Drug major Cipla on Tuesday said it has received emergency use authorisation (EUA) permission from the Drug Controller General of India (DCGI) to launch antiviral drug Molnupiravir in the country to treat mild-to-moderate COVID-19.
The Mumbai-based firm said it plans to launch Molnupiravir under the brand name Cipmolnu.
"This launch is yet another step in our endeavour to enable access to all treatments in COVID care. We continue to be guided by the power of science to address the unmet needs of patients across the globe and bring care closer to the patients," Cipla MD and Global CEO Umang Vohra said in a statement.
Earlier during the year, Cipla entered into a non-exclusive voluntary licensing agreement with Merck Sharpe Dohme (MSD) to manufacture and supply Molnupiravir in India and to over 100 low and middle-income countries (LMICs).
The regulatory approval comes on the back of a five-month collaborative trial conducted by a consortium of companies.
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.
Molnupiravir is the first oral antiviral approved by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of mild-to-moderate COVID-19 at high risk of developing severe disease.
Molnupiravir inhibits the replication of multiple RNA viruses including SARS-CoV-2.
Cipla said it will soon make Cipmolnu 200mg capsules available at all leading pharmacies and COVID treatment centers across the country.