In recent developments, the Gujarat Food and Drug Control Administration (FDCA Gujarat) has taken stringent regulatory actions against eleven pharmaceutical companies situated in Bharuch, Baroda, Ahmedabad, and Gandhinagar.
This article delves into the details of the regulatory measures and their implications for the pharmaceutical industry.
Risk-Based Inspections (RBI)
The collaborative efforts with the Drugs Controller General of India (DCGI) have resulted in the cancellation of licenses for four companies and the cessation of production for one, specifically targeting non-compliance and quality concerns.
This joint initiative aims to ensure the pharmaceutical sector‘s adherence to regulatory standards.
Phase-2 Regulatory Scrutiny
Seven companies in Ahmedabad and Gandhinagar faced regulatory scrutiny during phase-2 inspections.
Licenses for four were canceled due to poor compliance with hygiene standards, quality control, and Good Manufacturing Practices (GMP), especially affecting MSMEs.
This phase also witnessed plant shutdowns, emphasizing the severity of the compliance issues.
Insights from Gujarat FDCA Commissioner
FDCA Gujarat Commissioner Dr. H G Koshia shed light on the situation, emphasizing the approval for restarting operations of a pharmaceutical unit in Bharuch district that complied with Form 25 and 28 licensing requirements.
The decision follows inspections in June 2023, where manufacturing halts were enforced due to non-compliance with GMPs and inadequate maintenance of analytical instruments.
Quality Woes in Vadodara
In Vadodara, two companies received show cause notices (SCNs), and four product licenses were canceled due to quality issues.
This underscores the broader challenges faced by pharmaceutical companies in maintaining stringent quality control measures.
Third Phase: Focus on Veterinary Drug Manufacturers
The third phase of risk-based inspections targeted four companies involved in veterinary drug production.
Three were ordered to cease manufacturing following an SCN, citing quality lapses detrimental to patient safety, particularly in the production of oral solid dosage forms.
Extension of Scrutiny to Drug Testing Labs
This move reflects a proactive approach to ensure the quality and safety of pharmaceutical products in the market.
Industry Plea for NABL Accredited Testing Labs
Industry experts are urging the Union health ministry to authorize NABL-accredited private testing labs.
This plea is in response to the Directorate General of Foreign Trade’s (DGFT) order, mandating the testing of cough syrup samples before exports due to contamination concerns.
The DGFT’s order, issued on May 22, 2023, restricts the export of cough syrups until samples are tested in government laboratories.
The Way Forward: Scrutiny on Testing Labs
In response to the international ramifications, the regulatory bodies are extending their scrutiny to testing labs.
his aligns with the broader goal of ensuring the safety and quality of pharmaceutical products not only for domestic consumption but also for exports.
Industry’s Call for NABL Accreditation
Industry experts emphasizing the need for NABL accreditation underscores the importance of standardized testing procedures.
This move can bolster confidence in the quality of pharmaceutical products, both domestically and internationally.
The regulatory actions by FDCA Gujarat signal a commitment to upholding pharmaceutical standards.
While these actions may pose short-term challenges for companies, they are essential for the long-term integrity and reputation of the industry.
The collaborative efforts with DCGI and the focus on testing labs reflect a comprehensive approach to address compliance and quality concerns.
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.
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