Enrofloxacin Addition in FMD vaccine: An anti-national act

An Anti-National Act of Dr. Gaya Prasad Committee on FMD Vaccine quality issue formed by GOI (ICAR) wrote that "Enrofloxacin Addition in FMD vaccine is legal and with no undesirable effects"

The Committee wrote in their report (https://www.researchgate.net/publication/267705649_Testing_of_FMD_Vaccine_intended_to_be_used_under_FMD-CP_of_Govt_of_India_at_CCS_NIAH_Baghpat_UP_India?ev=post) on FMD Vaccine Quality at page 9 at point 4: “Ït was informed by the manufacturer that the use of enrofloxacin as a preservative was permitted by DCGI (Annexure 7). The Committee was told that the concentration used does not have undesirable effects.”

From this statement, it is apparent that they believed on the manufacturer of the substandard vaccine adulterated with unethically permitted antibiotic as the preservative. They neither did any search, nor research nor had any knowledge. They went to the extremes to support the addition of the antibiotics (in low doses) which may destroy the ecology, environment and coming generations of India. They become blind or got blinded with ----power, only Dr. Gaya Prsad can explain the reasons for his blindness.

If they would have read even the single drug datasheet of enrofloxacin (https://animalhealth.bayer.com/ah/fileadmin/media/baytril/pdf_companion/kap6.pdf) from mother company (Bayer) then they would have changed their view. But the committee was made illiterate by the corporate power.

I request you to read the following lines from http://c.ymcdn.com/sites/www.aavpt.org/resource/resmgr/imported/fluoroquinolones.pdf

Federal law prohibits the extra-label (non-intended use) use of fluoroquinolones in food-producing animals (21 CFR 530.41). The prohibition is based on a finding by the Food and Drug Administration (FDA) that the extra-label use of these antibiotics in food-producing animals presents a risk to the public health because it could increase the level of drug-resistant zoonotic pathogens at the time of slaughter. Some researchers are concerned that such use can lead to the transfer of pathogens resistant to fluoroquinolones from animals to human beings. Food animals including, all pigs, feedlot cattle and, animals that are not members of a species routinely used for food production would also be considered food-producing animals if they or their products are processed for human consumption.

But in India neither animals nor human lives are valuable; it seems to be the country of money-money and money, of corporate houses and of traitors.

Extra-label drug use (ELDU) means "actual use or intended use of a drug in an animal in a manner that is not in accordance with the approved labelling. This includes, but is not limited to, use in species not listed in the labeling, use for indications (disease or other conditions) not listed in the labeling, use at dosage levels, frequencies, or routes of administration other than those stated in the labeling, and deviation from the labeled withdrawal time based on these different uses." (http://www.farad.org/eldu/eldumain.asp; http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/ActsRulesRegulations/ucm085377.htm). And to your surprise, you may not find the use of enrofloxacin as a preservative. The enrofloxacin is “- Only labelled for non-lactating dairy animals twenty months of age or less and beef animals for pneumonia.” (See page 21 of the link: http://www.nationaldairyfarm.com/sites/default/files/2015-Residue-Manual-WEB.pdf) and is not approved in lactating dairy cattle 20 months of age or older (page 52 of the above link).

Dr. Dr. Clell V. Bagley, D.V.M. wrote (http://extension.usu.edu/dairy/files/uploads/htms/drugs.htm) “Fluoroquinolones - Although data have not been sufficiently conclusive to prevent approval of sarafloxacin for chickens and beef cattle, it prompted FDA-CVM to prohibit the extra-label use of these compounds in 1997. Fluoroquinolone products labelled for either humans or companion animals may not be used in food animals. Any deviation from a food animal label (such as use with a different species, dosage, route of administration, or disease indication) is similarly illegal. In the case of the approved beef cattle formulation of enrofloxacin (Baytril 100), this prohibition extends to all non-beef-production animals, including lactating and nonlactating dairy cows, heifer replacements, and veal calves. Enrofloxacin may not be stored in dairy farm drug cabinets”.

