PIL at HC: NACO suppressed serious problems with blood testing

Columbus, Ohio, Jan 09, 2009
Dr. Saha

In the ongoing PIL before the Delhi High Court (Writ Petition Civil No. 5973/2008) against the use of spurious HIV test kits in India, I’ve filed a “Rejoinder” today (copy attached) against NACO’s claim that an expert from US Center for Disease Control (CDC), Dr. Robert Martin, gave a report that there is no evidence of substandard HIV kits in India. CDC had previously said that Dr. Martin has “no authority” to evaluate the quality of HIV kits in any country, which I filed with the original PIL. In the Rejoinder we filed in the court today, we have submitted glaring evidence containing internal emails (obtained from CDC through the “Freedom of Information Act”) in which Dr. Martin has categorically admitted that NACO does not validate test kits in an “appropriate manner” and not only for HIV testing, the current approach followed by NACO for testing of blood for other deadly diseases like “Dengue”, “Typhoid” and “Hepatitis” is “too fragmented and inadequate” (copy attached). Other incriminating documents showing serious problems with blood testing by NACO are also included with this “Rejoinder”. Obviously, NACO has deliberately suppressed the incriminating observations made by Dr. Martin.

NACO has the sole responsibility for control of all blood banks in India. The World Bank published evidence of fraud and corruption with HIV/AIDS and other health programs in India in their DIR report in 2008. The evidence filed in the court today underscores the serious danger that innocent patients in India face everyday under any condition that may require blood transfusion. This PIL will come up for hearing on Wednesday (January 14, 2009). You can contact my attorney Mr. R. Venkataraman (Tel: 9910090030) or senior advocate Mr. M.N. Krishnamani (Tel: 9811065316) who would argue this PIL next week. You can also contact me for any questions or any other documents mentioned in the Rejoinder. I will be coming to Delhi towards the end of this month to start a nation-wide protest including an indefinite “hunger strike” from February 6, 2009 demanding justice for all victims of “medical negligence” in India.

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IN THE HIGH COURT AT NEW DELHI
WRIT JURISDICTION

W.P.(C) NO. 5973 OF 2008

IN THE MATTER OF:

DR. KUNAL SAHA ..PETITIONER

VERSUS

1. National AIDS Control Organization (NACO)
9th Floor, Chandralok Building
36, Janpath, New Delhi 110001
Represented by its Director General
Smt. Sujata Rao

2. Union of India, represented by
Secretary to Govt.
Secretary,
Ministry of Health & Family Welfare
Nirman Bhawan
Maulana Azad Road,
New Delhi-110011 ..RESPONDENTS

REJOINDER AFFIDAVIT ON BEHALF OF THE PETITIONER

I, Malay Ganguly S/o Shri Hrishikesh Ganguly (Power of Attorney Holder of the Petitioner, Dr. Kunal Saha) R/O Flat-E1, Subol Apartment, 1st Floor, 7 Nilgung Road, P.O. Belgharia, Kolkata – 700056 presently at New Delhi do hereby solemnly affirm and state as under:

1. That I have gone through the copy of the Counter affidavit filed by the Respondents and having understood the contents thereof in reply thereto, I am filing the present affidavit.

2. That it is important to mention that in the reply affidavit filed by the Respondents, there is not even an attempt to meet the basic contentions raised by the Petitioner, i.e. that sub-standard HIV kits were procured during the second national AIDS control project (NACP-II) between 1999 and 2006 and that innocent people might already have been exposed to the deadly AIDS virus as a result of use of sub-standard test kits in hospitals and blood banks in India. In fact, as discussed below, the Respondents have actually admitted in their response affidavit that sub-standard HIV kits were utilized by some government hospitals during the NACP-II and “the tests using these kits were invalid and showed inconsistent results” (para no. 5, Respondent affidavit). Therefore, it is humbly submitted that the primary legal contentions in this PIL against the Respondents remains uncontroverted.

3. That at the outset, the Petitioner would like to draw attention to some of the most outrageous points raised by the Respondents in their affidavit that are blatantly untrue or gross distortion of facts. It is obvious that these distortions/lies were made by the Respondents with a clear intention to mislead this Hon’ble Court. It is, therefore, very important that these points are clarified first:-

