Govt Of India Consultation Paper on Drug Registry-30/03/2022

The drug registry platform is proposed to be a centralized repository of all the drugs which are approved and are available in the Indian Market. A two-stage process is envisioned for building the drug registry, initial focus will be on creating a master database of drugs in India.

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This paper only focuses on the Drug Registry within the National Digital Health Ecosystem (NDHE). It describes NHA’s current thinking related to the functionalities of the proposed Drug Registry, the process for its creation and potential benefits to various ecosystem stakeholders. Each section has specific open questions where feedback from stakeholders is sought. The paper consists of five chapters. Chapter 1 provides the background information and introduction to ABDM; Chapter 2 aims to create a framework for analysis by setting the current context of drug registry in India, analyzing selected international case studies and deriving key learnings for drug registry creation in India; Chapter 3 outlines some of the stakeholders to be considered in the design and build of drug registry and provide an initial assessment for the value proposition for each; Chapter 4 introduces the guiding principles for drug registry and DIAT tool; Chapter 5 outlines the process for the creation of drug registry in detail including the role of various stakeholders, and provides detailed information on Drug Registry data and proposed data standards and codes.

The Ayushman Bharat Digital Mission (ABDM) plans to develop the Drug Registry building block as a public good. Inputs from all are sought through this consultation paper to ensure Drug Registry is beneficial to all parties.

Ayushman Bharat Digital Mission (ABDM) has been launched to create a national digital health ecosystem that supports universal health coverage in an efficient, accessible, inclusive, affordable, timely, and safe manner. ABDM envisions open, interoperable, standards-based digital systems, and ensures the security, confidentiality, and privacy of health-related personal information. Registries are one of the core building blocks of the ABDM which if standardized would help in enabling interoperability of healthcare data. These registries shall be designed with strong data governance mechanisms, adhering to the principles of verifiability, accessibility, and identity management.

One of the critical components of these registries is the Drug registry, which is envisioned to be a single, up to date, recognized registry of all the drugs. It is being conceptualized as the primary source of information for all other databases and lists and facilitates the exchange of standardized data across all systems of medicine, from allopathy to Ayurveda.

A central database of the approved drugs sold in the market will serve multiple benefits including free availability of verified information for all drugs, simplified regulatory flows, smoother supply chain management, streamlined insurance claim processing, innovations in clinical decisions, disease management and assurance models.

Initially, the goal is to comprehensively capture relevant & accurate details of all drugs sold in India. Over time, the drug registry is envisaged to help smoothen the inventory flow throughout the drug supply chain, improving the quality and patient trust and ultimately enabling patientcentric digitization by ensuring machine readability of prescribed drugs.

This document covers the strategic and technical design associated with the Drug Registry. The potential sources of input data, self-certification, verification, and data distribution flow have been proposed in the document to ensure the creation of a single nationally recognized source of truth for data on drugs that is trusted, digitally enabled, and widely adopted by the healthcare ecosystem stakeholders. We look forward to feedback and support from the ecosystem partners to enable the design and adoption of a Drug registry in India.

The concept of a registry that could serve as a comprehensive national source of truth for data on drugs was a core part of the original National Digital Health Blueprint.

Drug registry platform is proposed to utilize the output of the Drug Information Authoring Tool (DIAT) developed by C-DAC Pune. DIAT tool will facilitate the import/ upload of drug information from various data sources i.e., CDSCO, State Drug controlling organizations, Manufacturers, and other data providers. Uploaded data will go through a cleansing and certification process. The Common Drug Codes for India (CDCI), as an output of the DIAT tool, is proposed to be imported to the centralized Drug Registry database and will be published through the drug registry portal. The Drug Registry platform will also provide API integration with various other government and private entities for the utilization of drug registry data

Drug Registry aims to address a key challenge in pharma landscape in India: the lack of a nationally recognized source of truth for data on drugs in India that is trusted, digitally enabled and widely adopted by healthcare ecosystem stakeholders.

As different authorities have different responsibilities and collect data at different times of the product lifecycle, the data is present in different forms with multiple regulatory authorities, which in turn leads to a lack of a central database on the approved drugs sold in the market. The lack of visibility creates certain challenges for multiple stakeholders in the healthcare ecosystem.

The drug registry is, therefore, the key building block to ensure this standardization of healthcare data. The Drug
Registry is proposed to be a single, up-to-date repository of all the drugs present in the domestic market. It will be the primary source of information for all other databases and lists and facilitates the exchange of standardized data across all systems of medicine, from allopathy to Ayurveda. Every drug entry in the registry is proposed to have a unique drug code and information corresponding to a comprehensive list of data attributes defined across clinical, regulatory and supply chain domains. Moreover, any new drugs that come into the Indian market are also proposed to be added to the registry.

This document has been published to invite stakeholder comments and consultation on the strategic and functional fundamentals of the Drug Registry. Drug Registry is envisioned to be a nationally recognized registry of all the drugs across various systems of medicines that are sold in the Indian market.

Govt Of India Consultation Paper on Drug Registry-30/03/2022

 


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