The fluoroquinolones were the first group of antimicrobials prohibited from extra-label use by the FDA because of their potential for creating antimicrobial-resistant strains that posed a threat to human health. The FDA banned the extra-label use of fluoroquinolones in 1997. Not only in dairy animals FDA, in 2005, withdrew the approval for enrofloxacin products in poultry and effectively made use of these drugs in poultry species illegal (http://www.farad.org/publications/digests/092009ProhibitedDrugsUpdated.pdf).

The dangers of enrofloxacin use in animals even those are not food animals are as under (http://www.wedgewoodpetrx.com/learning-center/professional-monographs/enrofloxacin-for-veterinary-use.html):

• Enrofloxacin and the other fluoroquinolones antibiotics can cause developmental cartilage abnormalities. As a consequence, most veterinarians try to avoid these drugs in young animals.

• Enrofloxacin should be used with caution or avoided in animals at risk for seizures. This drug is not used in humans due to central nervous system stimulation.

• Enrofloxacin should not be used for regional antibiotic perfusion because it is too irritating and will cause vasculitis.

• In Dogs: GI side-effects including vomiting, diarrhoea and elevated liver enzymes; Rare CNS signs including ataxia, seizures, depression, and anxiety, not recommended in pups.

• In Cats: GI side effects include vomiting, diarrhoea, anorexia, elevated liver enzymes. CNS signs include ataxia, seizures, depression, vocalization, and aggression. Rare ocular toxicity may occur.

• In Horses: As Injection, it is highly irritant and when given orally it can cause mucous membrane irritation, redness, slobbering, and swelling.

• All food animals: Prohibited

                    Dear Friends, low dosages of antibiotics are even more dangerous than the therapeutic use of the antibiotics because “Low doses of antibiotics can stimulate the formation of bacterial biofilms that lead to chronic lung, sinus, and ear infections. The biofilms can grow stronger instead of weaker in presence of the antibiotics. The emergence of drug-resistant bacteria is a global challenge and is an outcome of the irregular and subtherapeutic use of antibiotics besides several other factors.

            So be careful and think twice about the explanation of Dr. Gaya Prasad Committee, either its addition into FMD vaccine supported by the committee is wise or anti-national.

The common adverse effects of Fluoroquinolones (ciprofloxacin, norfloxacin, ofloxacin, enrofloxacin, levofloxacin etc, FQ) include gastrointestinal disorders as nausea, vomiting, diarrhoea, and abdominal cramps. Besides, skin rashes, allergies, and photosensitivity are also frequently seen. Some less common complications of FQ use are neutropenia, eosinophilia, and elevated liver enzymes (1-4%) but luckily all are reversible with proper post-therapeutic care (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3668199/). Several studies associated arthropathy in kids after use of FQ in growing age up to 18 years.

In a study in 2003, Chalumeau and co-workers reported (https://www.ncbi.nlm.nih.gov/pubmed/12777590) from a prospective, multicenter, observational, cohort study that compared potential adverse events in 276 pediatric patients who received FQs and 249 matched controls who received an antibiotic agent other than FQ. The chances for potential adverse events in the FQ group were 3.7 times more than the non-FQ group. The most commonly affected systems were the gastrointestinal followed by musculoskeletal (arthralgias of large joints or myalgias but no tendinopathy), skin, and central nervous systems.

The recent model list of essential drugs prepared by the WHO includes only 340 items and 532 formulations of which only 12 are FDCs(2). The combination of metronidazole and norfloxacin does not figure in this list (https://www.indianpediatrics.net/sep1998/sep-941-942.htm), but in India, you may find in almost every pediatric prescription (http://www.drugsupdate.com/brand/showavailablebrands/631), often as the first drug of life.

When the use of FQs is permitted?
Even the most studies supporting the use of fluoroquinolones to cure septic cases in kids when no other alternative is left agree with the bad effects of fluoroquinolones in kids (http://www.jwatch.org/em200712210000003/2007/12/21/should-we-prescribe-fluoroquinolone-antibiotics).

