Express Pharma MagazineRaising GMP standards for vaccines

September 23, 2021by arp_admin0

India has huge vaccine manufacturiing capabilities but ensuring strict adherence to Good Manufacturing Practices (GMP) will be crucial to build credibility in the safety and effectiveness of its vaccines for continued progress. India Vaccine Inc should ramp up its capabilities in terms of people, technology and processes to ensure top-notch standards in GMP and data documentation.

India was the largest (second if the European Union is considered as one component) vaccine-exporting country in the pre-pandemic period (specifically 2017-19). Further, it is also home to the world’s largest vaccine manufacturer – namely, the Serum Institute of India, which accounts for the production of more than 1.5 billion doses. The country exports vaccines (for polio, diphtheria, tetanus, pertussis, BCG, hepatitis B, measles, mumps, rubella, etc.) to more than 170 countries, and 65 per cent of the children worldwide have received at least one vaccine manufactured by the Serum Institute. While the years 2020 and 2021 registered a reduction in the export of vaccines from India, it continues to be amongst the top five countries in the production of COVID-19 vaccines worldwide.

This being noted, India faced global regulatory blocks for its home-grown vaccine until April 2021-22. However, with the availability of additional trial data from April/May 2021 onwards, and published studies and research conducted by independent research centres (such as papers published by the Lancet, the Cambridge University Press and Dr Fauci’s institute), the discomfiting skepticism has eased. Further, basis the representations by the Government of India, Covaxin manufactured by Bharat Biotech may be approved by the World Health Organization (WHO) for emergency use by the end of this month.

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