Wednesday, June 28, 2017

The Hard Facts of Corruption in Veterinary Vaccine Testing in India: वेटेरिनरी वैक्सीन की जांच में भ्रष्टाचार का सच




Pointwise counter details of the 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 researchers headed by Dr. Bhoj Raj Singh are as under:
  1. Investigation of CCS NIAH, Baghpat: The expert committee visited CCS NIAH, Baghpat on 20-11-2014 to investigate the issue related to FMD vaccine stability and sterility testing. Acting Director Dr. Bhoj Raj Singh was not present in the Institute on the day of the visit.
Reality: The committee has never informed about the visit to the Acting Director Dr. Bhoj Raj Singh. The Acting Director Dr. Bhoj Raj Singh was also looking his regular duties at Indian Veterinary Research Institute Izatnagar, on the day of uninformed visit of the committee.
  1. The committee wrote “Standard Operating Procedure (SOP) for stability testing was not available on the workbench for the guidance of the laboratory workers.-----the laboratory procedures carried out have not been recorded properly, nor everyday test results were verified by any scientist”.
Reality: SOP was not only available there but also given to every bench worker to keep with him or her and was with them even on the day of the visit. Results were recorded daily and the Acting Director himself observed all the records as and when he was there at CCS NIAH, Baghpat.
  1. The committee wrote, “No scientist of CCS NIAH was aware of the tests conducted on the FMD vaccine batches as they were not involved in the testing.------------------As per the deposition of Joint Director and Assistant Directors, the tests were conducted under the supervision of Dr. BR Singh and the result obtained was not discussed with them by the Acting Director”.
Reality: The paragraph contains contradictory statements: At one point the committee wrote “No scientist of CCS NIAH was aware of the tests conducted on the FMD vaccine” and in the same paragraph it wrote, “the tests were conducted under the supervision of Dr. BR Singh”. How both statements can be true, at least one statement is false.
Moreover, in the signed statement from the scientists at CCS NIAH, the facts are clear that tests were conducted in supervision and or by the scientists of CCS NIAH, Baghpat, and the results were discussed: 
  1. Shingini Sharma (Joint Director, at CCS NIAH and in-charge of FMD vaccine testing in 2014) writes on 9/11th October 2014 to the Acting Director:- “This is to submit that an abstract titled “Emulsion stability of Foot and Mouth Disease (FMD) vaccine for use in India by Droplet and Centrifugation test” (acceptance letter at the conference enclosed)----------------------------to be held at DUVASU Mathura on 30th October-1st November 2014. The abstract comprise the work carried out by the scientific staff at CCS National Institute of Animal Health including the undersigned so permission may be granted to attend the conference on the above-mentioned dates.-----------. (Shingini Sharma) Joint Director.
  2. Two other scientists of the team testing the FMD vaccine, Dr. Ashwani Kumar and Dr. Reyaz Ahmed (Assistant Directors) have also signed the abstract submitted dated.
  3. Shingini Sharma (Joint Director and i/c FMD Vaccine testing at CCSNIAH, Baghpat) made corrections in the abstract.
Now the question is who is lying, the committee or the Scientists or staff of CCS NIAH or there is a forgery in the documents, needs investigation. 
 The Committee’s report’s Point no. 3 stands invalid once the truth mentioned above.
  1. The Committee’s report’s Point no. 4 stands invalid in light of the truth mentioned above.
  2. The committee wrote “The tests conducted were not validated as per the record available at the Institute. From the record, it was clear that they did not follow the test protocols as per IP (2014). According to IP, the vaccine inoculums should be 10 ml and not 1 ml as used by CCS NIAH. The incubation temperature should be 30-35oC for FTM and 20-25oC for SCDM, CCS NIAH incubated FTM at 37o The duration of incubation was not as per the IP 2014”.
Reality: CCS NIAH in its research/ report has never claimed that the sterility was done as per IP 2014 and in research, the methodology can vary if it is fully defined as in the CCS NIAH report we did. However, it is apparent from the expert committee that the committee has not seen the Sterility test protocol of IP 2014. Please see at 2.2.11. Sterility in IP 2014 page 63 “Quantity in each container of injectable preparation if is 40 to 100 ml (as in case of FMD vaccine containers) then inoculums should be 20 ml” and not 10 ml as stated by the committee, mean they have also not followed the IP 2014 to the truth even in retesting. As far as incubation at 37oC is concerned it is in no way associated with false positive (a negative sample cannot turn positive however there may be a chance that some positive may be negative). There may be, even more, numbers of failed samples if tested at 30-35C incubation not less (http://www.hardydiagnostics.com/tect_faq.html) than reported by CCS NIAH.
