Corruption in Foot n Mouth Disease (FMD) Vaccine testing under FMD control programme (FMD-CP). 1

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Nero Fiddled when Rome Burned

It is n old saying but still true in India

Indian farmers are dying of the poverty their animals are dying due to diseases but authorities in India are fiddling.

1.       Based on information under Right to Information Act (RTI) FMD-CP of compulsory FMD vaccination of animals is going on since more than a decade in India.

2.       Since the year 2005, more than 11400 FMD outbreaks are officially reported in India.

3.       Drug Controller General of India (DCGI) enacting body to Drug and Cosmetics Act has never thought to examine the quality of vaccine used under FMD-CP. Never took a single vaccine sample and sent for testing. Why?

4.       However, Indian Council of Agriculture Research (ICAR), a self-appointed police, set up several inquiries to prove that vaccine was good, either veterinarian were responsible or farmers were responsible for the outbreaks of FMD. As a punishment, many veterinarians have been suspended and farmers lost their animals. Why?

5.       Despite the use of the same FMD vaccine FMD outbreaks occurred in ICAR Institutes including two big outbreaks in its prestigious and premiere Veterinary Research Institute killing hundreds of valuable cows, no action was taken. Nobody knows who was responsible; prestigious veterinarians, administration or the vaccine. Why?

Answer to all questions (why) is:

1.       DCGI, Vaccine testing agency, and FMD vaccine producers are all hands in gloves, otherwise, DCGI, the custodian of maintaining the quality of vaccine and drugs in the Indian market has never thought of sampling even once for the FMD vaccine despite deaths of lakhs of animals of poor farmers.

2.       The testing agency to assure the quality of vaccine never thought of testing vaccine quality used even in cases when FMD devastated their own farms. Because, they passed the substandard vaccine, when they were deaf to losses at their own farms how can you expect to look for the losses to the farmers. It is because it was not their own loss but loss of taxpayers’ money, and they will get salary even after whole India gets burned.

3.       Why DCGI and IVRI (the passing agency) are mum and protecting the producers of substandard vaccines and faked drugs (>25% drugs in the Indian market are fake), there is nothing done without motive.

When PM of India will do “Kisaano ke man ki baat”.

India loses more than 20000 crores annually due to FMD.

India spends more than 500 crores annually on vaccination (if include the cost of the vaccine, cost of vaccination, and men days of veterinarians and other staff doing vaccination under FMD-CP.

We all got deaf because it is the matter of poor farmers, it is not the matter of those sitting in AC rooms enjoying on taxes paid at every step by poor people of India.

Corruption in Foot n Mouth Disease (FMD) Vaccine testing under FMD control programme (FMD-CP). Part 2 https://web.facebook.com/bhojr.singh.39/posts/1716105468665747

Bahut uljhe hue rishte, badhe lambe fasane hain, Badi taaza wo yaadein hain magar kisse puraane hain

Relations of FMD Vaccine Clearing Agency and Vaccine producers

1.    The vaccine quality clearing Institute is the main vendor (source) of vaccine technologies to vaccine producing companies, and the Institute gets the royalty on the sale of the vaccine. Those who are passing the vaccine are also the beneficiary of the companies. Then, how they can be truthful for the country? Why DCGI permitted this relation, for what benefit, for whose interests?

2.    Research advisory Board of the Institute (IVRI, the vaccine clearing agency) have officials of Indian Immunologicals Ltd. (IIL), then how the truthful testing of the vaccine produced by ILL can be done in IVRI? Why DCGI permitted this play?

3.    Technologies developed in IVRI spending crores of rupees have been sold to IIL and other vaccine producers at the through-away price (just a few lakhs). Why? The technologies were developed on taxpayers’ money, but the sale at so low cost indicates entanglement. Who got benefitted?

Nakli Police ke fasane

(Acts of fake police)

Why real police (DCGI) is silent?

Lakh Chupao Chhup Na Sakega Asli Naqli chehra.

From information under RTI, ICAR has no power:

1.    To form any inquiry committee to examine any vaccine quality.

2.    No scientist of IVRI or other organization have right for sampling under drug and cosmetics act?

3.    IVRI, Izatnagar has no authority to test FMD vaccine quality.

These facts are ignored by ICAR Animal Science Division and appointed a fake inspector (Dr. Gaya Prasad) with two havildars (Dr. Ravindra Sharma, Director Research, LUVASU, Hissar & Dr. B Patnayak, Director PDFMD, Mukteshwar). None of the three had:

1.    The experience of FMD Vaccine production.

2.    FMD vaccine testing.

3.    None of them ever produced or tested oil adjuvant vaccine.

But where is the need of expertise and experience to be appointed as fake police?

