The proposed Digital Drugs Regulatory System aims to unify and modernise regulatory activities for enhanced quality assurance.
The central drug regulator is exploring the creation of Standard Operating Procedures (SOPs) for videography during sampling and testing procedures. This is in line with the government's emphasis on digitising drug regulation to enhance transparency and prevent corruption.
The Drugs Consultative Committee (DCC), chaired by Dr Rajeev Singh Raghuvanshi, the Drugs Controller General India (DCGI), has emphasised the necessity of establishing a specific SOP. This SOP would be designed for recording procedures, including sample receipt, seal opening, and sample distribution to analysts.
To address this, the committee has opted to establish a sub-committee. The sub-committee will include two individuals from the Central lab, two from the state lab, one from CDSCO, and one technologist with expertise in the field. The sub-committee will deliberate and provide recommendations on the matter.
The DCC meeting highlighted the ongoing discussions at the government level regarding using digital platforms to enhance transparency in inspections, sample drawing, and testing. The focus is on leveraging digital platforms to prevent corruption and reduce opportunities for discretion.
One example mentioned is the Department of Health and Family Welfare's efforts to introduce online entry of recommendations during inspections by drug inspectors. Technologies such as videography are being considered to prevent tampering with samples and maintain the integrity of drug testing processes.
Furthermore, the committee discussed the possibility of the laboratory head visiting Central Forensic Laboratories (CFL) to gain insights into their procedures before formulating the SOP.
It's noteworthy that the CDSCO has recently initiated the establishment of a Digital Drugs Regulatory System (DDRS), envisioned as a unified digital ecosystem for all regulatory activities related to drugs, medical devices, cosmetics, etc.
The DDRS aims to build trust in the quality of healthcare products, ensure transparency and accountability in regulatory processes, and enforce compliance with Indian pharmacopoeia and standards.
According to the CDSCO, DDRS will replace all existing portals once operational and serve as a single-window, single sign-on, and unified portal for regulatory activities.
The CDSCO has invited Expressions of Interest (EoI) for the selection of a Software Services Provider (SSP) for the digital transformation of CDSCO, the Indian Pharmacopoeia Commission (IPC), and the National Institute of Biologicals (NIB) for an expected period of eight to 10 years.
The proposed DDRS is expected to be modular and address various aspects. This includes the creation of a unified portal for end-to-end management of regulated products and the integration of different stakeholders. Additionally, it will feature dynamic online registries for real-time information. The system will also include tools for tracking and tracing the entire value chain. Moreover, it will have mechanisms for monitoring corrective or punitive outcomes of vigilance and enforcement.
The CDSCO has outlined requirements for the SSP, specifying responsibilities such as designing, developing, implementing, and maintaining user interfaces for web, mobile, and other platforms for a decade.
The system should incorporate features such as monitoring, reporting, inspection, assessment, and auditing. Additionally, it should include integration of payment gateways, user guides, manuals, and training videos. Interactive charts and communication platforms for interface between authorities, labs, manufacturers, and other stakeholders are also essential.
Emphasising the aim of bringing all stakeholders together, the DDRS is expected to integrate with key government platforms and state government systems. This move would foster collaboration among regulators, businesses, and supporting agencies.
The CDSCO's move towards digital transformation reflects a comprehensive approach to modernising the regulatory system and ensuring the quality and safety of healthcare products in India and globally.
The College of Healthcare Information Management Executives (CHIME) is an executive organization dedicated to serving senior digital health leaders. CHIME includes more than 5,000 members in 56 countries and two US territories and partners with over 150 healthcare IT businesses and professional services firms. CHIME enables its members and business partners to collaborate, exchange ideas, develop professionally and advocate the effective use of information management to improve the health and care throughout the communities they serve. CHIME's members are chief information officers (CIOs), chief medical information officers (CMIOs), chief nursing information officers (CNIOs), chief innovation officers (CIOs), chief digital officers (CDOs), and other senior healthcare leaders. The CHIME India Chapter became the first international chapter outside North America in 2016 and is now a community of over 70+ members in India. For more information, please visit www.chimecentral.org