A) Denial of World Bank DIR report about spurious HIV kits: As explained in the original writ petition, the primary basis of the instant PIL has been an exhaustive “Detailed Implementation Review” (DIR) report published by the World Bank after a long investigation of Indian hospitals and blood banks in 2007. The World Bank found numerous evidence of fraud and corruption during the NACP-II including supply of poor quality HIV kits “potentially resulting in the further spread of (HIV) disease or in the wastage of blood”. The Respondents have allegedly started CBI investigations against some of the accused but NACO has repeatedly claimed in the response affidavit that they have sent a response to the DIR report which has been “accepted” by the World Bank (Respondent’s affidavit: para nos. 3 and 4 of “preliminary submission” and para nos. 5, 12, 13, 17 and 20). It is ironic that the Respondents have never denied the veracity of the allegations against use of sub-standard HIV kits during NACP-II as reported in the DIR report. Irrespective of whether or not World Bank actually “accepted” the response from NACO, the Respondents have not denied the specific allegation that sub-standard HIV kits were used during the NACP-II by some hospitals and blood banks, as mentioned above. Interestingly, the Respondents have also claimed that the defective test kits were later “replaced” by NACO (para no. 5). It is ironic that the Respondents never explained why and how these sub-standard HIV kits were procured and circulated by NACO. More importantly, the Respondents also have not explained why NACO never wanted to investigate whether any patient might have been affected with the deadly AIDS virus due to the use of spurious test kits during NACP-II before these kits were replaced by NACO. The Respondents have remained absolutely silent about these vital questions that may have grave significance on public health in India and that form the primary basis of the instant PIL.

B) Production of anecdotal and tainted opinion from CDC expert: In order to denigrate the primary contentions in the instant PIL and to malign the professional credibility of the Petitioner, NACO has filed a letter dated December 7, 2007 with their affidavit (as Annexure-VI) from one Dr. Robert Martin, allegedly an HIV expert from the Center for Disease Control (CDC) in USA. In fact, this is the only piece of document that NACO has produced to establish that only good quality HIV kits were used during NACP-II. NACO has repeatedly misrepresented this letter from Dr. Martin to claim that since this CDC expert has provided opinion in their support, there can possibly be no sub-standard test kits used in India (NACO response affidavit page nos. 3, 10, 11, 15, and 16). As explained below, documents recently obtained by the Petitioner would clearly discredit the said opinion given by Dr. Martin and show a devious motive on part of the Respondents to obtain opinion from this alleged expert from the CDC. These documents were recently obtained by the Petitioner from the CDC under the “Freedom of Information Act” (FOIA) in USA. These documents would clearly show that NACO actually approached Dr. Martin when he was already in India involved with a different project with NACO and the government of India (GOI). NACO also put undue pressures on Dr. Martin to obtain a favourable letter in order to rebut the serious complaints against sub-standard HIV kits which came into limelight at that stage and to discredit the Petitioner. These documents contain direct email exchanges between Dr. Martin and NACO/World Bank/CDC officials and would show beyond the shadow of any doubt that far from being supportive of NACO’s status for testing of blood in India, Dr. Martin was reluctant to write a supportive letter which NACO eventually produced as the only piece of supporting evidence (Annexure-V1). Even more shockingly, these documents would also show that Dr. Martin has indeed expressed serious concerns about the testing procedures followed by NACO not only for detection of HIV but also other deadly diseases like Hepatitis, Typhoid, and Dengue. A quick look into some of these communications would make it abundantly clear that NACO has not come clean with the facts in this serious matter related to public health in India. Some of the incriminating points that became apparent from the email exchanges between Dr. Martin and NACO/World Bank officials who were involved in this matter are discussed below:
i) NACO has deliberately suppressed concerns raised by Dr. Martin about blood testing in India: The Respondents have suppressed serious concerns expressed by Dr. Martin about the testing of blood in India. Even before issuing the letter on December 7, 2007 which NACO has used as the only piece of supporting evidence (Annexure-VI) to discredit the Petitioner and defend their case, Dr. Martin candidly expressed his unwillingness to criticize the Petitioner. Dr. Martin also expressed concerns about the serious flaws associated with the testing of blood by NACO on different occasions. One such email from Dr. Martin written on November 30, 2007, i.e. 7 days before he wrote the Annexure-VI to NACO is annexed herewith and marked as Exhibit-A. The serious problems with blood testing in India would be glaringly evident from this email from Dr. Martin as he writes, “I also don’t want to give the impression that NACO is addressing the purchase and validation of test kits in an appropriate manner – they are not and we (both Bharat and I) have had those discussions with NACO in the past. As you know, NACO is developing capacity at NICD to both validate kits and provide EQA to certain of the laboratories performing testing. That is a big job for NACO and is also a workaround to the real problem of no focal point within the Indian government for validating test kits whether HIV, Dengue, Typhoid, Hepatitis etc. The current approach is much too fragmented and inadequate – it appears an institute is identified and then they appear to test only once the product from each manufacturer, there appears to be no process for continuing to test each lot purchased. I am sure that Dr. Sokhey (NACO Additional Project Director) will not be happy at my reluctance to provide a statement criticizing with World Bank consultant (Petitioner), but I’m sure you understand our reasoning”. (emphasis added)

