India always stand in the first row whenever there is a chance to serve for humanities and social welfare. Pharmaceutical sectors in India is one of the highest contributing segments, firms are not only generating revenue and also serving patients across the globe with high quality (safe, pure and efficacious) medicines.
Pharmaceutical quality is “assuring every dose is safe and effective, free of contamination and defects”. – US FDA
Even in pandemic condition, Indian pharmaceutical organization are much ahead to show case their talent towards innovation and meanwhile collaborating with the other research organization across the globe to accelerate the journey of inventing a reliable treatment of COVID-19.
Drug manufacturers around the world are racing to develop a vaccine against the novel coronavirus. India, a leading manufacturer of vaccines and generic medicines, is expected to play a major role in this race, with several institutes working on different drugs. Indian firms are capable to product billion of dosages from their world class manufacturing facility within short span to fast-track the treatment worldwide.
An Indian pharmaceutical organization Bharat Biotech has successfully developed COVAXIN, India’s first vaccine candidate for COVID-19 in collaboration with the Indian Council of Medical Research (ICMR) and National Institute of Virology (NIV). The strain of SARS-CoV-2 was isolated in NIV, Pune and transferred to Bharat Biotech. Vaccine was developed and manufactured in Bharat Biotech’s BSL-3 (Bio-Safety Level 3) High Containment facility located in Genome Valley, Hyderabad, India.
The Drug Controller General of India- Central Drugs Standard Control Organization (CDSCO) and Ministry of Health & Family Welfare granted permission to initiate Phase I & II Human clinical trials after the company submitted results generated from preclinical studies, demonstrating extensive safety and effective immune responses. Human clinical trials are scheduled to start across India in July 2020.
Apart from Bharat Biotech, there are multiple vaccine trials ongoing in India, including those of candidates by Zydus Cadila, Serum Institute of India and Panacea Biotec, all of them are in pre-clinical stage as of now.
To be sure, apart from developing its own vaccine, Serum Institute is also in agreement to manufacture the candidate jointly being developed by University of Oxford and Astrazeneca plc. Bharat Biotech also has another vaccine candidate, ‘CoroFlu’, that it is developing in collaboration with University of Wisconsin–Madison and vaccine manufacturer FluGen.
The British firm has already begun large-scale, mid-stage human trials of the drug developed by researchers at University of Oxford. Other possible vaccines being tested include one by American firm Moderna, which is scheduled to go into Phase III clinical trials from mid-July.
China’s military has been given permission to use a vaccine candidate developed in association with CanSino Biologics. According to Reuters the drug showed some promise in early clinical trials. The Ad5-nCoV is one of the eight vaccine candidates developed by Chinese firms to move into human trials.
US-based biopharmaceutical firm Gilead Sciences Inc. said a five-day course of its antiviral drug Remdesivir showed a modest benefit to patients with moderate COVID-19 symptoms. Gilead also extended their agreement with several Indian pharmaceutical firms like i.e. Hetero, Jubilant Life Sciences, Cipla, Dr. Reddys, Zydus cadila and Mylan for manufacturing of drug substance (API) and formulation. Whereas Hetero already announced the approval and launch of first generic ‘COVIFOR’ (Remdesivir) in India for the treatment of Covid-19 on 21st June 20.
References:
India’s first coronavirus vaccine gets nod for human trials , https://www.indiatoday.in/india/story/coronavirus-india-vaccine-candidate-hyderabad-bharat-biotech-clinical-trial-icmr-dgca-1695289-2020-06-29; accessed on 30-06-2020.
COVAXIN, India’s First COVID-19 Vaccine Candidate, Set For Phase I, II Human Trials; https://www.ndtv.com/india-news/coronavirus-vaccine-india-covaxin-india-s-first-covid-19-vaccine-candidate-set-for-phase-i-ii-human-trials-2254189; accessed on 30-06-2020.
Cansino’s COVID-19 Vaccine Candidate Approved For Military Use In China; https://www.ndtv.com/world-news/covid-19-vaccine-cansinos-covid-19-vaccine-candidate-approved-for-military-use-in-china-2253819; accessed on 30-06-2020.
Bharat Biotech’s Covid-19 vaccine first in India to receive nod for human trials; https://www.livemint.com/news/india/bharat-biotech-s-covid-19-vaccine-first-in-india-to-receive-nod-for-human-trials-11593445763769.html; accessed on 30-06-2020.
Hetero, Press release ; http://heteroworld.com/pdf/Hetero_Remdesivir_Launch_FINAL_21062020.pdf; accessed on 29-06-2020.