India pulls up US agency for doing unauthorized Nipah virus research
The Indian government has pulled up the US government’s Center for Disease Control and Prevention (CDC) for funding an “unapproved” Indian laboratory in Manipal to do work on the deadly Nipah virus, and that too without permission.
Nipah is considered a potential bio-weapon.
An Indian Health Ministry letter to the CDC said that the work was undertaken despite awareness that high risk pathogens can be tested only in a BSL4 lab. As the highest level of biological safety, a BSL4 lab works 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 such contraventions of virus research guidelines, bypassing the Indian Council of Medical Research (ICMR)/ Health Ministry Screening Committee (HMSC) which are authorized to give or deny permission.
The CDC has admitted that the training program did not have the necessary approvals “due to some confusion about clearance for private institutions.” It also said that 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 the Manipal Centre for Virus Research (MCVR), ordering them to halt 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 unauthorized funding.
A memorandum sent out said that the CDC was advised “to stop funding research without approval and working with the 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 NipahVirus Disease (NIV) in spite of the known fact that NIV is a BSL 4 level pathogen whereas MCVR is a level BSL2+lab. Prior to this training to MCVR, CDC had 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.”
But 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 added.
According to the CDC, after “realizing” the need for further permissions, it had 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 Indian and U.S. government policy,” the CDC spokesperson added, but without explaining 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 the 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.
The U.S. Centers for Disease Control and Prevention (CDC) announced in June 2015the award of more than US$15 million dollars to twelve different Indian organizations to help implement Global Health Security Agenda (GHSA) projects across the country. The cooperative agreements will allow for the expansion of various disease detection networks, as well as provide resources needed to help strengthen India’s overall preparedness for potential global disease threats.
Funding recipients include:
- All India Institute of Medical Sciences
- Christian Medical Association of India (CMAI)
- Manipal University
- Ministry of Health and Family Welfare-International Health Division
- National Centre for Disease Control
- National Institute of Epidemiology
- National Institute of Health and Family Welfare
- National Institute of Mental Health and Neurosciences
- National Institute for Research in Tuberculosis
- National Institute of Veterinary Epidemiology and Disease Informatics
- National Institute of Virology, Pune
- Public Health Institute
CDC India will provide technical assistance and project support to each of the funding recipients. These partnerships provide important opportunities for CDC and India to collaborate on many fundamental GHSA activities, which include increasing the capacity to detect and respond to emerging infectious diseases; strengthening infrastructure for outbreak and emergency response; enhancing the public health workforce; linking surveillance and lab networks; and working to better understand and prevent antimicrobial resistance.
CDC maintains offices in New Delhi and Hyderabad that support the initiatives of the Global Disease Detection Regional Center (GDD), the Global Immunization Division, the Division of Global HIV and Tuberculosis, and the Influenza Program. CDC India has collaborated with the Government of India, Indian institutions, and international organizations to address a wide range of infectious and non-communicable diseases since 2001.
The GHSA aims to bring multiple countries and multiple sectors together, including health, agriculture, and science to strengthen worldwide capacity to detect, prevent and respond to public health threats of all kinds. More than US$50 million in CDC funding over the next year will go to 49 organizations working in 24 countries to help support implementation of the GHSA and Ebola preparedness.