As far as the incubation period is concerned it was 14 days and then followed by 7 days and it is not different than IP-2014.
Conclusion: The reference to IP 2014 is used to mislead and it is quoted wrongly.
  1. The committee wrote, “There was no chart displayed with daily temperature recorded-----------recommended for storage of FMD vaccine by the manufacturer”.
Reality: The FMD vaccine vials were stored in normal frost-free refrigerators set to have a temperature ranging between 4-7 C which is the same as recommended by manufacturers for storage of the FMD vaccine. Moreover, there was no display of temperature in fridges which is why it was not recorded otherwise it would have been false or incorrect.
  1. The committee wrote “The Institute could not provide any clear answer as to why the stability testing was done when it is not required as per the Indian Pharmacopeia (2014).
Reality: nothing could be a bigger falsehood than this statement of the committee. It is mentioned in all old volumes of IP and also in IP 2014 (on page 955 of volume 2) that “Injections that are emulsions should not show any evidence of separation-------”. However, IP does not talk about testing the separation for which internationally several methods are in practice as used in our testing.
Conclusion: The committee again tried to mislead and made the false statement that it is not written in IP.
  1. The committee wrote, “Dr. BR Singh/ CCS NIAH did not have the approval from the competent authority in DADF, GOI to undertake stability and sterility testing and doing research on FMD vaccine”.
Reality: It was none but DADF that ordered to test of the FMD Vaccine and was very much aware of the testing/ research (http://ccsniah.gov.in/).
  1. The committee wrote, “Dr. BR Singh also did not have the approval of DADF, GOI for publication of testing results and putting the same in the public domain of Research Gate and Internet”.
Reality: Being Acting Director of CCS NIAH he was given all the powers of a regular Director as per DADF order. All the Directors have the right to publish the findings of the research/ testing at the Institutes under their control without any additional approval. Moreover, the Director Indian Veterinary Research Institute (controlling authority of Dr. BR Singh permitted the presentation of the results at an International Conference.
  1. The committee wrote “Repeated freezing and thawing of vaccine samples------------------------, so why it was done----?”
Reality: It was explained to the committee time and again but one who is not ready to understand, you cannot make him/ her understand. It is the method to check the strength of any emulsion, as the FMD vaccine is an emulsion this was done as per standard protocol (http://www.particlesciences.com/docs/technical_briefs/TB_2011_2.pdf).
  1. The committee wrote, “The FMD vaccine is an oil-adjuvanted vaccine and there was no record available to indicate whether the medium contained Polysorbate 80 which is an important requirement under IP for testing sterility of oil-based vaccine.”
Reality: The committee was not interested in finding the facts but was eager to see only flaws which is why it could not see the protocols. Even if one considers that Polysorbate 80 was not added to the medium, not adding polysorbate 80 can only reduce the chances of detection of infection in the emulsion vaccine or in any oily preparation. It is added to increase sensitivity not to decrease the sensitivity (read on page 47 of http://www.ajprd.com/downloadebooks_pdf/51.pdf, The use of Polysorbate 80 in the final test medium is required to facilitate total dissolution of the oil or ointment being tested so that any organisms present in the material will not be isolated from the growth medium).
Conclusion: The comment of the committee again tried to confuse the readers of the report.
  1. The committee wrote, “Though the physical parameters tested by CCS NIAH are not required as per the IP-----thus the drop count test results are not reliable or valid”.
Reality: The drop count method has subjectivity and results may vary from observer to observer, to counter the error seven tests were used in CCS NIAH testing, the committee did not mention those because they wanted to see only weaknesses but ignored the strength of testing using 6 other tests to minimize any subjective error (http://www.particlesciences.com/docs/technical_briefs/TB_2011_2.pdf ).
  1. The committee wrote “On the inspection of the sterility tests conducted by CCS NIAH it was observed that no record was available about the media prepared and their sterility. Further, no screw cap tube/ bottles were used; ------------------- and sterility test results were mentioned as yes or no, and not verified by any responsible officer/ scientist.”
