Protecting human life becomes the top priority in any crisis, and this aspect cannot be emphasized better than appreciating the fact that we have been in a lock down, limited or compete, for almost 5 months now, and economic progression has become secondary for nations across the globe. It is not as if the pandemic is behind us, and things are returning back to normalcy because we are in a better situation. People have realized that a stringent lock down is not a long term solution, and we need to get back to the maximum extent possible without overstressing our healthcare infrastructure. Needless to mention, awareness about the precautions to be adopted to stay away from COVID-19 has drastically improved during the lockdown, but there is still a long way to go and India is creating world records in the number of COVID-19 new cases coming up every day.
Given the grim situation, the only practical solution seems to be an effective COVID-19 Vaccine (Vaccine), and world over, more than one hundred Vaccine candidates are being developed. Russia has announced its Vaccine, and everyone is wondering that if the solution has been found, why is not being made available.
As a response, it may be noted that the development of a vaccine usually takes eight to ten years and it involves multiple time consuming steps such as conducting research, undertaking clinical and phase-wise trials, assessing efficiency, side-effects and any long-term impact, undergoing stringent testing protocols and strict regulatory scrutiny. In a nut shell, it is the fear of the unknown risks which is holding back the rolling out of the Vaccine, and marketing and sale of the same will not be allowed until its benefits outweigh the risks.
Per the Indian regulatory framework prescribed under the Drugs and Cosmetics Act, 1940 and applicable regulations, a vaccine falls in the category of “drug”, and any new drug would have to comply with the provisions of New Drugs and Clinical Trial Rules, 2019 and the approval mechanism provided thereunder.
In the context of Covid-19, the drug regulator had on May 25, 2020 issued a Rapid Response Framework (Rapid Framework) to prescribe a fast-track approval mechanism for the Vaccine, and it permits use of studies conducted outside India, subject to the quality, results and other compliances. The efforts of the Government of India (GOI) in coming up with fast-track process are commendable and will go a long way in providing swift approvals for Vaccine.
India, known as the vaccine capital of the world, is currently catering to over fifty per cent of the worldwide demand of many vaccines. With abundance of resources, cheap man-power and new reforms by the GOI, the Indian pharma industry is best placed to exploit the opportunity and manufacture the Vaccine at large scale at economic prices.
In this context, it is notable that Serum Institute of India has partnered with Gavi and the Bill & Melinda Gates Foundation to manufacture and deliver up to 100 million doses of the potential Vaccines for India and low and middle income countries in 2021. More collaborative partnerships at a global level are expected on these lines.
In order to effectively distribute the Vaccine, the National Expert Group on Vaccine Administration for Covid-19 was constituted to discuss conceptualization and implementation mechanisms, including setting up of a digital platform for management of inventory and delivery of vaccines, tracking vaccination process with specific focus on last mile delivery and related issues such as procuring, financing and distributing the vaccine. It is expected that the concerned committee will engage with all stakeholders including state governments and vaccine manufacturers.
At a global level, India has co-sponsored a UN General Assembly resolution that called for a fair, transparent and equitable access to essential medical supplies and any future vaccines developed to fight COVID-19 pandemic.
Despite best efforts, it seems like the Vaccine will take some more time and until then we will have to espouse the “social vaccine”, i.e., physical distancing, hand hygiene and face masks.
(Arvind Sharma is Partner, Shardul Amarchand Mangaldas and Co. Views expressed are personal.) – Financial Express