NRI Dr.
Kunal Saha expert and researcher on HIV/AIDS,
challenge bogus HIV-test kits used in India
LA, July 09, 2007
Gary Singh
The information about the hearing
tomorrow (July 10) at the SC in relation to the bogus HIV-test
kits which has put thousands of lives in India at danger. We have
"intervened" in this criminal case for the sake of the
defenseless patients. The entire petition is also pasted below.
...... Dr. Kunal Saha
TO: Chief Reporter/Bureau Chief July 9, 2007
RE: Historic
criminal case in SC tomorrow on bogus HIV-test kits
A historic criminal case against Mr. Amit Sarda, owner of the
Monozyme India Ltd that produced sub-standard HIV-test kits, will
come before Justices Mr. Asok Bhan and V.S. Sirpukar in the Court
No. 3 (Item No. 37) (Sarda vs. State of West Bengal) in the Supreme
Court on Tuesday, July 10.
I, on behalf of the People for Better Treatment (PBT), a humanitarian
society dedicated to protect patients interests in India, have
intervened in this matter of grave significance in public health.
We have submitted how these corrupt businessmen (including the
state of WB that did not attempt to underscore the obvious flaws
in the laboratory report) in collusion with some unscrupulous
people at the National AIDS Control Organization (NACO) have tried
to fool the court into believing that the HIV-testing kits worked
well. These kits have already infected countless innocent people
with the deadly AIDS virus through contaminated blood from the
hospitals/blood banks.
IN THE SUPREME COURT OF INDIA
CRIMINAL ORIGINAL JURISDICTION
WRIT PETITION (CRIMINAL) NO. OF 2007
(In Intervention of Special Leave Petition (Criminal) No. 1807
of 2007)
IN THE MATTER OF:
Dr. Kunal Saha, Through
his power of attorney, Mr. Malay Ganguly, Subal Apartment, 1st
Floor, Flat E-1, 7, Nilgung Road, Belgharia, Kolkata 700056 ............Petitioner
Versus
1. Mr. Amit Sarda, S/O
Sh. Govind Sarda, 14/1, Judges Court Road, Alipore, Kolkata 700027
2. The State of West Bengal,
through Home Secretary (Police) , Writers Building, Kolkata 70001,
West Bengal
PETITION UNDER ARTICLE
32 OF THE CONSTITUTION OF INDIA
To,
The Honble Chief Justice of India and His Companion
Justices of Supreme Court of India.,
The humble writ petition of the petitioner abovenamed.
Most Respectfully Showeth:
1. That the petitioner is a dual citizen of
India and USA, having his permanent residence at 3937 Kul Circle
South, Hilliard, Ohio 43026, USA and a local residence at Subol
Apartment, 7 Nilgunge Road, Kolkata 700056, INDIA. The petitioner
is a medical graduate from Calcutta University but has been living
in the USA since 1988 as a medical expert and researcher on HIV/AIDS.
The petitioner has been working as a professor in the field of
Virology and Immunology with a focus on the study of HIV/AIDS
in top academic institutions in the USA for the past many years.
The petitioner has also worked with Hepatitis B (HBV) and Hepatitis
C (HCV) viruses since these microorganisms are also commonly associated
with HIV and could be transmitted through contaminated blood like
HIV. Over the years, the petitioner has presented in many national
and international scientific conferences and has published numerous
scientific articles on Virology/Immunology and HIV/AIDS in reputed
international medical journals. A copy of petitioners resume
is annexed herewith and marked as Annexure - P1. It may be pertinent
to mention that the petitioner is also the founding president
of People for Better Treatment (PBT), a registered, humanitarian
society in India, which has been engaged in protecting/helping
the victims of medical malpractice and working to promote a better
healthcare system and better public awareness about healthcare
in India.
