NEW DELHI: With the DCGI approving the anti-COVID-19 pill Molnupiravir for emergency use in the country, Strides Pharma said Tuesday that it will launch the capsule immediately, while six other local drug companies announced the launch of their generic versions of the medication shortly.
Strides, Dr. Reddy's, Sun Pharma, Cipla, Hetero, Torrent and Optimus said they have received approvals from the Controller General of Drugs of India (DCGI) to manufacture and market their versions of Molnupiravir, an oral drug for COVID-19, for restricted use. in an emergency situation (USA) in India.
They plan to market the capsules under their respective brand names and make them available at all leading pharmacies and COVID treatment centers across the country.
Earlier this year, these companies had signed non-exclusive voluntary license agreements with MSD to manufacture and supply the generic version of Molnupiravir in more than 100 low- and middle-income countries (LMICs), including India.
In a statement, Strides Pharma Science Ltd said it will "immediately launch Molnupiravir in India under its brand name Stripiravir."
The company is marketing the product with a group-integrated supply chain for active pharmaceutical ingredients and solid oral doses from its large-scale WHO Prequalified (PQ) manufacturing capabilities, he added.
"We are delighted to receive approval from DCGI for the launch of molnupiravir, which has shown promising results in several clinical studies.
The product provides a therapeutic benefit to patients with mild to moderate COVID symptoms and can be administered at home, "said Strides Pharma Science Ltd CEO and CEO R Ananthanarayanan.
Dr Reddy's Laboratories said it will soon introduce molnupiravir (200mg) capsules of antiviral drugs under the brand name 'Molflu' in India.
The approval to launch Molnupiravir is an important advance not only as a treatment option, but also because of the collaborative way that Indian pharmaceutical companies came together, said Dr. Reddy's Co-Chairman and Managing Director GV Prasad.
Dr Reddy's said that it is capable of manufacturing the Active Pharmaceutical Ingredient (API) as well as the formulation of molnupiravir, and has made preparations with adequate capacity to ensure that it can help patients in India as well as populations. of patients in need across the country. world.
Sun Pharmaceutical Industries said it will market its molnupiravir capsules under the brand name 'Molxvir' in India.
"Our effort is to make the product available in a week," said Kirti Ganorkar, CEO of India Business at Sun Pharma.
Stating that molnupiravir is an important addition to the portfolio of oral therapies available for the treatment of COVID-19 patients, he said: "In keeping with our ongoing efforts to accelerate access to new drugs for the treatment of COVID-19, We will make Molxvir available to patients at an affordable price.
"On the production plans, Ganorkar said:" Currently the plan is to manufacture molnupiravir in one of our large plants in India and if necessary we can increase the capacity. "
"Mumbai-based Cipla will sell the drug under the brand name 'Cipmolnu' and said it will soon make the capsules available in all major pharmacies and Covid treatment centers across the country.
"This launch is a further step in our effort to enable access to all treatments in COVID care," said Cipla Ltd CEO and Global CEO Umang Vohra.
Hyderabad-based Hetero said it will market the product under the brand name 'Movfor'.
Stating that the authorities' approval consolidates India's efforts to address the world's greatest health threat, COVID-19, Hetero Group of Companies Chairman B Partha Saradhi Reddy said: "This improved access to Critical drugs will always remain the top priority for us.
"Hetero said it will market the capsule under the Movfor brand and it will be produced at its facilities in Telangana and Himachal Pradesh.
"Hetero's Movfor will be available in a pack of 40 capsules (200 mg per capsule) and will be marketed by its partner company 'Hetero Healthcare' in India with the support of its strong distribution network across the country," he added.
Ahmedabad-based Torrent Pharmaceuticals Ltd said it is introducing Molnupiravir under the brand name Molnutor in India.
?? We are pleased to partner with MSD to bring Molnupiravir to patients across India.
Molnupiravir will be an important addition to the munitions of our healthcare system in the fight against Covid-19, "said Torrent Pharma (Chief Executive Officer of India) Aman Mehta.
Another homegrown drug maker, Aurobindo Pharma, said it will market its generic version of Molnupiravir under the brand name Molnaflu and enjoys backward integration with in-house API manufacturing, equipping it with stronger control over the supply chain. supply and cost efficiency.
"The product will be manufactured in the company's manufacturing facilities in India that are approved by global regulatory agencies, including the USFDA and UKMHRA," he added.
DCGI's timely permission for the generic version of molnupiravir opens access to an affordable treatment option for COVID19 patients and enables us to help fight the pandemic with high-quality, effective pharmaceuticals, said Aurobindo Pharma Vice President K Nithyananda Reddy.
Optimus Pharma also said that it would launch its version of Molnupiravir on the Indian market in a day or two.
