DCC Revolutionizing Drug Regulation: Central Drug Regulator Advances Towards a Digital Era

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In a significant stride towards transparency and corruption prevention in drug regulation, the central drug regulator is gearing up to introduce a digital platform. The recent Drugs Consultative Committee (DCC) meeting, chaired by the Drugs Controller General (India) Dr Rajeev Singh Raghuvanshi, highlighted the imperative need for Standard Operating Procedures (SOPs) for videography in procedures related to sampling and testing.

DCC

The DCC emphasized the creation of an SOP specifically for videography in the processes of sample receipt, seal opening, and sample distribution to analysts. To achieve this, a sub-committee is set to be formed, comprising experts from Central and state labs, the Central Drugs Standard Control Organisation (CDSCO), and a technologist with expertise in the field. Their role will be to deliberate on and provide recommendations for this innovative approach.

The committee underscored the government’s consideration of leveraging digital platforms to enhance transparency in inspection, drawing, and testing of drug samples. The key deliberation point was how digital platforms could play a pivotal role in preventing corruption and minimizing discretionary powers.

For example, the Department of Health and Family Welfare is actively working on implementing online entry of recommendations during inspections by drug inspectors. Technologies such as videography are seen as essential tools to prevent sample tampering and ensure the integrity of drug-testing processes.

Furthermore, discussions within the committee highlighted the importance of seeking inspiration from Central Forensic Laboratories (CFL) regarding their procedures. This collaborative approach aims to enhance the development of SOPs related to videography in drug regulation procedures.

Notably, the CDSCO has recently initiated efforts to establish a Digital Drugs Regulatory System (DDRS) as a unified digital ecosystem. Envisioned as a single window, single sign-on, and unified portal for all regulatory activities, DDRS aims to instill trust and confidence in the quality of drugs, medical devices, and cosmetics in both domestic and global markets.

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). This digital platform is expected to revolutionize regulatory systems and ensure the production of quality medicines for India and the world.

The proposed DDRS is designed to be modular, addressing various aspects such as end-to-end management, seamless integration of stakeholders, real-time information capture, and dynamic online registries. It aims to track and trace the entire value chain, promoting better inventory management and monitoring corrective or punitive outcomes.

As the CDSCO progresses in its mission to usher in a new era of regulatory systems, the proposed DDRS stands as a testament to the commitment towards a transparent, accountable, and efficient drug regulatory environment. Stay tuned for further updates on this transformative journey in drug regulation.

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