Clean Data, Clean Pills

How Indian Pharma Companies Can Beat Quality Issues with Data
Governance & Data Immutability

The pharmaceutical industry plays a critical role in global health, with the production and distribution of
drugs saving lives and improving quality of life around the world. However, in recent days, the industry
has been hit by a series of scandals that have eroded trust and put patient safety at risk. Here is a recent
article that explains the issue: https://www.reuters.com/business/healthcare-pharmaceuticals/india-
cancels-licences-some-drug-firms-crackdown-fake-products-says-source-2023-03-30/

One of the biggest issues facing the industry is the problem of data manipulation and contamination,
which has landed many of India's top drugmakers in trouble. Here is an example of that, even though
this is a dated article this problem persists across the industry:
https://www.statnews.com/2019/07/22/indian-pharmaceutical-industry-drug-quality-charges/

Here is an excerpt from the article that highlights the issues:

“The second category of violations pertains to data integrity: maintaining

meticulous and accurate records of all stages of manufacturing and quality
testing. “Bottle of Lies” documents how the FDA’s investigators repeatedly
discovered falsified records at Indian plants. When a batch would fail testing,
rather than destroy the batch or remedy the manufacturing process, the quality
control staff at these plants generally manipulated the records to create false data
that supported releasing the batch to the market.”
India Pharmaceuticals have an opportunity to continue to be the “Pharmacy to the world”. In order to
do that, they need to establish trust and transparency in their process. They can do that through better
data governance.

In this blog post, we will explore how data governance and data immutability can help pharma
companies restore trust and improve the quality of drugs produced.

Data governance is the process of managing the availability, usability, integrity, and security of data used
in an organization. In the pharmaceutical industry, data governance is critical to ensure that data is
captured, managed, and used in a consistent and controlled manner. This helps to eliminate data
manipulation issues and improve the overall quality of drugs produced.

By implementing robust data governance practices, pharma companies can ensure that all data is
captured accurately, and that any changes or updates are recorded and auditable. This can help to
prevent issues such as the ones discovered by the FDA in the case of Dr. Reddy's Laboratories. With
proper data governance practices in place, pharma companies can ensure that they are meeting
regulatory requirements and producing drugs that are safe and effective.

Data immutability, on the other hand, refers to the ability to prevent data from being modified or
deleted after it has been recorded. This is critical in the pharmaceutical industry, where data integrity is
paramount. By using data immutability technologies like blockchain, pharma companies can ensure that
all data is tamper-proof, transparent, and auditable. This can help to build trust with regulators and
customers and improve the overall quality of drugs produced.

With data immutability technologies from Aldefi, pharma companies can create a tamper-proof record
of all data related to drug production, including the results of quality control tests, the manufacturing
process, and any other data relevant to the drug's production. This can help to prevent issues such as
the ones discovered by the FDA in the case of Dr. Reddy's Laboratories, where the company was testing
drug batches in a laboratory that the FDA was never told existed and often shipping to the U.S. products
that had repeatedly failed tests for impurities.

By implementing data governance and data immutability technologies, pharma companies can restore
trust and improve the quality of drugs produced. These technologies can help to ensure that data is
captured accurately, that any changes or updates are recorded and auditable, and that data is tamper-
proof, transparent, and auditable. This can help to prevent issues such as data manipulation and
contamination, which have eroded trust in the pharmaceutical industry.
Photo Credits: Mettler-Toledo

In conclusion, data governance and data immutability are critical to restoring trust in the pharmaceutical
industry. By implementing these technologies, pharma companies can ensure that they are meeting
regulatory requirements and producing drugs that are safe and effective. These technologies can help to
prevent issues such as data manipulation and contamination, which have eroded trust in the industry.
With proper data governance and data immutability practices in place, pharma companies can build
trust with regulators and customers and improve the overall quality of drugs produced.

About Aldefi:
Aldefi software is the ultimate defender of your enterprise's sensitive and vital data, ensuring that it
stays unaltered, secure, and trustworthy. Our software boasts advanced features, including data
immutability, consolidated audit trails that keep tabs on changes to your organization's sensitive data,
and data contracts that protect against schema alterations during data producer-consumer interactions.

Our cutting-edge technology empowers businesses to achieve unparalleled levels of data security. By
leveraging these state-of-the-art capabilities, Aldefi software provides robust solutions that guarantee
the integrity, trustworthiness, and security of your data. You can rest easy knowing that your company's
critical information is in safe hands with Aldefi.