As cases of the highly transmissible Omicron variant continued to rise, the drug regulator on Tuesday granted emergency use authorisation (EUA) to Molnupiravir, the world’s first Covid-19 pill. The repurposed antiviral drug, which was developed initially to treat influenza, will be manufactured by 13 companies in the country, and could be available in a week to treat patients.
The regulator also granted EUA to Hyderabad-based Biological E. for Corbevax, India’s first indigenously developed RBD protein sub-unit vaccine against Covid-19, and to Serum Institute of India (SII) for Covovax, the recombinant nanoparticle protein-based vaccine that has been developed by the American biotechnology firm Novavax.
Molnupiravir, which has been developed by US-based biotechnology company Ridgeback Biotherapeutics in collaboration with the American pharma giant Merck, works by introducing errors in the genetic code of SARS-CoV-2, which prevents the virus from replicating.
“Considering the emergency and unmet medical need in Covid-19”, the subject expert committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) had advised the regulator to grant permission for manufacture and marketing of 200 mg capsules of molnupiravir with a recommended dose of 800 mg twice daily for 5 days, the Health Ministry said on Tuesday.
The recommendation is for treatment of adult patients of Covid-19 with blood oxygen saturation (SpO2) >93%, and who have a “high risk of progression of the disease including hospitalisation or death”, the Ministry said. The SEC has recommended the sale of the drug only against a prescription from a medical specialist.
“Based on the recommendation of the SEC…, the drug is being approved for 13 companies who have submitted their clinical trial report, interim or complete report,” the Ministry said. CDSCO had received a total 22 applications to manufacture and market molnupiravir in the country, it said.
The drug will be manufactured by seven Hyderabad-based companies: Dr Reddy’s, Natco, MSN, Hetero, Optimus, Aurobindo, and Mylan; two Mumbai-based companies, Cipla and Sun Pharma; Ahmedabad-based Torrent and BDR; Bengaluru-based Strides; and Pune-based Emcure.
Sun Pharma said on Tuesday that its product, brand name Molxvir, was likely to be available within a week “at an affordable price”. “We are also in the process of launching a toll-free helpline to ensure the availability of Molxvir to doctors and patients across India,” the company said.
Cipla said its molnupiravir pill, brand name Cipmolnu 200 mg, will be available soon at all leading pharmacies and Covid treatment centres across the country. “The company has adequate manufacturing capacities and a solid distribution mechanism in place to ensure speedy access to this effective treatment pan India,” Cipla said.
Dr Reddy’s said it would soon launch its molnupiravir capsule under the brand name Molflu. “(The) company…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 (and)…around the world,” Dr Reddy’s said.
Ahmedabad-headquartered Torrent Pharmaceuticals, which had announced a collaboration for clinical trial of molnupiravir with Cipla, Dr Reddy’s, Emcure, and Sun Pharma this June, said its drug would be sold in India under the brand name Molnutor.
Also on Tuesday, Biological E. said it “plans to complete production at a rate of 75 million doses (of Corbevax) per month, anticipating over 100 million doses per month from February 2022”. Corbevax is built on the traditional protein subunit vaccine platform, but differs from inactivated whole-cell vaccines in that it contains only the antigenic parts of the virus to trigger a protective immune response.
The Centre has made an advance payment of Rs 1,500 crore to reserve 30 crore doses of Corbevax. The company said in tests at 33 study sites across India, the vaccine had shown “high persistence of immune response after the second dose”.
Adar Poonawalla, chief executive of SII, said: “The approval of Covovax…is a significant milestone in strengthening our immunisation efforts across India and LMICs (low- and medium-income countries). We are proud to deliver a highly effective protein-based Covid-19 vaccine of more than 90% efficacy rate, based on clinical data demonstrating a favourable safety profile…”