2. This writ petition is filed to intervene
the Special Leave Petition (Criminal) No. 1807/2007 (Amit Sarda
vs. State of West Bengal) which is pending before this Honble
Court. In this SLP (Criminal), Mr. Sarda has sought for an anticipatory
bail in relation to the pending criminal charges against him filed
by the State of West Bengal under Sections 120B/406/420/467/468/469/471/270
of the Indian Penal Code (IPC) read with Sections 13 and 27 of
the Drugs and Cosmetics Act, 1940. The said SLP has grave and
significant ramifications on public health across India. The said
SLP emanates from criminal charges against Mr. Sarda (and other
members of his family) for producing and/or supplying sub-standard/expired
medical diagnostic kits for testing of Hepatitis B (HBV) and
Hepatitis C (HVC) viruses in blood. It is alleged that Monozyme
India Ltd., a company owned/co-owned by the Sarda family, has
distributed the alleged sub-standard/expired HBV and HCV testing
kits through a large number of Regional Blood Transfusion Centers
(RBTC) putting the lives of innocent citizens in serious danger
of contracting infections with lethal viruses like HBV and HVC
through tainted blood transfusion.
3. That mandatory testing of HBV and HCV (also
HIV) viruses in blood is an important safety measure designed
to protect patients from receiving contaminated blood/blood products.
The diagnostic kits, such as those supplied by the Monozyme
India Ltd, are routinely used in the hospitals, blood banks and
other blood transfusion centers for detection of deadly viruses
like HBV and HCV in the donated blood samples.
4. That the allegations against Mr. Sarda (and
other co-accused) is clear from the FIR and Charge Sheet filed
by the Calcutta police (Annexure P1 and Annexure P2, respectively,
annexed with the SLP). Calcutta police received complaints of
sub-standard/expired kits (for testing of HBV and HCV) supplied
by the Monozyme India Ltd and seized the allegedly defective kits.
Further analysis of the seized HBV and HCV testing kits by the
Institute of Post Graduate Medical Education and Research in Kolkata
have found that both the HBV kit (that detects hepatitis B virus
surface antigen or HBsAg) and the HCV kit (that detects antibody
to hepatitis C virus) that were supplied by the Monozyme India
Ltd. were not sensitive and failed to detect the presence of
these two viruses in blood (page 56 of SLP). The alleged defective
kits seized by the Calcutta police were also sent to the National
Institute of Biologicals (NIB) in Noida, UP for analysis.
5. That it is pertinent to mention that the
primary basis of the said SLP filed by Mr. Sarda has been that
NIB, a national reference laboratory, has tested the alleged sub-standard/expired
kits from Monozyme India Ltd. and found that these kits were
of standard quality. Indeed, the certificate of analysis issued
by the NIB has stated that the kit was 100% sensitive and
specific. The NIB testing report has concluded, The above mentioned
kit is of Standard Quality (Annexure P6 with the SLP). In an
order dated 19th January, 2007 in a related petition for bail
(C.R.M. No. 524 of 2007), the Calcutta High Court has also accepted
the certificate of analysis from the NIB and considered that
the kits for testing of HBV and HCV from Monozyme India Ltd
were of standard quality.
6. That it is pertinent to mention in this regard
that Hepatitis B (HBV) and Hepatitis C (HCV) are two completely
different viruses even though they share their primary target
for infection in the human liver. While HBV can cause liver cirrhosis,
HCV is primarily responsible for causing liver cancer in the infected
subjects (hepatocellular carcinoma). The diagnostic kits that
are used to detect the presence of HBV and HCV in blood are also
different by nature as these kits contain distinct and separate
biological reagents.
7. That it must be pointed out that the NIB
certificate of analysis as produced in this case with the said
SLP as Annexure-P6, tested only a sample of the allegedly defective
kits that were used for detection of HBV (HbsAg) as can be seen
under the Name of Kit in the said certificate of analysis.
There is absolutely no evidence that NIB has also tested the alleged
sub-standard/expired kits from Monozyme India Ltd that were
used for testing of HCV virus contamination in blood, as alleged
in the FIR and charge sheet. The NIB certificate of analysis
produced in this case has certified only about the HBV testing
kits from Monozyme India Ltd. which has absolutely no connection
with the alleged defective kits for testing of HCV.
