26th June 2023 (7 Topics)
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A new regime
Context:
Recently, the Drug Controller General of India has cleared, under the provisions of ‘emergency use authorisation’, of a new mRNA vaccine for COVID-19 developed by Pune-based Gennova Biopharmaceuticals, which is a pioneer in India for mRNA vaccines.
New variants and vaccines:
- The new GEMCOVAC-OM vaccine: This vaccine is specifically designed to target the Omicron variant of COVID-19, which is significant because it demonstrates that an Indian company has the capability to produce mRNA vaccines.
- WHO’s stance on variants: As public interest in new variants and vaccines has waned, leading to a decline in the uptake of booster doses in India.
- Significance: GEMCOVAC-OM represents a promising step towards India's preparedness for future viruses, showcasing the country's potential to develop effective vaccines against emerging threats.
Formation and Approval ecosystem in India:
- New Drugs and Clinical Trials Rules, 2019: The introduction of EUA for COVID-19 vaccines in India was made possible due to a technicality in the "New Drugs and Clinical Trials Rules, 2019," rather than evidence-based assessments or a well-established regulatory framework.
- Old system and slow process: In India, the regulatory system has historically focused on evaluating formulations that have already been approved abroad, rather than conducting extensive clinical trials domestically.
- Need for fast process: India should establish a streamlined regulatory process that eliminates unnecessary steps but maintains a strong focus on safety and monitoring adverse reactions for new drugs and vaccines.
Concerns with Emergency-Use vaccines:
- Ensures that vaccines are safe and effective process: Vaccine development typically follows a progressive testing process, starting from laboratory experiments to animal studies and gradually expanding human trials.
- Emergency usage and short-cuts: Global drug regulators, including the U.S. FDA, allowed vaccine developers to combine and expedite stages of testing to evaluate efficacy, leading to the adoption of emergency use authorizations (EUA).
- COVID’s comeback: It is important to note that while the pandemic might be considered over, COVID-19 is still a prevalent global health concern, causing thousands of deaths.
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