PremiumTapeworm drug Niclosamide, which is on the WHO's list of essential medicines for treating covid-19 cases, is also on a phase 2 trial of 96 subjects by Telangana-based Laxai Life Sciences Pvt. Ltd
MUMBAI/DELHI : Reliance Industries Ltd (RIL) has sough the drug regulator’s permission to repurpose a generic drug used to treat tapeworm infestations for potential covid-19 treatment.
In its annual report for 2020-21, the Mukesh Ambani-led group said it submitted an application to the Drugs Controller General of India (DCGI) to allow Niclosamide to be used for treating covid-19 patients. The drug is on the World Health Organization’s (WHO) list of essential medicines for treating covid-19 cases.
According to the government’s clinical trial registry, there are three trials currently underway in India to study the use of Niclosamide for covid-19.
The largest of them is a phase 2 trial of 96 subjects by Telangana-based Laxai Life Sciences Pvt. Ltd.
The trial, which is being conducted by contract research provider Insignia Clinical Services Pvt. Ltd, is evaluating the safety and efficacy of Niclosamide for the treatment of hospitalized patients with covid-19. Enrolment for the trial started on Tuesday.
“We are conducting the trial in moderate covid-19 patients who are at risk of moving to severe disease. The drug is known to work in two ways. It will prevent further viral replication, which could stop disease progression and also prevent lung fibrosis. We are working with a novel formulation of this drug, which will provide much-needed relief to such patients and solve the problem of unmet medical needs in covid-19 treatment in India and elsewhere," Laxai Life Sciences chief executive Dr. Ram Upadhayaya said in an interview.
He said results are expected soon.
Another trial is a 32-subject phase 1 trial by Hyderabad-based Daewoong Pharmaceutical (India) Pvt. Ltd to study the safety of the drug in covid-19 patients. The trial is complete, and the data has been sent to the regulator, a person involved with the trial said.
However, the drug has not yet received authorization from the Indian regulator for the treatment of covid-19 patients.
“I am not aware of any good study about Niclosamide in treatment of covid-19 that has been published in a journal. So as of now, I cannot prescribe it," said Dr. Ram Shankar Mishra, director of internal medicine at Max Super Speciality Hospital in Delhi’s Saket.
RIL’s team has also designed a process to produce sanitizers aligned with WHO specifications at 20% of market cost, RIL said in its annual report. It said its team is working with the Council of Scientific and Industrial Research laboratories to certify Nexar polymer, which has shown to destroy the lipid layer of various viruses and bacteria.
The company has also developed novel cost-effective diagnostic kits called ‘R-Green’ and ‘R-Green Pro’ for covid-19 detection, which have received Indian Council of Medical Research approvals.
Last May, RIL launched its diagnostics operations, conducting over 2,000 covid-19 tests every day. It has developed its own confirmatory tests for covid-19, which are available to all RIL employees and will soon be rolled out in the community.
RIL is also working to address shortages of ventilators in hospitals across the country by deploying a concept developed in Italy, which uses a CPAP (continuous positive airway pressure) machine with a 3D-printed charlotte valve and special snorkelling mask.