The DCGI, based on the review of clinical data for molnupiravir, has approved it for the treatment of adult patients with Covid-19, with SpO2 less than 93 percent and who are at high risk of disease progression, including hospitalization. or death.
MSD India Region Managing Director Rehan A Khan said the approval supports patient access to molnupiravir in India and more than 100 low- and middle-income countries.
"MSD has a long history of making our medicines and vaccines accessible globally, and we remain committed to doing the same to combat the COVID-19 pandemic," he stated.
The company is pleased to work with its voluntary licenses and manufacturing to expand access to molnupiravir, Khan noted.
The Central Medicines Standard Control Organization (CDSCO) has granted emergency restricted use authorization to two new vaccines and one medicine for COVID-19, bringing the number of preventatives and treatments available in India to 12.
Here is the list:
1. Covishield: Co-developed by the University of Oxford and the British-Swedish company AstraZeneca, the vaccine is manufactured by the Serum Institute of India (SII) as Covishield in India.
The two-dose vaccine uses adenoviruses that infect chimpanzees to carry the gene responsible for the spike protein of the new coronavirus.
The virus uses the spike protein to enter and infect human cells.
Adenoviruses are common viruses that generally cause a mild cold or flu-like illness.
2. Covaxin: The indigenous two-dose vaccine, developed by Hyderabad-based Bharat Biotech in collaboration with the Indian Council for Medical Research and the National Institute of Virology, uses an inactivated virus developed by chemically treating samples of novel coronaviruses to render them incapable. to reproduce.
3. Sputnik V: Developed by Russia's Gamaleya Research Institute, the two-dose Sputnik V is a vector vaccine produced using a combination of two adenoviruses called Ad5 and Ad26.
Adenoviruses are common viruses that generally cause a mild cold or flu-like illness.
4. ZyCoV-D: The DNA vaccine produced by Ahmedabad-based Zydus Cadila is a three-dose vaccine.
Instead of using regular syringes, the vaccine will be given with a needleless applicator.
DNA-based vaccines work by transferring a genetically modified model of viral genes into small molecules of DNA or genetic material to inject into the people being vaccinated.
5. Modern: Developed by the American company Moderna, the two-dose vaccine uses a genetic code of messenger RNA (mRNA) to produce the viral protein to train the immune system for a future encounter with the infectious coronavirus.
RNA acts as genetic material in many viruses, and mRNA is used to make proteins in a cell.
6. Johnson and Johnson: The single dose adenovirus vector vaccine is developed by the American company Johnson and Johnson.
It contains a part of a modified virus that is not the virus that causes COVID-19.
This modified virus is called a vector virus.
The vector virus cannot reproduce by itself and is therefore harmless.
This vector virus instructs the cells of the body to create an immune response.
7. Corbevax: Manufactured by Hyderabad-based Biological-E, the vaccine consists of a receptor-binding domain (RBD) version of the SARS-CoV-2 spike protein, which the virus uses to enter and infect cells.
It will be administered intramuscularly in two doses.
It has been designed using technology similar to that used to develop hepatitis B vaccines.
Covovax: Developed by the American biotechnology company Novavax and manufactured under license by IBS, Covovax is a two-dose subunit vaccine that contains purified parts of the virus necessary to elicit a protective immune response.
TREATMENTS:
Molnupiravir from the American company Merck is an antiviral drug that inhibits the reproduction of certain viruses.
The drug will be manufactured in India by 13 companies.
It has been approved under emergency use authorization for the treatment of adults with COVID-19 "who are at high risk of disease progression."
10.Tocilizumab: Developed by the Swiss pharmaceutical company Roche, tocilizumab is an immunosuppressant that is primarily used to treat rheumatoid arthritis and has been reused to fight lung infection in Covid-19 patients.
It is imported and distributed by Cipla in India and can be considered for use in the presence of serious illness.
11,2-deoxy-D-glucose (2-DG): Developed by Dr Reddy's Laboratories in collaboration with the Defense Research and Development Organization (DRDO), 2-DG is an oral drug administered in India by prescription only.
The virus relies on glycolysis or the breakdown of glucose for energy.
The drug hinders the process of glycolysis and prevents the growth of the virus.
12. REGEN-COV2 Antibody Cocktail: Developed by Roche, it is a combination of the monoclonal antibodies Casirivimab and Imdevimab that are administered together for the treatment of patients with mild to moderate COVID-19.
Monoclonal antibodies are artificial antibodies created in the laboratory that mimic the activity of our immune system.
Casirivimab and imdevimab are specifically directed against the SARS-CoV-2 spike protein and are designed to block the binding and entry of the virus into human cells.