Reality: As far as records of media are concerned it is a self-contradiction of the report, the committee itself wrote at point two “Only Dr. Reyaz prepared the liquid medium for sterility testing.” As far as the use of cotton plugs instead of screw caps is concerned, nowhere in IP 2014 or in earlier editions of IP it is mentioned what should be used (non-absorbent cotton plugs or plastic screw caps). Moreover, most of the standard recommendations are “---cotton plugs/ screw caps” and not even vice-versa, and non-absorbent cotton plugs are preferred under certain circumstances for capping the SCDM medium to facilitate the growth of fungi (http://www.microbiologyonline.org.uk/media/transfer/doc/sgm_basic_practical_microbiology_2.pdf; Techniques http://www.nuffieldfoundation.org/practical-biology/aseptic-techniques; https://books.google.co.in/books?id=8h4Ze5s6sFUC&pg=PA42&lpg=PA42&dq=Bacteriological+culture+cotton+plug+versus+screw+cap&source=bl&ots=RprpnZgabA&sig=xzKiC6zjF_bNw8yLTSMzBZTuYBU&hl=hi&sa=X&ved=0ahUKEwiDy_un8o3NAhXFv48KHQqLC-YQ6AEITjAI#v=onepage&q=Bacteriological%20culture%20cotton%20plug%20versus%20screw%20cap&f=false ).
  1. The committee wrote, “Though CCS NIAH had qualified bacteriologist as joint Director, his expertise was not used ------------------with doubtful motive.”
Reality: The expertise was used but he was not willing to be included as an author due to his meager contribution in the testing as he was the in-charge of bacterial vaccine testing. His expertise was very much used. Moreover, Dr. BR Singh is a well-known Bacteriologist (https://www.researchgate.net/profile/Bhoj_Singh) nominated from the office of the chairman of the GOI Expert Committee. Thus it was not required to include an additional bacteriologist in the testing.
Conclusion: The Committee was biased and made absurd allegations without considering the facts, thus an urgent inquiry is needed.
  1. The committee wrote, “FMD vaccine bottles were stored in frost-free refrigerators----------must be stored in walk-in cold rooms maintained at 6-8oC, why the vaccine batches were stored at 45oC before stability testing------------.”
Reality: Here again the committee misled the readers; in IIL literature itself (http://www.indimmune.com/wp-content/uploads/2014/02/Raksha.pdf) it is written that vaccine can be stored at 2-8oC (not 6-8oC), in their literature, it is nowhere mentioned that it should be stored in the walk-in cold room.
The vaccine was stored at 45oC before testing the stability to follow one of the methods to test the stability of the emulsion (http://www.particlesciences.com/docs/technical_briefs/TB_2011_2.pdf).
  1. The committee wrote “Biometric system was not working in the BSL 2 laboratory area. The laminar flow workbench---was dusty-------requirements under GLP.”
Reality: The requirement of the Biometric system in conducting the tests done at CCS NIAH is beyond understanding, nowhere in IP this is requirement mentioned. The rest of the observations are subjective, you may say any one dirty in comparison to others but is not an absolute. As far as regular monitoring of microbiological contamination and load is concerned the laboratory was under the contract and the contractor’s services were regularly verified by the Joint Director, a bacteriologist. Moreover, the facility was approved for GLP and quality facility by a learned committee.
  1. The committee wrote “Dr. BR Singh------------------------------south Indian states.”
Reality: Dr. BR Singh still holds that all the tests were conducted under his supervision and by the staff of CCS NIAH on whose expertise he has no doubt. Moreover, the last line is again the falsification of the statement; the vaccine was substandard because it failed in all the tests conducted at CCS NIAH. The ineffectiveness of the vaccine is evident because outbreaks are reported almost in all parts of India even after vaccination, even in the most renowned Institutes of ICAR (http://timesofindia.indiatimes.com/city/kanpur/Foot-and-mouth-disease-returns-to-IVRI-alert-sounded/articleshow/50537613.cms).
  1. Inspection at FMD Vaccine manufacturing premises
It is better not to comment on observations of the Committee at different FMD vaccine manufacturing premises. How the licensing and routine inspections are done at vaccine manufacturing units is clear from the information received from the Drug Controller General of India (DCGI).
  1. In the last 6 years (January 2010 to 31st March 2016), three of the four FMD vaccine-producing premises have been inspected only once that too in 2015 (March to May 2015) that is after the report we published and the learned inquiry committee submitted its report.
  2. One of the vaccine premises (Brilliant Biopharma Ltd) has never been inspected.
  3. One of the inspectors is none but the one who tests the vaccine quality (Dr. AK Tiwari) at the Indian Veterinary Research Institute, Izatnagar.
