Treachery with India: vaccine testing at ICAR-IVRI
भारत में वैक्सीन कैसे पास किए जाते हैं?
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/
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/
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 -------.
No comments:
Post a Comment