DCGI plans unified Online Portal for Drug Quality and Patient Safety

Last Updated on December 31, 2023 by The Health Master

Online Portal for Drug Quality and Patient Safety

The Drugs Controller General of India (DCGI) is collaborating with following to create a unified online portal:

• State drug controllers (SDCs),
• Indian Pharmacopoeia Commission (IPC),
• Bureau of Indian Standards (BIS),
• Indian Council of Medical Research (ICMR), and
• National Institute of Biologicals (NIB) .

This portal aims to enhance regulatory oversight, ensure the quality of drugs, and prioritize patient safety.

The Objective of the Unified Online Portal:

The proposed unified online portal seeks to achieve the following goals:

Ensuring Safe and Efficacious Medicines:

The portal will facilitate the transparent delivery of safe and effective medicines to consumers by establishing traceability from producers to end-users.

Accountability of Stakeholders:

All involved stakeholders, including drug manufacturers, retailers, and wholesalers, will be held accountable for maintaining drug quality and ensuring effective traceability through the portal.

Discussion with Union Minister of Health and Chemicals:

Recently, the idea of the unified online portal was discussed with Dr. Mansukh Mandaviya, the Union Minister of Health and Chemicals.

The Importance of Drug Regulatory Systems:

Dr. Rajeev Singh Raghuvanshi, DCGI, emphasized the crucial role of drug regulatory systems in safeguarding public health.

The system ensures the safety, efficacy, and quality of human and veterinary drugs, medical devices, diagnostics, and cosmetics.

Additionally, it supports research and innovation in pharmacotherapy and provides accurate information about medicine usage.

Government’s Efforts to Enhance Regulatory Practices:

The Government of India is actively working to upgrade regulatory practices to establish uniform Good Manufacturing Practice (GMP) standards across all states.

A science-based regulatory framework is seen as instrumental in promoting research and development within the country, aligning with public health objectives to guarantee the safety and efficacy of drugs.

Maharashtra’s Proposal for a Quality Assurance Portal:

The Maharashtra Food and Drug Administration (FDA) has proposed the launch of a quality assurance portal to provide safe medicines to consumers and patients.

This portal will help manufacturers monitor medicine production batches and distribution data for better quality control.

Implementation of QR Codes for Pharma Industry:

The pharma industry is gearing up for the implementation of QR codes starting August 1, 2023, in line with the Drugs (Eighth Amendment) Rules, 2022.

The QR codes will be added to the labels of the top 300 formulations to identify counterfeit or misbranded medicines.

This will allow for product recalls if the quality is compromised during manufacturing.

Addressing Counterfeiting Concerns:

According to the State of Counterfeiting in India 2022 report, counterfeiting constitutes nearly 25% to 30% of pharma products.

The unified online portal and QR codes are part of the government’s proactive approach to tackle this issue and ensure consumers have access to authentic and safe medications.

Conclusion:

The proposed unified online portal, along with the implementation of QR codes, represents a significant step in India’s efforts to enhance drug quality and patient safety.

By fostering accountability and transparency among stakeholders, the regulatory system aims to ensure the delivery of safe and efficacious medicines to the public.

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

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