Interestingly DCGI accepts that there were FMD outbreaks in Karnataka, Tamil Nadu, Andhra Pradesh, and Uttar Pradesh (i.,e., areas covered under FMD-CP, compulsory FMD vaccination program) in the last 6 years (January 2010 to 31st March 2016) but they never launched any prosecution. Moreover, DCGI collected 8 samples and sent them to the Indian Veterinary Research Institute (RTI), but the Indian Veterinary Research Institute reports that it has never received those samples.  
Moreover, the committee claimed that all the vaccine batches produced by different premises were tested for safety and potency as per IP, which means at least 18 animals per batch were used, Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA, under Ministry of Environment, Forests, and Climate Change, GOI) informed telephonically (not ready to give in writing even under RTI (said they do not maintain the records, example of Good Management Practices) that it has not given permission for use of those many animals (146 batches in 2014 means, 2620 animals) in the year 2014.
Who is truthful and who is not is the dilemma and can be cleared only after the judicial inquiry.
  1. Response of DADF
The committee wrote “DADF replied that at no point in time, CCS NIAH was permitted to conduct research---------and conduct stability and sterility testing at Baghpat. DADF did not permit Dr. BR Singh to publish the test results and release them in the press.”
As far as permission to conduct the Research published, the Acting Director was given the powers of the regular director.
It was not the first time that CCS NIAH Director went public to disclose what is happening in the CCS NIAH and there at CCS NIAH I could not see any permission from DADF or from any of the competent authority.
  1. Overall observations of the Committee as per Terms of Reference: The committee wrote
  2. 1. Conduct of sterility test on the samples of the same FMD vaccine batches used in CCSNIAH and Indian Veterinary Research Institute, Bengaluru. The test will be conducted in the Standardization Division of IVRI, Izatnagar; fresh samples will also be drawn from all FMD vaccine manufacturers for testing.
  3. The committee mentions “As per ToR, the Standardization Division of IVRI, the laboratory approved by DCGI of India----------------- collected from vaccine manufacturers”.
Reality:
  1. The Standardization Division of IVRI, Izatnagar is not an approved laboratory for testing of FMD vaccine as per DCGI.
  2. Samples were collected by Indian Veterinary Research Institute Scientists directly from the vaccine manufacturers for all batches to be tested. The truth is that as per CDSCO guiding documents available at http://www.cdsco.nic.in/forms/list.aspx?lid=1563&Id=31, Indian Veterinary Research Institute, scientists are neither permitted to take samples nor follow the guidelines of CDSCO document.
  3. The committee neither tested the samples stored at CCS NIAH or the duplicate samples kept at Indian Veterinary Research Institute, Bengaluru.
  4. The committee neither took samples of the same batches as tested at CCS NIAH from the vaccine available at different veterinary hospitals all over India, nor from the state FMD vaccine depots. However, the committee chose to test the samples not legally collected, not collected by legally authorized persons, got these tested in an unauthorized (for FMD Vaccine testing) laboratory to benefit the producers of the substandard vaccine.
  5. The committee wrote, “Standardization Division of IVRI, meticulously followed the IP (2014) protocol ----.”
Reality:
When the samples were not collected in the required numbers i.e., 20 per batch for testing, how it was meticulous testing, samples were collected ranging from one vial each from 4 batches, two vials each from 3 batches, 10 vials each from 6 batches and 20 vials each from two batches that to directly from the firms and dispatched by the firm. This kind of variation and numbers (20 vials per batch) is the violation of IP (2014) guidelines. It was expected with the unauthorized and inexperienced people deputed for sampling
When the vaccine samples were tested for sterility presence of an antimicrobial should be taken care of. We know that if firm adds excess amount of preservative (antimicrobial) then results may be not showing detection of bacteria in the samples. The meticulous team did not test for the presence of any antimicrobial present in the vaccine samples collected directly from the vaccine manufacturers. And who knows that producers of substandard FMD vaccine did not add any antimicrobial to the vaccine vials submitted by them for sterility testing?
Sampling rules and protocols were flawed probably to benefit the vaccine producers.
Now we should also look at the GLP of the Indian Veterinary Research Institute claimed by the expert committee:
  1. At point 1 of the report, the committee wrote “proper laboratory registers were not maintained” at CCS NIAH
In Indian Veterinary Research Institute there was: No record of media preparation, no maintenance of the temperature of Incubators. The testing facility including incubators was never been validated by any external agency.