Furthermore, after the Petitioner raised questions to the CDC about Dr. Martin’s dubious role for giving a supportive letter to NACO about HIV kits in India, Dr. Martin admitted in an official communication with his colleagues that he was concerned about NACO’s motive to use his letter of December 7, 2007 (Annexure-VI by Respondents). Dr. Martin again has categorically stated on December 19, 2007, “My letter (of December 7, 2007) did not address the many other issues regarding procurement and validation of test kits – issues over which I expressed concern” (emphasis added). The said email from Dr. Martin is annexed herewith and marked as Exhibit-B, which also contains the questions raised by the Petitioner following the slanderous “press release” issued by NACO on December 14, 2007.

On yet another day, Dr. Martin raised similar concerns (in response to media reports in India) about defective HIV kits procured by NACO in an email dated January 28, 2008 as he writes, “A big part of the problem, of course, is that the mechanisms are not in place to refute some of these charges – for example, the charge about substandard test kits – don’t know where those data come from and to refute those charges there are no data because no one is in charge of validating test kits or assuring their performance their performance at the local level. So the fact is, no one know if they are substandard or not” (emphasis added) (Exhibit-C).

It is shocking that despite these repeated and categorical comments and concerns expressed by Dr. Martin about inherent flaws with the test kits and blood testing procedure in India, the Respondents have suppressed these facts and instead, they have tried to utilize selective comments obtained under extraneous pressures on Dr. Martin (see below) to discredit the Petitioner and to suppress the serious allegations against poor quality HIV kits.
ii) Dr. Martin’s reluctance to criticize the Petitioner: As mentioned above, the Respondents have filed a letter dated December 7, 2007 from Dr. Martin (with some criticisms of the Petitioner) as the sole piece of evidence to argue that Petitioner has no credibility and the complaints against sub-standard HIV kits has no merit. In the email dated November 30, 2007 (Exhibit-A), Dr. Martin has candidly stated “After thinking the situation and discussing with Bharat (another CDC expert), I am reluctant to put my thoughts about Dr. Saha’s (Petitioner) criticisms in writing. ……………….I am sure that Dr. Sokhey (the liaison person at NACO who organized Dr. Martin’s involvement as an expert to investigate HIV kits issue) will not be happy at my reluctance to provide a statement criticizing the World Bank consultant (Petitioner), but I’m sure you understand our reasoning.” (emphasis added). Ironically, only 7 days after Dr. Martin categorically stated that he could not criticize the Petitioner on scientific grounds, he was pressured enough by NACO to produce a letter (criticizing the Petitioner), which was submitted by the Respondents as their only supporting evidence (Annexure-VI).

iii) Dr. Martin’s final report was altered: Dr. Martin visited NACO on November 22, 2007 to investigate documents related to sub-standard HIV kits. Dr. Martin prepared a final report of his investigation of the sub-standard HIV kits and attached the report to his email dated November 30, 2007 (Exhibit-A). As can be seen in Exhibit-A, the size of this attached final report from Dr. Martin is only 38 KB. Interestingly, when Dr. Martin eventually emailed his opinion to NACO on December 7, 2007, the size of the same final report was increased from 38 KB to 83 KB indicating that substantial alterations were made in his final opinion after it was prepared on November 30, 2007. What actually transpired between November 30 and December 7, 2007 between Dr. Martin and NACO officials remains unclear at this point. However, it is clear from other documents obtained by the Petitioner that extraneous pressures were exerted on Dr. Martin from officials at NACO/World Bank to somehow obtain a supportive report (see below). The email from Dr. Martin sent on December 7, 2007 to NACO director (S. Rao) and additional director (Dr. Sokhey) is annexed herewith and marked as Exhibit-D which also contains the final letter produced by the Respondents as Annexure-VI. The obvious question remains as to why the final report that Dr. Martin had already prepared on November 30, 2007 after his investigation of NACO documents on November 22, 2007 was altered? It may be pertinent to mention in this regard that while Dr. Martin has refused to answer any questions about his involvement with the NACO after the Petitioner raised these issues with the CDC, following a legal notice to the CDC Director by Petitioner’s attorney in USA, the CDC has tried to distance itself from this controversy as they have categorically stated that Dr. Martin has no authority “to assess the quality of HIV test kits in any country”. The CDC’s response about Dr. Martin has been filed with the original writ petition as Annexure-P10. Why would NACO hire a foreign expert (Dr. Martin) who had an ongoing connection with NACO and has “no authority” to test the quality of HIV kits in any country to investigate allegations against poor quality HIV kits and then used his opinion to establish that there was no problem with the quality of HIV test kits in India?

