Unique drug codes, global trade item numbers, and digital supply chain tracking are a few outcomes of the Drug Registry proposed by the National Health Authority (NHA) in a consultation paper released on March 30. The registry is part of the Ayushman Bharat Digital Mission (ABDM) – the Indian government’s multi-tiered health digitisation drive.
The Drug Registry is expected to help health tech companies issue prescriptions, insurance companies cross-check claims, and pharmacies track logistics, among other use cases. It would also allow the public to verify details of their drugs through a public portal, the consultation paper revealed.
Such a registry was first mentioned in the National Digital Health Blueprint over three years ago, but the consultation paper on it has only been released now, with its requiring multiple iterations, NHA Director Kiran Gopal Vaska had revealed at a webinar.
Comments on the consultation paper can be submitted through the form on the NDHM’s website or via email to firstname.lastname@example.org until May 1, 2022.
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Technical structure of the Drug Registry
The paper proposes a two-pronged approach to the registry:
- A master database of drugs: The database would be the initial focus of the registry.
- Digital supply chain tracking: This would be the next step for the registry.
Both these stages will be built upon the Drug Information Authority System (DIAT) developed by the Centre for Advanced Computing (C-DAC) in Pune.
What is the DIAT?
- The DIAT is a computer software built by C-DAC, Pune.
- It allows role-based access to various entities such as healthcare facilities, pharmacies, regulators, etc., to enter data about drugs into the system.
- Once this data is entered into the system, it will be mapped against the SNOMED-CT (a system containing clinical terminology and language for digitisation of data in the Drug Registry).
- The mapping against SNOMED-CT would involve assigning a unique identifier called a ‘Unique Drug Code’ to each drug. It will also output other information about the drug such as “substances, generics, brands, package details, dose forms, route of administration, product name, and manufacturer.”
- The data can then be used by all systems that are already using SNOMED-CT, while those who are not using it can still use the Unique Drug Code as a numerical ID.
What is SNOMED-CT?
“After careful analysis of different parameters such as interoperability, coverage, local customization, open availability, ease of implementation and wider acceptance extending SNOMED-CT to also include drug codes and made available to all clinical and non-clinical systems as was found fastest, reliable, and easier to roll-out for the purpose.” — NHA
- SNOMED-CT is an internationally-known set of terms that helps in electronically recording health information, drugs, details of insurance processes, etc.
- The National Resource Centre for EHR Standards (NRCeS) is the National Release Centre for SNOMED-CT in India, and it will also be building Common Drug Codes for India (CDCI) to additionally provide standards related to India-specific drugs, manufacturers, etc.
The CDCI is distributed in two different formats for ease of use and adoption, these are CDCI [Terminology Integrated Package] and CDCI [Flat Files Package]. The NHA said that it is working with the NRCeS to help adopt SNOMED-CT for the Drug Registry.
What data will be included in the Drug Registry?
1. Generic drugs (Branded drugs with same composition but sold after the patent on the original drug has expired)
- Composition Details
- How it is administered
- Form of dosage
- Anatomical Therapeutic Chemical Classification
- Additional information incl. Drug-drug interactions, Drug usage, Contraindications, etc.
2. Branded drugs (Marketed or produced in India by a company)
- Brand Name
- Manufacturer Name
- License Number
- License Status
- Generic Name
- Additional details including “National List of Essential Medicines (NLEM) status, Drug Price Control Order (DPCO) status, Type – Over the Counter (OTC) v/s Prescription and drug release mechanism”
3. Individual units of drugs (Primary, secondary, or tertiary packaging level)
- GTIN: A Global Trade Item Number (GTIN) will be allocated to individual units of drugs. Details such as medicate name, dose, route of administration name, etc. in a barcode on the packaging of the unit, which will be scanned throughout the supply chain for “smoother inventory management.”
