India's COVID-19 vaccine plans are gaining momentum as Prime Minister Narendra Modi is scheduled to visit the Zydus Biotech Park in Ahmedabad, Bharat Biotech in Hyderabad and Serum Institute of India in Pune to personally review the vaccine development and manufacturing process.
As India enters a decisive phase of the fight against coronavirus, the Prime Minister's visit to these facilities and discussions with the scientists are to help him get a first-hand perspective of the preparations, challenges and roadmap in India's vaccination plans. Further, PM Modi's visit will attract global attention to advertise India's capabilities in vaccine manufacturing and in turn open up huge business opportunities, say industry observers.
Currently, the Serum Institute of India's (SII) Covishield, licenced from Astra Zeneca and Oxford University and Bharat Biotech's Covaxin are now in the final Phase-II/III stage of trials and results are expected within the next 1-2 months. Zydus's COVID-19 vaccine, ZyCov-D, is now entering into the final lap of trials. Besides, Dr Reddy's Laboratories and Hetero Drugs have teamed up separately with the Gamaleya Institute and the Russian Direct Investment Fund (RDIF) to make available 100 million doses of Russia's COVID-19 vaccine Sputnik-V in India.
According to informed sources, the Drug Controller General of India (DCGI) has given only "emergency manufacturing authorisation license" to SII and Bharat Biotech to manufacture and stockpile the vaccines. That means they can only stockpile for the time being. The next step for the DCGI and the review committee will be to see the final trial results and take a final decision on allowing manufacturing and distribution, like any other vaccine or biological product. In the normal process, the DCGI will assess data - with clear statements and evidence about quality, stability, validation, animal toxicity & clinical (safety & efficacy) status of the product and give a 'Market Authorisation for Biologicals' under rules of the Drugs and Cosmetics Act, 1945.
Further, a 'product permission document' with accurate record of technical data has to be submitted, which will thereafter serve as an official reference document during the course of post-approval inspections and post-approval change evaluations. Considering the products may have to seek regulatory approvals from various regulators across the world, DCGI's approval norms have been made similar and simpler, followed by leading food and drug administrations around the world, said sources.
India has already simplified the regulatory process, as done by most other nations, allowing 'Emergency Use Authorisation' for a few re-purposed drugs since the pandemic hit the world. With this, the product has only restricted use and cannot be sourced directly from medical stores. The Vaccine Task Force (VTF) and the National Expert Group on Vaccine Administration for COVID-19 (NEGVAC) is currently spearheading and co-ordinating the vaccination plans. They are developing a digitally enabled ecosystem coordinating various state and central governments, hospitals and cold chain companies to ensure a smooth immunisation process. The plan is to inoculate about 30 crore people by July, who will be frontline healthcare workers like doctors, nurses and senior citizens. States like Maharashtra have already constituted their own expert groups for implementing large-scale immunisation.
They also point out that final approval will be a regulatory challenge across the globe, as Antrax is the only vaccine in history to be granted approval for emergency use authorisation (EUA) in the US.
In 2005, the US Food and Drug Administration (FDA) issued an EUA for Anthrax Vaccine Adsorbed (AVA) for prevention of inhalation anthrax in individuals between 18 and 65 years of age, deemed by the Department of Defense (DoD) to be at heightened risk of exposure due to attack with anthrax. The authorisation followed a 'determination by DoD that there is a significant potential for a military emergency involving a heightened risk to US military forces of anthrax attack'.
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