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With the government emphasising on bringing in a digital platform for drug regulation and enforcement for transparency and prevention of corruption, the central drug regulator is looking into preparing Standard Operating Procedures(SOPs) for videography of the procedures related to sampling and testing to ensure transparency.
A recent Drugs Consultative Committee (DCC) convened under the chairmanship of Drugs Controller General (India) [DCGI] Dr Rajeev Singh Raghuvanshi, stressed for preparing an SOP for videography of the procedures of sample receipt, seal opening and sample distribution to the analyst.
It has also decided to form a sub-committee comprising two persons from Central lab, two persons from state lab, one from Central Drugs Standard Control Organisation (CDSCO) and one technologist having expertise in the field to deliberate and give recommendations in the matter.
The Committee was apprised that consideration of use of digital platforms for improving transparency in the inspection & drawing and testing of samples have been discussed at the higher level of the government.
The point of deliberation was, “Digital platforms can also be leveraged to prevent corruption and reduce the scope for discretion".
For instance, the Department of Health and Family Welfare is working on online entry of recommendations during inspection by drug inspectors. Other technologies such as videography may be leveraged to prevent tampering of samples, integrity of drug-testing processes etc, it added.
Further the Committee discussed that the laboratory head may visit any of the Central Forensic Laboratory (CFL) to get ideas regarding their procedures before preparing the SOP in this regard.
It may be noted that the CDSCO has recently initiated efforts to set up a Digital Drugs Regulatory System (DDRS) as a unified digital ecosystem as a single window, single sign on and unified portal for all regulatory activities.
The proposed DDRS is aimed at building trust and confidence in the quality of drugs, medical devices, cosmetics, etc., in the domestic and global market, transparency and accountability in the regulation of the quality, effective enforcement of quality, safety and efficacy at the field level, and ensuring compliance to Indian pharmacopoeia & standards, according to the CDSCO.
"The aim is to develop DDRS as a unified digital ecosystem. Once operational, all existing portals will be discontinued, and DDRS will serve as a Single Window, Single Sign On, and Unified Portal for all regulatory activities," said the drug regulator.
It has floated an invitation for Expression of Interest (EoI) for selection of Software Services Provider (SSP) for digital transformation of CDSCO, Indian Pharmacopoeia Commission (IPC) and National Institute of Biologicals (NIB) for an expected period of eight to 10 years.
"This platform is envisioned to serve as a new approach to the regulatory system in the form of India’s DPI for regulatory systems, thereby ensuring quality medicines for India and the world," it added.
The proposed DDRS should be modular and should take care of various aspects such as creation of a unified portal for end-to-end management of all categories of products regulated by CLA and State Licensing Authorities; design and develop a modular, flexible, and unified system that enables integration of different stakeholders seamlessly; develop dynamic online registries for capturing and displaying real-time information in a sortable, searchable and filterable manner; systems to track and trace the entire value chain to gather information on all licensed products, better inventory management and monitoring the corrective or punitive outcomes of vigilance and enforcement.
The CDSCO has initiated efforts to select a Software Services Provider (SSP), who should take care of designing, development, implementation and maintenance including user interfaces for the web, mobile and other platforms for ten years.
This should include features such as monitoring and reporting; inspection, assessment and auditing; integration of payment gateway and others; apart from user guides, manuals, training videos, interactive charts, communication platform for interface between State Licensing Authorities, Central Licensing Authority, Labs, manufacturers and others.
It also stipulates that the system should be designed in a way that enables various analytics (in-house and third-party) to be performed and to assess the proper functioning of different aspects of the regulatory system, such as algorithms for basic checks and balances for verification of documents such as duplication in batch number or name, algorithms to scan the database to avoid duplicate licenses, algorithms to measure employee performance and others, algorithms to detect whether states are undertaking specific sampling, targeted cases, etc, and algorithms for identifying companies that are manufacturing drugs at risk, drug quality surveillance, etc., among others.
"DDRS shall aim at bringing all stakeholders, viz Central government Regulators and Agencies, State Government Regulators and Agencies, Businesses (Manufacturers, Importers, Exporters, Distributors, Retailers, etc.) and integrate with key Central Government Platforms like Aadhaar, Pan, DigiLocker, GST, DGFT, Customs, etc., state government platforms and other support & services agencies like Private Laboratories, Audit Agencies, Consultants etc., together," said the CDSCO while inviting Expression of Interest from eligible candidates for SSP.
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