U.S. Food and Drug Administration is providing an update on the agency’s efforts to combat the extremely concerning actions by companies and individuals that are exploiting or taking advantage of widespread fear among consumers during the COVID-19 pandemic. In response to scammers on the internet selling unproven medical products, the FDA has taken – and continues to take – a number of steps to find and stop those selling unapproved products that fraudulently claim to mitigate, prevent, treat, diagnose or cure COVID-19.
To date, the FDA has issued 42 warning letters to companies making bogus COVID-19 claims, including one to a seller of fraudulent chlorine dioxide products, equivalent to industrial bleach, frequently referred to as “Miracle Mineral Solution” or “MMS”, as a treatment for COVID-19. After the seller refused to take corrective action, a federal court issued a preliminary injunction requiring the seller to immediately stop distributing its unproven and potentially dangerous product.
Additionally, as part of the FDA’s Operation Quack Hack, in just a few short weeks, the agency has discovered hundreds of such products including fraudulent drugs, testing kits and personal protective equipment (PPE) sold online with unproven claims. We continue to work with online marketplaces, domain name registrars, payment processors and social media websites to remove from their platforms products that fraudulently claim to mitigate, prevent, treat, diagnose or cure COVID-19 and to keep those products from reappearing under different names. At this time, the FDA has sent hundreds of abuse complaints to domain name registrars and internet marketplaces, who in most instances, have voluntarily removed the identified postings. We will continue to monitor the online ecosystem for fraudulent products peddled by bad actors seeking to profit from this global pandemic.
There are a number of examples of unproven products that the FDA is keeping out of the country. Recently, the agency intercepted and investigated a case of mislabeled COVID-19 “treatment kits” offered for import. As a result, Special Agents with the FDA’s Office of Criminal Investigations, with the help of domestic and international law enforcement counterparts in the United Kingdom, led the Department of Justice to bring a criminal complaint against a British man who sought to profit from this pandemic and jeopardize public health.
Until the curve is flattened, and even after, the FDA will continue to carry out the agency’s mission of protecting the health and safety of American consumers and strive to prevent unlawful FDA-regulated products from entering, or being distributed in, domestic commerce.
Glenmark Pharmaceuticals, a research-led, integrated global pharmaceutical company has initiated Phase 3 clinical trials in India on Antiviral tablet Favipiravir, for which it received approval from India’s drug regulator DCGI in late April. Glenmark is the first company in India to initiate Phase 3 clinical trials on Favipiravir for COVID-19 patients in India. Favipiravir is a generic version of Avigan® of Fujifilm Toyama Chemical Co. Ltd., Japan, a subsidiary of Fujifilm Corporation. Clinical trials have commenced and over 10 leading government & private hospitals in India are being enrolled for the study. Glenmark estimates study completion by July/August 2020.
Glenmark has successfully developed the API and the formulations for the product through its in-house R&D team. Favipiravir has demonstrated activity against influenza viruses and has been approved in Japan for the treatment of novel influenza virus infections. The molecule if commercialized, will be marketed under the brand name ‘FabiFlu®’ in India.
Commenting on this development, Dr. Monika Tandon, Vice President & Head, Clinical Development, Global Specialty/Branded Portfolio, Glenmark Pharmaceuticals Ltd., said, “Several health and medical experts, both in and outside of Glenmark are eager to see the effect that Favipiravir has on COVID-19 cases. We believe the study results will be significant as there is currently no effective treatment for the virus.” She added, “The data we get from these trials will point us in a clearer direction with regard to COVID-19 treatment and management.”
Further, Mr. Sujesh Vasudevan, President, India Formulations, Middle East and Africa, Glenmark Pharmaceuticals Ltd. mentioned “Our effort is to launch a treatment for COVID-19 patients as soon as possible and control the spread of the pandemic. We will do all it takes to ensure accessibility of the product across the country if the clinical trials are successful.”
Glenmark was the first pharmaceutical company in India to be given an approval by the regulator to start the trial on COVID-19 patients in India. As per the approved clinical trial protocol, 150 subjects with mild to moderate COVID-19 will be randomized in the study in a 1:1 ratio to Favipiravir with standard supportive care or standalone standard supportive care. Treatment duration is a maximum of 14 days and the total study duration will be a maximum of 28 days from randomization.
