Major cracks down on Pharma MSMEs for gross GMP violations

August 29, 2023

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Last Updated on January 5, 2024 by The Health Master

Pharma MSMEs

The Gujarat Food and Drug Control Administration (FDCA) has issued show cause notices to three pharma MSMEs in Ahmedabad and Baroda for gross violations of good manufacturing practices (GMP) norms.

The companies have been asked to stop production immediately and furnish reports on quality control and GMP compliance.

The FDCA’s crackdown is part of a series of risk-based inspections being carried out all over India as a result of reports that Indian pharmaceutical companies were exporting contaminated medications.

Click for more articles on Gujarat FDCA

Round of inspections: Pharma MSMEs

In the latest round of inspections, the FDCA has also canceled the license of one section of a company that produced unstable products with multiple quality failures.

The risk-based inspections are based on current good manufacturing practices (cGMP) and good laboratory practices (GLP) under the Drugs and Cosmetics (D&C) Rules, 1945.

The inspections cover a wide range of areas, including sanitation, hygiene, self-inspection, quality audits, prevention of cross-contamination, and bacterial contamination during production.

The FDCA’s actions are a clear signal that the government is taking the issue of pharmaceutical quality very seriously.

The inspections are also a reminder to pharma companies that they must comply with GMP norms in order to protect public health.

Observations

Risk-based inspections:

The FDCA is conducting risk-based inspections of pharma companies to audit their compliance with GMP norms. These inspections are based on the company’s size, location, history of compliance, and the type of products they manufacture.

GMP violations:

The FDCA has found a number of GMP violations at the three pharma MSMEs in Ahmedabad and Baroda.

These violations include:

Poor sanitation and hygiene practices
Inadequate quality control measures
Lack of proper documentation
Failure to prevent cross-contamination
Bacterial contamination of products

Show cause notices:

The FDCA has issued show cause notices to the three pharma MSMEs. The companies have been asked to explain why their licenses should not be cancelled.

Possible penalties:

If the companies are found guilty of violating GMP norms, their licenses could be canceled. They could also be fined or imprisoned.

Impact on patients:

The GMP violations at these pharma MSMEs could have a serious impact on patients. Medicines that are not manufactured in accordance with GMP norms may not be safe or effective.

Must read: Understanding GMP, cGMP, and WHO-GMP

Major Key Points:

The Gujarat FDCA has issued show cause notices to three pharma MSMEs in Ahmedabad and Baroda for gross violations of GMP norms.
The companies have been asked to stop production immediately and furnish reports on quality control and GMP compliance.
The FDCA’s crackdown is part of a series of risk-based inspections being carried out all over India as a result of reports that Indian pharmaceutical companies were exporting contaminated medications.
In the latest round of inspections, the FDCA has also canceled the license of one section of a company that produced unstable products with multiple quality failures.
The risk-based inspections are based on current good manufacturing practices (cGMP) and good laboratory practices (GLP) under the Drugs and Cosmetics (D&C) Rules, 1945.
The inspections cover a wide range of areas, including sanitation, hygiene, self-inspection, quality audits, prevention of cross-contamination, and bacterial contamination during production.
The FDCA’s actions are a clear signal that the government is taking the issue of pharmaceutical quality very seriously.
The inspections are also a reminder to pharma companies that they must comply with GMP norms in order to protect public health.

Click for more articles on GMP

Conclusion:

The Gujarat FDCA’s crackdown on pharma MSMEs for GMP violations is a welcome move. It is important to ensure that medicines are manufactured in a safe and hygienic manner.

The FDCA’s actions should send a strong message to pharma companies that they will be held accountable for violating GMP norms.

Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.