With COVID-19, ICMR has bitten more than it can chew
By its own admission, ICMR is the apex body for formulation, coordination and promotion of biomedical research in the country. Established in British era as Indian Fund Research Association (IFRA), the organisation got its current name in 1949 and was later included into the Ministry of Health and Family Welfare in 1976. The primary aim of the institute is to promote biomedical research to reduce the burden of disease in the country by researching methods and strategies for management of non-communicable diseases, mental health, drug research, look into environmental and occupational health issues, fertility control, maternal and child health with the added responsibility of control and management of communicable diseases. This is when the Ministry of Health and Family Welfare has a separate body for management of AIDS and National Level Programmes for Management of Leprosy, Tuberculosis, Filariasis, Vector Borne diseases and an entire National Centre for Disease Control under its command.
In recent past, NCDC has put our comprehensive information for Seasonal Flu (H1N1) including technical guidelines for testing, epidemiology, laboratory procedures for detection, guidelines for patient care, publishing communication on number of cases detected, tested, deaths and publishing communication for prevention of spread of the disease. Data for this outbreak goes back all the way to 2010. Similar data and communication exists for the local outbreak of Nipah virus in Kerala, Ebola virus as well as Zika Virus. Even for COVID-19, the NCDC’s published list of documents and advisories far supercede what the ICMR has given us so far. In fact, the central helpline number 1075 being used during this crisis has been active since 2008 and NCDC has been publishing districtwise weekly outbreak reports for all communicable diseases since mid 2009. Why is it that ICMR started giving us these numbers at the beginning of the outbreak is not clearly known.
Even before giving out numbers, ICMR has been publishing information on COVID-19 for a while now. Whether it is the testing algorithm being applied in the country, published on March 9th or discussing the country's preparedness for COVID-19 on Feb 11 or activating the Viral Research and Diagnostics Laboratory (VRDL) network for detecting nCoV on January 28th.
A high level technical committee was formed on the 18th of March under the Chairmanship of a member from NITI Aayog, Government of India’s ‘think tank’ on policy, four members from AIIMS, New Delhi, two members from Public Health Foundation of India, a public private institute working on health policy, seven members from ICMR or its allied institutes, and two members from the social sector having extensive experience working with HIV-AIDS. Director of NCDC, which is a separate department on its own was also made part of this committee, clearly being marshalled by ICMR and its Director General, Prof. Dr. Balram Bhargava, a commonly known name in the wake of COVID-19 in India and who also happens to be the Secretary to the Government of India, Department of Health Research, under which the ICMR operates.
In the wake of reports of the novel Coronavirus, the National Institute of Virology had to be the go-to- Institution for anybody in the country. As the testing requirement needed to be ramped up and be made available across the country, ICMR roped in VRDL network, which was established for precisely this reason. ICMR is quite right when it came to utilising the labs under its purview, such as the National Institute of Virology or the VRDL network. But after that, ICMR seems to have gone on an overdrive and taking on tasks that it has neither the authority nor the experience in handling.
Approving Testing Labs
Since testing capacities of state run-laboratories are quite limited, there was a call for engaging testing capacities available in the private sector. Instead of encouraging private labs to engage in the testing, ICMR asked private labs to seek their approval before they could begin testing. It is understandable that ICMR did not want any random lab to claim that it could carry out COVID tests and fleece people. But by putting in place an approval process, it simply delayed labs from engaging actively in testing themselves. Private labs that are often admired for their ingenuity in doing business and ability to cut costs and improve efficiencies, now spent their time and energy in seeking approvals from ICMR.
Not that ICMR was quite sure what it wanted private labs to do. It first sent out this “Performa” (sic) asking private testing labs questions such as whether they carried out influenza testing by RT-PCR or not, if they had biosafety cabinets, if they had reagents to perform COVID-19 testing, if they had accreditations from NABL, CAP or ILAC and what tests were included as part of the accreditation, whether they were willing to do this testing for free? Instead of defining criteria that would be necessary to perform the testing, ICMR was basically collecting information on lab capabilities in the private sector.
After spending a few days on this needless exercise, the Ministry of Health and Family Welfare notified on 21st March, what private labs needed to do, to be “approved” by ICMR. However, this notification did not come without its own problems.
ICMR clarified that labs that had prior experience in handling RNA virus testing and which were currently holding NABL accreditation for such testing would be approved by it. But instead of relying on the expertise of the lab to carry out the test, it prohibited labs from carrying out “in-house” developed tests and rely on CE-IVD or US FDA approved kits for testing.
Additionally, it decreed a price-cap of Rs. 4500/- for the test without giving any basis for arriving at this figure. At a time, when testing kits were globally in demand and testing needed to be scaled up significantly, ICMR was allowing private players to engage in testing only after it had ensured that their hands were tied behind their backs securely.
Approving RT-PCR Testing Kits
Once private testing laboratories were roped in, private diagnostic kit manufacturers too offered their services. Since, ICMR had pre-ordained that only CE-IVD or US-FDA approved kits would be acceptable for testing and none of the kits manufactured in India had these approvals, ICMR now got into the action itself, now to determine, if kits manufactured by private local manufacturers were good enough to be used by labs.
Usually, the Medical Devices and Diagnostic Division of the Central Drugs Standard Control Organisation (CDSCO) is responsible for granting In-vitro Diagnostics (IVD) use approvals in India. To do so, it needs a performance evaluation for three batches of kits made by the manufacturer. Since, CDSCO, itself does not have any testing facilities, it relies on various government laboratories or NABL accredited laboratories to carry out the performance evaluation. Since NIV is the premier institute for virology testing in the country, the burden of evaluating the kits fell on NIV, once again, forcing the organization to carry out kit evaluation alongside the bulk of the testing that it was already doing.