  1. At point number 6 Committee says “there was no chart displayed with daily temperatures recorded to ensure the exact storage temperature recommended for storage of FMD vaccine by manufacturer”.
In the Indian Veterinary Research Institute, the temperature of the cold room ranged between 2C to 21C only, where is the recommended temperature (2-8C) in the range recommended for storage of the FMD vaccine; no one knows but the expert GoI committee.
  1. At point 7 the committee wrote, “-----why the stability test was done-----------”.
Now the question is if the committee was retesting the vaccine, why it has not tested the vaccine for stability and it is certainly required as per IP 2014 (page 955 of IP 2014 volume 2). Though in one RTI they say that “they follow IP protocols for testing safety, potency, sterility, innocuity and stability”, but in another, they say “—tested for sterility, safety, innocuity, and potency only”. God knows only what the truth is.
  1. At point 15 committee writes “FMD vaccine bottles were stored in frost-free refrigerators that are not suitable for vaccine storage”.
At the Indian Veterinary Research Institute, the vaccine archiving facility (storage facility) is mentioned as the “cold room of BP Division, deep freeze, and refrigerators”.  So what was wrong with keeping the vaccine in refrigerators at CCS NIAH set to have temperature 4-7oC, you may see the condition of Cold room temperature at IVRI (varying from 2 to 21oC) and decide where the vaccine storage was better at CCS NIAH or at IVRI.
  1. Validation of GLP, no never done in Indian Veterinary Research Institute, as per RTI information.
  2. At point 16 of the Expert Committee Report, it wrote that “Biometric system was not working in BSL-II laboratory area.
In the Indian Veterinary Research Institute, the Biometric system is not available in the Standardization Division of IVRI, Izatnagar, and was recently started in 2016 at IVRI, Bengaluru BSL-2 facility.
  1. More on GLP of Indian Veterinary Research Institute, rat-bitten vaccine bottles in storage area indicate the quality of GLP and its maintenance at IVRI, storage of very old (expired in 2009) vaccine bottles but could not show vaccine bottles of the disputed vaccine tested in late 2014 only (RTI). However in writing they claim that they do not maintain vaccine samples older than 3 months since expiry (RTI). Vials tested and passed without opening (RTI). Though claim that hourly temperature is recorded but on the day of visit (30-4-16) temperature recording register entries were missing till 3 PM since morning indicating the quality of data maintained and GLP at IVRI.
  2. Moreover, the inability of the head of the Standardization Division to show the FMD vaccine vials collected and tested there on the order of the committee further indicates that samples were neither collected nor tested in reality (RTI).
  3. The outbreak of FMD occurred in January 2016 and >23 animals died of FMD after vaccination with the IIL FMD vaccine, the quality of the FMD vaccine can be assessed by the fact that the Indian Veterinary Research Institute ordered 3 times in a year vaccination though IIL claims that vaccine protects for 44-48 weeks from FMD.
  4. The big question is, if the Indian Veterinary Research Institute has the expertise to test the vaccine and follow IP-2014, then why they have not tested the right size of the sample for testing. The flawed not only this time but have never done testing based on standard 20 vial sample size in the past also.
  5. When the Indian Veterinary Research Institute people so-called experts doing testing meticulously do not understand the need to test simple physical parameters including stability of emulsion in an emulsion vaccine (page 955 of IP 2014 volume 2) how they can be called experienced when in reality they are ignorant, they say that “they follow IP protocols, but they do not test for stability.
  6. Competence of staff of CCS NIAH for conducting FMD vaccine sterility and stability testing, the committee wrote that “only contractual laboratory workers -------were entrusted with the responsibility of testing and checking the results------
The reality is very much different
  1. The in-charge of FMD vaccine testing (Dr. Shingini Sharma, Joint Director at CCS NIAH) is trained at the Indian Veterinary Research Institute Bengaluru for FMD vaccine testing, she was doing the test. It is written in DADF reports that FMD vaccine testing has been going on in CCS NIAH since 2011 (DADF Annual Report 2011-12, please see chapter 3 at page 30, http://dadf.gov.in/sites/default/files/Annual_Report_2011-12_cover_0.pdf). It states that The Institute has started functioning and is carrying out the following activities. The virology laboratory has been made functional with facilities for testing of quality assurance of FMD vaccine by way of testing of serum samples by LPB-ELISA and sterility of vaccines.
