Last Updated on July 12, 2024 by The Health Master
DCGI
In a move to ensure patient safety and enhance the reputation of Indian drugs, the Drugs Controller General of India (DCGI), Rajeev Raghuvanshi, has announced a multi-pronged approach that includes stricter inspections, improved documentation, and a revolutionary digital transformation plan.
Expanding the Audit Net
Building on the success of manufacturing facility inspections, the CDSCO along with State regulators is extending its reach to other critical players in the pharmaceutical ecosystem.
Public testing labs and Clinical Research Organizations (CROs) are now also under the scanner.
Over 600 units have been inspected so far, demonstrating the regulator’s commitment to comprehensive quality oversight.
Schedule M Audits
The focus on quality extends to ensuring compliance with the latest Good Manufacturing Practices (GMP) guidelines.
Starting July 1st, the CDSCO along with State Regulators will be auditing large pharma units for adherence to the revised Schedule M regulations, a cornerstone of GMP compliance.
Around 250 companies have been identified for these audits.
Recognizing the need for robust internal expertise, Raghuvanshi proposed the creation of an in-house scientific cadre at the CDSCO.
This team would be responsible for reviewing applications from pharmaceutical companies, currently handled solely by external subject matter experts.
An internal cadre is expected to improve efficiency and consistency in decision-making, potentially expediting the review process by 50-60%.
The Digital Drug Regulatory System
The DCGI unveiled a groundbreaking plan for a Digital Drug Regulatory System (DDRS).
This ambitious project envisions a centralized online platform for all pharmaceutical regulations.
Initially, it will function as an enhanced version of the existing SUGAM portal.
Over time, the DDRS will integrate state drug controllers, customs and GST departments, research institutions like ICMR and IPC, and even retail outlets.
The ultimate goal is to create a comprehensive “raw material to patient” tracking system, ensuring transparency and accountability across the entire pharmaceutical supply chain.
The DCGI’s multi-faceted approach signifies a new era of quality consciousness in the Indian pharmaceutical industry.
By combining stricter enforcement, a focus on scientific expertise, and a commitment to digital transformation, India is poised to solidify its position as a global leader in safe and reliable pharmaceuticals.
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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