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Centre proposes creation of national drug registry

The NHA has sought comments from experts and other stakeholders up to May 1 to refine the proposal

G.S. Mudur New Delhi Published 01.04.22, 01:25 AM
Representational image.

Representational image. Shutterstock

The Union health ministry has proposed the creation of a national drug registry, a digital public database providing clinical and other information about all drugs approved in the country under various systems of medicine.

The drug registry is intended to be a repository of reliable information to help patients, healthcare providers and policy-makers in different ways, the National Health Authority, an agency under the health ministry, said on Thursday, announcing the proposal.


The registry would serve as a “source of truth” for patients, enable healthcare providers to track the history of treatment with greater efficiency than currently possible, and give policy makers an accurate picture of drug supply in the country, the NHA said.

The NHA has pitched the proposal for a drug registry in a complex national pharmaceuticals landscape where modern medicines are sold alongside traditional medicines with different processes guiding their regulatory approvals and the lack of a single database of drugs.

The NHA has sought comments from experts and other stakeholders up to May 1 to refine the proposal.

“This is a welcome proposal, but just putting together all the drugs in the market into a single database will be a Herculean task,” said Santanu Tripathi, former head of clinical pharmacology at the Calcutta School of Tropical Medicine. “A lot will depend on how well it is organised.”

For meaningful use, the registry would need to list drugs along with indications (conditions for which they can be prescribed), contraindications (conditions under which they should not be prescribed, and potential interactions of each drug with other drugs, a senior pharmacologist said.

India’s apex drug regulatory authority, the Central Drugs Standard Control Organisation, is tasked with approving medicines. But while the CDSCO approves modern medicines after examining clinical trial data, Indian rules allow traditional medicines to be sold without rigorous clinical trials.

“Modern medicines and traditional medicines should be clearly separated in the registry,” Tripathi said.

The drug registry would allow healthcare providers to track with ease drugs previously consumed by their patients and to use the database to substitute brands guided by the generic listing of drugs.

Public access to a database of all drugs will also come with a risk of self-substitution by patients.

The availability of clinical data of all drugs will empower people with increased knowledge about drugs and their effects. But, the NHA has cautioned: “This may also promote self-substitution of drugs without consultation with doctors that could lead to delays in diagnosis or adverse drug reactions.

To mitigate this risk, the NHA has proposed that only licensed pharmacies and doctors should change a drug from one brand to another. Drug dispensation points such as retail pharmacies should discourage substitution by patients, the NHA said.

But health experts say this is an unrealistic expectation in a nation where retail pharmacies sell prescription-only medicines without prescriptions.

The NHA said the drug registry was intended to be a fresh initiative under the national digital health mission that has already launched three databases — a voluntary unique health account for patients, a healthcare professionals registry, and a health facility registry.

In the long-term, the NHA said, policy-makers could use aggregated, anonymised electronic medical records data and the drug registry to track disease incidence and drug consumption that could enable evidence-based informed health policy decisions.

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