Latest Indian Regulatory Guidelines For The Development Of Covid -19 Vaccine

 

The pharmaceutical and the life science industry have been the point of public discussion in this time of the pandemic. The whole enterprise's role was vital not only for the development of different treatment methods or vaccines for Covid -19 but also to make sure that supplies for another kind of disorder remain uninterrupted.

The regulator of drugs also acted rapidly and definitively at the time of pandemic to make sure that all pharmaceutical companies receive the necessary support so that they can maintain an adequate supply of medicines.

Coronavirus still poses a threat to the whole global population. It spreads very quickly, and a large volume of the population is vulnerable to it. The vaccine offers some degree of protection by training the body's immune system to fight the virus. Because of this, the world raced to develop an efficient vaccine to end the pandemic. But for proper development, there are some necessary regulatory guidelines.

This document of guidelines is directed to the national authorities, who are accountable for proper management of deployment, execution, and supervision of Covid-19 vaccines. Like in most of the countries, the setting up of a Covid-19 vaccine deployment is in proper alignment with the Ministry of Health, these regulatory guidelines also keep the same intention to develop the coordination mechanism across every sector of the Government and multi-stakeholders.

The clinical progress of a Covid-19 vaccine is a complicated process that involves multi-disciplinary research along with sufficient laboratory facility, non-clinical and clinical data to make sure it is safe and efficient, and of good quality. Across the globe, India is one of the primary producers of vaccines and meets a significant part of the population's world requirement.

A comprehensive guideline for vaccine development will offer a clear regulatory step to the developers of the vaccine. The Central Drugs Standard Control Organization (CDSCO) published draft guidelines for developing a vaccine in such a grave situation. It came up with some guidelines considering the Drug and Cosmetics Rules, 1945 and the New Drugs and Clinical Trials Rules, 2019, along with International perspectives of WHO, USFDA. This guideline helps in easing the development of a sufficient, best quality, and safe vaccine.

Research organizations should follow all the guidelines published by CDSCO during the development and approval of vaccines.  But these guidelines are vibrant as well as recommendations. It does not replace statutory laws.

Stakeholders having any queries about these guidelines can send it to dci@nic.in, and vgsjdci@gmail.com. The guidelines are updated by CDSCO depending on several challenges that researchers face at the time of execution of the advanced scientific and technological methodologies.