FQs are approved by FDA and EU (https://www.ncbi.nlm.nih.gov/pubmed/21949152; https://ec.europa.eu/health//sites/health/files/files/paediatrics/2012-09_pediatric_report-annex1-2_en.pdf; http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Ciprofloxacin_Bayer/human_referral_000024.jsp) for use in children for emergency use for the treatment of inhalation anthrax, complicated urinary tract infections, and pyelonephritis and cystic fibrosis caused by Pseudomonas aeruginosa. WHO permits FQs (http://www.who.int/maternal_child_adolescent/documents/9241546700/en/) for the treatment of life-threatening bacterial infections, such as resistant tuberculosis, dysentery, and cholera, with the caution that uses these nasty antibiotics if the benefits outweigh the risk of arthropathy. American Academy of Pediatrics (AAP) suggest the use of FQs for treatment of multidrug-resistant infections for which there is no safe and effective alternative, and when parenteral therapy is not feasible and no other effective oral agent is available (https://www.ncbi.nlm.nih.gov/pubmed/16951028).

 But who cares in India, paediatricians are prescribing these FQ drugs indiscriminately even giving any second thought and using it as the first line of treatment which otherwise should be the last option.

Treachery with India: vaccine testing at ICAR-IVRI. How are Vaccines passed in India?

Treachery with India: vaccine testing at ICAR-IVRI

भारत में वैक्सीन कैसे पास किए जाते हैं?

भारतीय पशु चिकित्सा अनुसंधान संस्थान में वैक्सीन टेस्टिंग: देश के साथ गद्दारी 

Dear friends, if you remember we tested 59 batches of Foot and Mouth Disease (FMD) Vaccine in 2014 at CCS National Institute of Animal Health, Baghpat and found that FMD vaccine used under FMD Control Programme in India is of sub-standard quality (https://www.researchgate.net/publication/267705649_Testing_of_FMD_Vaccine_intended_to_be_used_under_FMD-CP_of_Govt_of_India_at_CCS_NIAH_Baghpat_UP_India). The vaccine producing lobby uploaded a report based on ICAR-Indian Veterinary Research Institute’s FMD Vaccine testing (https://www.researchgate.net/publication/275045724_GoI_Expert_Committee_clears_FMD_vaccine_Manufacturers_report_2015pdf) in their support crafted by Dr. Gaya Prasad (then ADG at ICAR) based on false allegations and forged proofs (https://www.researchgate.net/publication/304022747_Point_wise_counter_details_of_GoI_Expert_Committee_Headed_by_Dr_Gaya_Prasad_the_great_microbiologist_of_India_report_against_CCS_NIAH_Baghpat_report_based_on_testing_of_FMD_vaccine_by_inexperienced_re). Dr. Gaya Prasad and the Vaccine testing team claimed that their report is as per Indian Pharmacopeia (IP) FMD Monograph and IP-2014.

Let us see what public edition of IP-2014 and its different monographs and Appendices say about quality testing of the veterinary vaccine with special reference to FMD vaccine.

1.       Oil adjuvant emulsion stability: Stability is the ability of a vaccine to retain its chemical, physical, microbiological and biological properties within specified limits throughout its shelf life, (IP 2007, Vol. 3. General Monographs, Veterinary Vaccines, page 1504).  And in IP-2014 page 955, the definition of emulsion injections, --emulsion should not show any evidence of separation--).

2.       For Sterility test 20 vials must be tested per batch if the size of the batch is more than 500 vials (IP-2014, Annexure 23, 2.2.11 Sterility, page 59). From each vial containing 100 ml, or more contents 20 ml of contents, should be used for inoculation of each of the test medium.

3.       For safety testing: Use minimum 3 susceptible non-vaccinated cattle (2ml vaccine divided into 20 intra-dermal injections on the tongue) of not less than 6 months of age, (IP-2000, Monograph, Foot and Mouth Disease Vaccine, page 110).

4.       For potency testing, three groups of 5 cattle each of not less than 10 months old should be used. Animals in the first group are given 3 ml dose, in second one-third of the dose (1 ml) and in the third group one-tenth of the dose (0.3 ml) should be used to vaccinate. Two cattle of the same stock are kept as control (no vaccine). After 21 days, challenge with 10⁴ ID₅₀ doses of virulent virus and observe for 8 days and sacrifice the animals. Control animals must show the lesions at tongue as well as on other sites (test is valid only when at least 3 of the feet of each control animal are affected). A few of the vaccinated animals may show lesions at the tongue at inoculation site but not anywhere else, (IP-2000, Foot and Mouth Disease Vaccine, page 110).

