The Indian government has sharply censured the U.S. government's Centers for Disease Control and Prevention (CDC) for funding an “unapproved” Indian laboratory in Manipal, and not securing the necessary permissions for undertaking training in India for work on Nipah virus, considered a potential bio-weapon.
A Union Health Ministry communication to CDC said the work was undertaken despite knowing that high risk pathogens can be tested only in BSL4 lab. As the highest level of biological safety, a BSL4 lab consists of work with highly dangerous and exotic microbes. Infections caused by these microbes, including Ebola and Marburg viruses, are frequently fatal, and come without treatment or vaccines.
The Ministry said it is taking a “very serious view” of all such contraventions of virus research guidelines that bypass the Indian Council of Medical Research (ICMR)/ Health Ministry Screening Committee (HMSC) for permissions.
When asked by The Hindu , the CDC admitted that the training programme did not have the necessary approvals “due to some confusion about clearance for private institutions,” but it had not commissioned the research directly.
Meanwhile, in a communication dated October 30, 2019, the Ministry of Health and Family Welfare said it had written to both CDC and Manipal Centre for Virus Research (MCVR), ordering them to shut down the study. It told the Manipal institute to transfer all the Nipah virus samples to the certified ICMR-National Institute of Virology in Pune, and demanded that CDC stop all unauthorised funding.
A memorandum sent out said the CDC was advised “to stop funding research without approval and working with Nipah virus — a pathogen that belongs to Risk Group 4 classification (RG4) considered lethal since it can be turned into biological weapons.”
“It has been brought to our notice that CDC had trained MCVR for diagnosis of Nipah virus disease (NIV) in spite of the known fact that NIV is BSL 4 level pathogen whereas MCVR is a level BSL2+lab. Prior to this training to MCVR, CDC has not consulted national/govt agencies as per norm. Since Nipah is a high risk pathogen with potential for being used as agent of bio-terrorism the samples were to be handled more carefully and tested only in a BSL4.”
In a written response to queries, directed through the U.S. Embassy, the CDC said, “The training was done through the Global Health Security Agenda (GHSA) and was aimed at strengthening laboratory systems in India which allowed for detection of Nipah virus.”
“All trainings followed appropriate biosafety precautions and procedures as per international standards and were attended by government of India laboratorians,” the Atlanta based CDC, said. According to the CDC, after “realising” the need for further permissions, it had subsequently applied for clearances with the Health Ministry, but those were denied.
“When the clearance was not obtained, the project was closed and no further funding was released to MCVR, in accordance with GoI and U.S. Government policy,” the CDC spokesperson added, but did not explain why it had been unaware of the procedures for funding in the first place.
Dr. Arunkumar, Director of MCVR, said: “We did not take approval from HMSC. Prior to testing, MCVR inactivated the virus. Inactivation of the virus was carried out in BSL3 facility at MCVR. Once inactivated, the virus cannot spread. Molecular testing was carried at MCVR in its BSL2 facility. No Nipah virus sample was transferred from MCVR to any other lab (except NIV) within and outside the country.”
“Nipah virus diagnostic training of MCVR by CDC in 2017 was under the supervision of GHSA cell in DGHS and was reviewed every quarter by DGHS and ICMR. The Nipah Virus diagnostic training was conducted at MCVR as part of the capacity building exercise under the CDC sponsored project on hospital based Acute Febrile Illness surveillance,” Dr. Arunkumar added.
MCVR is reported to have carried out tests on the Nipah virus during the outbreak in Kerala in 2018 and 2019. Dr. R. Gangakhedkar of the ICMR said the training was funded by the CDC and had no approval from HMSC.
“At the time the decision was taken (in 2018, after the outbreak), we were informed that MCVR is only a BSL2 facility. We were not aware that it has a BSL3 facility in the Centre. The entire exercise of testing samples lasted for 10 days or so. Everything happened in a small capsule of time,” he added.
(with inputs from Suhasini Haidar in Delhi and R. Prasad in Chennai)
