Saturday, September 15, 2018

Indian Disease Disseminating Research Institute (IDDRI): भारतीय रोग प्रसारण अनुसन्धान संस्थान

Indian Disease Disseminating Research Institute (IDDRI)
भारतीय रोग प्रसारण अनुसन्धान संस्थान 
(Proposed)
भारत का प्रथम प्रामाणिक रोग वितरण संस्थान
(https://www.researchgate.net/publication/332103614_Indian_Disease_Disseminating_Research_Institute_IDDRI/stats)
Under memorable leadership of Dr. Raj Kumar Singh, Director ICAR-IVRI
The Institute has grossly defied all the provisions of The Prevention and Control of Infectious and Contagious Diseases in Animals Act, 2009.  
http://www.dahd.nic.in/sites/default/filess/Gazette_20-03-09.pdf

The RTI enquiry (IVTRI/R/2018/50040) revealed that Sadistic traitors of Indian livestock health produced and sold veterinary biologicals and diagnostic for 25 years without a valid license, neither CDSCO nor any other agency took action against traitors, why?


 Besides, other Heinous acts of the Institute (Indian Veterinary Research Institute, Under memorable leadership of Dr. Raj Kumar Singh, Director ICAR-IVRI) are:
1. Disease distribution through production and sale of milk and milk products from TB, JD and Brucellosis positive animals. Under Food Safety and Standards Regulations 2011 and THE FOOD SAFETY AND STANDARDS ACT, 2006 section 3(zz)(ii), the milk from diseased animals is classified as―unsafe food‖ injurious to health. Under Section 26 of the Act Responsibilities of the Food business operator are fixed and subsection 26(2) prohibits from store, sell or distribute any article of food– (i) which is unsafe and under subsection 26 (3)(e) The seller is held liable under this Act for any article of food which is sold with knowledge of being unsafe. Section 59 of the Act made provision for Punishment for unsafe food.–Any person who, whether by himself or by any other person on his behalf, manufactures for sale or stores or sells or distributes or imports any article of food for human consumption which is unsafe, shall be punishable,– (i) where such failure or contravention does not result in injury, with imprisonment for a term which may extend to six months and also with fine which may extend to one lakh rupees; (ii) where such failure or contravention results in a non-grievous injury, with imprisonment for a term which may extend to one year and also with fine which may extend to three lakh rupees; (iii) where such failure or contravention results in a grievous injury, with imprisonment for a term which may extend to six years and also with fine which may extend to five lakh rupees; (iv) where such failure or contravention results in death, with imprisonment for a term which shall not be less than seven years but which may extend to imprisonment for life and also with fine which shall not be less than ten lakh rupees.
2. Disease Distribution Through sale/ auction of diseased animals suffering from Scheduled Infectious diseases including Bovine Tuberculosis, Paratuberculosis (Johne’s Disease), and Brucellosis, and auctioning animals at the time of FMD outbreak in the Institute premises, the Institute intentionally spread the infectious and contagious diseases faraway places. All these acts of the Indian Veterinary Research Institute (IVRI) are punishable under different sections of The Prevention and Control of Infectious and Contagious Diseases in Animals Act, 2009. Further, the institute was engaged in faulty passing of diagnostics and vaccines to control infectious and contagious diseases, that is intentionally spreading such scheduled diseases (Brucellosis, Foot and Mouth Disease, Paratuberculosis, Bovine tuberculosis, PPR, Glanders, Classical swine fever, New Castle disease/ Ranikhet Disease, Sheep and Goat pox etc.) to each and every nook and corner of India.
The section 5 of the Act defines Duty of the owner to segregate infected animals. 1.     Every owner or person in charge of an animal, which he has reason to believe is infective of a scheduled disease, shall segregate such animal and have it kept in a place away from all other animals which are healthy, and take all possible steps to prevent the infected animal from coming in contact with any other animal. 2.     The owner or other people in charge of, or having control over, the animal referred to in sub-section (1) shall confine that animal and prevent it from grazing in a commonplace or to drink water from any common source including a vessel, pond, lake or river. 3.     