Fraud Unearthed at Ranbaxy Bata Mandi ,Paonta Sahib plant

Discussion in 'Ranbaxy' started by Anonymous, Mar 23, 2008 at 10:33 PM.

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  1. Anonymous

    Anonymous Guest

    Major Fraud unearthed by USFDA at Ranbaxy Bata Mandi plant

    In a major blow to Ranbaxy , the officer of criminal investigations of US FDA , Mr Jose Hernandez unearthed a serious fraud at the new Bata Mandi facility near Paonta Sahib.During the first day of the Pre Approval Inspection conduted on March 3rd , the investigator found that the Equipment validation was completed prior to even receipt of the granulation equipment used for Tacrolimus capsule exhibit batches .There were no human resources at the site for last full year whereas the chief of technical operations Mr Ramesh Parekh showed that many people were actually working at the new site .The investigation will be completed on 7th March 2008 .The inspector has taken interviews of key technical staff to record their versions so that criminal investigations can be proven.

    The name of people who were shown as part of the R and D / manufacturing had no records to prove that they actually had taken trial batches .This will become another case like Able labs in USA which had to shut down after the frauds were found .

    US FDA had again raided the US facilities and offices again in end of 2007 to find discrepancies .Actually the Ranbaxy guys are too smart and they have been managing the inspections over a long time now but this will not continue for long .For info to some , I am a freelance journalist and has no relationship with Ranbaxy .The only objective is to bring out the truth .
     

  2. Anonymous

    Anonymous Guest

    It has become a way of working at Ranbaxy with all the fudging and manipulation of data in QC, Mfg and development areas .Even the top gives green signal to manipulate , thats worst and there is no concrete plans to improve .Thats what the industry is watching , what change they will bring to imrove such things .P Sahib plant is already under investigation and now batamandi plant here has boomed even before take off .This is a setback .These guys never improve .It needs to do with high level politics and bad culture and attitude is difficult to change .
    Dewas plant was bad anyway from the beginning as it is the mother plant where all thees seeds of politics are sown by so call leadership.....
     
  3. Anonymous

    Anonymous Guest

    Last year, two of India's largest and most respected drugmakers, Ranbaxy Laboratories and Wockhardt, received FDA warning letters about quality-control and documentation issues at their Indian plants. Both companies were told that if they did not improve, some of their Indian-made products would be barred from the United States.

    In February, the FDA's Office of Criminal Investigations raided the New Jersey offices of Ranbaxy. The FDA would not comment on the raid, and the company has said it is cooperating with the agency. A company spokesman said that the FDA was conducting "a wide dragnet," and a source familiar with the investigation said that it involved an unusually large number of investigators which is rare.It seems Ranbaxy is in for a big trouble ahead .Working with Parexel consultants has only made the situation comples rather than doing anything good for the co.

    Many people have left due to surmounting and endless issues related to quality including giving affidavits by its senior person exiting to US FDA that they dont have anything connected with Ranbaxy after their exit .One of the person is the ex Head of R and D team at Gurgaon.
     
  4. Anonymous

    Anonymous Guest

    If insiders are to be believed , Bata mandi plant which received many critical 483s including data integrity and personal integrity issues may not get the approval from Us FDA as the parent site of Paonta Sahib is under investigation and clearance has not been given to this site for any further product approvals .

    Batamandi site is dependant on the main PS site for QC , warehousing etc apart from other support functions .This will jeopardise the chances of getting the approvals .

    The management is still not serious of the mistakes and the serious frauds .Lots of complaints have also been sent recently by employees to FDA .That shows lots of enimity with the company which is surprising .But company has to bear the brunt now as there is no or poor leadership .

    Leadership crisis cud hit Ranbaxy...
     
  5. Anonymous

    Anonymous Guest

    The initial blog of this same thread was blocked by cafepharma which had lot of truth .Anyway Ranbaxy cannot hide the facts from people for long .Hiring consultants can only make the pocket fat for consultants .Ranbaxy has hired the GMP consultants for many years for now but it does not resolve any issues .A major change in attitude and thinking process is the need of the hour .You see QA head , Regulatory head , Manufacturing head .They are all crooks and have managed big positions by wrong means , be it politics , threat, cooersion, boss pleasing , extra curricular ( you know what i mean ) .It has led to only one thing ...deterioration in the standards for what Ranbaxy was known in the past .No good talent is getting attracted these days .Even to taht extent that they are not able to get teh QA head for long now .
     
  6. Anonymous

    Anonymous Guest

    Look disgruntled employee, we get it. The company screwed you over, so you are using the interenet as a means of getting revenge. Stop reposting the same nonsense. People are bored with you and your fake news.
     
  7. Anonymous

    Anonymous Guest

    Yes, don't you know that this forum is only for people to post raves, heap praise and offer exaltation to their pharma employers, benefactors and masters?
     
  8. Anonymous

    Anonymous Guest

    Point taken. I'll shut up now.
     
  9. Anonymous

    Anonymous Guest

    hi
     
  10. Anonymous

    Anonymous Guest

    Can anybody inform what is the latest status of Ranbaxy's Paonta Sahib and Bata Mandi plant approval from FDA? Is their Dewas plant is also in trouble?
    There is a strong rumour also that Ranbaxy is actively looking for a new Regulatory head and QA head.
     
  11. Anonymous

    Anonymous Guest

    All this is nonsense, I think first you should peep into yourself, before blaming others. This is obvious that no system is fool proof, hence there may be loopholes in the system but you can't blame the entire organization for it. The 483s shall be responded as per the norms and ranbaxy will standout ever shining as it was a few years back. Wait and see the result of hard and intelligent efforts put together. Dogs keep barking.........Elephants keep marching.

