CDC, America’s front line public health agency, has partnered with Manipal Centre for Virus Research (MCVR) to carry out illness surveillance across India.Hindustan Times, New Delhi

India has asked the United States Centre for Disease Control and Prevention (CDC) to stop funding research in India without government approval after the agency appeared to have helped an under-qualified Indian laboratory to work on the Nipah virus, a pathogen that is considered a potential bio-weapon, according to officials and government documents accessed by HT.

CDC, America’s front line public health agency, has partnered with Manipal Centre for Virus Research (MCVR) to carry out illness surveillance across India, and government officials who asked not to be named said the agency seems to have helped MCVR study the Nipah virus, a pathogen that belongs to Risk Group 4 (RG4) classification.

RG4 viruses are considered lethal and their handling is heavily controlled since they can be turned into biological weapons, requiring labs that have biological safety level 4 (BSL4) certification to study it. MCVR does not meet the criteria.

MCVR carried out tests on the Nipah virus of which there was an outbreak in Kerala in 2018 and 2019, said one of the government officials cited above, asking not to be named.

Our apprehension is that the lab was being used to map the Nipah virus, which can be used to develop a vaccine, the intellectual property right of which will not be with India. Importantly, understanding how the human body reacted to the virus will also produce a more virulent form of virus for biological warfare,” said a second government official who did not want to be named.

To be sure, MCVR was designated by the government of Kerala as one of the testing agencies for the Nipah virus during the outbreak.

The concern at present, the two officials cited above said, were related to more detailed studies of the virus and of funding that was not approved by the government.

The government has now asked both agencies to stop the disease surveillance project – technically called AFI surveillance that tracks mystery diseases in key government hospitals – and for MCVR to store only BSL-2 grade pathogen. It has also asked CDC to comply with Indian rules and ensure all funding has been approved by the government.

The ministry has taken serious view of in the entire matter, MCVR (Manipal Centre for Virus Research) directed [to store] samples of pathogens specific to BSL-2 facilities only and should immediately stop AFI surveillance undertaken by it in other states also,” said an internal government memo titled Unapproved, US-funded Indian Laboratory stored samples of Nipah Virus – a bioterrorism agent”. The memo was reviewed by Hindustan Times.

According to the first official, the action came after the coronavirus outbreak triggered a review of all research into biological weapons grade pathogens in India. Researches without prior approval have sent alarm bells across the government, the first official added.

The memo quoted above also adds that the foreigners division of the home ministry is inquiring into how CDC and MCVR were working on the virus. All foreign funding needs to be cleared by MHA. The memo adds that while the health ministry has no specific comments” on the nature of action that MHA should take under the Foreign Contribution Regulation Act

2010, but — considering the seriousness of the matter” – it said MHA may take action as seen appropriate”.

Home ministry officials did not respond to queries on what action was being contemplated.

In a separate communication to CDC, also accessed by HT, the health ministry said: It has been brought to this ministry’s notice that CDC has trained MCVR for diagnosis of Nipah virus disease in spite of the known fact that Nipah virus is BSL-4 level pathogen whereas MCVR is a BSL 2+ laboratory. Prior to this training to MCVR, CDC had not consulted any government agency as per norm.”

The note added: Since Nipah is a high-risk pathogen with a potential of being used as Agent of bio-terrorism the samples were to be handled more carefully and tested in a BSL-IV laboratory and not in MCVR… The lapse on part of MCVR in handling Nipah virus samples with active support from CDC has been viewed separately by the ministry of health and family welfare … Therefore, CDC is advised to stop all funding of MCVR/Manipal University …Similarly, funding for any other research activity in the country that is not approved by the ICMR should be stopped immediately.”

CDC country director, Dr Meghna Desai, said that the agency did not commission research on Nipah in India, and that the project was part of a multi-nation partnership. Through the Global Health Security Agenda, we provided training to strengthen laboratory systems in India which allowed for detection of Nipah virus,” she said.

Replying to whether CDC has been asked to stop all funding of ongoing research not been cleared by ICMR, Dr Desai said: CDC works closely with the ministry of health and family welfare and the Indian Council of Medical Research on projects that help address Government of India priorities in public health. CDC will continue to work with the Indian Council of Medical Research and the Ministry of Health and Family Welfare.”

MCVR denied that it had carried out research into the virus, saying it had carried out detection tests when the outbreak took place and had been asked by the health ministry to stop doing so when the outbreak was deemed over in 2018.

No virus isolation was done at MIV (Manipal Institute of Virology). Samples were sent to ICMR-NIV Pune for virus isolation work at their BSL-4 laboratory. We have observed/implemented all safety precautions while processing the samples,” said a statement from the office of the Vice Chancellor of Manipal University.

The university said that its work related to risky viruses conform to World Health Organization diagnostic protocols, which includes the pathogens being inactivated by lysis buffer” before being processed.

Experts said that labs with BSL-3 rating can carry out some tests but not advanced studies. A biosafety level-3 (BSL 3) lab is good enough for conducting polymerase chain reaction (PCR) test that is used to know the genetic material of a microorganism. Advance research such as virus isolation from living cells needs more advanced BSL-4 laboratory,” said Dr Shobha Broor, professor, department of microbiology at All India Institute of Medical Sciences, Delhi.

(With inputs from Rhythma Kaul)