The Health Ministry recently issued a draft regulatory guideline for vaccine development with special attention on the COVID-19 vaccine to offer vaccine developers guidance to make sure that the vaccines are well categorized and manufactured consistently.

In contrast to chemical drugs, vaccines are a complicated unrelated class of products and thus specified consideration based on the development of chemistry, manufacturing as well as controls data, clinical data, as well as non-clinical data, will offer the best understanding of all guiding landscape for their development as well as approval in a good way.

Thus, these comprehensive guidelines, along with controlling pathways, have been prepared to offer for CMC and non-clinical and clinical development of the vaccines that also include Covid-19 vaccines. These guidelines specify that vaccines stay stable at required storage settings for a clinical trial period at the time of the clinical development stage and throughout the shelf life after approval. Sufficient toxicity data and immunogenicity in reference of humoral and cell-mediated immune responses are created in some non-clinical studies in some relevant animal models.

It further specifies that some of the challenge studies in some of the pertinent animal species and non-human primates might be conducted alongside the clinical trials. Sufficient clinical data for the establishment of safety and humoral, cell-mediated immunogenicity are created.

This also ensures that Post Marketing Surveillance involving the assessment of Adverse Events that follows immunization and Adverse Events of Special Interest is done to assess vaccine safety in the post-market scenario.

The main aim of vaccine development guidelines is to create sufficient data on the best quality, safety, efficacy and immunogenicity to upkeep marketing authorization applications. As vaccines belong to a heterogeneous medical product class, maximum consideration for vaccine development must be given on a product-specific basis.

Needs might vary based on the kind of vaccine, whether it is inactivated or live-attenuated microorganisms based or simply antigen-based derived from the pathogen, or r-DNA technology or by chemical synthesis process. Requirements also varied based on the process of manufacture, method of action, and the nature of diseases presented along with the target population.

According to the Drug and Device regulations in India, products like vaccines, LMO, stem cell-derived products, and rDNA derived products are considered new drugs. For such products, the manufacturer must acquire manufacturing permission from CDSCO as per the New Drugs and Clinical Rules. The license for manufacturing this product is given after proper evaluation and inspection by the respective state licensing authority and CDSCO.

Thus all vaccines, including Covid-19 vaccines that are manufactured or imported to our country, must abide by the requirements and all guidelines specified in latest modifications pertaining to Drugs and Cosmetics Rules 1945 and New Drugs and Clinical Trials Rules 2019.

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