iv) Extraneous pressures exerted on Dr. Martin to obtain a favourable report: As mentioned above, Dr. Martin was already in India and working on a different project with NACO/GOI (Exhibit-E) when high-ranked NACO official (Dr. Sokhey) and member of Delhi World Bank (Dr. Suneeta Singh) contacted him in mid-November, 2007 to look into the complaints against spurious HIV kits. Dr. Martin was put under pressure from the beginning to produce a favourable report about his analysis of the documents related to defective HIV test kits in India. Documents obtained from the CDC make it abundantly clear that the investigation by Dr. Martin was a completely staged event and pre-planned by interested NACO and World Bank/CDC officials with an oblique motive. It is evident that while Dr. Martin was deeply engaged in Delhi with unrelated health projects with the GOI, NACO/World Bank officials roped him in to obtain a supportive opinion on HIV kits (Exhibit-E). Dr. Martin was contacted by NACO/World Bank in mid-November, 2007 after the Washington Post, a popular national daily in USA, published a major investigative article about the abuse of World Bank funds for purchase of sub-standard HIV kits in India. Apart from the fact that Dr. Martin had “no authority” to assess the quality of HIV kits in another country as affirmed by the CDC (letter from CDC attached as Annexure-P10 with the original writ petition), Dr. Martin obviously had a direct conflict of interest for getting involved with any investigation against NACO. More importantly, it is abundantly clear from the internal communications between Dr. Martin and others at the NACO/World Bank in Delhi that he was pressured to provide a favourable report after looking into some documents at NACO building in the morning of November 22, 2007. In fact, high-ranked NACO official (Dr. Jotna Sokhey) wanted to discuss the report with Dr. Martin “on 21st or early morning on 22nd”, that is even before Dr. Martin had examined the alleged documents (see email from Jotna to Suneeta on page 6 of Exhibit-F). Following Dr. Martin’s visit to NACO on November 22, 2007, he was again directly told on the same day by Dr. Suneeta Singh (World Bank) and Dr. Rubina Imtiza (CDC, Delhi) that NACO should be provided a brief note about his findings as soon as possible, even before submitting his final report as Dr. Suneeta Singh writes to Dr. Martin at 4:30 pm on November 22, 2007, “Dr. Sokhey (NACO) reiterated later to me that a brief note about your impressions of the information presented would be extremely useful to them, and I hope that you can put that together for them soonest” (see email from Suneeta to Dr. Martin on page 1 of Exhibit-F). These email exchanges between Dr. Martin and NACO/World Bank officials in Delhi leaves no room for any doubt that Dr. Martin was pressured to provide a favourable report about his impression of the documents related to HIV test kits.

C. Misrepresentation of Dr. Martin’s letter by the Respondents: The only supporting document that the Respondents have submitted as Annexure-VI is the letter from Dr. Martin dated December 7, 2007 which was obtained under a dubious circumstance, as discussed above. But even then, a closer look at this letter from Dr. Martin would also show that there is absolutely nothing in this report that actually supported the view that sub-standard HIV kits were not used in India. It would be clear from this letter that Dr. Martin did not pass any opinion suggesting that HIV kits used in India were of standard quality. Dr. Martin has merely stated, “It appears that there is not enough information make any such conclusion about the quality of the test kits”. He has further stated, “CDC cannot pass judgment on the quality of test kits used” (see Annexure-VI filed by the Respondents).

It must be noted that Dr. Martin has never discussed with Dr. Saha (Petitioner) before expressing his opinion on December 7, 2007 and that he refused to talk with Dr. Saha even after Dr. Saha contacted CDC. Obviously, Dr. Martin can have absolutely no idea about the “information” that Dr. Saha actually observed during his investigation in association with the World Bank team in March-April, 2007. In fact, Dr. Saha examined a lot more data and interviewed other hospital/blood bank employees during his investigation to come to the conclusion that poor quality kits were probably used by some hospitals/blood banks during the NACP-II. More importantly, the World Bank DIR report has also drawn the very same conclusions for their own multi-faceted investigation. As mentioned above, Dr. Martin has made categorical comments on several occasions that the current approach for testing of blood with kits procured by NACO was “much too fragmented and inadequate” (Exhibit-A), “My letter did not address the many other issues regarding procurement and validation of test kits – issues over which I expressed concern” (Exhibit-B) and that “no one is in charge of validating test kits or assuring their performance” (Exhibit-C). It is truly shocking that despite admission of serious concerns about testing of blood in India before his colleagues in USA, Dr. Martin has never tried to bring these serious concerns about public health to the appropriate authority or to public at large. This is against all norms and procedures observed in ethical practice of medicine. The Petitioner has already filed a complaint to the CDC for taking appropriate action against this unethical and immoral behavior by Dr. Martin. In any event, there can be no argument that NACO has grossly distorted and misrepresented the opinions expressed by Dr. Martin about the quality of HIV kits used during NACP-II.