Yes, Dr. Gaya Prasad has acted as chief of fake police in many cases of FMD vaccine failure investigations, and in all cases, the report was one and the same:

The vaccine is good Veterinary doctors and farmers are wrong.

Dear friend the big question is:

1.    When fake-police (ICAR Animal Science Division) was acting as police why the real police (DCGI) was sleeping?

2.    Was it getting its share to sleep from fake police?

3.    Was it getting the share from the companies producing the substandard vaccine?

4.    Why was DCGI deaf for the cries of poor farmers?

5.    Why the custodian of Drug and Cosmetics Act of India was working for the private people and enjoying on taxpayers’ money.

6.    Why has DCGI  not acted even on the complaint of Director CCSNIAH, Baghpat, reporting substandard of FMD vaccine despite the news, MoS meetings?

7.    Why Nero Fiddled when Rome burned?

Tomorrow we will discuss role of IVRI and quality of GLP (which was not in CCSNIAH, Baghpat) in IVRI, Izatnagar (every information based on RTI)

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Corruption in Foot n Mouth Disease (FMD) Vaccine testing under FMD control program (FMD-CP). Part 3

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Saiyan Bhaye Kotwal to Dar Khe ka? Bhale hi saiyan farzi Kotwal sahi [Because the real kotwal (Drug Controller General of India, DCGI) is in slumber, no chance of its getting up]

" Banen hain ahal-e-hawas Muddai bhi Munsif bhi

Kise vakeel karein ? kisase munsifi chahen ? "

" बनें हैं अहल-इ-हवस मुद्दई भी मुंसिफ भी 

किसे वकील करें ? किससे मुंसिफ़ी चाहें ? "

Faiz Ahmed Faiz

Dear Friends, today I will talk (based on information either under RTI or available publically) on:

Great achievements of team of Kotwal (forget it that they have ever produced or developed and Oil adjuvant vaccine like one was found substandard in our testing, or any other)

1.    One of the members, presently Director PDFMD, has faced CBI inquiry in the fake purchase, but instead of him, notification was issued to all ICAR people not to repeat the act.

2.    The same, Director PDFMD is entangled in a case of forgery in documents and is facing a case at Delhi under section 409/420/467/468/471, IPC Section 34 and 120B (FIR No. 0304/ 2015 at InderPuri).

3.    Another, head of vaccine testing team at IVRI, Izatnagar has remained absconding for about a year, served in US, came back and joined, ICAR inquiry found him guilty but excused on signing an apology. How is it justified to serve at two places at any one time? In reward acting as dean of Premiere Institute of Veterinary Sciences so that the students may follow the example in future.

4.     Another member of vaccine testing team at IVRI, gets royalty from the company and was appointed as head of the re-sampling team it is another fact that neither he has the authority of sampling (as per DCGI and Drug and Cosmetics Act) nor has any experience of sampling, if he would had it, he would had not done like:

a.     Handing over the samples to the company for dispatch.

b.    Collecting variable numbers of vials from the different disputed batches (6-11).

c.     Would have followed Indian Pharmacopeia Guidelines indicating the requirement of at least 20 vials of each batch for sterility testing.

d.    Would have ensured the safety of the samples to the end of dispute, not have discarded those specific samples, while having very old (5 years) samples in coffers (walk in cold room where temperature often reaches more than 20oC, where temperature, since the testing of disputed batches, is entered between 2-7oC, ignoring the display showing any oC).

e.    Must have ensured need of having the register (archiving document) for keeping the record of vaccines or other material in the coffers, especially when the case is of such gravity.

5.    Officials of IIL are Member of Board of Management and Research Advisory Committee of the Premiere Institute of Veterinary Sciences entrusted to give the report on the quality of ILL vaccine. How the honesty can be ensured, and to what extent?

Why all it happened and still going on?

Why DCGI is slumbering?

Why are country’s caretakers slumbering?

What were the authorities getting from companies producing the substandard vaccine?

Why taxpayers are bluffed?

Why farmers are cheated?

Dear friends tomorrow we will talk about more of GLP at Premiere Institute of Veterinary Sciences and a new test developed for vaccine evaluation at the Premiere Institute of Veterinary Sciences, The Rat Scan.