All other infected animals shall be segregated by the Municipality, Panchayat or other local administration. However, IVRI had neither segregated nor quarantined such animals but sold to Farmers which could not properly understand the seriousness of the problem. This heinous act of the institute further contravened the provision under Section 11. Precautionary measures in relation to controlled areas. No person shall take out of the controlled area- a.     any animal, alive or dead, which is infected with, or reasonably suspected to have been infected with, any scheduled disease notified under sub-section (1) of section 6, b.    any kind of fodder, bedding or other material which has come into contact with any animal infected with such disease or could, in any manner, carry the infection of the notified disease, or(c) the carcass, skin or any other part or product of such animal. By arranging an auction of animals at the Institute in January 2016 when PPR and FMD outbreak was there in the institute, the Institute also flawed provision of the Act under Section13 Prohibition of bringing of infected animals into the market and other places. Section 23 of the Act directs a.    to keep it segregated from other apparently healthy animals, or b.    to subject it to such treatment as may be required under the circumstances. That is it is compulsory to segregate and treat the animals suffering (from scheduled diseases), however, the institute has neither segregated nor treated despite the fact that several animals are suffering from bovine tuberculosis, brucellosis and Paratuberculosis, and the Institute claims it to be the Mecca Madina of Veterinary Sciences in India.
The Section 31 prohibiting Administering defective vaccine suggest penalties under section 32. “Any person who contravenes the provisions of this Act or obstructs the Competent Officer in performing his duties shall be guilty of an offence punishable with fine which may extend to one thousand rupees, and in case of failure to pay the penalty with imprisonment for a term which may extend to one month; and in the case of any subsequent offence (whether under the same provision or any other provision of this Act except in case of sections 31 and 33) with a fine of two thousand rupees, or with imprisonment for a term which may extend to two months in case of non-payment of the penalty”.
The gravity of the crime cannot be estimated in case of IVRI as it not only administered defective vaccines (faulty FMD, which led to at least three outbreaks in the institute just after vaccination, faulty PPR vaccine which led to outbreak of PPR in the Institute), not tested for efficacy and safety, but also made all vets of the country to vaccinate animals with defective vaccines and spread or failure in control of Brucellosis, Foot and Mouth Disease, Paratuberculosis, Bovine tuberculosis, PPR, Glanders, Classical swine fever, Newcastle disease, Sheep and Goat pox etc.. For such cases Section 35 of the Act also makes the Director IVRI liable for punishment. Section 35. For Prevention of the escape of causative organism states 1.     In every institution, laboratory or clinic, engaged in the manufacture, testing or research, related to vaccines, sera, diagnostics or chemotherapeutic drugs and aimed at the prevention or treatment of any scheduled disease, adequate precautionary measures shall be taken- a.     to ensure that the causative organism of any scheduled disease does not escape or otherwise get released; b.    to guard against any such escape or release; and c.     to warn and to protect everyone concerned in the event of an escape.
Though Section 25 of the (PCICDA) Act, 2009 suggest Resort to euthanasia for infected animals.—If the Veterinary Officer deems it necessary that an animal, which is infected with a scheduled disease, euthanasia has to be resorted to, for preventing the spread of the disease to other animals in the area or to protect public health if the disease is of zoonotic importance, he may, notwithstanding anything contained in any other law for the time being in force, by an order in writing, direct euthanasia of the animal and the carcass disposed of immediately to his satisfaction. In No case sale of diseased animals. But IVRI opted for the sale of diseased animals to distribute and spread the diseases.

That is why the proposal for change of the name of the Institute (Indian Veterinary Research Institute) was submitted in August 2018 to rename it as Indian Disease Disseminating Research Institute/ IDDRI).

