A new regime – India must keep an eye on adverse reactions from new drugs and vaccines

Source: The post is based on an article “A new regime – India must keep an eye on adverse reactions from new drugs and vaccines” published in The Hindu on 26^th June 2023.

Syllabus: GS 2 – Issues Related to Health

Relevance: concerns associated with drugs development in India

News: India’s first indigenous mRNA vaccine for the Omicron variant, GEMCOVAC-OM has been approved under emergency use guidelines by the Drug Controller General of India.

About the vaccine

Read Here: GEMCOVAC-OM: India’s first mRNA vaccine against Omicron approved

What is the significance of this vaccine for India?

Although the WHO has officially declared the end of the pandemic, the development of the vaccine demonstrates India’s capacity to produce an mRNA vaccine, which can be rapidly manufactured and scaled up, offering protection against future viruses.

How are vaccines developed?

Vaccine development involves different testing stages, including petri dish studies, animal trials, and human testing with expanding cohorts. These stages are meant to ensure that vaccines produced are effective and do not cause harm.

However, the scenario during the pandemic was different. Therefore, drug regulators globally allowed vaccine makers to combine multiple stages while evaluating efficacy.

This flexibility was facilitated through the framework of Emergency Use Authorizations (EUA).

What are the differences between drug approval in India and the US?

In the U.S., Food and Drug Administration (FDA) takes many years to evaluate new drugs and vaccines.

Whereas, India’s regulatory system focuses on first evaluating a drug formulation approved abroad and then assessing its suitability in India.

Further, the history of clinical trials in India has been characterized by mistrust, arbitrary decrees, and lax regulations. 

In India, there is still a long way to go before there is a reliable system of staged clinical trials and independent regulation for new drugs.

What can be the way ahead?

The FDA still authorises updated COVID-19 vaccines under EUA provisions because people are still dying globally due to covid. However, this alone cannot be the basis for continuing with the EUA regime in India.

India needs to establish a streamlined regulatory process that eliminates unnecessary steps while keeping a close watch on safety and unfavourable responses from new vaccines or drugs.