    Best of blogging enjoy
     
  12. Anonymous

    Anonymous Guest

    Do you realise that the company has NOT RESOLVED previous 483 issues related to Paonta Sahib FOR TWO YEARS NOW? And now the facilities at Bata Mandi and Dewas are under the scanner. I suppose the company is shining so much that you are completely blinded by the glare!
     
  13. Anonymous

    Anonymous Guest

    Hi
    What is happening to Ranbaxy now a days?I am told recently a marketing fellow has become head of all things technical - Manufacturing,QA and Supply Chain.Ranbaxy has drifted from "research based" long ago and with supply agreement with Orchid in place, has become a marketing company.Dr Parvinder Singh must be turning in his grave now.
     
  14. Anonymous

    Anonymous Guest

    You are right, Ranbaxy became a marketing company overnight with one Orchid Agreement. Are you kidding me? the company still has 8 manufacturing facilities around the world. Since when does aligning yourself with a strong competitor make you a marketing company?
     
  15. Anonymous

    Anonymous Guest

    Since when, you ask? Well, since 3 of those 8 manufacturing facilities went down the toilet because they failed FDA inspections. And since the facility in Romania lost its lustre.
     
  16. Anonymous

    Anonymous Guest

    Re: Ranbaxy will bounce back

    I saw a lot of things bad written about Ranbaxy. Actually it's fall was scripted by some idiot R&D guys especially NDDS group who couldn't deliver waht they promiosed to the management. they have all run away and remain ones are running for cover. Big money was spent on NDDS.
     
  17. Anonymous

    Anonymous Guest

    If all is nonsense then read the story in eco times india and many international dailies:

    NEW DELHI: Two manufacturing facilities of Ranbaxy Laboratories are learnt to have come under the scanner of the US Food and Drug Administration (USFDA), the drug regulatory body in the US.

    All pharma companies have to get USFDA approval for selling medicines in the US. This is in addition to the company’s Paonta Sahib (Himachal Pradesh) plant, which has been the subject of USFDA investigations for the past two years.

    According to sources, USFDA carried out inspections at Ranbaxy’s manufacturing plant at Dewas (Madhya Pradesh) and Batamandi (Himachal Pradesh) earlier this year. USFDA is learnt to have raised concerns over cross contamination at the Dewas plant.

    Sources said that USFDA has given a ‘not approved’ rating to new products manufactured at the facility, although this could not be independently confirmed. In the Batamandi plant, USFDA is learnt to have raised objections over the validation of equipment used to manufacture products at the facility.


    A detailed questionnaire listing these points and inviting responses from Ranbaxy elicited the following summary response from the company spokesperson, “Our facilities are inspected by USFDA and other regulatory agencies on an ongoing basis.”

    Ranbaxy addded, “All resulting comments are addressed by our technical teams who work to satisfy the authorities. We remain committed as always to supply highest-quality products to our customers in India and overseas.” A specific query about whether new products manufactured at Dewas and Batamandi could be exported to the US went unanswered by the spokesperson.

    In an e-mail response to ET, an USFDA spokesperson said, “The inspections have concluded. The agency has nothing further to discuss.”

    The US is Ranbaxy’s single largest market, and in 2007, its US sales stood at $386 million, accounting for 22.89% of the company’s global sales. It is believed that Ranbaxy’s manufacturing facility in New Jersey is now a major supplier for the US market.

    Of course, Ranbaxy is not the only Indian company that has had a run in with USFDA. A few months ago, Sun Pharma had to withdraw batches of generic metformin tablets, used to treat diabetes, on efficacy grounds. A couple of years ago, USFDA had also asked Wockhardt to correct several deficiencies.

    This is not the first time the Gurgaon-based Ranbaxy has come under USFDA’s scrutiny either. In February last year, USFDA’s criminal branch conducted a search at the company’s New Jersey facility in the US for alleged document fraud and activities related to sub-standard product manufacturing.

    In November last year, Ranbaxy voluntarily recalled 73 million pills of Gabapentin from the US retail market after discovering impurities outside the approved specification limit.

    In 2006, USFDA had conducted investigations at the company’s Paonta Sahib plant. While the company said that it has provided the FDA with all the requisite information and data, it is yet to get a clean chit from the regulator.
    Ranbaxy’s new owner Daiichi Sankyo is aware of the company’s issues with USFDA.

    Daiichi Sankyo president and CEO Takashi Shoda had earlier told ET that it is conducting an independent due diligence on the issue. According to the company’s website, it has manufacturing facilities in 11 countries. Its Indian facilities meet the requirements of all regulatory agencies such as MCA-UK, MCC-South Africa, USFDA and TGA-Australia.
     
  18. Anonymous

    Anonymous Guest

    First you make a bid that is a 50% premium over a company's stock price AND THEN you do due diligence on issues that undermine that company's manufacturing capabilities, and credibility in its biggest market, i.e., the US. Now there's a smart business decision if there ever was one.

    A shitload of money for a company that's neck deep in crap - absolutely priceless I tell you.
     
  19. Anonymous

    Anonymous Guest

    - Two brand new manufacturing facilites that need to be fixed before they have even been commissioned: 50 million dollars.
    - Losses from shuttered manufacturing facility facing FDA censure for >2 years: 50 million dollars.
    - Fees paid to lawyers worldwide to challenge Lipitor patents: 50 million dollars.
    - Selling your piece of crap company to Japanese businessmen who bought the India growth story: PRICELESS.

    There are some things money can't buy. For everything else, there's MalvinderCard.
     
  20. Anonymous

    Anonymous Guest

    You can be sure Diiachi has an out if the Reg Due Diligence fails; this deal doesn't closed until next March.

    Watch the stock drop like a rock when it happens.

    I don't know what the Indian equivalent is but here we say "Don't count your chickens until they hatch."

    I hope Malav et al haven't spent the money yet.