Health Ministry Issues Draft Guidelines For Development Of Vaccines

Mumbai, 22 Sept 2020:

The Union health ministry has issued draft regulatory guidelines for development of vaccines with special consideration for COVID-19 vaccine to provide guidance to the vaccine developers to ensure that vaccines are well-characterized and manufactured consistently.

Unlike chemical drugs, vaccines are complex heterogeneous class of medical products, and hence specific consideration in respect of development of chemistry, manufacturing, and controls (CMC) data, non-clinical data and clinical data will provide clear understanding of regulatory landscape for their development and approval in a scientific manner.

Therefore, these detailed guidelines and regulatory pathways have been prepared to provide for CMC, nonclinical and clinical development of vaccines including COVID-19 vaccines. These guidelines stipulate that vaccines remain stable at the recommended storage conditions for the duration of clinical trial during clinical development stage and throughout its shelf life post approval. Adequate toxicity data as well as immunogenicity in respect of humoral and/or cell-mediated immune response are generated in nonclinical studies in relevant animal models.

It further stipulates that challenge studies in relevant animal species and non-human primates may be conducted concurrently with clinical trials. Adequate clinical data to establish safety and humoral, cell-mediated immunogenicity are generated.

This will also ensure that Post Marketing Surveillance (PMS) including assessment of Adverse Events Following Immunization (AEFI) and Adverse Events of Special Interest (AESI) is carried out to assess vaccine safety in post market scenario.

The main objective of development of vaccines is to generate adequate data on quality, safety, immunogenicity and/or efficacy to support application for marketing authorization.

As vaccines are heterogeneous classes of medical products, much of the considerations for their development should be given on a product-specific basis.

Requirements may vary depending on the type of vaccine whether it is inactivated or live attenuated microorganisms based or antigen based which is extracted from pathogen or derived from r-DNA technology or by chemical synthesis, or a vaccine containing naked nucleic acid, including plasmids for expressing specific antigens or otherwise, it will also be dependent on manufacturing process, its mechanism of action and the nature of the disease to be prevented as well as target population.

This guidance provided in these documents will be applicable in general for CMC data, nonclinical and clinical development of any vaccine including COVID-19 vaccines.

Import or manufacture for sale of drugs including vaccines are regulated under Drugs and Cosmetics Act, 1940 and Drugs & cosmetics Rules, 1945 and New Drugs and Clinical Trials Rules, 2019. Detailed requirements and guidelines for conduct of nonclinical and clinical studies and approval of new drugs which includes vaccines are specified in the second schedule of New Drugs and Clinical Trials Rules, 2019.

As per the rules, products like vaccines, r-DNA derived products, LMO, Stem cell derived products, gene therapeutic products, etc are always considered to be new drugs. For such products manufacturers are required to obtain manufacturing permission from Central Drugs Standard Control Organisation (CDSCO) under the New Drugs and Clinical Trials Rules, 2019 before Licencing the product under the Drugs and Cosmetics Rules,1945.

The manufacturing licence for such product is granted after joint evaluation and inspection by the concerned State Licencing Authority and CDSCO.

In general, all vaccines including the vaccines against coronavirus infection manufactured / imported into the country are required to comply with the requirements and guidelines specified in the Drugs and Cosmetics Rules, 1945 and New Drugs and Clinical Trials (NDCT) Rules, 2019 and other applicable guidelines published by CDSCO form time to time in case of manufacturer r-DNA derived vaccines the requirements and guidelines prescribed by Department of Biotechnology are also required to be complied with.

In general, all vaccines including the vaccines against coronavirus infection manufactured/imported into the country are required to comply with the requirements and guidelines for CMC specified in the Drugs and Cosmetics Rules, 1945 and NDCT Rules, 2019 and other applicable guidelines published by CDSCO from time to time.

All vaccines are required to be characterized and manufactured in compliance with the Good Manufacturing Practices (GMP) as prescribed in the Rules. Pharmabiz