- Serial Number
- Batch/Lot Number
- Expiry date
4. The following data will mandatorily be shown to the public:
- Composition Details
- Route of Administration
- Dose Form
- Brand Name
- Manufacturer Name
- License Status
- Package Details
- Schedule of Drugs
- Classification of Drugs
Data Sources for the Drug Registry
“…to begin with, the drug registry is proposed to have allopathic prescription medicines and later expand to include other systems of medicine,” the paper said.
Data from SUGAM portal: All those with licenses to manufacture and distribute drugs have to register themselves on the SUGAM portal of the Central Drugs Standards Control Organisation (CDSCO), according to the Drugs and Cosmetics Act, 1984. Licensees have to register the details of the licenses granted on the portal, and can also use it to apply for NOCs, licenses, registration certificates, permissions, and approvals, the paper revealed.
Data from State Drug Control Organisation (SDCO): “Since the regulation of the manufacture, sales and distribution of drugs is a primary responsibility of the State authorities, all the drug details corresponding to a branded drug will lie with individual state authorities (i.e SDCO),” the paper said. The SDCOs can bulk import this data into the registry in a ‘pre-specified import format’
Data from the Indian Pharmacopoeia Commission (IPC): “IPC may contribute these publications to NHA which will then be uploaded against the respective clinical and regulatory information attributes in Drug Registry,” the paper said.
Government welfare programmes and databases:
The following databases can be used to weed out any duplication or fill in any missing information about a drug.
- Integrated Pharmaceutical Database Management System (IPDMS), for fixing or managing the prices of scheduled, non-scheduled, and new drugs, and monitoring the ingredients and production of scheduled drugs.
- Pradhan Mantri Bharatiya Janaushadi Pariyojana (PMBJP) database, which has information about generic drugs, particularly those sold through Jan Aushadi Kendras.
- National List of Essential Medicines (NLEM), which has details of medicines sold at the primary, secondary, and tertiary levels of healthcare.
- Affordable Medicines and Reliable Implants for Treatment (AMRIT) programme, which contains information about cancer and cardiovascular drugs and implants available at low prices.
Pharmaceutical companies: Details of drugs and the stock-keeping units held by pharmaceutical companies can be added to the registry.
Other sources: “Various organizations, for instance, hospitals, e-pharmacies maintain their drug database for purposes such as prescription, dispensing, etc. The drug registry will invite data contributions from these organizations for the initial population of the drug registry,” the paper said.
Process of adding data to the Drug Registry
Data can be entered into the system in two ways:
- Through Application Program Interfaces (APIs)
- Through imports in a pre-specified import format
The data entered into the system will go through the following processes before being included in the registry:
Self-certification and verification of data: Pharmaceutical companies will have to self-certify the correctness of information about drugs through a digital signature before the data is published. This will not be required in case the information is supplied or even changed at a later stage by a regulator.
Punishment in case of false information: “Drug manufacturers/suppliers or health facility, providing false /incorrect or manipulated drug information will be liable for prosecution as per the applicable law,” read the consultation paper.
Updating the data in the registry: “A time-to-time update and up-keeping of drug information are crucial if there is any change in drug information,” the paper said. Manufacturers or suppliers can update the data in the registry in the following ways:
- A new entry is allowed in case of changes to the dose form, composition of the drug, how it is administered, and the drug’s name.
- A new version of the same entry is allowed in case there are changes to the functioning of the drug, its indications, contraindications, drug usage, package details, schedule, and interaction with other drugs.
- A change in status made through a new version of the same entry is allowed if a drug is withdrawn, suspended, or retired.
Status of the Ayushman Bharat Digital Mission
Over 21 crore Health IDs have been issued under the ABDM. Recently, the Ministry of Health and Family Welfare provided state-wise breakdown of the IDs issued so far.
Last month, the cabinet cleared Rs 1,600 crores for the ABDM and sources told MediaNama that this would help in the digitisation of government hospitals. Here’s a look at the status of other ABDM components:
- Unified Health Interface: After a public consultation in July last year, the NHA has allowed certain private sector entities to build their services on top of it.
- Health Data Retention Policy: The NHA has yet to reveal the final form of the Health Data and Retention Policy which was opened to public consultation in November last year.
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