  2. The question is under what circumstances Dr. Shingini Sharma give three different statements conflicting with each other to deny the vaccine testing at CCS NIAH, either she was bribed or she was threatened or something else happened to her only learned committee or she can explain.
  3. Other staff of CCS NIAH engaged in Vaccine testing were also in the rank of Assistant Directors (Dr. Ashwini Kumar and Dr. Reyaz Ahmed) and also signed the abstract of the report. Why they denied involvement in FMD vaccine testing is a matter of high-level inquiry, under what circumstances such high officials of CCS NIAH turned hostile to the truth.
  4. As in every laboratory contractual workers are engaged to assist the scientists, in CCS NIAH also contractual workers were engaged but none of them was less than graduate of science and except one all were postgraduate either in Microbiology or Biotechnology, if postgraduate are not able to learn the technique so simple to be done then Indian Institutes awarding such degrees must be closed.
  5. To examine the issue of emulsion stability as per IP vet requirements. The committee wrote that “As per IP 2014 the emulsion stability testing is not mandatory”. If the committee can write this sentence then I doubt that they have ever seen the Indian Pharmacopeia or not or they have some common sense or not.
It is mentioned in all old volumes and also in IP 2014 (on page 955 of volume 2) that “Injections that are emulsions should not show any evidence of separation-------”. If this is the definition of injections that are emulsions in IP then what else is mandatory then to fulfill the definition.
Moreover when the committee or the so-called meticulous scientists of IVRI testing the FMD vaccine do not understand the need for emulsion testing how they can understand the meaning of “freezing and thawing, storing at 45oC required for testing stability (http://www.particlesciences.com/docs/technical_briefs/TB_2011_2.pdf). I may say that they (so called meticulous) need to be retrained and educated, their all experience is bogus.

  1. To examine the issue of the use of enrofloxacin antibiotic as a preservative by M/S Intervet, Pune. It is said by the committee that it was permitted by DCGI. Now the question is on whose recommendation it was permitted by DCGI, was it not the chairman of this committee too (Dr. Gaya Prasad) or someone else, but question is: Why it was permitted when it is not permitted anywhere else due to detrimental effect on growth, physical and mental health of consumers taking this antibiotic in traces (might be coming in milk or meat of the vaccinated animals).
  1. To investigate the role of Dr. BR Singh, Acting Director, CCS NIAH, Baghpat in leaking test report findings to the print and electronic media without approval of the competent authority: The issue is already discussed above at
Being Acting Director of CCS NIAH he was given all the powers of a regular Director as per DADF order. All the Directors have the right to publish the findings in the Institutes under their control without any additional approval. Moreover, Director Indian Veterinary Research Institute (controlling authority of Dr. BR Singh permitted presentation of the results in an International Conference. As far as permission to publish, the Acting Director was given powers of the regular director. Moreover, it was not the first time that CCS NIAH Director went public to disclose what is happening in the CCS NIAH and I could not see any permission from DADF in the Institute.
  1. Conclusion
In conclusion of the report the so-called learned committee has gone too far than the ToRs:
  1. The committee wrote “The CCS NIAH ----report is based on tests conducted by inexperienced laboratory worker------. The stability test is not required as per IP (2014)”.
  2. This is the sentence full of enmity and indicator of collusion with the vaccine producer firms and also the conspiracy under which scientists of CCS NIAH got hostile to the truth despite being fully involved in the testing.
  3. The Acting Director Dr. BR Singh was appointed as an Expert in Microbiology and when he was guiding and monitoring the research conducted at CCS NIAH how the question of inexperience came.
  4. About the stability test, it is already written how important is it and how it is included in the definition of injection that is an emulsion (on page 955 of volume 2 of IP 2014)
  5. The committee wrote, “The results of testing by CCS NIAH are highly questionable as the same batches of FMD vaccine passed sterility testing at standardization Division of IVRI.”
The issue is clear; the samples were collected by inexperienced people from companies producing the spurious vaccine, samples were collected in numbers differing than recommended by IP 2014, and testing was done by a non-authorized laboratory for FMD vaccine testing. For details see the reply above at point D-1.
  1. The committee wrote, “All three manufacturers have quality control laboratory-------as per national and international standard and duly approved by DCGI.”
We have discussed how DCGI is monitoring these vaccine producers at point B above.
  1. The committee wrote “Indian Veterinary Research Institute, Bengaluru was established more than 40 years ago for FMD vaccine----------------------------------------Dr. BR Singh’s report appears to have been written with ulterior motives to damage the credibility of incredible scientist and their competency.”
