Abstract

EFFECT OF COVID-19 ON PHARMACOVIGILANCE & HOW GLOBAL LIFE SCIENCE COMPANIES CAN BE BETTER PREPARED FOR THE FUTURE PANDEMICS

Mohd. Arif Uddin* and Sameeksha Poldasari

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Abstract

It is more than 2 years since the COVID-19 outbreak reported its first suspected cases in China. At the start of the pandemic, many countries including India seemed „safe‟ and insulated as they watched many high-income countries across the world grapple with the devastating effects of the coronavirus. Sadly, this „safe‟ state only lasted until January 27, 2020, in India when a 20 yr old female presented to the Emergency Department in General Hospital, Thrissur, Kerala, with a one-day history of dry cough and sore throat and was confirmed as having covid suspect on 30 January 2020. India faced multiple major challenges on the COVID-19 front. Thus the importance of monitoring the safety of drugs, vaccines, and medical devices has been stressed in the backdrop of a world health crisis. While the healthcare industries in every country are bent down upon coming up with effective vaccines, the stakeholders of Pharmacovigilance / Drug safety have been proactively working towards monitoring their safety. The main challenges faced by pharmacovigilance during the pandemic include the collection of data, analysis of data, and safety reporting, and the key problems faced by life science were in drug manufacturing, demand for an existing drug, and launch of a new drug, research, and development. However, the Pharmacovigilance industry has been facing persistent challenges in its functioning, owing to operational disruptions due to the pandemic. The volatility of the situation demands clinical remedies and therefore, pharmaceutical giants have been under duress, making every effort to bring about timesensitive and effective solutions in the form of Covid-19 drugs and vaccines.

Keywords: Pharmacovigilance, Drug Safety, Materovigilance, Clinical Remedies, Good Pharmacovigilance Practices (GPP).