Updated on July 16 | Article Appeared in July 2020 Issue
We are witnessing COVID-19 pandemic since September 2019 when China first imposed lockdown and then every country had to do this because of growing number of cases and mortality. Since January, scientists all over the world are trying to develop a vaccine or cure against this deadly virus but there is no hope yet. Here, we are providing a list of drugs from India that are being considered for COVID-19 treatment with complete status till date.
Note: This article does not endorse any drug/therapy for COVID-19 or any other condition.
Itolizumab
Patent (holding company) – Active, Biocon
Mode of action- humanized IgG1 anti-CD6 monoclonal antibody, earlier approved for the treatment of Psoriasis, handling the hyperactivity of the immune system and managing cytokine storm
Clinical trial- 30 patients’ clinical trial where 20 patients were out on Itolizumab, 10 randomised on standard care.
Controversies, if any – small sample size, the trial was also open-label without, which means there is good chance that the results were biased towards more favourable outcomes.
Authorization by Global regulators – drug not approved in the EU or US
Authorization by Indian regulators – fast-tracked by Drug Controller General of India received emergency use on 11.07.2020
Companies involved- Biocon
Price – Rs. 32000 for treatment (Rs. 8,000/vial)
Favipiravir
Patent (holding company) – Expired, generic version of Avigan, a Fujifilm drug commonly used in Japan for the treatment of influenza
Mode of action- Oral antiviral drug
Clinical trial- Glenmark’s clinical trial of 150 mild to moderate patients
Controversies, if any – Cannot be given to patients with severe renal complications, hepatic impairment, pregnant and lactating women, according reports by Fujita Health University, Avigan has failed to show any ability to treat COVID-19.
Authorization by Global regulators – drug not approved in the EU or US, approved in Russia and parts of the Middle East
Authorization by Indian regulators – fast-tracked by Drug Controller General of India Received Emergency Use on 19.06.2020
Companies involved- Glenmark Pharmaceuticals
Price – Fabiflu, at Rs75 / tablet
Dexamethasone
Patent (holding company) – NA
Mode of action- Works as corticosteroid medication. It is used in the treatment of many conditions such as rheumatic problems, a number of skin diseases, severe allergies, asthma, chronic obstructive lung disease, croup, brain swelling, eye pain following eye surgery, and along with antibiotics in tuberculosis.
Clinical trial- Clinical trial ongoing – UK’s RECOVERY Trial
Controversies, if any – N.A
Authorization by Global regulators – U.K and U.S. issued an emergency use authorization
Authorization by Indian regulators – “off-label” drug for COVID-19 severe cases
Companies involved- Several
Price – ~ Rs. 2/ tablet
Remdesivir
Patent (holding company)- Upto 2035, Gilead Sciences
Mode of action- Anti-viral drug, earlier tried on Ebola
Authorization by Global regulators- Hospital-only, Injectible drug,
Authorization by Indian regulators Has Emergency Use Authorisation in India on 01.06.2020 by CDSCO
Clinical trial- The first randomised double-blind study showed no statistically significant treatment efficacy in severe COVID-19 patients. Well-designed clinical trials show Remdesivir to be effective, shown to shorten recovery time & hospital stay but does not reduce mortality. A study published on May 22 – sponsored by NIAID – showed that Remdesivir didn’t affect the recovery of Asians.
Controversies, if any – several like lobbying and money making
Companies involved- Gilead Sciences, USA; Hetero Pharma(Covifor), India; Cipla(Cipremi), India Price – $2,340 and Rs 5400 for 5 day course in India
Hydroxychloroquine
Patent (holding company) – NA
Mode of action- Approved as a treatment in mild cases and as prophylactic
Clinical trial- WHO’s SOLIDARITY and UK’s RECOVERY trials show HCQ does not show benefits in treatment
Controversies, if any – Side-effects like Severe heart arrhythmia
Authorization by Global regulators – USFDA revoked Emergency Use Authorisation,
Authorization by Indian regulators – India moved the drug out of treatment protocol for severe cases
Companies involved- Several
Price – Rs. 1 to 10/tablet
Tocilizumab
Patent (holding company) – Active, Hoffmann La Roche
Mode of action- humanized IL-6 receptor inhibitor monoclonal antibody, counter the severe inflammation (cytokine storm)
Clinical trial- Phase II clinical trial will be carried out
Controversies, if any – Can increase the risk of bacterial infections
Authorization by Global regulators – drug not approved in the EU or US
Authorization by Indian regulators – “restricted use” on severely ill COVID-19 patients on “emergency and compassionate grounds”
Companies involved- Roche Pharma, marketed by Cipla in India
Price – Rs 40,000 each/vial
Others
Convalescent Plasma Therapy – Approved as an “off-label” therapy and works best when given early on in the treatment cycle.
Methylprednisolone – For use as an anti-inflammatory drug, Low molecular weight Heparin, use to prevent blood clots & thrombogenic response.
Antibiotics – Azithromycin, Ivermectin – To deal with infections.