D. No explanation for defective kits manufactured by companies other than SD Bioling/Monozyme: The Respondents have filed a single piece of evidence with their affidavit (Annexure-VI), which is the opinion from Dr. Martin. But a cursory glance into this letter from Dr. Martin would clearly show that his opinion about defective HIV kits was exclusively on the kits produced by SD Bioline/Monozyme India Ltd. While kits produced by SD Bioline/Monozyme were certainly of poor quality, there were other manufactures that also produced inferior quality test kits as found in the World Bank DIR report. Dr. Martin made absolutely no observation about the problems associated with the test kits from other companies, e.g. Enzaids HIV 1&2 Elisa kits, that also produced poor results as shown in the DIR report. Indeed, that Dr. Martin gave his opinion only on the kits produced by SD Bioline/Monozyme is clear from the affidavit filed by the Respondents (see page 7).

4. PARA-WISE RESPONSE TO RESPONDENT’S AFFIDAVIT:
A. Personal attacks against the Petitioner (Paragraphs 1-4): The contents of the preliminary submission and paragraphs 1-4 of the Counter affidavit are wrong and denied. In order to belittle the significance of this instant PIL, the Respondents have attacked the Petitioner’s personal as well as professional reputations and made outlandish claim that no public interest is involved in the present writ petition. The Respondents have also claimed that the reason this PIL was filed is for “personal vengeance”, “to boast his (Petitioner) ego and professional reputation” and “to settle his (Petitioner) personal score against the Respondents”. The fundamental question involved in the instant writ petition raises a seminal question which is equally significant for public health in India and humanity at large. Whether use of spurious HIV kits in hospitals and blood banks in India endangering the innocent patients’ lives violates the fundamental right to life for all citizens? There can be no dispute that the answer of this important question is an emphatic “yes”.

The World Bank DIR report has already shown irrefutable evidence of sub-standard test kits used during the NACP-II. The DIR report was prepared by the World Bank, not by the Petitioner. The Petitioner was only one of the numerous doctors, scientists and other investigators who were involved with this massive investigation by the Bank. Therefore, the question of any “personal vengeance” or “to settle personal score” does not arise in this case. While the Respondents have repeatedly asserted that the NACO has already taken appropriate steps in view of the DIR report and that the World Bank has “accepted” the NACO response, nowhere the Respondents have stated that the DIR report was false or contained erroneous information. Even if NACO has now adopted proper procedures in response to the DIR report to prevent supply of poor quality HIV kits, this in no way mitigates the grave injustice that many innocent people might have suffered as a result of the use of spurious HIV kits during the NACP-II. The present PIL has sought a transparent and impartial investigation for the failure of NACO during the NACP-II. It is ironic that the Respondents did not even deny the specific cases cited in the original PIL where innocent patients were infected with HIV through contaminated blood. Rather, in one case, the Respondents, despite being the principal authority for controlling HIV/AIDS in India, have merely defended that the tainted blood was supplied by a private blood bank and thus, NACO could not be held responsible (para 4 of Respondent’s affidavit). In another instance where researchers from the All India Institute of Medical Sciences (AIIMS) found clear evidence of HIV transmission through contaminated blood, the Respondents have simply claimed that the “strategy of testing by the National programme was not followed” by the AIIMS researchers (see para 13 of Respondent’s affidavit). These are outrageous admissions by the NACO that clearly undersocre their failure to curb the spread of HIV.