To urgently develop safe and effective Biomedical solutions against SARS CoV-2, Department of Biotechnology and Biotechnology Industry Research Assistance Council (BIRAC) had invited applications for COVID-19 Research Consortium. In addition, BIRAC has also created a provision to fund COVID-19 solutions that are ready for immediate deployment under a ‘Fast Track Review Process’.
Under the research consortium, DBT and BIRAC have continuously been evaluating applications with an intent to support Industry/ Academia and Jointly Academia & Industry for developing Diagnostics, Vaccines, Novel Therapeutics, Repurposing of Drugs or any other intervention for control of COVID-19. Through a rolling multitiered review mechanism, 70 proposals of devices, diagnostics, vaccine candidates, therapeutics and other interventions have been recommended for receiving financial support. The shortlisted proposals includes 10 Vaccines candidates, 34 Diagnostics products or scale-up facilities, 10 Therapeutics options, 02 proposals on Drug Repurposing and 14 projects which are categorised as preventive interventions.
To be able to provide an accelerator approach for vaccine development, DBT has identified institutes which will provide animal models for testing pre-clinical efficacy and also make available neutralization assays. IIT Indore will produce Pseudovirus SARS CoV-2 which can be used for development of in-vitro assays. Enzene biosciences limited will make available Spike protein and Receptor Binding Domain protein in large quantities to vaccine and diagnostic companies as a reagent. The portfolio of vaccine candidates has further been enhanced by providing support for development of Next-generation mRNA vaccine candidate by Gennova and also separately to CMC, Vellore for a lipid encapsulated mRNA based vaccine.
Early development work for developing an Intranasal vaccine candidate for COVID-19 has also been awarded to Indian Institute of Chemical Technology.
University Delhi South Campus has initiated work towards discovering neutralizing antibodies from an existing phage display based library and are being supported under National Biopharma Mission of DBT.
To ensure complete indigenization of COVID diagnostics, support has already been provided to AMTZ and other companies to scale-up production of RT PCR kits. In addition anticipating long term need for diagnostics, DBT/ BIRAC have also committed support for different types of diagnostics platforms like: Fluorescence and Electrochemistry Mediated Rapid Detection of SARS-Cov-2 Nucleic Acid from Bennett University, Greater Noida; portable microfluidics embedded on chip rRT-PCR and microelectrode array coupled point-of care optoelectronic device for large scale screening: JNU, Delhi; Development and evaluation of aptamer based lateral flow assay kit for detection of SARS-CoV2 detection to IIT Delhi and CRISPER based diagnosis of Covid-19 using paper microfluidics form IIT Guwahati. Other companies to get funding support are Denovo, Biolabs, ShineBiotech, Prantae, Proma Therapeutics, Achira. In total, 34 companies and academic institutes will receive financial support for ensuring there is no shortage of indigenous diagnostic kits in the near future.
Department of Biotechnology has also launched a National Biomedical Resource Indigenization Consortium (NBRIC) in a Public Private Partnership model to foster indigenous innovation focused on developing reagents and resources for diagnostics, vaccines and therapeutics for COVID19 which is in partnership with ABLE and CII and is being hosted by C-CAMP.
Under its ‘Fast Track Review Process’ Process BIRAC has created a provision to fund COVID solutions that are ready for immediate deployment. Through this initiative Startups with PPE solutions have been approved for supporting manufacturing of “Full body coverage suits” to Aarna Biomedical Products and for “Face Shields” to Alpha Corpusles Pvt Ltd. Automoted Sanitizer to MicroGO, Remote patient monitoring Stasis Health Pvt Ltd. Turtle Shell for DOZEE a sleep monitoring device, Monitra for remote monitoring of patients, Perisodhana for N-95 Mask’s and Remidio for Ambu bags.
Indian Council of Medical Research (ICMR)-National Institute of Virology (NIV) at Pune has developed and validated the indigenous IgG ELISA test “COVID KAVACH ELISA” for antibody detection for COVID-19.
