Accused of violating packaging rules for some prescription drugs.
By The American Bazaar Staff
NEW DELHI: It’s the turn of yet another Indian pharmaceutical company to run afoul of regulatory authorities in the United States: this time, it’s the reputed Dr. Reddy’s Laboratories Ltd. which is being accused of violating packaging rules for some prescription drugs between 2008 and 2012.
The allegations by the U.S. government’s Consumer Product Safety Commission (CPSC) are the latest in a series of regulatory troubles facing Indian pharmaceutical firms in their biggest export market, the United States, reported Reuters.
In a U.S. stock exchange filing this week, Dr. Reddy’s said the CPSC planned to seek civil penalties against the company for allegedly violating rules intended to prevent children from ingesting harmful substances. The company said any unfavorable outcome could result in “significant liabilities” and added that it disagreed with the allegations, the Reuters report said.
India’s $15 billion-a-year industry has come under the scanner of the US Food and Drug Administration since last year, and more than a dozen companies have faced the heat, which have led to product recalls and bans on some products.
Earlier this week, the Regulatory Affairs Professionals Society had reported that for at least the 12th time since May 2013, the FDA sent a Warning Letter to an Indian pharmaceutical manufacturer accusing it of falsifying data used to support the ongoing approval of its drug products. The company, Marck Biosciencies, was subject to an October-November 2013 inspection by FDA at its Kheda, India manufacturing facility.
There, FDA said it found troubling deficiencies, including that the company generated unofficial “visual inspection records” that contained data that were “different from the official batch records reviewed by [Marck’s] quality unit.”
FDA said a review of those records showed that the products often contained “significantly more quality defects” than the official records indicated. For example, official records only indicated that 18 units of a drug batch failed to meet specifications, whereas the total number was actually 200. FDA said the company was unable to prove that all units had been rejected from further processing.
In other cases, FDA found Marck to be using “scratch paper” (i.e. “scrap paper”) to record “critical manufacturing data.” Those data did not always match the official records, FDA alleged, implying that the data were later altered to be more favorable.
“The use of unofficial and scratch paper records is not acceptable current good manufacturing practices (CGMP),” FDA wrote.
The report also said that in another alarming instance, FDA said that its inspectors interviewed Marck employees who admitted that certain activities recorded as having been performed were in fact falsified, and had never been performed.
Elsewhere, FDA inspectors said they found “significant mold growth” in an on-site washroom located “at the entry of the sterile manufacturing area.” The mold growth was apparently so bad that the room had partially “caved in.” This was especially concerning given a recent finding by the UK’s Medicines and Healthcare Products regulatory Agency (MHRA) which found fungal growth in one of the facility’s parenteral products, FDA said.
Regulators also found “numerous dead insects” throughout the facility and “dead and decaying frogs” near the facility’s exit dock. The facility is reportedly situated near a “swamp-like perimeter,” FDA noted.
The facility was advised to implement a corrective action plan and to hire a third-party auditor to ensure organizational compliance.
1 Comment
All i will say is i would recommend that you don’t use any medication made by Dr Reddys.When i started to get tablets that were made by Dr Reddys i was suspicious that might be the conection as to why i was starting to what has turned out to be some serious mental health issues and some worring physical issues.All i can say is that after some research i was very very much more inclined to belive the conection.In fack i was shocked at what i found out and all i can say is that anyone should make sure they note any Doctor that they see check their badge and research ther background with pictures if possible and if they have any remote conection to Dr Reddys i would be more than concerned as all i can say is that i have come to understand that many Companies without naming any!! require research and tests on humans which is not always possible or is it ???!!! Also i saw mentiond that Dr Kallam Anji Reddys is dead ? is he??Maby i Read Wrong??The truth is out there !!! Karen