I have posted on how Ranbaxy and Johnson and Johnson sell at a higher price/spurious products and how Johnson and Johnson is relaunching the same product that was whose licence was canceled for using a Carcinogen in the formula.
Some Retailers allow a discount of 20% on MRP, while periodically going on strike for increased margins.
On checking up with a Retailer well known to% discount , in some products, they make at least 30 % Margin!
Imagine the profit the Drug Companies are making!
The net profit of the Drug Companies are making is very high after paying out millions of Dollars paid out to doctors for prescribing their products!
Nine drug makers, including Ranbaxy, Dr Reddy’s Labs, Glenmark, Cipla and Cadila Health, are likely to face a hefty penalty from the National Pharmaceutical Pricing Authority (NPPA) over allegedly selling anti-asthma drugDoxofylline without prior price approval. The move comes in the wake of a recent Supreme Court order against the industry that brought the widely prescribed medicine under price control.
The total penalty on the nine firms is estimated to be Rs 2,500 crore because the fine will be calculated in retrospect from 2009, when the price of the drug was fixed by NPPA.
According to official sources, NPPA has already sent notices to four drug companies — Ranbaxy, Cipla, Cadila and Glenmark — for allegedly overcharging on sale of their individual brands containing Doxofylline.
I had posted articles on how Ranbaxy had fallen short of FDA Standards and Johnson & Johnson Product Licence was canceled in India for the presence of Carcinogen.
Ranbaxy
However I have received emails and in the form of comments to that post(Johnson and Johnson) expressing a desire to continue with their products on the ground that they are being used for quite a number of years and would I mail more information on the subject.
I hold no grudge against Pharma Companies, so long as what they produce is of acceptable standard and are not exorbitantly Priced.
A suspicion and a report that the Products are suspect or have failed tests is sufficient for me to inform people to stop using the products for we are dealing with Lives.
One should know that FDA of US also has corrupt Officials(Please read The Final Diagnosis of Arthur Hailey) and when FDA issues warning it must be understood that they are being issued despite Money and Political Pressure.
Yet the desire to continue with their products persists, such is the power of Television Advertisements!
Now I find Johnson & Johnson coming out with very catchy advertisements in TV placing the Products as a family’s Trusted product for the same Product that was banned.
“We understand their concerns and are diligently working with them to resolve the issue,” Peggy Ballman, a J&J spokeswoman, said in a statement, adding that there were no consumer complaints or adverse events reported due to its use of the process. An investigation by the Maharashtra Food and Drug Administration revealed that J&J, at its plant in Mulund, had used ethylene oxide – a substance used to produce industrial chemicals and to sterilize medical equipment – to kill bacteria in its baby powder and had not conducted mandatory tests to make sure there were no remaining traces in the powder. According to the U.S. Department of Labor, acute exposure to ethylene oxide can cause lung damage, nausea, vomiting and cancer.
As for as Ranbaxy is concerned, it has been served with Notices, not once, but Five Notices in Five Years!
The following are examples of the observations that support our conclusion that Ranbaxy submitted untrue statements of material fact in drug applications filed with the Agency: 1. Ranbaxy submitted stability information in numerous approved and pending applications that contain untrue statements of material fact, because Ranbaxy failed to include critical information about the storage and testing of the product. During a February 2006 inspection of the Paonta Sahib manufacturing facility, FDA found that hundreds of stability samples, many of which were being used for room temperature or accelerated stability studies, were being stored in refrigerators at approximately between the time they were removed from their stability chamber and the time they were tested. Among other things, FDA investigators found that the sample logbooks did not identify the samples that were being held in the refrigerators, their storage duration in the refrigerators, and the justification for this storage. FDA issued a June 15, 2006 warning letter to Ranbaxy based on its findings during this inspection, including the circumstances of these refrigerated stability samples.
Ranbaxy, the international Drug Manufacturer admitted in the United States to charges of making and distributing adulterated drugs at its two Indian plants of Paonta Sahib and Dewas and agreed to a $500 million settlement.
Ranbaxy .
“Daiichi Sankyo believes certain former shareholders of Ranbaxy concealed and misrepresented critical information concerning the US Department of Justice and Food and Drug Administration (FDA) investigations,” Daiichi said in a statement.
FDA warning to Ranbaxy.
Adulterated Drugs.
Mr. Malvinder Mohan Singh
CEO & Managing Director Ranbaxy Laboratories Limited
Corporate Office
Plot 90; Sector 32
Gurgaon – 122001 (Haryana)
India
Dear Mr. Singh:
The Center for Drug Evaluation and Research has determined that Ranbaxy Laboratories
Limited (Ranbaxy) submitted untrue statements of material fact in abbreviated and new
drug applications filed with the Agency. These findings concern the submission of
information, such as from stability test results in support of pending and approved drug
applications, from the Ranbaxy Laboratories Limited site located at Paonta Sahib, Sirmour District, Himachal Pradesh, India, (herein referred to as the “Paonta Sahib site”).
The following are examples of the observations that support our conclusion that Ranbaxy
submitted untrue statements of material fact in drug applications filed with the Agency:
1. Ranbaxy submitted stability information in numerous approved and pending
applications that contain untrue statements of material fact, because Ranbaxy failed to
include critical information about the storage and testing of the product. During a
February 2006 inspection of the Paonta Sahib manufacturing facility, FDA found
that hundreds of stability samples, many of which were being used for room
temperature or accelerated stability studies, were being stored in refrigerators at
approximately between the time they were removed from their stability
chamber and the time they were tested. Among other things, FDA investigators
found that the sample logbooks did not identify the samples that were being held in
the refrigerators, their storage duration in the refrigerators, and the justification for
this storage. FDA issued a June 15, 2006 warning letter to Ranbaxy based on its
findings during this inspection, including the circumstances of these refrigerated
stability samples.
2. Ranbaxy submitted an August 26, 2006 warning letter response that included
corrections to the stability data previously submitted to the agency in several
abbreviated new drug applications (ANDAs). The corrected stability test reports for
Fluconazole Tablets, Ciprofloxacin Tablets, and show instances
where stability test dates that previously had been submitted to the applications were
false. In some cases stability testing was conducted several months later than the
dates reported in the applications. Additionally, the firm reported stability test results
for a given batch as occurring at the required accelerated or long term (e.g., 3, 6, 9, 12
(
(b)
(4)
(b) (4) (b) (4)month ) time intervals, but actually conducted all of these tests on the same day, or
within a period of days.”
For Fluconazole Tablets and Ciprofloxacin Tablets, we found that even after Ranbaxy
submitted its August 2006 warning letter response with the corrected stability test
dates, the firm continued to submit the false stability test dates in annual report
submissions to the respective applications.
These submissions of false information about
the stability testing of the products were
material to FDA’s review of the applications.
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