Probably committee made a mistake in writing the last sentence of this point. Certainly, Dr. BR Singh had no association or disassociation with the so called incredible scientist of IVRI, Bengaluru. However, credibility is apparent by the fact that even after so long-standing experience the man was unable to understand the truthful testing as per Pharmacopeia and kept on testing the sterility of FMD vaccine batches based on 5 vials per batch. Moreover, credibility is also evident by the fact that the man tested only samples from the 3 batches of the 146 submitted to him in the year 2014 but cleared all, and without following IP claimed that testing was done as per IP-2014.
Further, the credibility and truthfulness of the incredible scientists are also evident by the fact that for testing 15 batches of FMD vaccine he requested payment for 400 cattle, I could not under what Pharmacopeia guidelines he used so many animals for testing 15 batches as per IP 2014, per batch 18 animals are required (total for 15 batches may be 270 cattle) and if we consider 20 cattle per batch as reported in RTI by IVRI Bengaluru they to reported testing of 9 batches in 2013 and 2014 used 180 cattle the count would have been 300, not 400.
  1. The committee wrote, “IVRI, Bengaluru campus is following the protocols of sterility, safety, and potency testing as per IP (2014) and they are testing the vaccine samples randomly as per MOU with DADF.”
How the IP-2014 is going to be followed at the Indian Veterinary Research Institute, Bengaluru campus is discussed above at point 4 also, thus no point in discussing it here again. How the random sample testing varied at the hands of meticulous people is exampled by the Indian Veterinary Research Institute, Bengaluru, they tested 3 samples out of 146 in 2014, 3 again in 2015 out of 40 batches, 6 out of 72 batches in 2013, and 9 out of 15 in 2012. Only learned committee members can explain this randomness.
  1. The committee wrote, “The fraudulent stability and sterility testing report of Dr. BR Singh CCS NIAH released to the press and the internet has caused damage to the international reputation of FMD control program (CP) launched by DADF, GOI, and credibility of FMD vaccine batches used in the control program.”
The report of Dr. BR Singh, CCS NIAH has brought only truth to the surface so that everyone can understand the ongoing fraud and cheating with the country at IACR and DADF hands gloved with substandard vaccine producers. The substandard FMD vaccine produced by Indian firms not only failed in India but also led to FMD outbreaks in Algeria and Tunisia (http://www.animals24-7.org/2015/06/09/foot-and-mouth-disease-spreads-indian-outbreak-of-foot-in-mouth-disease-may-inhibit-global-vaccination-effort/). In India even after vaccination the FMD occurred in vaccinated animals, DCGI accept that there were FMD outbreaks in Karnataka, Tamil Nadu, Andhra Pradesh and Uttar Pradesh (i.e., areas fully covered under FMD-CP, compulsory FMD vaccination program) in the last 6 years. Besides, FMD outbreaks occurred in vaccinated animals in National Institutes including the Indian Veterinary Research Institute and NDRI Karnal, Military Dairy Farm Meerut, Dairy Farm of Veterinary College Ludhiana and much more, 9 of the ten FMD outbreaks investigated in UP by DUVASU, Mathura were in vaccinated animals only (http://epubs.icar.org.in/ejournal/index.php/IJAnS/article/view/50967).

  1. The committee wrote, “Fraudulent report based on scientifically and technically unsound data has also caused aspersions on reputed Indian Veterinary Research Institute.”
From the above discussions, it might be clear that which report is unsound and fraudulent. Nothing to say about the Indian Veterinary Research Institute, which cannot stop FMD even after vaccinating its animals twice in a year regularly and now ordered for 4 monthly vaccinations (http://www.jagran.com/uttar-pradesh/bareilly-city-14003387.html).

  1. The committee wrote, “The CC NIAH / Dr. BR Singh report may also hamper the prospects of Indian manufacturers exporting FMD vaccine to other countries”.
No one is so blunt to accept a wrong report, the performance is the question when the Indian FMD vaccine failed in Tunisia and Algeria (http://www.animals24-7.org/2015/06/09/foot-and-mouth-disease-spreads-indian-outbreak-of-foot-in-mouth-disease-may-inhibit-global-vaccination-effort/) who will purchase. These are due to wrong deeds of the firms producing substandard FMD vaccine which hampered prospects of export of FMD vaccine. If it is only reported, then reports of long experienced, and so-called meticulous scientists must have boosted the export of the FMD vaccine. The learned committee’s report was also published more than a year ago, what happened people started to doubt the integrity of the Expert Committee itself (http://www.dailyo.in/politics/foot-and-mouth-disease-br-singh-whistle-blowers-scam-veterinary-scientist/story/1/10929.html).
