Industry

Quality concerns lead to Suspension of Manufacturing Licenses in Multiple Pharma Companies

Licenses for specific products have been either suspended or cancelled for another 66 companies.

The Health Master

August 11, 2023

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Drug Medicine Pharma manufacturing Factory Industry Unit — Picture: Pixabay

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Last Updated on December 31, 2023 by The Health Master

Suspension of Manufacturing Licenses

In a recent development that has raised concerns in the pharmaceutical industry, approximately 40 pharmaceutical companies have ceased manufacturing operations.

Licenses for specific products have been either suspended or cancelled for another 66 pharmaceutical companies.

These actions have been taken following an in-depth risk-based evaluation conducted earlier this year on 162 firms in the sector.

Union Health Minister Dr. Mansukh Mandaviya, while addressing Parliament, revealed alarming statistics and developments in the pharmaceutical sector.

A notable case has even led to the registration of a First Information Report (FIR), highlighting the seriousness of the situation.

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Widespread Scrutiny and Regulatory Actions

The Central Drugs Standard Control Organization (CDSCO), in conjunction with State drug Authorities, conducted inspections that led to the issuance of warning letters in 21 cases.

A staggering total of 143 show-cause notices were also handed out as part of the regulatory process.

Identified Deficiencies

Government officials, representing the health ministry, expressed their concerns by revealing various inadequacies unearthed during the inspections.

The highlighted deficiencies encompassed a range of critical areas:

Raw materials not undergoing pre-use testing
Absence of product quality reviews
Inadequate investigation into quality failures
Insufficient infrastructure to prevent cross-contamination
Suboptimal design of manufacturing and testing areas
Shortage of qualified professionals
Inadequate documentation practices

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Urgent Adoption of Good Manufacturing Practices (GMP)

The dire need for rectification and enhancement in the pharmaceutical manufacturing sector has prompted the government to advocate for the adoption of Good Manufacturing Practices (GMP) on par with internationally recognized standards set forth by the World Health Organization (WHO).

The existing scenario reveals that only a mere 2,000 out of India’s 10,500 manufacturing units adhere to these crucial practices.

Challenges to India’s Reputation in Pharmaceuticals

India, renowned for positioning itself as a global provider of cost-effective and high-quality generic medicines, faces a challenging crossroads.

There have been multiple instances where foreign countries have alleged the presence of contamination in pharmaceutical products originating from India.

Particularly concerning are cases involving syrups, eye drops, and ointments.

Conclusion

As the government intensifies efforts to rectify quality concerns in the pharmaceutical sector, the challenge lies in maintaining India’s reputation as a reliable supplier of affordable and safe medicines while addressing the identified shortcomings.

Urgent action to bolster manufacturing practices and ensure stringent quality control is pivotal to regaining the trust of both domestic and international consumers.

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

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