The assertions made by the Respondents that the Petitioner has filed the instant PIL “to boast his ego and professional reputation” or “to settle a personal score” are also utterly ridiculous. The Petitioner is a well-known AIDS researcher settled in the US for the past more than two decades. The Petitioner’s academic qualification is evident from his accomplishments in the field of HIV research over the past many years. He published numerous scientific articles in world-renowned medical journals including two articles in “Nature Medicine”, one of the top-most journals in medicine. The Petitioner has also obtained many grants from the US National Institute of Health (NIH) and other reputed organizations for his work on HIV/AIDS. The Petitioner has presented his research work on HIV/AIDS in numerous national and international scientific conferences. The Petitioner has also been a regular reviewer for the US National Institute of Health (NIH) and many international medical journals for research in the field of HIV/AIDS. The Respondents have stooped down to an abysmally low level by trying to denigrate Petitioner’s scientific qualifications in a blatant and pitiful manner. The World Bank hired the Petitioner as a medical consultant for the investigative team only because of his scientific reputation in the field of HIV/AIDS. In fact, the Respondents have deliberately tried to slander the professional reputation of the Petitioner by putting out frivolous “press release” and through bogus assertions admittedly obtained from the Internet. The Respondents have claimed that they obtained this information from a website (www.lexis.com) which was scribbled by hand. The said website is simply an uncontrolled web search engine like thousand other search engines, good and bad, available on the Internet. It appears that the Respondents did not even print the entire document from the Internet but just copied some selective sentences which they submitted as Annexure-I with their affidavit. This only shows the disingenuous character of the Respondents. The Respondents have copied, “Dr. Saha was denied tenure as Assistant Professor with 11-0 voting against him” (page 5). The Petitioner was hired as an “Assistant Professor” by the Ohio State University (OSU) in 1998 and therefore, the question for denial of “tenure as Assistant Professor” does not arise. This is nothing but a despicable attempt to dissuade the Petitioner to unravel the truth about the travesty of use of sub-standard HIV kits at the expense of innocent patients’ lives in India. The Petitioner reserves the right to file separate litigation against the Respondents for these slanderous comments and defamation. In any event, the Petitioner’s personal or professional qualification is not an issue here as it has absolutely nothing to do with the primary grounds for the instant writ petition, i.e. findings by the World Bank that spurious HIV kits were used during NACP-II. The pitiful personal attacks against the Petitioner only underscore the dubious nature of the Respondents.

B. Results with defective HIV kits from Mumbai hospitals (Paragraph 5). The content of the paragraph 5 of the Counter affidavit is wrong and denied. In fact, the Respondents have admitted the specific allegations made in the original PIL that the results obtained with the allegedly defective HIV kits (SD Bioline/Monozyme and Enzaids) at the GT Hospital and KEM Hospital in Mumbai were “invalid and showed inconsistent results”. The Respondents have also claimed that these sub-standard kits were later “replaced”. It is shocking to observe that despite admitting that poor quality kits were used by major hospitals in Mumbai during NACP-II, the Respondents never felt it necessary to probe whether as a result of use of sub-standard kits at these major hospitals in Mumbai, any patient became infected with the AIDS virus or anybody was mistakenly diagnosed with AIDS. This utter disregard to human lives by NACO during is the principal underlying reason for filing the instant PIL.

C. Replacement of defective kits (Paragraph 6). The content of the paragraph 6 of the Counter affidavit is wrong and denied. As discussed in the last paragraph, it is astonishing to note that in order to minimize the significance of defective HIV kits, the Respondents have simply claimed that the defective batch of kits were “replaced in September 2004”. It is obvious that because NACO realized that some kits were defective, they decided to replace those kits. But what about the kits from the defective lots that was already used for testing of blood before they were replaced? How NACO, the supreme authority for AIDS control in India, could simply ignore a grave finding that some approved HIV kits that were being used in major hospitals/blood banks were of sub-standard quality by simply saying that the defective kits were later replaced? It is pertinent to mention in this context that in the official response that NACO/GOI has sent to the World Bank against the DIR report, NACO has directly admitted, “It is a fact that in 2005-06 Monozyme supplied expired HCV and HBV rapid test kits to blood banks in West Bengal. No HIV kits were supplied and there was no instance of pregnancy kits being substituted for HIV diagnostic kits”. Such brazen admission by NACO only underscores the pitiful status of quality control of blood supply in India. The “criminal” case against the Monozyme India Ltd which was initiated by the West Bengal government in 2006 is still pending before the Calcutta High Court. Unfortunately, NACO has shown no interest for expedited justice in the said criminal case despite its direct relevance to testing of blood and its significance to public health.

D. Personal attacks against Petitioner (Paragraph 7). The content of the paragraph 7 of the Counter affidavit is wrong and denied. Although the Respondents have admitted that none of the NACO officials including Respondent No. 3 (NACO Director) have ever met or have any personal knowledge about the Petitioner, without providing any reason whatsoever, the Respondents have made a ludicrous assertion that the Petitioner has been “persistently harassing” NACO. The Petitioner has filed the instant PIL as a conscientious citizen to draw attention to a grave situation where innocent people in India might be contracting the deadly AIDS virus as a result of use of sub-standard HIV kits. As discussed earlier, there can be absolutely no reason for the Petitioner, a permanent resident of USA, to “harass” NACO or to file a frivolous PIL. It is truly unfortunate that rather than sharing Petitioner’s concerns about HIV kits with the seriousness and empathy that it deserves, NACO has decided to annihilate the messenger by making shameless personal attacks against the Petitioner. In fact, the Respondents have made an unfathomable submission that the Indian Ambassador has been instructed to take action against the Petitioner in the USA for causing “harassment” to NACO. However, on repeated inquiries to the Indian Ambassador in Washington, DC, the Petitioner was told by the US Ambassador’s office (Ambassador’s assistant: Mr. Matthew) that no complaints against the Petitioner have been received from NACO/GOI in this regard. Such despicable attempt to threaten the Petitioner only for drawing attention to a serious issue related to public health and HIV/AIDS is truly unfortunate.