8. It is truly astonishing to note that the
present SLP has sought a complete exoneration from all charges
for the alleged sub-standard/expired HBV and HCV diagnostic kits
on the basis of a single certificate of analysis report from
NIB that did not even test the alleged sub-standard/expired kits
supplied by Monozyme India Ltd for detection of HCV. It is unfortunate
that a division bench of the Calcutta High Court has also failed
to appreciate the basic medical fallacy in the said certificate
of analysis (Annexure P6 with the SLP) in a related matter
(C.R.M. No. 524 of 2007; Annexure P4 in the SLP) and allowed
the bail application of other co-accused in this case on the misguided
notion that the said certificate of analysis from NIB represented
a clean chit for both types (HBV and HCV) of the alleged sub-standard/expired
kits supplied by the Monozyme India Ltd.
9. That the said certificate of analysis from
the NIB which was produced as a concrete evidence of standard
quality of the HBV detection kits from Monozyme India Ltd. is
also far from convincing as it contains numerous information that
raises serious scientific questions. For example, the said certificate
of analysis from NIB has noted under Description of Outer Cover
that the kit box that they have tested to produce this certificate
of analysis was in an opened condition. Standard practice for
quality assurance and testing of all medical kits used for detection
of viral infections such as HBV, HCV or HIV must ensure that the
kit box that they plan to test is in an intact and unopened
condition. There are many other obvious shortcomings in the said
certificate of analysis from the NIB. The name and address
of the manufacturer, manufacturing license number, date of
manufacturing and expiry date in the said certificate of analysis
were either Incomplete or Not Mentioned in the inner cover
(Container). These information are essential component for quality
assurance of any medical diagnostic kit. In this regard, Section
9 of the Drugs and Cosmetic Act, 1940 categorically provides that
a drug would be considered as a misbranded drug if it is not
labeled in the prescribed manner. Although a Lot No of the
kit tested by the NIB is noted, no Batch No is given in the
said certificate of analysis. Finally, the 100% sensitivity
as well as specificity as observed for the HBV kit tested
by the NIB in the said report raises doubt about proper evaluation
of this kit. The World Health Organization (WHO) has conducted
a comparative evaluation of different commercially available HBV
kits (similar to the kit tested by the NIB) produced by manufacturers
from various countries including India. The WHO report of testing
of HBV kits is annexed herewith and marked as Annexure P2.
While all kits from different countries performed well under
WHO guidelines for HBV kits, none of these kits showed 100%
specificity or sensitivity (Table 2, p. 19 of Annexure P3).
10. It is reported in the certificate of analysis
from the NIB that the cold chain for the HBV kit tested was
not maintained. It is extremely important for blood testing
kits for HBV, HCV or HIV that the cold chain (usually between
20C and 80C) is maintained as otherwise the important biological
components present in these kits rapidly deteriorate. Breakage
of the cold chain is likely to yield spurious results for these
medical diagnostic kits. In fact, Mr. Sarda in his SLP has also
claimed that he came to learn that if these diagnostic kits are
kept outside in inappropriate environment for one or more hours,
the result of the testing cannot be accurate (paragraph 20e).
On the face of such candid submission by the petitioner in his
SLP, the clear admission in the testing report from NIB that the
cold chain of the HBV kit that they tested was not maintained
suggests that the results reported the certificate of analysis
could not be trusted.
11. That in order to refute the allegation that
the kits from Monozyme India Ltd. had expired, it has been argued
in the SLP by Mr. Sarda (paragraph 38) that Monozyme India Ltd.
as a distributor could not be blamed for the expired kits as
the company could not have opened the cartoon/boxes and checked
each kit. Ironically, as clearly noted in the Certificate of
Analysis from the NIB, the Outer Cover of the kit box was open,
thus, raising more doubts about the authenticity of the test results
reported in the certificate of analysis from the NIB.
