By PTI
NEW DELHI: With the DCGI approving the anti-COVID-19 pill Molnupiravir for emergency use in the country, Strides Pharma on Tuesday said it will launch the capsule immediately while six other homegrown pharma companies announced rolling out their generic versions of the drug shortly.
Strides, Dr Reddy’s, Sun Pharma, Cipla, Hetero, Torrent and Optimus said they have received approvals from the Drugs Controller General of India (DCGI) to manufacture and market their versions of Molnupiravir, an oral medication for COVID-19, for restricted use in emergency situation (EUA) in India.
They plan to market the capsules under their respective brands and make them available at all leading pharmacies and COVID-treatment centres across the country.
Earlier this year, these companies had signed non-exclusive voluntary licensing agreements with MSD to manufacture and supply the generic version of Molnupiravir in over 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 Stripiravir”.
The company is commercialising the product with a group integrated supply chain for active pharmaceutical ingredients and solid oral dosage from its large-scale WHO pre-qualified (PQ) manufacturing capacities, it added.
“We are delighted to receive the DCGI approval for launching Molnupiravir, which has shown promising results in several clinical studies.
The product provides therapeutic benefit to the patients with mild-to-moderate COVID symptoms and can be administered at home,” Strides Pharma Science Ltd Managing Director and CEO R Ananthanarayanan said.
Dr Reddy’s Laboratories said it will soon introduce antiviral drug Molnupiravir capsules (200mg) under the brand name ‘Molflu’ in India.
The approval to launch Molnupiravir is an important development not only as a treatment option, but also for the collaborative manner in which Indian pharma companies came together, Dr Reddy’s Co-Chairman and Managing Director G V Prasad said.
Dr Reddy’s said it is able to manufacture the active pharmaceutical ingredient (API) as well as the formulation for Molnupiravir, and has made adequate capacity preparations to ensure that it is able to help patients in India as well as in patient populations in need around the world.
Sun Pharmaceutical Industries said it will market its Molnupiravir capsules under the brand name ‘Molxvir’ in India.
“Our endeavour is to make the product available in a week’s time,” Sun Pharma CEO of India Business Kirti Ganorkar said.
Stating that Molnupiravir is an important addition to the portfolio of oral therapies available for treating COVID-19 patients, he said, “In line with our consistent efforts to accelerate access to new drugs for COVID-19 treatment, we will make Molxvir available to patients at an affordable price.
” On the production plans, Ganorkar said, “Currently, the plan is to manufacture molnupiravir at one of our big plants in India, and if there is a need, we can ramp up capacity.
” Mumbai-based Cipla will sell the drug under the ‘Cipmolnu’ brand and said it will soon make available the capsules at all leading pharmacies and Covid-treatment centres across the country.
“This launch is yet another step in our endeavour to enable access to all treatments in COVID care,” Cipla Ltd MD and Global CEO Umang Vohra said.
Hyderabad-based Hetero said it will market the product under the ‘Movfor’ brand.
Stating that the approval by the authorities 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 improving access to critical medicines will always remain the highest of priorities to us.
” Hetero said it will market the capsule under the brand Movfor and will be produced at its facilities at Telangana and Himachal Pradesh.
“Hetero’s Movfor will be made available in a 40 capsule pack (200 mg per capsule) and will be marketed by its associate company ‘Hetero Healthcare’ in India with the support of its strong distribution network across the country,” it 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 our healthcare system’s ammunition in the fight against Covid-19,” Torrent Pharma (Executive Director India) Aman Mehta said.
Another homegrown drug maker Aurobindo Pharma said it will market its generic version of Molnupiravir under the Molnaflu brand and it enjoys backward integration with in-house API manufacturing which equips it with stronger control on supply chain and cost efficiencies.
“The product will be manufactured at the company’s manufacturing facilities in India that are approved by global regulatory agencies including USFDA and UKMHRA,” it added.
The timely permission from DCGI for the generic version of Molnupiravir opens up access to an affordable treatment option for COVID19 patients and enable us to help battle the pandemic with effective and high-quality pharmaceutical products, Aurobindo Pharma Vice Chairman K Nithyananda Reddy said.
Optimus Pharma also said it would be launching its version of Molnupiravir in the Indian market in a day or two.
The DCGI, based on the review of clinical data of Molnupiravir has approved it for treatment of adult patients with Covid-19, with SpO2 less than 93 per cent and who have high risk of progression of the disease including hospitalisation or death.
MSD India Region Managing Director Rehan A Khan said the approval supports patient access to Molnupiravir in India and for more than 100 low-and middle-income countries.
“MSD has a long track record of making our medicines and vaccines accessible globally, and we remain committed to doing the same for combating the COVID-19 pandemic,” he stated.
The company is pleased to work with its voluntary licensing and manufacturing in expanding access for Molnupiravir, Khan noted.
The Central Drugs Standard Control Organisation (CDSCO) has granted restricted emergency use authorisation to two new vaccines and a drug for COVID-19, taking to 12 the number of preventives and treatments available in India.
Here is the list:
1. Covishield: Co-developed by the University of Oxford and British-Swedish company AstraZeneca, the vaccine is manufactured by 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 novel coronavirus.
The virus uses the spike protein to enter and infect the human cells.
Adenoviruses are common viruses that typically cause 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 of Medical Research and the National Institute of Virology, uses an inactivated virus developed by chemically treating novel coronavirus samples to make them incapable of reproduction.
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 typically cause 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 administered by a needle-free applicator.
The DNA-based vaccinations operate by transferring a genetically modified blueprint of viral genes into small molecules of DNA or genetic material for injection into persons being vaccinated.
5. Moderna: Developed by US-based company Moderna, the two-dose vaccine uses 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 a genetic material in many viruses and mRNA is used in making 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 piece of a modified virus that is not the virus that causes COVID-19.
This modified virus is called the vector virus.
The vector virus cannot reproduce itself, so it is harmless.
This vector virus gives instructions to cells in the body to create an immune response.
7. Corbevax: Made by Hyderabad-based firm Biological-E, the vaccine consists of a version of the receptor binding domain (RBD) of the SARS-CoV-2 spike protein, which the virus uses to enter and infect the cells.
It will be administered intramuscularly in two doses.
It has been designed using a similar technology used for developing Hepatitis B vaccines.8.
Covovax: Developed by American biotechnology company Novavax and manufactured under license by SII, Covovax is a two-dose subunit vaccine that contains purified parts of the virus necessary to elicit a protective immune response.
TREATMENTS:
9.American company Merck’s Molnupiravir is an antiviral medication that inhibits the reproduction of certain viruses.
The drug will be manufactured in India by 13 companies.
It has been approved under emergency use authorisation for treating adults with COVID-19 “who have high risk of progression to disease”.
10.Tocilizumab: Developed by Swiss pharmaceutical company Roche, tocilizumab is an immunosuppressant primarily used to treat rheumatoid arthritis and has been repurposed to fight lung infection in Covid-19 patients.
It is imported and distributed by Cipla in India, and may be considered for use in the presence of severe disease.
11.2-deoxy-D-glucose (2-DG): Developed by Dr Reddy’s Laboratories in collaboration with the Defence Research and Development Organization (DRDO), 2-DG is an oral drug administered in India only on prescription.
The virus depends upon glycolysis or 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 monoclonal antibodies Casirivimab and Imdevimab that are administered together for treating mild to moderate COVID-19 patients.
Monoclonal antibodies are artificial antibodies created in the lab that mimic the activity of our immune system.
Casirivimab and imdevimab are specifically directed against the spike protein of SARS-CoV-2, and are designed to block the virus’ attachment and entry into human cells.
