Last Updated on August 15, 2023 by The Health Master
Suspension of Manufacturing Licenses
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.
A notable case has even led to the registration of a First Information Report (FIR), highlighting the seriousness of the situation.
Widespread Scrutiny and Regulatory Actions
A staggering total of 143 show-cause notices were also handed out as part of the regulatory process.
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
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.
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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