SOPs for Videography in Drug Regulation Procedures

This committee is tasked with providing recommendations and insights into the incorporation of videography in drug regulation procedures.

The Health Master

November 27, 2023

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Last Updated on October 9, 2024 by The Health Master

Drug Regulation

In a groundbreaking move towards transparency and corruption prevention in drug regulation, the government is steering efforts to establish a digital platform.

Central to this initiative is the formulation of Standard Operating Procedures (SOPs) for the videography of procedures related to sampling and testing, ensuring an unprecedented level of transparency.

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The Call for SOPs: A Committee’s Decision

Under the leadership of Drugs Controller General (India) [DCGI] Dr Rajeev Singh Raghuvanshi, the Drugs Consultative Committee (DCC) recently convened to stress the need for an SOP for videography.

This SOP specifically addresses crucial procedures like sample receipt, seal opening, and sample distribution to analysts.

Formation of a Sub-Committee

The DCC decided to form a sub-committee comprising experts from Central and state labs, along with a technologist.

This committee is tasked with providing recommendations and insights into the incorporation of videography in drug regulation procedures.

Government’s Digital Platform Discourse

At the heart of the discussion lies the potential use of digital platforms to enhance transparency, reduce corruption, and minimize discretionary powers.

Various government departments, including the Department of Health and Family Welfare, are exploring digital avenues to streamline processes.

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Digital Platforms for Inspection & Drawing

The Department of Health and Family Welfare is actively working on the online entry of inspection recommendations by drug inspectors.

Additionally, technologies like videography are being considered to prevent tampering of samples, ensuring the integrity of drug-testing processes.

Laboratory Collaboration for SOP Development

The committee recognized the importance of collaboration and knowledge exchange in developing effective SOPs.

A suggestion was made for laboratory heads to visit Central Forensic Laboratories (CFL) to gain insights into their procedures before formulating the SOP.

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Initiative Towards a Digital Drugs Regulatory System (DDRS)

The Central Drugs Standard Control Organisation (CDSCO) has taken a significant step towards establishing a Digital Drugs Regulatory System (DDRS).

This unified digital ecosystem aims to be a single-window solution for all drug regulatory activities.

Building Trust and Confidence

The proposed DDRS seeks to build trust and confidence in the quality of drugs, medical devices, and cosmetics in both domestic and global markets.

It emphasizes transparency, accountability, and effective enforcement of quality standards at the field level.

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Expression of Interest for Digital Transformation

The CDSCO has invited Expression of Interest (EoI) for the selection of a Software Services Provider (SSP) for the digital transformation of CDSCO, Indian Pharmacopoeia Commission (IPC), and National Institute of Biologicals (NIB).

The envisioned duration for this digital transformation is eight to ten years.

Modularity and Functionality of DDRS

The proposed DDRS is expected to be modular, offering a unified portal for end-to-end management of all products regulated by Central and State Licensing Authorities.

It aims to integrate different stakeholders seamlessly and develop dynamic online registries for real-time information.

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Features of the DDRS

The CDSCO has outlined various features expected from the DDRS, including monitoring and reporting, inspection and auditing capabilities, integration of payment gateways, and user guides.

The system is envisioned to be user-friendly across web, mobile, and other platforms.

Ensuring Accountability Through Algorithms

The CDSCO has outlined the need for the DDRS to incorporate algorithms that perform checks and balances.

These include verifying documents for duplication in batch numbers or names, detecting duplicate licenses, assessing employee performance, and identifying companies at risk in manufacturing drugs.

Integration with Key Platforms

The DDRS aims to bring together various stakeholders, including government regulators, businesses, and support agencies, by integrating with key platforms like Aadhaar, Pan, DigiLocker, GST, DGFT, Customs, and state government platforms.

Conclusion

As India takes strides towards a digital era in drug regulation, the envisioned DDRS promises a revolutionary approach.

This unified digital ecosystem seeks to ensure the quality of medicines, both nationally and globally, fostering transparency and accountability.

FAQs

What is the primary objective of the Digital Drugs Regulatory System (DDRS)?
The primary objective of DDRS is to establish a unified digital ecosystem, ensuring quality medicines, transparency, and accountability in drug regulation.
How long is the expected duration for the digital transformation of CDSCO, IPC, and NIB?
The digital transformation is anticipated to span eight to ten years.
What steps are being taken to prevent corruption in drug regulation procedures?
Measures such as videography and online entry of inspection recommendations are being explored to enhance transparency and reduce corruption.
How will the DDRS integrate with different stakeholders in drug regulation?
The DDRS aims to seamlessly integrate with various stakeholders, including government regulators, businesses, and support agencies.
What is the significance of the sub-committee formed by the DCC in drug regulation?
The sub-committee, comprising experts from Central and state labs, plays a crucial role in providing recommendations for incorporating videography in drug regulation procedures.

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