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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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