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homehealthcare NewsPharma compliance post the COVID 19 pandemic witnessing a tough run

Pharma compliance post the COVID-19 pandemic witnessing a tough run

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By Ekta Batra  |  Mar 6, 2023 3:05 PM IST (Published)
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India, according to compliance experts, has some of the best facilities and are subject to the same type of inspections seen globally. However the reason for the uptick in regulator action post COVID-19 on Indian plants is possibly due to a combination of a higher volume of inspections due to a backlog and also unresolved and fresh deficiencies in facilities.

healthcare | Mar 6, 2023 3:05 PM IST
The post COVID-19 period seems to have been tough for Indian pharma companies from a compliance perspective. There have been around 60 official action indicated status (AIS) issued from November 2020 to 2022 and around 20 import alerts issued from 2020 to 2023 to Indian companies.

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For example, even if a company adopts global standards such as Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), the enforcement of the standards differs.
So what are some steps towards remediation?
Regulators point out that there has to be more empowerment given to employees. With an environment of feedback and free flowing dialogue within companies, critical information is exchanged.
Also, changing the duality of the mindset when it comes to manufacturing for India and for developed countries like the US.
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