Location address: Indian Veterinary Research Institute, Izatnagar, Bareilly-243 122, India
Mandates:
1.      Disseminating and spreading of zoonoses, animal, poultry and other livestock diseases in all parts of India and the world & devising novel methods to achieve the mandate.
Goal:
To make India the house and repository of all possible zoonoses, animal, poultry and other livestock diseases.
Suggestions for Logo, Monogram etc are invited. Due credits will be given to designers.
Objective:
1.      To benefit the producers of substandard vaccines, diagnostics and therapeutics.
2.      To promote the researchers/ developers of technologies useful in achieving the first objective.
3.      To create a human resource expert in treachery to the Nation and Farmers of India.
Important  Probable Collaborators:
1.      Indian Pharmaceutical Companies producing substandard or fake vaccines, diagnostics and therapeutics.
2.      Drug Controller General of India (DCGI) and Central Drug Standard Control Organization.
3.      Division of Biological Products of Indian Veterinary Research Institute, Izatnagar.
4.      Division of Biological Standardization of Indian Veterinary Research Institute, Izatnagar.
5.      Livestock Management Section and Division of Livestock Products and Technology, Indian Veterinary Research Institute, Izatnagar.
6.      Joint Directorate of Central Animal Disease Research and Diagnosis, Indian Veterinary Research Institute, Izatnagar.
7.      Indian Veterinary Research Institute, Bengaluru Campus.
8.      Project Directorate on Foot and Mouth Disease, Mukteshwars [International Centre for Foot & Mouth Disease (ICFMD), Bhubaneswar)]
9.      CCS National Institute of Animal Health Baghpat.
Major  Probable Funding agencies:
1.      Indian Council of for Agricultural Research (IAR), New Delhi.
2.      Department of Animal Husbandry, Dairying and Fisheries (DADF), Govt. Of India.
3.      Different Indian Pharmaceutical Companies
   
                                                      Major beneficiaries:
1.      Directors of different State Animal Husbandry Departments.
2.      Directors of Different collaborating Institutes.
3.      Different Indian Pharmaceutical Companies
Facilities and Expertise available:
1.      The only Govt. of India Authorized Institute to pass or quality certification of the biological products (vaccines, diagnostics etc.) for use in animals, birds and livestock.
2.      Experts to certify the GMP (Good Manufacturing Practices) to all defaulting Indian Pharmaceutical Companies.
3.      Experts duly authorized to write and modify and interpret Indian Pharmacopeia.
4.      Experts in writing forged reports/ Pass Certificates even without testing or looking at the product(s).
5.      Experts in conducting in-silico tests and drawing the conclusion about any of the vaccines or diagnostics.
6.      Livestock and a Dairy Farm to amplify and produce Disease Carrying and Disease Transferring livestock products, the repository of diseases.

Achievements in last one decade
1.      Development of a livestock farm having all possible diseases of animals and of zoonotic importance as Tuberculosis, Brucellosis, Pasteurellosis, Paratuberculosis, Foot and Mouth Disease, PPR, Swine fever, Salmonellosis, NDM E. coli etc by adopting novel techniques (http://azad-azadindia.blogspot.com/2017/06/blog-post_30.html).
3.      Track record of producing and passing false or substandard vaccines and diagnostics (Annexure 1).
4.      Track record of selling diseased (having brucellosis, TB, JD etc.) animals (non-productive) to farmers of India (Annexure 2).

5.      Selling milk and milk products made from Brucellosis and TB positive animals to residents of Bareilly city.
    List of Diseases sold by IDDRI
Tuberculosis, Brucellosis, Paratuberculosis, Foot and Mouth Disease
Through selling diseased animals.
List of Diseases Spread/ Disseminated by IDDRI
Tuberculosis, Brucellosis, Pasteurellosis, Paratuberculosis, Foot and Mouth Disease, PPR, Swine fever, Glanders, Pox, NDM E. coli, Salmonellosis, and all those preventable through vaccination.
Through passing substandard vaccines and diagnostics.  
Annexure 1. False or substandard vaccines and diagnostics produced and passed by IDDRI in last 10 years
1.     In the last 10 years, Indian Veterinary Research Institute cleared all more than 120 batches of commercial Vaccines for Poultry use, without testing for safety and potency. The RTI reply (IVTRI/A/2018/60012) revealed that in last 10 years Standardization Division where all the vaccines are tested have not received/ purchased any SPF eggs/ chicks required for safety and potency testing of poultry vaccines as per Indian Pharmacopeia (IP), i.e., they have not tested any of the batches for safety and potency. 

