It has been a month since Kerala’s Rajiv Gandhi Centre for Biotechnology (RGCB) sought the approval of the Indian Council of Medical Research (ICMR) for a rapid test kit (antibody test) developed by it, but the nodal agency is yet to grant its final approval.
The kit, which was sent to the ICMR for approval on April 22, 2020, is a simple device which can be used as a pregnancy test kit to detect the presence of COVID-19-specific IgG and IgM antibodies in an individual, within no time.
Antibody test which has a different objective from that of an RT-PCR test is primarily used to detect the past exposure of a person to the virus. This becomes pivotal in analysing the prevalence of the virus in a particular category of people (health professionals, migrants and high-risk groups among others) and also in particular geographical locations like red zones. Such examinations would help governments formulate policies and ease lockdown relaxations accordingly, instead of imposing a complete shutdown.
Despite the promising nature of the kit, the ICMR’s delay in validating it has been questioned by many.
The delay is being ascribed to bureaucracy, centralization of power with the ICMR, the apex body of biomedical research in the country, and the absence of a comprehensive approach in addressing a pandemic situation.
“ICMR has been given excess powers and the system has been highly centralised. It is not a desirable practice that all competent research institutions have to seek its approval for all their innovations. We have virology institutes to validate a researched product. I don’t understand why the states shouldn’t go to virology institutes directly for validations. What is the role of ICMR in between?” asks Dr B Ekbal, a public health expert and a member of the State Planning Board.
Rigmarole of red tapism
Dr Ekbal’s argument clearly substantiates the story of RGCB’s rapid test kit. The antibody test kit which was first sent to ICMR was sent back to the National Institute of Virology in Alappuzha, Kerala for validation. No one has a clear answer to why a research product of a competent institution like RGCB requires the nod of ICMR, which again sends it to a virology institute in the same state for validation.
“This is the practice and convention we have been following. We sent our product to ICMR which was then redirected to National Institute of Virology’s centre in Alappuzha for validation. We were told that further enhancement of sensitivity was required and we are working on it,” says Dr M Radhakrishna Pillai, the Director of RGCB, who did not elaborate more on the role of ICMR.
ICMR took 16 days to get back to Rajiv Gandhi Centre, only to direct them to go for validation with the National Institute of Virology in Kerala. The institute took only four days to validate and gave the feedback to ICMR. The intermediary role of ICMR in the entire affair has been questioned, especially when the test kit had to come back to a state-based institute for validation.
Is ICMR as powerful as it’s being touted?
Besides, ICMR is neither a statutory body nor a regulatory one. According to the Supreme Court Judgment in Prof N K Ganguli vs. CBI, The Indian Council of Medical Research (ICMR), a registered society under the Societies Registration Act of 1860, “is a premier research institute dealing with the formulation, coordination and promotion of biomedical research. Its functional object is to initiate, aid develop and coordinate medical and scientific research in India and to promote and assist institutions for the study of diseases, their prevention, causation and remedy”. There is no reference to regulatory powers.
When asked why the ICMR plays an authoritative mediator between research institutions and validating centres, ICMR authorities said that there is no need of the research institutions to seek approval from ICMR. “They may send the products directly to competent virology institutes under ICMR for validation,” says Dr Rajni Kant Srivastava, the head of Research Management, Policy, Planning and Biomedical Communication at ICMR.
“ICMR is not a regulatory body, so they don’t give approval for any innovation. However any new kit, diagnostics or therapy can be tested and validated by ICMR,” Dr Srivastava told The Federal over the phone.
Not power, but mere tradition
If this is the case, the question is where ICMR derives this power from. How is it possible to micromanage all other competent research institutions if it does not have regulatory powers?
This looks bizarre. In the times of a pandemic that requires rapid responses from the side of authorities, the research institutions and various state governments are wasting time by adhering to the conventional bureaucratic practices which are not even endorsed by a statute.
“In my understanding, this is only a matter of practice and convention evolved over years”, says Hari Govind, a scholar of medical law who is an assistant professor at Cochin University of Science and Technology.
“In pandemic situations, a delay of one month is pathetic. A validation test does not require weeks and months,” says Dr KP Aravindan, a former faculty of Medical College Calicut and a public health expert.
The ICMR website provides the list of a few private players who have given the approval to commercially produce rapid antibody test kits. However, these private players have not yet started the production of rapid test kits.
When contacted, it was understood that ICMR has no follow up about this. “We don’t know whether they produce the kits or not. That is the call of the Drug Controller of India,” Dr Srivastava told The Federal.
Coordination, communication gaps
It is apparently clear that the absence of a comprehensive rapid response system in which all the decision-making authorities are kept on the same page in a pandemic situation is the root of the problem.
“The ICMR has approved over 40 antibody-based rapid test kits till now, including 10 manufactured in India. These rapid test kits were initially purported to be used in large clusters like among migrant labourers. Unfortunately, very few are available for use, and the migrants were not administered these tests before travelling. It would be nice for the ICMR to give daily data of rapid kits as well; similar to the one it gives for RT-PCR tests to give the country a clear picture of their actual availability and use. It would also be useful to clarify why the country did not get more kits procured from the ones approved, as well as the status of production of Indian companies,” Dr Akshay Baheti, assistant professor, department of radiodiagnosis, Tata Memorial Centre, Mumbai told The Federal.
Not a lone case
RGCB’s story is not a one-off case. Sree Chithira Thirunal Institute for Medical Science and Technology (SCTIMST), another prestigious institution in Kerala, had to wait for one month in order to get the approval from ICMR for the RNA extraction kit which they developed. This was said to be a milestone in the country’s battle against the novel coronavirus as this is far cheaper and ten times faster a technology for testing COVID-19, than that of RT-PCR.
SCT finally got the approval of ICMR after so much of public cry and lobbying. Thiruvananthapuram MP Shashi Tharoor, who is the governing body member of both SCT and RGCB, openly expressed his displeasure through the media for the inordinate delay on part of ICMR.
Only half of the problem is resolved. The RNA thus extracted has to be tested in an RT-LAMP testing kit which has been developed by SCTIMST and is awaiting ICMR’s approval.
“Approval for RNA Extraction alone is not enough,” Tharoor told The Federal. He said the SCTIMST had to submit this to any of the five centres approved by ICMR for validation. “They have been given a slot by one centre for June 5. They have been using the interim time to run validation tests and train hospital technicians.
“After speaking to Dr Balram Barghava, head of ICMR, I no longer have any complaint about delays because I do respect the thoroughness of their validation procedures when life and death are involved,” Dr Tharoor said.
The RNA kit developed by SCT can be used in both RT-PCR and RT-LAMP tests. “RT-PCR has to be purchased from abroad or from Mylabs, Pune, the only Indian manufacturer. RT-LAMP is an innovative technology that does not exist in India. SCT has invented it, once validated it will be a major breakthrough,” he said.
Unusual times demand unusual practices and action, not the age old practices of bureaucracy that slow pedal actions.