12. It is humbly submitted that your petitioner
has recently visited various hospitals and diagnostic laboratories
in different parts of India including the NIB with an investigative
team from the World Bank as a medical expert from the USA. Your
petitioners visit to India in March-April, 2007 with the World
Bank team was part of an ongoing investigation of alleged corruption,
among others, with the distribution and use of blood testing kits
that were funded by the World Bank. While the petitioner at this
stage is not in a position to disclose any detail of his findings
of different testing medical centers in India due to the contractual
Confidential Agreement that your petitioner has with the World
Bank, it is obvious that complaints of faulty blood testing kits
are common in India. The World Banks contractual offer with your
petitioner for his visit to India is annexed herewith and marked
as Annexure P3.
13. That it appears that Mr. Sarda (and other
co-accused) has deliberately tried to mislead this Honble Court
by harping on an ambiguous certificate of analysis from the
NIB that never analysed all the allegedly defective kits produced
by Monozyme India Ltd. However, the State of West Bengal has also
overlooked the obvious flaws present in the certificate of analysis
produced by the NIB. It is also pertinent to mention that the
State of West Bengal had previously filed their own report on
the analysis of the alleged sub-standard/expired kits from Monozyme
India Ltd. Tested through the Institute of Post Graduate Medical
Education and Research in Kolkata. It is surprising to note that
in spite of its immense significance in public health, the State
of West Bengal did not make any attempt whatsoever to clarify
the reason(s) for the two directly contradictory reports on the
standard of the same testing kits obtained from the NIB and
the Institute of Post Graduate Medical Education and Research
in Kolkata, respectively.
14. No crime should be considered as more heinous
than distribution of sub-standard/expired medical diagnostic kits
essential for testing of deadly viruses like HBV/HCV/HIV in blood
samples donated in our hospitals and blood banks. No human tragedy
could be greater than the tragedy of an unsuspecting patient receiving
these lethal viruses through contaminated blood in a hospital
or nursing home during an ordinary illness. It is also important
to remember that anybody could become a victim of these deadly
viruses in this manner since an emergency blood transfusion could
become life-saving for any person living in the modern society.
There is no denying that transmitting the deadly HBV/HCV virus
to an innocent patient through tainted blood blatantly violates
his/her fundamental right for life and liberty. Perpetrators of
such heinous crimes deserve the harshest punishment.
15. That the petitioner has not filed any similar
writ petition in this Honble Court or any other High Court throughout
India.
16. That this petition is made bonafide and
in the interest of justice.
PRAYER
In view of the submissions made in the above paragraphs, it
is humbly prayed that this Honble Court may graciously be pleased
to direct:
a) A writ or order in the nature of mandamus to dismiss the SLP
(Criminal) No. 1870/2007;
b) A writ or order to direct the Respondent Nos. 1 and 2 to present
all medical documents and analysis results obtained in relation
to the alleged sub-standard/expired kits for testing of HBV
and HCV;
c) A writ or order to direct the Respondent Nos. 1 and 2 to present
the original data presented in the certificate of analysis and
to explain the inconsistencies present in their report as explained
above in paragraphs 9 and 10.
d) A writ or order to form an independent board of medical experts
to analyse and investigate the performance of the alleged sub-standard/expired
kits from Monozyme India Ltd.
e) Such further or other order or orders be made and/or direction
or directions be given as to this Honble Court may deem fit and
proper.
AND YOUR PETITIONER, AS IN DUTY BOUND SHALL EVER PRAY
Drawn by: Mr. Avik Datta, Advocate
Drawn on:
Filed on : July 6, 2007
Filed By:
Mr. Sashi Bhushan Kumar
Advocate for the petitioner
ANNEXURES:
Annexure P1: Resume of Dr. Saha
Annexure P2: WHO report of HBV kits.
Annexure P3: Dr. Sahas agreement with World Bank.
anku1@earthlink.net
EarthLink Revolves Around Yo
Please cover this important hearing at the SC tomorrow
and bring it to your readers/viewers to expose these devious people
who are hurting the defenseless patients of India. Please contact
my attorneys Mr. Avik Datta (Tel: 98912-84102), Mr. Sashi Bhusan
Kumar (Tel: 9868206641) or senior advocate Mr. M.N. Krishnamani
(Tel: 9811065316) who would argue this matter on my behalf tomorrow,
for more information.