 "Coronavirus, vaccine, covid, drugs, clinical trials")
With vaccine rollout beginning in some countries, the world ravaged by the COVID-19 pandemic is looking to India for the large-scale production and supply of coronavirus vaccines as it enters 2021.
As the pandemic hit the world in 2020, Indian pharma industry rose to the occasion and was able to manufacture and maintain supply chains even during the lockout period, and exported medicines such as HCQ and paracetamol to more than 150 countries, keeping its image of 'Reliable Pharmacy of the World'.
The world is again looking at India as a beacon of hope to manufacture and supply the huge number of vaccines needed to tackle the pandemic.
"India contributes 60 per cent of the vaccine production to the world. India is going to play a vital role in equitable distribution of vaccines around the world," Indian Pharmaceutical Alliance (IPA) Secretary General Sudarshan Jain told PTI.
While Indian companies such as Zydus, Bharat Biotech and Gennova are developing indigenous vaccines, other domestic companies are collaborating with global companies such as Serum Institute with AstraZeneca, Dr Reddys with Sputnik and Biological E with J&J, he added.
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"India will also be a benchmark in vaccine distribution and will be using technology to ensure targeted and phased distribution. India has always believed that global cooperation and coordination is fundamental to meet the COVID situation," Jain said.
Currently, three COVID-19 vaccines candidates of Bharat Biotech, Serum Institute of India and Pfizer are under active consideration of India's drug regulator and there is hope that early licensure is possible for all or any of them, according to the Union health ministry.
Indian Drug Manufacturers' Association (IDMA) Executive Director Ashok Kumar Madan said, "we are sure with all the attention given by the government, vaccines will too be available for use from January 2021 onwards. These vaccines are being approved by our Drugs Controller as per the stringent international norms. We take pride that almost 70 per cent of the WHO vaccine procurements are from India".
Indian firms have used different platforms to produce the vaccines. Scientists in these firms have the capability to produce the vaccine to counter the mutated forms in a short time, he added.
On the availability of the AstraZeneca-Oxford vaccine, Serum Institute of India (SII) CEO Adar Poonawalla told PTI that based on the trial results in India and the UK, and if approvals from regulatory bodies are in place in time, "then we can expect the vaccine to be available in India by January 2021 (only if it is proven immunogenic and efficacious)".
As part of various partnerships and collaborations for vaccine candidates, SII will keep aside 50 per cent of whatever quantity of the vaccine candidates are produced for India and the remaining quantity will go to low and middle income countries, he noted.
"So far, under at-risk manufacturing, we have already stockpiled 50 million doses. Currently, our capacity is 60-70 million doses per month, which will increase further up to 100 million doses of the vaccine per month by February 2021. However, we will progress to mass production only after it is proven efficacious and immunogenic for mass use," Poonawalla said.
About the price of the vaccine, he said, "we want the vaccine to be affordable and accessible to all. The Government of India will receive it at a far more affordable price of USD 3-4, since they will be buying in a larger volume. The priority is going to be India and the GAVI countries, after which only, the private market will open up where the pricing would be USD 6-8 per dose".
Stating that Covishield is an extremely viable and vital vaccine for India and other low-and-middle-income countries, Poonawalla said its efficacy in terms of affordability and composition makes it easier to transport and store for long periods at 2-8C i.e. normal refrigerator temperatures. For countries with warm climates, this will help to ensure equitable distribution and sustainable affordability.
"Add to that, we have a long-standing relationship with the Jenner Institute at the University of Oxford for our various other vaccine initiatives and are hopeful that it will be an efficacious and immunogenic vaccine viable for mass use," he added.
Zydus Group Chairman Pankaj R Patel said, "we are committed to offering a safe and efficacious vaccine to fight the pandemic and our researchers have been working tirelessly to make this happen".
The outcomes for the Phase I/II clinical trials of ZyCoV-D vaccine have been submitted to the DCGI (Drugs Controller General of India) and the company hopes to start the Phase III trials, which will be conducted on 30,000 volunteers across the country, he added.
"We have the capabilities to manufacture over 120 million doses to start with and shall ramp up depending on the demand. Our focus right through the year has been to support patients with access to critical medicines, diagnostics and other medical essentials in an affordable way to fight COVID-19 and this will continue to be a key factor in our vaccine launch as well," Patel said.
In September, billionaire philanthropist Bill Gates said that India's willingness to play a 'big role' in manufacturing COVID-19 vaccine and to supply to other developing countries will be a critical part in containing the pandemic globally.
Recently, Bharat Biotech Chairman and Managing Director Krishna Ella said that people who are infected should also take a vaccine, and India is well prepared regarding the logistics for the vaccine distribution as it has a very robust immunisation system.
Another domestic pharma firm Aurobindo Pharma has entered the vaccine fray by inking an exclusive licence agreement with US-based company COVAXX, to develop, commercialise and manufacture a vaccine to fight COVID-19 for India and UNICEF.
Joining hands in efforts to help with the availability of the vaccine, Wockhardt, in early December, said it is in discussions with a number of global COVID-19 vaccine developers to offer drug substance as well as fill and finish manufacturing facilities to them.
"2021 will be a year of transformative measures that have been set into motion across the industry. Resilience-strengthening efforts through aspects like digital transformation, securing manufacturing and supply chains, will continue," Cipla President and Global CFO Kedar Upadhye said.
According to the World Health Organization (WHO), the first human cases of COVID-19, the disease caused by the novel coronavirus, subsequently named SARS-CoV-2 were first reported by officials in Wuhan City in China, in December 2019.