5.       If the vaccine is intended to be used in pigs also (as you know FMD-CP also applicable for pigs and the same vaccine is to be used in pigs too): Inoculate 10 pigs (8 weeks old, unvaccinated, free of FMD antibodies) each with 0.5 ml vaccine, 2 pigs of the same stock are to be kept as un-vaccinated control. Challenge after 4 weeks with 10⁴ ID₅₀ doses of virulent virus and observe for 8 days and sacrifice them. Control animals must show the lesions at tongue as well as on other sites (test is valid only when at least 3 of the feet of each control animal are affected). A few of the vaccinated animals may show lesions at the inoculation site (heel bulb), (IP-2000, Foot and Mouth Disease Vaccine, page 110).

Now see what the traitors of the country claiming to be the National analysts and caretakers of whole India’s Veterinary Science and Veterinary Vaccine Quality do? (The whole information is based on RTI from Indian Veterinary Research Institute and Department of Animal Husbandry, Dairying, and Fisheries).

As per information under RTI, 188.68 million and 274.84 million doses of FMD vaccine were procured through Central Govt funding in 2013-14 and 2014-15, respectively. These doses were made in 72 batches and 146 batches of FMD vaccine by the different manufacturers of the vaccine. Suppose 50 doses are packed in each of the vials, i.e., on an average about 43 thousand vials of vaccine were produced per batch i.e., as per Public Edition of IP from each batch at least 20 vials should be collected for sterility testing. Samples of each of the batch were submitted to Indian Veterinary Research Institute, Bangalore, for testing the quality of the vaccine.

Now see how the secret version of IP-2014 was used to test the FMD vaccine Quality at Indian Veterinary Research Institute.

1.       Oil adjuvant emulsion stability: They do not test it because as per their secret edition of IP-2014 it is not written in IP thus not required. However, they do not show their secret pharmacopoeia to anyone.

2.       For sterility test, they take only five vials per batch, select the batch to be tested at random (only 3 batches of 146 in 2014 and 3 in 2015), of the selected batch they take one vial for the test at random, and test it as per their IP-2014, secret edition. And, use only 10 ml of the contents of the vials, in contrast, to recommended 20 ml in public edition of IP

3.        For safety testing: Only 3 batches tested in 2014 and 2015 each, that too only in two (instead of three as public edition of IP) bull calves (of undefined age, however, it appears from the RTI that instead of 6 month age animals they used 8-10 months aged animals) and with undefined dose as per their IP-2014, secret edition.

4.       For potency testing: Only 3 batches tested in 2014 and 2015 each, that too only in one group (instead of three as per public edition of IP) of bull calves between 8-10 months of age (not in animals of not less than 10 months age of as per public edition of IP) and with only full dose. Animals were not sacrificed after 8 days of the challenge but rehabilitated after 3 months (as per guidelines contained in their IP-2014, secret edition).

5.       The vaccine is intended to be used in pigs (http://www.poulvet.com/vetproducts/medicine_detail.php?mediid=701): But not a single batch of the FMD vaccine has been tested in pigs in last five years (Probably as per guidelines contained in their IP-2014, secret edition).

So dear friends you can see how some rogues at the National Institute (Indian Veterinary Research Institute) as caretaker of veterinary vaccine quality have created a new secret version of Indian Pharmacopoeia-2014, which is altogether different from the public version. Why is it done?

1.       To bluff the country.

2.       To cheat the animal owners and caretakers of India.

3.       To destroy the Indian farmers’ economy.

4.       To destroy the Indian Dairy husbandry.

5.       To benefit the producers of substandard veterinary vaccines.

6.       To earn in return of flawed testing.

7.       To hide the truth but for what?

Or anything else, you may tell much better than me and caretakers of Indian Veterinary Research Institute can tell you much better than me and you, as they understand the reason to the core of the truth.

Why the administrators at the central level at the state level are silent over all of the ongoing corruption?

Probably for their share.

Probably due to a traitor in the blood.

Probably many more reasons, they might know better than I and you.

But why are you silent?

Are you a traitor too?

Is there no blood in your veins?

Are you dead?                                                                                                                   

Are you selfish?

Do you belong to any of the class the producers and quality analyst of veterinary vaccines in India -------.