Govt plans central drug database

The Union government is working on a central database of therapeutic drugs, including those used in alternative systems, as part of its Ayushman Bharat Digital Mission (ABDM) in order to create a recognised repository of such information.

The plan at present has been circulated as a consultation paper for public feedback by the National Health Authority (NHA), which is the implementing agency of the digital mission.

“Envisioned under the ambitious Ayushman Bharat Digital Mission (ABDM), the Drug Registry is intended to be a single, up-to-date, centralised repository of all the drugs across all systems of medicine which are approved and are available in the Indian Market. The Drug Registry application is proposed be designed using open-source technologies and will be interoperable,” the NHA said in a statement on Thursday.

The consultation paper focuses only on drugs registry within the national digital health ecosystem, the process for its creation and potential benefits to various ecosystem stakeholders such as health care providers, patients, regulatory bodies, pharmaceutical companies, and other players in the pharmaceutical supply chain.

Experts said it can work as a ready reckoner since the data will be officially verified. “For people, it will be quite helpful to know what medicines are approved for use as there are some banned medicines also sold on the sly in markets that most are not aware of. Also, more than allopathic medicines, it will help inform people about medicines from alternative systems as those are not regulated as effectively,” said Dr RK Singal, senior director and head, internal medicine, BLK Super-Speciality Hospital.

Each section has specific open questions where feedback from stakeholders is sought, and comments from the public are invited to ensure that the registry is designed and developed in a collaborative and consultative manner.

“Through the drug registry, the ABDM aims to provide a standardised, comprehensive set of verified data on all the approved drugs marketed in the country that would enable a more efficient regulatory process. To enable inclusivity and widen the perspectives on the table, I urge all stakeholders to go through the shared consultation papers and provide us with their valuable feedback,” said RS Sharma, chief executive officer, National Health Authority.

The concept of a registry that could serve as a comprehensive national source of legitimate data on drugs was a core part of the original National Digital Health blueprint. A two-stage process is envisioned for the drug registry -- the initial focus will be on creating a master database of drugs in India, according to the consultation paper.

A drug registry platform is proposed to utilise the output of the Drug Information Authoring Tool (DIAT) developed by C-DAC Pune. The DIAT tool will facilitate the import and upload of drug information from various data sources i.e., Central Drugs Standard Control Organisation, state drugs controlling organisations, manufacturers, and other data providers. Also, any new drugs that come into the Indian market are also proposed to be added to the registry.

The NHA will also organise a public webinar around mid-April, to discuss the strategic and functional fundamentals of the registry mentioned in the consultation paper, and how it was going to help masses in the long run.