E. Opinions of foreign experts (Paragraphs 8-9). The contents of the paragraph 8 and 9 of the Counter affidavit are wrong and denied. The Respondents have tried to belittle the qualification and experience of the Petitioner as an AIDS researcher in the USA by claiming that since the Petitioner did not work for the UNAIDS, WHO or CDC, he cannot be considered as an expert on HIV. If this was true, then most world-renowned HIV researchers including the noble prize winning HIV scientist, Prof. Luc Montagnier at Columbia University in New York City, would not be considered as experts on HIV. The Petitioner himself was a fellow at the HIV/AIDS center at Columbia University in New York City before joining Ohio State University as a faculty member in 1998. As mentioned before, the Petitioner has a long track record of outstanding work in the field of HIV/AIDS. The World Bank also hired the Petitioner for investigation of HIV kits in India only because of his scientific background. The brazen and derogatory comments against the Petitioner only underscore the heinous nature of the Respondents.

The Respondents have also tried to draw support from the observations of Dr. Robert Martin from CDC and one Dr. Elizabeth Dax from Australia. The obvious conflict of interest and apparent sinister role of Dr. Martin has been discussed before. Dr. Dax, from Australia also has a long-term close relationship with NACO and GOI. In fact, according to the information available at the website of the “Australian Department of Foreign Affairs and Trade” (www.dfat.gov.au) and Australian “National Reference Serology Laboratory” (www.nrl.gov.au) where Dr. Dax holds an official position, Dr. Dax received direct funding from GOI in 2000-2001 for her own project entitled, “Program expenditure on health and social issues”. Dr. Dax also held a workshop in New Delhi organized by NACO on 21-25 May, 2001 and she was also funded to build a reference laboratory in Maharashtra in 2001. The allegations against spurious HIV kits surfaced only in 2007. Obviously, Dr. Dax had a direct conflict of interest for any investigation against NACO. Why did NACO select two international HIV experts (Dr. Dax and Dr. Martin) for a fair and impartial investigation both of whom had obvious conflict of interests? After Dr. Dax was contacted by the Petitioner to clarify some of the opinions that she has expressed to NACO in the context of defective HIV kits, she refused to answer any questions. When the Australian ministry of health was contacted for cooperation in this regard, they also expressed their inability to direct Dr. Dax to answer the relevant questions about sub-standard HIV kits in India (Exhibit-G).

F. Violation of the RTI Act, 2005 (Paragraph 10): The content of the paragraph 10 of the Counter affidavit is wrong and denied. The Respondents have refused to provided any information under the RTI Act, 2005 about their investigation of the defective HIV kits on the ground that the Petitioner is not a bona fide citizen of India. Why should NACO refuse to provide information that are vital for protection of public health in India? In any event, the request for information under the RTI Act, 2005 was made by made by a bona fide Indian citizen, not by the Petitioner. After the Central Information Commission (CIC) upheld an appeal against NACO and directed them to provide the requested information, NACO has recently submitted the documents allegedly related to their investigation involving the World Bank and Dr. Martin. It is shocking that no internal communication between NACO officials and Dr. Martin or others at World Bank/CDC was provided by the Respondents. The Exhibits A-F (obtained from CDC under the “Freedom of Information Act” in USA) filed with this rejoineder establish beyond the shadow of any doubts that NACO did not come clean and tried to suppress all incriminating documents about their investigation of HIV kits in clear breach of the RTI Act, 2005.

G. NACO’s defense for spurious HIV kits (Paragraphs 11-13): The contents of the paragraphs 11-13 of the Counter affidavit are wrong and denied. The Respondents have claimed that the World Bank has “accepted” their response to DIR report. However, the Respondents have not produced any documents to support these claims. More importantly, even if these claims by NACO were true, that would not in any way mitigate the basic concern raised in the instant PIL, i.e. sub-standard HIV kits were used during the NACP-II which endangered lives of innocent people. Ironically, the Respondents have admitted that the finding of AIIMS researcher that spurious HIV kits were used is true but instead of looking into this serious incidence with an open mind, the Respondents have only blamed the AIIMS researchers for not following NACO procedures for testing of blood.