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Corruption in Foot n Mouth Disease (FMD) Vaccine testing under FMD control programme (FMD-CP). Part 4

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What you want to buy in India? Everything is on sale, Conscience, Integrity, Certificate of Patriotism

Bharat mei rahne walo jara hoshiyaar-Yahan ke hum hain thanedaar

Yahan har chhej bikti hai---Imaan biktaa hai, certificate bikte hain, insaan bikta hai

 Babu ji tum kya kya khareedoge

Today’s topic is what play is going on in certification agencies and producers of substandard vaccine and what is the GLP and Rat Scan Test at the Premiere Veterinary Institute for Vaccines.

A.    Issue of fake quality assurance certificates and passing of bills of FMD vaccine (the question was raised in submission to MoS on 10-11-2014 and document was submitted)

1.      In last three years samples of 248 batches of FMD vaccine were sent, by CCSNIAH, Baghpat, to IVRI Bangaluru, the authorized centre to test and pass the vaccine (not to fail, there is no word in their dictionary like this), but none was substandard.

2.      Of the 248 samples sent IVRI Bangaluru tested only 12 (in 2014, the year when CCSNIAH gave its report, of 146 only 3 were tested), why?

3.      How the quality was assured and reports to clear FMD vaccines were prepared?

4.      How the bills of producers of FMD vaccine were cleared? Who were benefitted? Who were the main players of the caucus?

B.     GLP at IVRI

1.      GLP of testing facilty has Never been got certified from anywhere, because Hum hain Thanedaar.

2.      Temperature records of Cold room are faked and goes beyonf 20oC.

3.      Temperature records of Incubators not maintained.

4.      Media used in testing are never recorded in registers, when and how much made.

5.      Archiving register for samples not needed and never been prepared.

C.    Rat Scan test in Cold room of Premiere Veterinary Research Institute for examining vaccine samples: An innovation

1.      On visit to the cold room we found that there were several vaccine vials bitten and finely holed by rats.

2.      The Incharge wrote that old vials were actually holed by rats? Probably, IVRI has trained the rats to read the expiry dates so that they hole the vaccine vials in storage area and evaluate the quality of vaccine. Do those scientists trained the rats to read not deserve for Nobel Prize?

3.      The technology for Rat scan test for vaccine quality assurance and also methodology for training the rats to read should be patented, this is the best Example of Developed in India, Make in India and Made in India, our PM should reward the concerned scientists with Bharat Ratna or Rajeev Ratna Award wasting no time.

Why all this is happening; because:

1.      Care takers of the country are in deep slumber or getting their share for slumbering. Desh ke pahredaar so rahe hain.

2.      Players of corruption are playing free game behind the curtains of policy implementer. Khiladi khel khel mei crorepati aur arabpati bante jaa rahe ahain.

3.      Nobody is thinking for the country, for the farmers and for the Holy Cow, just talking. This is happening in India from top to bottom- Naa kaam kar, naa kaam kaa fikar kar bus fikar ka jikar kar.

4.      Punishing patriots and honesty, and rewarding traitors, has become habit of India. Sach saamne laane walon ko ki fansaa fansaa kar tadpa tadpa kar mara jaanaa Bharat desh ki pahchan ban gayaa hai.

5.      We are fattening on salaries paid from Taxpayers’ money for slumbering, for being traitor, for supporting fakes and traitors, for companies destroying the image of Made in India. Yahan sone ke paise milte hain, jaagne aur kaam karne ki sajaa.

Dear friends tomorrow we will talk about the adding of Enrofloxacin (a Fluroquinolone, poison below age of 16 years) in FMD Vaccine, permitted by Drug Controller General of India, to destroy the reproductive efficiency, to culminate athletic ability and to increase cases of epilepsy so that companies producing so-called medicines and vaccine keep on earning through Make in India Scheme. FMD vaccine is  inoculated in food and dairy animals and children and infants are the target. The aim is clear:

To destroy a country, spoil its future generations.

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Corruption in Foot n Mouth Disease (FMD) Vaccine testing under FMD control programme (FMD-CP). Part 5

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 Traitors of India & killers of future generations of India permitted the addition of Enrofloxacin in FMD vaccine.

 Traitors of India & killers of future generations of India permitted the addition of Enrofloxacin in FMD vaccine.

Enrofloxacin was banned long back in developed countries for use in dairy animals and growing animals all over the world but it is permitted in India not only for treatment but also for addition into FMD vaccine. Why?

1. Probably producer firms might have fed the drug regulators a big chunk.

2. Probably we are not patriotic to our nation (those who are not able to think of their own progeny how they can think of the Nation.

3. Probably people reaching at such high posts are either disloyal to the country or are antinational. 

Aug. 27, 2013 -- The FDA is strengthened its warning that fluoroquinolones, may cause sudden, serious, and potentially permanent nerve damage called peripheral neuropathy (Kelli Miller, WebMD Health News).

