Aciloc 300+’ medicines, valued at approximately ?2.45 crore. This action was taken considering the potential for confusion among doctors, pharmacists, and patients, as the active ingredient was completely changed while merely adding a ‘plus’ sign to the drug's name.
What is the issue?
The company previously held approval for ‘Aciloc 150’ and ‘Aciloc 300’, which contained Ranitidine as the active ingredient. However, the new ‘Plus’ version utilized a different ingredient, Famotidine. Despite this, the brand name and label design remained nearly identical. With both the old and new versions available in the market simultaneously, there was a risk of the wrong medication being dispensed.
The FDA clarified that using the same brand name after changing the drug's primary active ingredient violates regulations.
Statewide Action
Raids were conducted at the company’s major distribution centers on July 9 and 10. The details are as follows:
Nagpur: ?98.71 lakh
Pune: ?89.45 lakh
Bhiwandi (Thane): ?57.20 lakh
Stock worth over ?2.45 crore has been barred from sale.
Order to the Company
The FDA has directed Cadila to immediately recall all available stock from the market. Further investigation into this matter is underway, and legal action will be initiated under the Drugs and Cosmetics Act, 1940.
Tukaram Mundhe's View
Food and Drug Administration Commissioner Tukaram Mundhe stated, "Confusion arising among patients, doctors, or sellers due to a drug's name is a serious matter concerning public health. Regulations regarding brand names, labeling, and marketing must be strictly adhered to."
This action is considered significant for ensuring drug safety.
FDA: Issue with ‘Aciloc’ Name; Tukaram Mundhe’s Department Acts Against ?2.45 Crore Stock
Nagpur: The State Food and Drug Administration (FDA) has taken significant action regarding drug safety. Restrictive measures have been imposed on a stock of Cadila Pharmaceuticals Limited’s ‘Aciloc 150+’ and ‘Aciloc 300+’ medicines, valued at approximately ?2.45 crore. This action was taken considering the potential for confusion among doctors, pharmacists, and patients, as the active ingredient was completely changed while merely adding a ‘plus’ sign to the drug's name.
What is the issue?
The company previously held approval for ‘Aciloc 150’ and ‘Aciloc 300’, which contained Ranitidine as the active ingredient. However, the new ‘Plus’ version utilized a different ingredient, Famotidine. Despite this, the brand name and label design remained nearly identical. With both the old and new versions available in the market simultaneously, there was a risk of the wrong medication being dispensed.
The FDA clarified that using the same brand name after changing the drug's primary active ingredient violates regulations.
Statewide Action
Raids were conducted at the company’s major distribution centers on July 9 and 10. The details are as follows:
Nagpur: ?98.71 lakh
Pune: ?89.45 lakh
Bhiwandi (Thane): ?57.20 lakh
Stock worth over ?2.45 crore has been barred from sale.
Order to the Company
The FDA has directed Cadila to immediately recall all available stock from the market. Further investigation into this matter is underway, and legal action will be initiated under the Drugs and Cosmetics Act, 1940.
Tukaram Mundhe's View
Food and Drug Administration Commissioner Tukaram Mundhe stated, "Confusion arising among patients, doctors, or sellers due to a drug's name is a serious matter concerning public health. Regulations regarding brand names, labeling, and marketing must be strictly adhered to."
This action is considered significant for ensuring drug safety.
Nagpur: The State Food and Drug Administration (FDA) has taken significant action regarding drug safety. Restrictive measures have been imposed on a stock of Cadila Pharmaceuticals Limited’s ‘Aciloc 150+’ and ‘Aciloc 300+’ medicines, valued at approximately ?2.45 crore. This action was taken considering the potential for confusion among doctors, pharmacists, and patients, as the active ingredient was completely changed while merely adding a ‘plus’ sign to the drug's name.
What is the issue?
The company previously held approval for ‘Aciloc 150’ and ‘Aciloc 300’, which contained Ranitidine as the active ingredient. However, the new ‘Plus’ version utilized a different ingredient, Famotidine. Despite this, the brand name and label design remained nearly identical. With both the old and new versions available in the market simultaneously, there was a risk of the wrong medication being dispensed.
The FDA clarified that using the same brand name after changing the drug's primary active ingredient violates regulations.
Statewide Action
Raids were conducted at the company’s major distribution centers on July 9 and 10. The details are as follows:
Nagpur: ?98.71 lakh
Pune: ?89.45 lakh
Bhiwandi (Thane): ?57.20 lakh
Stock worth over ?2.45 crore has been barred from sale.
Order to the Company
The FDA has directed Cadila to immediately recall all available stock from the market. Further investigation into this matter is underway, and legal action will be initiated under the Drugs and Cosmetics Act, 1940.
Tukaram Mundhe's View
Food and Drug Administration Commissioner Tukaram Mundhe stated, "Confusion arising among patients, doctors, or sellers due to a drug's name is a serious matter concerning public health. Regulations regarding brand names, labeling, and marketing must be strictly adhered to."
This action is considered significant for ensuring drug safety.
