COVID-19: 3 indigenously developed products get manufacturing license providing cutting edge to corona management

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Published: July 16, 2020 7:09 PM

RGCB is also collaborating with an Australian company having a fixed dose combination (FDC) to treat COVID. Unlike conventional methods, this FDC is considered as a new drug and RGCB has initiated a few bridging bioequivalence and bioavailability studies of this formulation.

The Rapid Antibody Card will help study the presence of anti-SARS-CoV-2 IgG antibodies, with 100 per cent sensitivity and 98 per cent specificity.

A cost-effective Rapid Antibody Card, developed indigenously by the city-based Rajiv Gandhi Centre for Biotechnology, is among the three key products that have obtained manufacturing license, lending a cutting edge to COVID-19 management efforts in the country. The two other products of RGCB, under the central government, which have been granted license by the Central Drugs Standard Control Organization (CDSO), are Viral Transport Media (VTM) kit and a viral RNA extraction kit.

These products have been developed by RGCB in partnership with Sperogenx Biosciences Pvt Ltd, Bengaluru, and
POCT Services, New Delhi, under SARS-CoV-2 diagnostic umbrella. Of these, VTM and RNA kits have already been
test-marketed. Sperogenx is the development partner and POCT the commercial partner, a press release said.

The other products of RGCB Antigen detection system, ELISA and PCR kitsare under various stages of approval from the regulatory authorities in India. RGCB Director Professor M.Radhakrishna Pillai said that these products were a testimony of the commitment made by RGCB to the Central government in its battle against the pandemic.

The Rapid Antibody Card will help study the presence of anti-SARS-CoV-2 IgG antibodies, with 100 per cent sensitivity and 98 per cent specificity. It has the advantages of being cost-effective, sensitive and rapid. It also facilitates testing of a large number of samples at any level of clinical setting, public health centres and hospitals.

The VTM kit, formulated using raw material from Indian sources as per United States Centre for Disease Control (CDC) guidelines, is suitable for collection, transportation, maintenance and long-term storage of viral specimens.

It helps preserve the viability of viruses for up to 72 hours at refrigerated temperatures. The swabs have been
designed ergonomically with a pre-moulded breakpoint on their shaft. Though there are similar products available, this kit can be marketed at a price that is 30 to 35 per cent less.

The RNA kit facilitates fast manual isolation of viral RNA from the swab.It also has the price advantage as it is
manufactured using raw material available in India. The RGCB, in collaboration with POCT, is developing the ELISA kit that can be produced at lower cost.

This is affordable and easy-to-use, and can be done in a resource-limited setting for a serological assay in
multiple analyses at a time. It is also collaborating with Sperogenx to develop a COVID-19 Real Time Multiplex RT-PCR Kit for qualitative detection of the novel coronavirus.

This is a three-gene system that detects N gene, E gene and RdRP gene of 2019-nCoV and is a fully indigenous
product. It has been submitted for final validation to the International Centre for Medical Research and Training
(ICMRT).

The other initiatives of RGCB include developing/modifying some existing treatment options for the COVID patients in India. The products under development in this category include intravenous IgG, isolation and purification of IgG
from serum samples of COVID patients and use it intravenously as neutralization antibodies.

RGCB is also collaborating with an Australian company having a fixed dose combination (FDC) to treat COVID.
Unlike conventional methods, this FDC is considered as a new drug and RGCB has initiated a few bridging bioequivalence and bioavailability studies of this formulation. This will be tested on patients when the regulatory
approval is obtained.

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