  1. The committee wrote, “The report has the potential to create doubt about the national FMD control program in the minds of International organizations such as OIE and FAO.”
Even after 13 years of the FMD control program, we have not been able to control FMD, what can be more doubtful than the fact, that deaths have increased over 40 times due to FMD over the years of FMMD CP (http://scroll.in/article/690779/cows-are-dying-mysteriously-in-india-and-a-vaccine-might-be-to-blame).
  1. The committee wrote “The question raised by the CCS NIAH Dr. BR Singh’s report about the efficiency of FMD vaccine without any credible scientific data----------------------sanctity of FMD control program and quality of vaccine used”.
This as baseless as saying the night at noon time, it is clear from all above discussions and the performance of FMD vaccine. Effect of FMD CP can be evaluated on the basis of published reports. Due to FMD that too in vaccinated area Russia stopped meat import from India, was it also Dr. BR Singh’s or CCS NIAH report effect (http://www.financialexpress.com/article/markets/commodities/russia-restricts-import-of-meat-from-up-plants/137022/).
  1. The committee’s report’s Points 11 to 14 are examples of the autocratic and dictatorial attitude of the so-called expert committee of inexperienced people who have never produced or tested any vaccine in their career but became the judge, and the committee of the judges recommended punishment by going far away from ToR of the committee.
 Collusion of the committee members and test team head (Director) at Indian Veterinary Research Institute with the Indian Immunologicals Ltd. is evident by the fact that the director Indian Veterinary Research Institute (Dr. RK Singh), the head of the Institute responsible for testing of the vaccine quality has remained in collusion with Dr. VA Srinivasan (General manager of IIL), has coauthored several research papers together, Dr. VA Srinivasan is Member of Research Advisory Committee of Indian Veterinary Research Institute since last 5 years. Now the question is, how the Institute having an advisor from IIL can fail IIL’s vaccines, and it had never failed any vaccine batch of IIL vaccine in last 5 years. Not only this, Dr. VA Srinivasan of ILL is a coauthor of several research papers with Dr. B. Pattnaik, one of the members of the GoI Expert Committee constituted by ICAR, on how the committee could have gone against IIL.
The honesty and integrity of the GoI committee is evident by the fact that one of the members and so acclaimed FMD expert, Dr. B Pattnaik (Director of PD FMD, Mukteswar) is an accused in the court of Special Judge (PC Act) (CBI)-06, New Delhi District, Patiala House Court, New Delhi (FIR No. 304/15; PS Inder Puri) for forgery U/s 420/467/468/471/409/120B IPC. He is on bail and for cancellation of his bail, there is a discussion on 7th July in the court. Besides, Dr. B Pattnaik has also been found guilty on CBI inquiry in the case of fraudulent purchase as Director PD FMD, Mukteswar, Nainital.
With the apparent collusion of the committee with producers of substandard FMD vaccine and the criminal background of the member of the committee, it was not expected to have an honest and justice-full inquiry and the committee made to benefit the producers of substandard FMD vaccine did the job quite efficiently.
A request to MoS Dr. Sanjeev Balyan Ji (who was heading the meeting) which led to the formation of the committee was submitted for the formation of a committee with experts having experience in vaccine production and vaccine testing along with representatives of the DCGI. However, the request was not taken care of and a biased committee was made on 10th November 2014 and it submitted the biased and full of lies report on 12th January 2015.
How the Vaccine testing is done at the Indian Veterinary Research Institute, the fact was revealed by an RTI visit to the testing facility.
1. Samples for decades were there in the so-called cold store (where the temperature often goes up to 21C) and were lying in sealed (with intact seals) condition (never opened). However, in a written RTI reply, the Institute claimed that it discards samples after 3 months of testing.
2. Though sealed, several bottles of vaccines were bitten by rats (the Rat Scan test for vaccine testing).
3. If the results are decided before receiving and testing of vaccine then what is the need to open the vials?
Picture of the Rat-scan test (https://plus.google.com/112955465211109929462/posts/BbSxcF3PUz1) for Veterinary Vaccine at IVRI, Izatnagar.
Posted by at

No comments:

Post a Comment

Subscribe to: Post Comments (Atom)