In a first of kind its initiative, five large Indian pharmaceutical companies Cipla, Dr Reddy's, Emcure, Sun Pharma and Torrent Pharma have joined hands to conduct clinical trials of COVID-19 oral antiviral drug Molnupiravir for the treatment of mild COVID-19 in an outpatient setting in India.
As per the directive of the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization, Dr.Reddy’s will conduct the clinical trial using its product, and the other four pharma companies will be required to demonstrate equivalence of their product to the product used by Dr. Reddy’s in its clinical trial.
The parties will jointly sponsor, supervise and monitor the clinical trial in India.
Following the clinical trial protocol approval given by the Drugs Controller General of India, the clinical trial will be conducted for the treatment of mild COVID-19 in an outpatient setting. It is expected to take place between June and September this year across India with the recruitment of 1,200 patients.
Between March and April this year, these five pharma companies had individually entered into a non-exclusive voluntary licensing agreement with Merck Sharpe Dohme (MSD) to manufacture and supply Molnupiravir to India and over 100 low and middle-income countries (LMICs).
Frequently Asked Questions
A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.
There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.
Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.
"Such collaboration for a clinical trial is a first of its kind within the Indian
pharma industry, and will aim to investigate yet another line of treatment in the collective fight against the COVID-19 pandemic," the five companies said in a joint statement.
On successful completion of the clinical trial, each company will independently approach the regulatory authorities for approval to manufacture and supply Molnupiravir for the treatment of COVID-19 in India.
Molnupiravir is an oral anti-viral that inhibits the replication of multiple RNA viruses including SARS-CoV-2.
It is presently being studied by MSD (Called as Merck in US), through a collaboration with Ridgeback Biotherapeutics, in a Phase III trial for the treatment of non-hospitalized patients with confirmed COVID-19 globally.