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Kunal Saha, M.D., Ph.D.- helping India


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 Intervention of Special Leave Petition (Criminal) No. 1807 of 2007)



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


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



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.


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.


Drawn by: Mr. Avik Datta, Advocate

Drawn on:

Filed on : July 6, 2007
Filed By:

Mr. Sashi Bhushan Kumar

Advocate for the petitioner


Annexure P1: Resume of Dr. Saha

Annexure P2: WHO report of HBV kits.

Annexure P3: Dr. Sahas agreement with World Bank.
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.

Dr. Kunal Saha,
Asst. Professor, AIDS Center.,
Tel: 001-614-893-6772, Fax: 001-614-527-5236


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