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Covid drug: CSIR lab gets nod for phase-III trials

Our Bureau New Delhi | Updated on June 18, 2020 Published on June 18, 2020

The Lucknow-based Central Drug Research Institute (CDRI), a constitute laboratory of Council of Scientific and Industrial Research (CSIR), has been granted approval to carry out phase-III trials for an antiviral drug, Umifenovir, against Covid-19 infection.

CSIR-CDRI, which developed a new process technology for the drug that is used in parts of China and Russia for influenza treatment, will conduct a randomised, double-blind placebo controlled trial to establish efficacy, safety and tolerability of the drug at King George's Medical University (KGMU) Lucknow, Dr. Ram Manohar Lohia Institute of Medical Sciences (RMLIMS) and ERA’s Lucknow Medical College & Hospital, Lucknow, an official statement said on Thursday.

This drug has a good safety profile and acts by preventing entry of virus into human cells and also by priming the immune system. Umifenovir is mainly used for treatment of influenza and is available in China and Russia, and has recently come into prominence due to its potential use for Covid-19 patients.

To evaluate its efficacy in Indian patients, CSIR-CDRI has taken up the clinical trial. Further, it has developed the process technology for Umifenovir in record time and licensed the economical process technology for manufacturing and marketing the drug to Medizest Pharmaceuticals Private Ltd, Goa, who have already received test licence from the Drug Controller General of India (DCGI).

According to Tapas Kundu, CSIR-CDRI Director, all the raw materials for the drug are indigenously available and if the clinical trial is successful, Umifenovir can be a safe, efficacious, affordable drug against Covid-19 and can be part of National Programme against Covid-19. This drug has the potential for prophylactic use as well, he added.

The clinical trial application was processed on high priority as per the DCGI’s initiative against Covid-19. The next steps of the trial are being fast tracked to enable the availability of the drug to patients as soon as possible.

In another development, National Research Development Corporation (NRDC) has licensed manufacturing know-how of a PPE Suit being named as NavRakshak, developed at the Innovation Cell of the Institute of Naval Medicine, INHS Asvini Hospital (Mumbai) of the Indian Navy, to five MSME clients: Greenfield Vintrade Pvt Ltd (Kolkata), Vaishnavi Global Pvt Ltd (Mumbai), Bharat Silks (Bengaluru), Sure Safety (India) Ltd (Vadodara) and Swaps Couture (Mumbai) to meet the ongoing country-wide demand of quality PPE kits. These five manufacturers put together are planning to mass produce more than 10 million PPEs per year.

The PPE has been tested and certified at the Institute of Nuclear Medicine and Allied Sciences of the Defence Research and Development Organisation, one of the nine NABL accredited labs authorised by Ministry of Textile currently in India for PPE prototype sample testing.

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Published on June 18, 2020
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