India plans a digital Drug Regulatory System

The central government is planning to develop a unified digital ecosystem to serve as a single window, single sign on, and unified portal for all regulatory activities relating to drugs, pharmaceuticals, vaccines, medical devices, cosmetics, testing laboratories, and related areas.

The Digital Drugs Regulatory System (DDRS) will be used for end-to-end management of all categories of products regulated by the Central and State drug regulators. All processes like registration, approval, post-approval changes, import and export related licenses and approvals, enforcement, inspection and other stages involved in the complete lifecycle of the product will be covered.

The system will enable seamless integration with different stakeholders like other ministries and government departments, commissions, and external agencies such as Bureau of Indian Standards (BIS), Government e-Marketplace (GeM), Atomic Energy Regulatory Board (AERB), Goods and Services Tax Network (GST), Customs authorities, export-import agencies, Directorate General of Foreign Trade (DGFT), Central Bureau of Narcotics, Indian Council of Medical Research (ICMR), private laboratories, audit agencies, consultants, testing labs, Open Network for Digital Commerce (ONDC), etc., for coordination, verification of documents, obtaining relevant regulatory permissions and certifications, dual-use NOC, compliance purposes, etc.

Currently many of these activities are performed in the offline mode, including certification for export permission, post-approval changes, periodic safety update reports, adverse event reporting, payment of compensation, show-cause notice, etc.

The DDRS will function as dynamic online registries for capturing and displaying real-time information in a sortable, searchable and filterable manner for product categories including category, quantity, and supply details (by the manufacturers, importers, etc.), details of licensed entities and all permitted products, details of manufacturers, marketing firms, retailers, pharmacies, primary packing material, technical persons etc. Details of not of standard quality drugs, spurious, adulterated, misbranded products, inspection reports by drug Inspectors, lab reports, all the alerts issued by various agencies will be made accessible through the portal. All vendors and stakeholders (including whole sellers, suppliers of the pharmaceuticals materials and supplies meant for pharmaceutical use, sourcing of active pharmaceutical ingredients with information on sales, stock movement, inventory, geo-tagging, will all be available.

As the initial step, the Central Drugs Standard Control Organisation (CDSCO) has invited an expression of interest (EOI) for selection of Software Services Provider (SSP) for the digital transformation. The health ministry is hoping to have the first phase of the project – which covers all central agencies – to be completed in a year’s time. It hopes the new transparent system will enhance the credibility of India’s drug regulatory system and the trust in India made medicines.