2.    In last 4 years (20114-15 to 2017-18), the Institute cleared all 659 batches of commercial FMD vaccines, however, they have not tested those for sterility, safety and potency as per IP protocol. As per IP protocol, they require 20 vials of each batch for sterility testing but they never procured or got/provided more than 3 vials of each batch, they again used their mighty wisdom to mock the provisions of IP and to clear the vaccines for sterility. Further, probably they have not purchased any animal for FMD vaccine testing in last 4 years as they have not discarded any animal after testing, moreover, for each batch of the FMD vaccine they need about 20 animals as per IP protocol for Safety and Potency testing of an FMD vaccine batch and Indian Veterinary Research Institute in whole in not holding that much population of animals (20x659= 13180), nor they got permission from CPCSEA for using those number of animals for FMD vaccine testing. That is again clear that they again used their mighty wisdom to clear all the FMD vaccine batches. In Earlier years too, they tested only 27 Batches out of several hundred samples submitted to them. 

Testing of Vaccine and Diagnostic Quality in the Division of Standardization at Indian Veterinary Research Institute, Izatnagar
Brucella Strain 19 Live vaccine (40 batches produced,  from April 2008 to March 2013) Recommended calf dose was 5 ml
IP Recommendations
 The Recommended dose for safety in guinea pigs (10 healthy) test by IP 5x10*9/ G. pig or 1/10 of calf dose
Potency should be tested in 10 adult guinea pigs i/m  using 1/15th of calf dose
Recommended viable count/ dose 4x10*10
PPR live vaccine (39 batches produced from October 2009 to March 2013)
IP Recommendations
Safety should be tested in Guineapigs(0.5 ml ip, 0.5 ml im), Mice (0.1 ml ip) and Goats (100 doses/goat s/c)
Potency should be tested in Goats and Sheep  and challenge with 10*8.3 LD50 dose of pathogenic PPR virus
Vaccine titre should be >10*5 TCID50 per dose
Lapinized Swine Fever Vaccine
IP Recommendations
Safety should be tested in 3 piglets (10 doses per animal, intramuscular) and 10 mice (0.03 dose intracerebral)
Potency should be tested in CSF and BVDV antibody negative 12 piglets
There must be no less than 100 PD50 of virus per dose




Inactivated Enterotoxemia vaccine
IP Recommendations
Safety should be tested in 12 rabbits Mice by inoculating 5 ml of vaccine s/c

Potency should be tested in mice
Each dose should induce at least 2 IU of epsilon enterotoxin
The concentration of preservative, inactivating agent and Aluminium should be determined to keep in limits.




Fowl Pox Vaccine
IP Recommendations
Safety should be tested in SPF chicken  (6-8 week old) by inoculating 10 doses/ bird;  Potency test should be in SPF birds; A dose should have more than or equal to 2 TCID50 or EID 50 determined by SPF eggs.



Mesogenic RD Vaccine
IP Recommendations
Safety should be tested in 10 chicken (8-10 weeks old) by inoculating 10 doses of the vaccine in each bird
Potency is tested in more than or equal to 20 chicken with 8 or more birds in control and challenged with 10*5LD50
Titre of vaccine should be >10*5TCID or EID50


Year
Batched Produced
Tested for Safety
Tested in
Dose used in Safety
TCID50 or EID50/ ml
Potency/ Immunogenicity test
Comment

2009
1
1
Not mentioned
Not Mentioned
10*7.5
1
Vague testing and reporting

2010
1
1
10*7
1



IP Recommendations

F Strain RD Vaccine
Safety should be tested in 10 SPF chicken (youngest recommended age) by inoculating 10 doses of the vaccine in each bird
Potency is tested in more than or equal to 20 SPF chicken with 8 or more SPF chicken in control and challenged with 10*5 LD50, control should die within 6 days
Titre of vaccine should be >10*6TCID or EID50

