NEW DELHI: Ivermectin, an antiparasitic drug, being touted as a possible treatment for the coronavirus infection will not be included in the Health Ministry's Clinical Management Protocol for COVID-19, sources said on Thursday.
Some states including Uttar Pradesh are already using the drug-off label not only as a treatment option but also as a prophylaxis against COVID-19, a source said.
Already widely used against intestinational parasites and scabies, it is relatively a safe and cheap drug.
The experts of the ICMR's National Task Force for COVID-19 and the Joint Monitoring Group held its meeting on Thursday to deliberate on whether the drug should be included in the national treatment guidelines.
"Following deliberations, experts decided not to include Ivermectin in the national clinical management protocol for COVID-19 because of lack of sufficient evidence on its efficacy based on randomised trials held in India and abroad," a source said.
The Health Ministry has allowed the use of remdesivir for restricted emergency use purposes in moderate cases under "investigational therapies" in the Clinical Management Protocol for COVID-19.
The ministry has also okayed off-label application of tocilizumab, a drug that modifies the immune system or its functioning, and convalescent plasma for treating COVID-19 patients in moderate stage of the illness as "investigational therapies".
It also recommended hydroxychloroquine in patients during the early course of the disease and not on critically ill patients.
The centre has also included an inexpensive, widely used steroid dexamethasone in treatment protocols for COVID-19 patients in the moderate to severe stages of their illness among other therapeutic measures.
The ministry advised use of dexamethasone, which is already used in a wide range of conditions for its anti-inflammatory and immunosuppressant effects, as an alternative choice to methylprednisolone for managing moderate to severe cases of coronavirus infection.
Meanwhile, ICMR also issued an advisory for the use of indigenously developed Feluda paper strip test, which is based on CRISPR-Cas9 technology for diagnosis of SARS-CoV-2, by the laboratories.
The paper-strip uses cutting-edge CRISPR gene-editing technology to identify and target the genetic material of SARS-CoV-2, the virus that causes COVID-19 in less than an hour.
As claimed by the manufacturer, no further RT-PCR based confirmation is required for samples that are confirmed as positive or negative by the CRISPR SARS-CoV-2 test, the advisory stated.
The test has been developed by Council of Scientific and Industrial Research's (CSIRs) Institute of Genomics and Integrative Biology (IGIB), Delhi and has been validated by the National Centre for Biological Sciences and Tata Institute of Fundamental Research.
The test has been approved by the Drugs Controller General of India (DCGI) for use in the country.
"The test works by identifying SARS-CoV-2 virus strain and uses a Thermal Cycler instead of a qPCR machine for conducting the test. As claimed by the manufacturer, no further RT-PCR based confirmation is required for samples that are confirmed as positives or negatives by the CRISPR SARS-CoV-2 test, " the ICMR said in its advisory.
Existing government or private laboratories already approved by the ICMR for SARS-CoV-2 RT-PCR based testing may use this new CRISPR test if the laboratory desires to do so.
No further approval is required from ICMR for existing laboratories.
New laboratories intending to initiate molecular testing of SARS-CoV-2 testing by any method will be required to seek approval as per the standard process laid down by the ICMR and NABL before initiating any kind of molecular testing, the advisory said.
Any prescription for RT-PCR, CRISPR, TRUENAT, CBNAAT may be considered equivalent.
All testing data should be essentially entered into the ICMR COVID-19 web portal on a real time basis.
Union Health Minister Harsh Vardhan had recently said that based on tests in over 2,000 patients during the trials at the Institute of Genomics and Integrative Biology (IGIB) and testing in private labs, the tests showed 96 per cent sensitivity and 98 per cent specificity.
This compares favourably to ICMR's current acceptation criteria of RT-PCR kit of at least 95 per cent sensitivity and at least 99 per cent specificity, he had stated.