Workshops for regulators and mfr on vaccine development: Govt

Union health ministry also planning to strengthen pharmacovigilance systems for vaccine adverse drug reaction (ADR) in collaboration with global regulators.

Meeting Committee FDA
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The Union health ministry is planning to conduct workshops for regulators and manufacturers in the country for understanding latest technologies for vaccine development.

The latest in the series is coding process using MedDRA terminologies which has under its scope products related to vaccines, pharmaceuticals, biologics and drug-device combination products. The terminology is used through the entire regulatory process from pre-marketing to post-marketing, and for data entry, retrieval, evaluation and presentation.  

MedDRA is a clinically-validated international medical terminology developed under the auspices of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) and is used by regulatory authorities and the regulated biopharmaceutical industry.

ICH, formerly the International Conference on Harmonisation (ICH), has a 25-year track record of successful delivery of harmonised guidelines for global pharmaceutical development as well as their regulation, and a longer standing recognition of the need to harmonise.

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The need to harmonise was realized as it was important to have an independent evaluation of medicinal products before they are allowed on the market was reached at different times in different regions. However in many cases the realisation was driven by tragedies, such as that with thalidomide in Europe in the 1960s.

This comes close on the heels of union health ministry also planning to strengthen pharmacovigilance systems for vaccine adverse drug reaction (ADR) in collaboration with global regulators, Pharmacovigilance Programme of India (PvPI) and immunization programme of India to meet the requirements for reporting vaccine ADRs.

“This collectively will be instrumental in achieving vaccine pharmacovigilance right from collecting to coding and finally sending individual case safety reports (ICSRs) to PvPI,” according to an official associated with the development.

Prime Minister Narendra Modi during his keynote speech at the inauguration of Grand Challenges meeting 2020 recently also reiterated that government is also putting in place a digitised network to deliver the vaccine to its citizens. “This digitised network along with digital health IDs will be used to ensure immunisation of our citizens,” he emphasized.

Grand Challenges, which was launched in 2003 by Bill Melinda Gates foundation, fosters innovation to solve key challenges in global health and development. The initiative focuses on fourteen major challenges including vaccine development, development of needle free delivery system for the vaccine, cure for chronic infections among others.

At the inaugural session, Bill Gates also stressed the need for research into three vital fields to remain prepared for the next pandemic – development of vaccine platforms so that vaccines against new infections can quickly be developed and manufactured, monoclonal antibodies and more effective ways of manufacturing it quickly for a pandemic situation and diagnostic platforms that are sensitive and specific and widely available so that huge number of people can be tested and accurately diagnosed.

Vaccine Safety workshop on ‘Literature Search and Synthesis on Vaccine Safety’ was also organised by World Health Organization (WHO) – India in New Delhi last year to enhance the understanding of all stakeholders on literature search and synthesis on vaccine safety.

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