Year
Batched Produced
Tested for Safety
Tested in
Dose used in Safety
TCID50 or EID50/ ml
Potency/ Immunogenicity test
Comment

2009
2
2
Chicken
Not mentioned
10*8.5
2
Probably no SPF chicken  used thus safety and potency is questionable

2010
1
1
10*8
1

2011
1
1
10*9
1



The above RTI reply revealed that IVRI has not tested even a single Poultry vaccine in SPF chicks or SPF eggs as they have not purchased any for the purpose in last 10 years. That is they have Flawed guidelines of Indian Pharmacopeia to benfit some one and bluffed the Indian Poultry Farmers.



Mallein for diagnosis of Glanders
Should be produced from Bogor, Mukteshwar or Zagreb Strain of B. mallei but Indian Veterinary Research Institute produce it from a local non-approved strain

IP Recommendations
Toxicity and safety should be tested in 2 Guinea pigs
Potency or sensitivity should be tested in 4 sensitized and 2 healthy non-sensitized ponies by occular intradermo-palpebral inoculation.
Protein should be assayed and it should be 0.95 mg to 1.05 mg/ ml, phenol should be <0 .5="" o:p="">



Year
Batched Produced
Tested for Safety / Toxicity
Tested in
Dose used in Safety
Protein mg/ ml
Potency/ Sensitivity test
Potency/ Sensitivity tested in
Comment

2010
1
1
Not mentioned
Not mentioned
Not determined
1
1 Horse
Improper and incomplete testing

2011
1
1
1
1 Horse

2014
1
1
1
1 Horse

2016
1
1
1
Not mentioned

2017
1
1
1
1 cattle

Note: Not produced from recommended strain, contents per dose were not determined and potency and safety not tested as per IP.

 Johnin PPD
IP Recommendations
Safety/ Toxicity should be tested in two guinea pigs
Potency should be tested  five guinea pigs along with two control G. pigs
Final product's strength in terms of purified Protein in mg/ ml
Phenol contents should not be more than 0.5%

Year
Batched Produced
Tested for Safety/ Toxicity
Tested in
Dose used in Safety
Protein mg/ ml
Potency/ Sensitivity test
Potency/ Sensitivity tested in
Comment
2009
1
1
Not mentioned
Not mentioned
Not determined
1
Cattle
Improper and incomplete testing
2011
1
1
1
2013
1
1
1
2014
2
2
2
2015
1
1
1
Not mentioned
2016
1
1
1
Cattle
2017
1
1
1
Note: Safety and potency not tested as per IP amount of PPD per dose was not determined.


 Tuberculin PPD
Should be produced from Strain AN5, the same strain is used at Indian Veterinary Research Institute
IP Recommendations
Safety/ Toxicity should be tested in two guinea pigs
Potency should be tested  nine albino guinea pigs along with two control G. pigs
Final product's strength in terms of units/ 0.1ml
Phenol contents should not be more than 0.5%
Year
Batched Produced
Tested for Safety/ Toxicity
Tested in
Dose used in Safety
Units/ 0.1ml
Potency/ Sensitivity test
Potency/ Sensitivity tested in
Comment
2009
1
1
Not mentioned
Not mentioned
Not determined
1
Not mentioned
Improper and incomplete testing
2010
1
1
1
Cattle
2011
1
1
1
2013
1
1
1
2014
2
2
2
2015
1
1
1
Not mentioned
2016
1
1
1
Cattle
2018
1
1
1
Not mentioned
Note: Safety and potency not tested as per IP. PPD units per dose were not determined

Exemplary Quality Assurance certificates issued from IDDRI















Annexure 2. Sale of Diseased Animals carrying zoonotic infections and other disorders



As the livestock farm is house of Brucellosis, the main cause of Abortions and Repeat-breeding, IDDRI disseminated the zoonotic Brucellosis.
JD (Paratuberculosis) is the main cause of weakness, debility and chronic diarrhea, often the cause of culling the animals at IDDRI.
Note: Based on RTI information. There may be few minor mistakes in analysis and may be corrected if found in due course of time.

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