Over the next few days,ICMR then started publishing performance evaluation reports for kits submitted to them by various manufacturers. Approvals were given on the basis of concordance with positive and negative samples available with NIV and not on the basis of sensitivity and specificity of these kits. Multiple publications regarding performances of various kits released consistently by ICMR are now missing from its website while the latest one clearly mentions the batch numbers that NIV and other ICMR authorised centres evaluated and found “satisfactory” while passing on the onus of batch to batch consistency of these kits onto the manufacturer.
Whether these approved kits will function consistently on the field during a pandemic is not something that can be taken lightly. Test results are the sole basis to determine if a person needs to be quarantined or not. If the ICMR and its subsidiary labs had no interest in determining if testing protocols across the country are uniform and can be consistently reliable, then it should simply not have indulged in the practice of approving kits in the first place. But even the experiences with approving RT-PCR kits did not not stop ICMR from approving rapid antibody kits, which ICMR itself does not recommend for COVID-19 diagnosis.
To cite an example of how things should have been done, the US-FDA provided Emergency Use Authorizations (EUA) to kits from multiple manufacturers in the wake of COVID-19 but has also authorized multiple laboratories that have developed their own tests, thereby reducing demand for “approved kits” and increasing immediate test availability. EUA are not FDA approvals, unlike the ICMR approvals, Indian manufacturers are claiming.
Purchasing and Distributing Kits
Approving kits is not where ICMR stopped. Rather, it went onto create a new setup for storage and distribution of kits, notifying 16 depots in the country and even displaying its micro- management tendencies by suggesting creation of WhatsApp groups for each region in its formal notification itself. This is when the NCDC already has a mechanism in place for nationwide inventory and supply of kits and reagents.
Bouyed by the importance it had gained in recent times, ICMR then placed orders for Rapid Antibody kits that it had already approved. After significant delays, the kits were received and distributed to the states, when Bengal complained of their non-performance along with Rajasthan, prompting ICMR to suspend Rapid Antibody based testing using the very kits that it had approved and procured.
The whole exercise blew up in its face, when the Delhi High Court gave its judgement to settle dispute over distributorship rights between some firms, which had supplied the same rapid antibody kits to ICMR. To save face, ICMR released a statement citing scale and “first effort by an agency” to procure such kits and credit terms agreed during procurement to ensure that there was no monetary loss during this entire exercise. Precious time lost in this exercise and its impact on the testing strategy for COVID-19 in India, find no mention in this statement, as if they are not priorities at all. What can only be seen as in effort to save face, ICMR has now forced NIV to develop an antibody based test kit, which it has self approved and is now looking for manufacturing partners, since it has no manufacturing capacities of it own.
Instead of sharing information and decentralizing processes, ICMR seems to be keen on instructing and managing day to day affairs. Advisory like this, seems to add more confusion, than clear existing ones. Here, ICMR states that it will “provide reagents, probes and master-mix to selected labs (list of Govt Labs (123) as well as separate list of Govt labs(6), which will not receive reagents from ICMR”.
What ICMR Should have done
Instead of trying to reinvent the wheel and put new systems in place, ICMR should have simply asked all labs, capable of testing (say NABL labs approved for viral testing) to simply adopt the protocols that the World Health Organization has already published. Ordering primers and probes, would hardly take a week and labs would have been able to initiate testing immediately.
In case, ICMR really thought that WHO protocols were not adequate, it could have established a testing protocol for the country and made it public for labs to follow. By providing a standardized testing protocol that was based on locally available reagents than an assembled kit, ICMR would have substantially reduced the cost of testing in the country from the word go.
If ICMR was really concerned regarding the quality of testing in the country, it could have quickly set up an External Quality Assurance Program with all the positive and negative samples at its disposal at NIV. This way, we would also have data if labs engaged in testing are performing consistently or not, giving a better picture of the testing scenario. Currently, all samples deemed positive in private labs or VDRLs are sent to NIV for a secondary test, before being declared positive. However, all samples that test negative are deemed negative, without even a random check, to determine if they are true negatives.
Before the country went into a lockdown, ICMR has suggested that community transmission of COVID-19 was inevitable. To determine this, ICMR initiated a sentinel surveillance programme to determine the spread of the virus and gave its first report on 19th March that consisted of over 800 randomly selected samples. India had reported less than 200 positive cases at that point in time. With over 35,000 cases reported so far, it is high time that follow up reports be published by ICMR.
Apart from providing testing services, ICMR- NIV also gathered media attention after they managed to sequence the Coronavirus strain, making India the fifth country in the world to do so. The sequence was generated after the first case emerged in Kerala in January and reported in March first week. Knowing whether other strains of nCoV-2 have been found in India such as those from Italy or Spain or if there is an altogether new variant in the country, would help scientists understand the disease better in the country and also work towards remedial measures.
As a premier medical research institute, ICMR is focusing on potential treatments for COVID-19 and regularly updates on steps it is taking in this regard. Expediting this research and fast-tracking trials of a vaccine, if available in the near future, is something that ICMR needs to concentrate its efforts on. Collating data on the number of samples tested and providing regular updates on the number of samples tested positive so far, is something that the Ministry of Health and Family Welfare can do.
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