This was not the first serious warning for fluoroquinolones. In 2008, the FDA mandated a boxed warning, the most serious type of warning, to be added to the medications, alerting patients of the risk of tendon damage and rupture.

FDA approved it only for the treatment of Bovine Respiratory Disease (BRD), very rare in India, in dairy replacement heifers of less than twenty (20) months of age.

As per drug data and producer company guidelines, the drug is not only prohibited for use in lactating dairy cows, but also should be stored with those drugs used for lactating animals.

Quinolone Antibiotics Have a Dangerous and a VERY DARK History.

Floxacin antibiotics should be used only when there is no alternative. (British National Formulary, Australian Medicines Handbook)

.

Fluoroquinolones are antibiotics that contain fluoride, which allows them to penetrate into sensitive tissues like your brain and central nervous system.

Dear friends enrofloxacin and the member of this group should not be used in growing animals and children because it causes abnormalities in the development of articular cartilage i.e., weaken joints, kills athletic potential.

In such big country with more than 120 crores, no Olympic Gold Medal in athletics. Is this antibiotic the reason?

It should not be used in meat producing egg producing animals and birds because from there it enters into food chain.

Must not be used in dairy animals (cow, buffalo, goats) because it enters into milk and then into your body.

Side-effects of taking floxacins include

1. Hepatotoxicity:  Liver damage, Vomiting, diarrhea and elevated liver enzymes leading to Loss of hunger.

2. Neurotoxicity: Nerve and brain problems, it harms nervous system causing ataxia, seizures, depression aggression, eye weakness (Cataracts), anxiety, lethargy, Convulsions, restlessness, nervousness, confusion, weakness, insomnia, euphoria, nightmares, hallucinations, and psychosis. It do it by inhibition or disruption of the central nervous system GABA receptors.

3. Causes phototoxicity, sun allergy and increases skin cancer risk many fold.

4. Causes disruption of mitochondrial function and energy production

5. Causes Oxidative injury and cellular death, i.e. make old in young age.

6. Pulls magnesium from the body leading to Neurologic Side Effects and Tendon Problems, through disruption of cellular enzyme function.

7. Cardiotoxicity: heart damage and/or Prolonged QT Interval

8. Chondrotoxicity: damage to joints and cartilage

9. Tendinopathy: damage and rupture of tendons and other connective tissue

10. Genotoxic: Damage to DNA and genes

11. Nephrotoxicity: Damage to Kidneys

12. This group of antibiotics causes permanent damage. LIFELONG disabilities, chronic health problems and even increased the risk of cancer and sudden death. They may make you permanently bed ridden.

In how many consumers side effects are seen (http://articles.mercola.com/sites/articles/archive/2014/11/01/fluoroquinolone-antibiotic-side-effects.aspx)

1. Nervous system symptoms occurred in 91 percent of patients taking fluoroquinolones (pain, tingling and numbness, dizziness, malaise, weakness, headaches, anxiety and panic, loss of memory, and psychosis).

2. Musculoskeletal symptoms in 73 percent of patients (tendon ruptures, tendonitis, weakness, and joint swelling).

3. Sensory symptoms in 42 percent of patients (tinnitus, altered visual, olfactory, and auditory function)

4. Cardiovascular symptoms in 36 percent of patients (tachycardia, shortness of breath, chest pain, and palpitations).

5. Skin reactions in 29 percent of patients (rashes, hair loss, sweating, and intolerance to heat or cold).

6. Gastrointestinal symptoms in 18 percent of patients (nausea, vomiting, diarrhea, and abdominal pain).

Fluoroquinolones (enrofloxacin, norfloxacin, ofloxacin and ciprofloxacin etc.) must not be given to those are:

1. Pregnant, may cripple progeny.

2. Breast feeding (Fluoroquinolones enter breast milk).

3. Epileptics (Chances to recur increases many many folds)

4. Having

a. Stroke

b. Kidney problems

c. Heart problems (eg, QT-interval prolongation, uncorrected hypokalemia or hypomagnesemia, significant bradycardia).

d. Peripheral neuropathy (e.g., pain, burning, tingling, numbness, weakness, change in sensation), often irreversible damage). Peripheral neuropathy is damage to the nerves that send information to and from the brain and spinal cord and the rest of the body.

e. Brain injuries

5. Children below 16 years of age because it damages to the musculoskeletal system i.e.,

a. Weak muscles

Weak ligaments and tendons

b. Weak joints

c. Arthritis, arthralgias, tendinopathy, gait abnormality.

