Indian and Israeli governments are collaborating on a COVID-19 clinical trial, leveraging patients in India and technology in Israel. The Israelis and Indians are working on this joint venture to produce what purportedly is a superior COVID-19 test that can identify SARS-CoV-2 presence in under 30 seconds. If successful, the two countries would produce the product in India and co-market to the rest of the world to monetize the effort. Although Dr. Balram Bhargava with the Indian Council on Medical Research (ICMR) provided an expedited approval on July 28, some Indian politics has surfaced around rules involving foreign collection of patient samples. Regardless, the Indian Defense Research and Development Organization (DRDO) now collaborates with Israel’s Directorate of Defense Research and Development (DRDD) on this study involving Indian subjects. The studies include a number of tests such as audio, breath, thermal and polyomino to isolate proteins associated with SARS-CoV-2, the virus behind COVID-19. Apparently the expedited approval by Mr. Bhargava occurred a day after an Israeli team arrived in India to commence this effort. The 35-member Israeli team was afforded the luxury of importance and urgency: the Delhi Government waived a mandatory seven-day quarantine period for the group. However, the study still requires the endorsement of a full committee and this is expected in August, reports The Hindu.
The TrialSite offers a breakdown of this interesting unfolding research-related activity in India. The clinical trial involves four different Israeli-based technologies that have the potential to detect SARS-CoV-2 in less than 30 seconds. The studies have started but the samples cannot be taken back to Israel till full approvals in place.
What is the ICMR?
The Indian Council for Medical Research (ICMR) is the “apex body for biomedical research” as well as “foreign-aided research” in India.
What will DRDO’s role be in the joint India and Israel research?
The Indian Defense Research and Development Organization (DRDO) will oversee and control this research in India.
Has the study been fully approved?
No. The DRDO was forced to seek the approval of the HSMC (Indian Health Ministry Screening Committee) because the process involves “foreign collaboration.” This occurred after the ethics committees (ECs) from the two participating hospitals suggested this level of approval.
Is there a conflict of approval authority here?
It would appear that way. Although the Israeli team is awaiting HSMC according to Principal Scientific Advisor K. Vijay Raghavan these conditions are waived as he communicated to DRDO Chairman Dr. Satheesh Reddy on July 27 that government-based research departments such as the DRDO do not require HSMC approval.
Mr. Raghavan conveyed that under the rules of India now during COVID-19 the research can occur based on accord with “guidelines issued by a vaccine task force constituted by the Prime Minister’s Office (PMO),” reports The Hindu. This empowers DRDO to determine its research imperative.
What Hospitals (e.g. study sites) are participating?
The study, according to reports from The Hindu, are being conducted at two hospitals including Lady Hardinge Medical College and Ram Manohar Lohia Hospital. The patient samples are currently getting collected and stored at these providers.
Apparently the Israeli defense-based scientific team will also conduct the research at Sir Gangaram Hospital and Lok Nayak Jairakash Hospital (LNJP).
What does the study entail?
The DRDO is proposing that the saliva samples from 5,000 Indian subjects be transferred to the Israeli defense team (DRDD).
Raghavan reports that this effort represents a “research validation” study involving RT-PCR tests that may have to be undertaken on study subjects. The positive results could be communicated to the ICMR in such a way as to not impede the accelerated nature of the research program.
Complications involved with the study.
Yes. As the ICMR chief approved the trial on the 28th but expressed a need for caution as the subjects saliva could include COVID-19—a live virus. This triggers 1997 guidelines for exchange of samples for biomedical research purposes and hence the importance of ICMR central control of study information.
What is the Israeli point of view?
The Israel Embassy issued a statement for the Indian press announcing that these clinical trials are underway to collect a large number of patient samples from India and if the results back in Israel go well they would mass produce in India and co-market to the world as a joint Indian and Israeli venture.