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A new regime

  • Published
    26th Jun, 2023

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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