Pharma compliance post the COVID-19 pandemic witnessing a tough run
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.
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.
Including the likes of Sun Pharma and Glenmark. So, what has resulted in this uptick? And what are the key trends when it comes to quality and compliance in India?
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.
Data integrity is not an India issue. However, regulators continue to find data integrity issues, which sometimes is not only about falsifying data but can also be about not reporting data accurately.
Also Read | Data integrity, difference in regulatory standards and more — Takeaways from BioAsia compliance panel
Hence data integrity can be linked to basic issues such as incomplete records to forging of signatures. Data integrity in a plant points to the lack of a strong internal audit programme.
The US drug regulator points to the fact that they find data integrity issues not only across pharma products but across other commodities such as food and clinical trials that they oversee in the country.
One of the reasons for it, they say, is due to the lack of understanding of procedures by people who are executing the tasks. Sometimes there is a lack of culture to accept or make mistakes, which results in falsifying or hiding data.
One of the key issues has been why do regulatory standards differ between regulators, while a plant is cleared by the US Food and Drug Administration (FDA), the same isn't by say the UK Medicines and Healthcare products Regulatory Agency (MHRA). That is possibly due to differing compliance standards between regulators.
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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