6. In the athletes, their career is finished by this group of antibiotics (causes rupture of the Achilles tendon, may occur even after short-term use of fluoroquinolones).

7. In Elderly: Because according to the JAMA study conducted by Lee and colleagues, fluoroquinolones cause two-fold increase in the risk of dissection and aneurysm (brain and heart haematoma) in elderly. The BMJ study found nearly a three-fold increase in the risk of aneurysm on following about 1.7 million patients. Fluoroquinolone-associated tendon disorders are more likely to occur in the elderly (>60 years of age) with the Achilles tendon being the most common site affected.

Dear friends, it is the right time to question:

1. Who permitted the use of this dangerous drug to be added in the FMD vaccine?

2. Why was the use of the drug as preservative permitted to be added in the FMD vaccine?

3. Who got benefitted?

4. Whose life is risked?

5. Why are we still silent on the ongoing conspiracy to ruin our nation?

6. When shall we oppose the wrongdoings with us and our children?

7. When shall we boycott such Anti-national vaccines and Anti-national companies?

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Corruption in Foot n Mouth Disease (FMD) Vaccine testing under FMD control programme (FMD-CP). Part 6

It is not the first time when IIL vaccine failed, but the company always tried the same route.

In 2004-05 its Sheep Pox Vaccine of IIL was found sub-standard and then authorized Govt. Analyst Dr. Rishendra Verma proved that the vaccine was substandard.

According to Dr. Verma, at that time too ILL tried so many means to get the vaccine passed.

Then State of Rajasthan filed a case against ILL in the Court of Chief Judicial Magistrate Bikaner, the case was challenged in High court and ended in 2013, but without proving that their vaccine was of the promised quality.

For wide-spread failure of FMD vaccine in 2014 and outbreaks of FMD throughout India, Nishkam Sewa Samiti, filed a case (PIL, Misc. Bench. 12586, 2014) against the company, but it managed to stop hearing and no date in last 1.5 years, God knows, how?

Though IIL says that it is the fully owned subsidiary of NDDB, it has fought a case against NDDB too.

It appears that instead of improving vaccine quality company has concentrated to excel in its legal skills to shut the mouths of people telling the truth.

This year too, large FMD outbreak devastated the dairy farm of the Premiere Veterinary Research Institute despite regular six monthly vaccinations (though the company claims that it’s Oil Adjuvant FMD vaccine used under FMDCP all over India and in IVRI protects against FMD for about a year).

Elated by the quality of IIL FMD vaccine, IVRI has recently decided to vaccinate its animals thrice in a year. On what grounds, nobody knows. After all, the vaccine is of very good quality (as approved by IVRI itself). That is why the vaccine should be used time and again. Who knows one day IVRI may recommend its daily use for some marvellous advantages. More vaccine batches to be produced and to be passed. And in turn more income to the company, and more-------------------to the vaccine passing authority (IVRI).

Dear friends, outbreaks occurred in IVRI, Punjab, Haryana, Rajasthan and in UP in 2016, because they were doing vaccination only twice in a year in contrast to companies claim of protection for about a year. It is said that excess of anything is always detrimental. However, recent recommendations from IVRI to vaccinate animals thrice in a year speak something else.

Dear friends, ponder on the facts I put for your consideration for next few days as I may be away from you for a few days and may not load you.

You all are learned people understand much better than me the meaning of each and every word I put to you.

Now, I make the appeal again to extend your kind help:

a.    To fight for truth.

b.    To fight for the quality vaccine.

c.    To fight for poor farmers and animals raisers of India.

d.    To fight for the dignity of the veterinary profession.

e.    To fight for the country (so that in coming days nobody can say that India in Hub of substandard vaccines and drugs).

f.     To fight for Make in India and Made India’s image.

g.    To fight for the dignity of the truthful scientists of India.

h.    To fight for the patriotism and Nationalism.

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The issue is serious. It is related to health of India's valuable livestock wealth and so also to poor, economically deprived farmers of our country whose subsistence is linked livestock production and agriculture. Keeping the gravity of the matter ahead government should go for in-depth inquiry of this issue. That is necessary in the interest of the country as whole and science in particular. No profit maker should be allowed to loot and ruin the livestock wealth.

घोटालों की लम्बी परंतु अधूरी कहानी: मुँह पका खुर पका वैक्सीन -FMD Vaccine और FMD-CP https://www.linkedin.com/pulse/corruption-fmd-vaccine-quality-assurance-control-india-bhoj-raj-singh

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