India Project Riddled With Wrongdoing

(Washington, D.C.) – After nearly one year’s delay, the World Bank announced last Thursday that it will further investigate disclosures involving the distribution of defective HIV/AIDS test kits, mass purchased as part of a health care project in India. GAP client Dr. Kunal Saha first informed the Bank’s Department of Institutional Integrity (INT) of the use of the faulty kits in a draft report in May 2007. In the ensuing months, various World Bank officials have attempted to conceal the facts about the case, discredit Dr. Saha in both the US and India, and use the US Center for Disease Control (CDC) to cover-up fraud. Statements made by World Bank officials to the media last week about this issue were grossly misleading.

As an investigator hired by INT, Dr. Saha compiled compelling evidence that defective kits were purchased with World Bank funds and supplied by the Indian government to hospitals and blood banks across the country. The kits, distributed by Monozyme, Ltd., gave ‘false negative’ results: HIV-contaminated blood was not reliably detected by these kits and could therefore be accepted for use in transfusions.

In December of last year, as articles appeared in the Indian press focusing on the widespread use of defective HIV test kits, the Bank and the Government of India solicited a misleading statement from a laboratory testing expert at the CDC vouching for the kits’ accuracy. The National AIDS Control Organization of India (NACO), which works with the Bank, stated to the Indian press:

The documents cited by Dr. Saha have been reviewed by Dr. Robert Martin, associate Director, Coordinating Centre for Health and Information Services, Centres for Disease Control and Prevention, USA who is also of the view that there is no evidence of use of poor quality HIV test kits in India and his allegations have no basis.

That press release can be found here.

Less than two months later, however, when obliged to release its own Detailed Implementation Review (DIR), the Bank was forced to acknowledge the validity of the claims made by Dr. Saha some seven months earlier – a direct contradiction of the CDC expert’s statements.

“Dr. Saha’s report should have raised red flags about a potential public health emergency in India,” said Bea Edwards, International Program Director at GAP. “Rather than acting immediately to arrest the potential spread of HIV through the World Bank project, however, the Bank instead sought to use the CDC to conceal the fraud.”

The World Bank DIR can be found here.


Saha is a recognized expert in the field of HIV/AIDS research with two decades of research and clinical experience. The World Bank’s anti-corruption unit, INT, retained him in March 2007 as part of a six-member team to review India’s Second National HIV/AIDS Control Project (NACP II), financed with $191 million in Bank funds. Saha, after working as a senior HIV/AIDS researcher at the Columbia University in New York and Ohio State University in Columbus, Ohio for more than 12 years, recently moved to work for a private organization.

After finding evidence that defective kits were in use, Saha notified INT of the immediate danger to public health. He found that although the local branches of NACO had received multiple complaints about the HIV test kits as early as October 2004, the agency had not acted to withdraw the kits. When the media in India and Europe reported complaints about the Monozyme kits in 2006, a NACO spokesperson dismissed the allegations, saying that the problem was confined to the state of West Bengal that year and that NACO had already addressed it.

Dr. Saha, however, possessed test data showing that the Monozyme kits were still in use in April 2007 in Chhattisgarh – a state in central India.

When no action resulted from the submission of his report to INT, Dr. Saha took his concerns to the Indian press. In response, a Bank official told the Hindustan Times: “The findings are personal opinions which the researcher has reached independently, and do not reflect the views of the World Bank.” (For this article, click here.)

In that same article, the Indian government tried to defame and discredit Dr. Saha: “This investigator has no credibility. The World Bank has not complained to NACO at all about defective HIV-kits being used in India,” a NACO spokesman stated.

In August, Dr. Saha contacted GAP and shortly thereafter presented his evidence in a face-to-face meeting with Bank officials. In response to this presentation, the Senior Institutional Integrity Officer wrote him on August 23, 2007:

We found the meeting both instructive and helpful. We recognize the need to follow up quickly on the issues you have raised and to that end would like to use your information in discussion with persons outside the Bank. [Emphasis added]

The follow-up, however, became a cover-up. A month later, Dr. Kees Kostermans, the Bank’s lead public-health specialist in South Asia, told the Washington Post that the Bank had no “specific evidence” that HIV had been transmitted in India because of faulty diagnostic kits. “Specific evidence” that a defective diagnostic kit may have transmitted a virus like HIV requires an analysis of both hospital/blood bank data, and the medical records of the patients in the follow up clinics – precisely the investigative procedure that the Bank should have started immediately but did not.

“This is like a judge blocking a case from going to trial, then stating that the jury’s failure to reach a verdict validates his dismissal of the charges,” added Edwards. (For that Post article click here.)

In December, the Bank solicited an opinion from Dr. Martin, CDC expert on the use of faulty HIV test kits procured by the Indian project. Dr. Martin did not consult Dr. Saha, and the CDC (through its General Counsel) will not identify the evidence that Dr. Martin purportedly reviewed. Meanwhile, NACO issued the statement found above about Saha, based on Martin’s putative review.

Hard Evidence of a Cover-Up

In January the INT report on Indian health care projects was released by the World Bank, in order to comply with United States legislation regarding the disbursement of funds. The internal report confirmed Dr. Saha’s allegations and more. The report’s revelations include:

  • Two years of test results provided by one hospital which showed that the Monozyme-supplied SD Bioline kits were yielding a high false negative rate.
  • Complaints from five Voluntary Counseling and Testing Centers to Municipal District AIDS Control Societies that Monzyme-supplied S.D. Bioline HIV ½ Rapid test kits were producing invalid, false negative and/or discordant results.
  • Indicators of fraudulent and corrupt practices in the procurement of diagnostic test kits and blood bank equipment – particularly when conducted through decentralized procurement.

The World Bank’s own documentation showed that these kits had serious problems, but the data do not seem to have stopped Bank officials from launching a smear campaign against Dr. Saha, whose allegations they knew to be correct. The end result of the Bank’s lack of action is an increased likelihood that an unknown number of Indian citizens have contracted HIV.

Despite the public release of the INT report in January, the World Bank’s Kostermans told the Washington Post just last week that the HIV test kits were not faulty. At the same time the Bank issued a statement saying: “We take these indicators of fraud and corruption extremely seriously. Working with the Indian authorities, we will take action against those found responsible…” The Bank and the Indian Government, which for the past year have strenuously fought to conceal the fraud and the public health danger from the press, patients and the public, are now supervising the investigation into the corruption they tried to conceal and are assuming responsibility for disciplining those who are culpable.

“This pledge is not credible” said Edwards. “The Bank always seems to take corruption ‘extremely seriously’ when one of its projects is challenged. Unfortunately, it does not follow through and take action.”

Edwards went further, attacking the Bank-CDC relationship: “Now that all the information is in and we can see the whole picture, it appears that the World Bank used the CDC in a health project cover-up. How is it possible that the World Bank can so easily manipulate a flagship public health agency of the U.S. government to smear a medical expert and suppress news of a public health emergency?”

In order to further probe the irregularities at NACO, Saha’s attorney in Delhi has sought all pertinent information related to NACO’s handling of complaints about defective kits under the newly enacted “Right to Information Act” (RTI Act) in India. NACO has remained completely unresponsive, however, and failed to comply within the legally mandated time limit. Saha is presently appealing to the “Central Information Commission”, the highest authority to uphold the RTI Act in India.