COVID19 pandemic has spread across 214 countries with a total of 38,55,788 confirmed cases and 2,65,862 deaths. Most countries in the world are struggling to contain the pandemic using possible interventions. There is an augmented demand of various types of diagnostic tests by countries all across the globe. Most of the diagnostic material for COVID19 is imported into India from other countries. Therefore, Indian scientists are tirelessly engaged in developing indigenous diagnostics for SARS-CoV-2, the causative agent of COVID19.
ICMR-National Institute of Virology (NIV), Pune is the apex laboratory of the country with state-of-art infrastructure and expertise for research in virology. NIV’s competent scientific team successfully isolated the SARS-CoV-2 virus from laboratory confirmed patients in India. This in turn has paved the way for development of indigenous diagnostics for SARS-CoV-2.
While real time RT-PCR is the frontline test for clinical diagnosis of SARS-CoV-2, robust antibody tests are critical for surveillance to understand the proportion of population exposed to infection.
The scientists at ICMR-NIV, Pune have enthusiastically worked to develop and validate the completely indigenous IgG ELISA test for antibody detection for SARS-CoV-2. The test was validated at two sites in Mumbai and has been found to have high sensitivity and specificity. In addition, the test will have the advantage of testing 90 samples together in a single run of 2.5 hours. Moreover, ELISA based testing is easily possible even at district level as the ELISA kit has inactivated virus. There are also minimal bio-safety and bio-security requirements as compared to the real-time RT-PCR test. The test has an advantage of having much higher sensitivity and specificity as compared to the several rapid test kits which have recently flooded the Indian market.
Speaking on the occasion, Dr. Harsh Vardhan said, “The robust indigenous IgG ELISA test for antibody detection developed by ICMR-NIV, Pune will play a critical role in surveillance of proportion of population exposed to SARS-CoV-2 Coronavirus infection.”
ICMR has partnered with Zydus Cadila for mass scale production of the ELISA test kits. After development at ICMR-NIV, Pune, technology has been transferred for mass scale production to Zydus Cadila, which is an innovation driven global healthcare company. Zydus has proactively taken up the challenge to expedite the approvals and commercial production of the ELISA test kits so that they can be made available for use at the earliest. The test is named as “COVID KAVACH ELISA”. This is a perfect example of “Make in India” in record time.
Indian Council of Medical Research (ICMR) and Bharat Biotech International Limited (BBIL) have partnered to develop a fully indigenous vaccine for COVID-19 using the virus strain isolated at ICMR’s National Institute of Virology (NIV), Pune.
The strain has been successfully transferred from NIV to BBIL to work on vaccine development. ICMR-NIV will provide continuous support to BBIL for vaccine development.
ICMR and BBIL will seek fast-track approvals to expedite vaccine development, subsequent animal studies and clinical evaluation of the candidate vaccine.
The Indian Council of Medical Research (ICMR), New Delhi, the apex body in India for the formulation, coordination and promotion of biomedical research, is one of the oldest medical research bodies in the world. ICMR’s research agenda align with the National health priorities.
These efforts are undertaken with a view to reduce the total burden of disease and to promote health and well-being of the population. ICMR promotes biomedical research in the country through intramural as well as extramural research.
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A two-week course of antiviral therapy with interferon beta-1b plus lopinavir-ritonavir and ribavirin, started within 7 days of showing COVID-19 symptoms, is safe and more effective at reducing the duration of viral shedding than lopinavir-ritonavir alone in patients with mild to moderate illness, according to the first randomised trial of this triple combination therapy involving 127 adults (aged 18 and older) from six public hospitals in Hong Kong.
The PM took a detailed review of the current status of India’s efforts in vaccine development, drug discovery, diagnosis and testing. Indian vaccine companies are well known for their quality, manufacturing capacity and global presence. Today in addition, they have come across as innovators in early stage vaccine development research. Similarly, Indian academia and start-ups have also pioneered in this area. Over 30 Indian vaccines are in different stages of corona vaccine development, with a few going on to the trial stages.
Health Minister Sh. Harsh Vardhan and Minister of State for AYUSH Sh. Shripad Yesso Naik jointly launched clinical research studies on Ayurveda interventions as an add-on to standard care to COVID 19 situation and Ayush Sanjivani application today at New Delhi. AYUSH Minister was participating in the programme through Video Conferencing from Goa.
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