Should all medicines sold have a digital footprint?

The deadline set by the Health Ministry for a public discussion on the sale of medicines in the country is set to lapse this week.

The objective behind this exercise was to frame rules for “efficient” sale of medicines in and from the country. The public notice says that the idea is to ensure availability of the right quality drugs to every person, curbing anti-microbial resistance (AMR), and regulating the supply of online medicines to persons or other entities in or outside India.

Towards this objective, the Ministry proposes an electronically enabled platform that connects the entire supply chain — from manufacturers and distributors to retailers and doctors, who interface with patients.

And the requirement is for all information on medicines, including quantity supplied, expiry dates, and prescriptions, to be uploaded onto this autonomously run platform. In rural or remote regions, the data can be uploaded via mobiles even.

The proposal has elicited bouquets and brickbats in equal measure. Concerns are being raised on privacy involving the acquisition and sharing of patient information and their medicine consumption patterns.

For the newest kids on the block — the e-pharmacies — the proposal is the official recognition they have been seeking. It reinforces their claims that an electronic footprint on the sale medicines can in fact curb misuse and abuse. E-pharmacies have been living in the shadows of the Drugs and Cosmetics (D&C) Act, which needs to be amended to legitimise their existence.

Initially only e-pharmacies were to be regulated, but now all stakeholders have to be e-enabled, points out Dharmil Sheth, co-founder of Pharmeasy, a technology platform for patients and pharmacies.

This helps track the sale of spurious drugs, besides tracing aberrations in the sale of any medicine, he says. Antibiotic resistance is rampant because of the irrational sale of these drugs by offline retail set-up, he observes.

All medicine prescriptions need to be uploaded by chemists now and not just the critical or prescription-driven ones like antibiotics, psychiatric drugs or cough syrups. This helps in the case of a drug recall or to track medicine-related adverse events, he says.

Opposing the government proposal is the All India Organisation of Chemists and Druggists (AIOCD). Planning a one day strike next month, JS Shinde, AIOCD President, questions the effort to go entirely online in a country with power cuts and when connectivity is dodgy or gets disrupted for any number of reasons, including law and order problems. Besides, he says, not all people have smart-phones. On the requirement that prescriptions be honoured only from doctors registered with the Medical Council of India, he says, this is not possible always, especially during an emergency. If pharmacies spend time verifying doctor credentials and uploading prescriptions, they will get attacked, he says. And in rural areas without doctors, if a basic medicine prescribed by a homoeopath, for example, is not honoured, the shop could get burnt down, he says.

LOCOST's S Srinivasan says the proposal will not help achieve the objective of improving the quality of medicines. Besides, he adds, it is impossible to audit operations of the over eight lakh retailers and distributors, and some 20,000 drugmakers on a digital platform.

Agreeing that digitisation can help trace misuse of drugs, he says, the digital framework should have been restricted to critical segments rather than the entire sweep of medicines. Cautioning on privacy, he points to the danger of mapping consumption patterns of patients that could lead to abuse of that information in the wrong hands.

The Indian Drug Manufacturers Association’s Daara Patel expresses concern on some points in the proposal that go against the spirit of the D&C Act. For example, the proposal requiring all medicines to be sold on prescription, or requiring online sellers to have a brick-and-mortar facility.

In fact, says Srinivasan, the framework should be easy to comply with and not so difficult that it forces people to violate it. A simple enough reasoning for the Government to keep in mind while framing new rules.