It has been more than a year-long struggle now with restrictions, efforts, recovery and fight by nations around the world against the virus but the pandemic is showing no signs of abating. Just when the world starts to settle down, resuming normalcy in some sense, the next wave hits us with new strains of virus again infecting masses and pushing nations towards yet another lockdown situation.
People were just reviving from the first outbreak of the pandemic, but then the second and third wave of the virus struck causing even more fatal and grimmer situations across the world. Since the vaccine is the only silver lining, everyone is looking towards select pharmaceutical companies to produce millions of doses of vaccines within a span of days and months.
However, it has been seen that the larger portion of doses are being supplied and reserved for developed countries as they are home to these select pharma companies, leaving poor and developing countries for want of vaccine supply. At the same time, vaccine companies are seen working towards speeding up production to best meet the global requirement. One of the biggest manufacturing deals have been locked by AstraZeneca-University of Oxford. The developer contracted 25 firms across 15 countries for manufacturing 2.9 billion vaccine doses[1]. The largest partnership was with the Serum Institute of India in Pune in June 2020 to produce one billion doses of the AstraZeneca vaccine.
Since India is the largest vaccine producer worldwide, it accounts for more than 60 per cent of the COVID-19 vaccine supply to the United Nations International Children’s Emergency Fund (UNICEF). Several Indian pharma companies are also continuing their efforts to develop a vaccine and testing its safety and immunogenicity in the Indian population. Not only industry, but the academia, regulatory bodies and Indian governments are working together to fight against the pandemic. To further this combined effort, some noticeable changes are being made in the Indian legal framework towards vaccine development and availability.
National legal framework to regulate COVID-19 vaccine
The Central Drugs Standard Control Organization (CDSCO) has been authorised to grant approval for conducting non-clinical and clinical trials, to grant manufacturing, imports, sale and distribution license to the manufacturer for medicinal and biological products, diagnostic tests and medical devices therein. Since a vaccine is categorised as a new drug under D&C Act, it also needs to abide by the requirements for conducting clinical trials under the New Drugs & Clinical Trials (NDCT) Rules, 2019.
Accelerated approval process
The Review Committee on Genetic Manipulation of the Department of Biotechnology, together with CDSCO, has formulated an accelerated regulatory approval policy and also formed an empowered committee, which could undertake review and examination of vaccine and drugs applications for COVID on priority without compromising on safety aspects. The accelerated approval process does not mandate a bridging study to be performed on the local population which is generally required under D&C Act. The accelerated approval of a new drug rather requires significant safety and efficacy data including details of the potential risk of vaccine-associated Enhanced Respiratory Disease (ERD) generated from its parallel ongoing/completed non-clinical/clinical experiments in other countries. For example, ZydusCadila (ZyCoV-D), Serum Institute of India (Covishield) and Bharat Biotech (COVAXIN) have received approval for their vaccines under the accelerated process.
Non-clinical and clinical study of COVID-19 vaccine
A new COVID-19 vaccine seeking approval from CDSCO for a first-in-human clinical trial will be required to submit non-clinical safety studies to substantiate its safe...
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