H. Criminal case against Monozyme India Ltd (Paragraph 14): The content of the paragraph 14 of the Counter affidavit is wrong and denied. Despite admitting that Monozyme India Ltd supplied sub-standard kits for testing of Hepatitis C virus in blood banks in West Bengal, NACO has shown no concern about the criminal case pending in West Bengal since 2006. NACO has full responsibility for supply of kits for testing of blood not only for HIV but also for Hepatitis B/C viruses. In order to suppress the corruption associated with the procuring of test kits from Monozyme India Ltd., the Respondents have claimed that no test kits from Monozyme were used in India in the “last 3 years”. This claim by NACO is nothing but a blatant lie as would be evident from the documents obtained by the World Bank during their investigation of hospitals in India in 2007 which clearly show that HIV kits produced by Monozyme India Ltd. (named as “Biozyme”) were being used in hospitals/blood banks in India at least until 2007 (Exhibit- H).

I. Fraud and deception with HIV kits (Paragraphs 15-17): The contents of the paragraphs 15-17 of the Counter affidavit are wrong and denied. No response is necessary as the Respondents have claimed that there is no evidence of any sub-standard HIV kits in India even though a plethora of evidence produced with this writ petitioner would indicate otherwise.

J. Opinion of Dr. Martin (Paragraph 18): The content of the paragraph 18 of the Counter affidavit is wrong and denied. The claim by the Respondents that an expert from CDC (Dr. Robert Martin) has testified in support of NACO has been dealt before.

K. No comments (Paragraph 19): No response provided by the Respondents.

L. Denial of all allegations (Paragraphs 20): The content of the paragraph 20 of the Counter affidavit is wrong and denied. The Respondents have denied all allegations of fraud and corruption in relation to the use of HIV kits in India. However, long before the Petitioner filed this instant PIL before this Hon’ble Court, the DIR report from the World Bank found categorical evidence of pervasive fraud and corruption during NACP-II. It is ironic that rather than trying to seriously probe into the issue of possible utilization of sub-standard HIV kits which would undoubtedly pose grave danger of transmission of HIV to innocent people through contaminated blood, the Respondents have attacked the Petitioner with scathing remarks without any basis whatsoever. In order to silence the Petitioner, the Respondents have also threatened him and submitted that GOI has already initiated a move to take punitive action against the Petitioner through the Indian Ambassador in USA. Contrary to the claim made by the Respondents, the Petitioner has not filed a single defamation lawsuit against anybody at NACO or Indian health department. However, as mentioned earlier, in view of the repeatedly slanderous and false personal attacks made by the Respondents, the Petitioner reserves the right to file defamation suits against NACO and other Respondents.

5. INTERIM PRAYERS:
In view of the shocking claim made by the Respondents in their counter affidavit and in view of the recent submission of documents (under RTI Act, 2005) by NACO as discussed under paragraph 4F above, it is humbly prayed that the Respondents be directed:

A) To produce the complaint that NACO/GOI has allegedly filed to the Indian Ambassador in USA to take up action against the Petitioner for “harassing” NACO.

B) To show cause NACO for deliberate suppression important documents (including those submitted as Exhibits A-F with this rejoinder) related to the investigation of defective HIV kits and did not produce these to Mr. R. Venkataraman, counsel for the Petitioner, in violation of the RTI Act, 2005.

C) To pass any other order this Hon’ble Court finds as necessary.

6. This petition is made bona fide and in the interest of justice.


DEPONENT

Verification:

I, the above named deponent do hereby verify that the statements made in the above Rejoinder Affidavit are true to my knowledge, legal submissions therein are true as per my Counsel’s advice and no part of it is false and nothing material has been concealed therefrom.
Verified at New Delhi on this ___ day of -- 2008.
DEPONENT

EXHIBITS:
Exhibit- A(1-page): Email from Dr. Martin to Rubina Imtiza on Nov. 30, 2007

Exhibit- B (4-page): Email from Dr. Martin to Dr. Ramana on December 19, 2007.

Exhibit- C (2-page): Email from Dr. Martin to Dr. Pawan on January 28, 2008

Exhibit- D (2-page): Email from Dr. Martin to S. Rao on December 7, 2007.

Exhibit- E (3-page): Emails between Dr. Martin and Kimberly Fox etc. on November 2, 2007.

Ex. F (6-page): Email communications between Dr. Martin and Dr. S. Singh (World Bank), Dr. Rubina Imtiaz (CDC) and Dr. Jotna Sokhey (NACO) between November 16 and November 22, 2007.

Ex. G (1-page): Letter from Govt. of Australia

Ex. H (4-page): Data obtained in 2007 with kits from Monozyme India Ltd.
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Dr. Saha in Columbus, Ohio