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E-Pharmacy: Why Is India Still Waiting to Legalize Its Regulation?

by Dr. Krishanga on August 30, 2023 at 6:17 PM
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Highlights:

In a world racing towards digital dominance, where convenience wears the crown and efficiency holds the scepter, the concept of e-pharmacy is seen as the logical next step. However, in a stark demonstration of how the regulatory system struggles to keep pace with ongoing technological advances, the state of the Indian pharmaceutical industry has been in a turmoil carrying the legacy of the past and unable to make the change to embrace the future (1).


The problem stems from the fairly big underground market of counterfeit medication, ease of purchase of prescription medicines in India and unqualified quacks practicing as doctors.

Is India Compromising the Healthcare Sector?

India's healthcare sector is subject to complex regulations to ensure the quality and safety of medicines. Age old practices refer to the manufacture, sale, and distribution of drugs. But with the rise of online sales, these laws lack any clarity and falter in handling the complexity of e-pharmacies, sending us into a legal spin.

‘Will India's e-pharmacy sector achieve its projected Rs 25,000 crore growth by 2022 while grappling with outdated laws? #epharmacy #onlinepharmacy’

The lack of a clear rulebook has created a series of problems for e-pharmacies. Chief among these are the locations of the search results. Under current legislation, e-pharmacies must have a physical infrastructure. This not only stifles innovation but also stalls their development. It's like telling a digital virtual object to stay in the physical realm, and they miss what's really important.

The interstate drug trade is another quagmire. State laws mean that drugs that are legal in one region can be illegal a few miles away. This legal confusion not only confuses consumers but also cripples e-pharmacies in the legal conundrum.

The economic side is equally murky. While some laws only require payment upon shipment, countless online payment methods tend to work outside these limitations. This confusion enhances concerns about liability and consumer safety, putting buyers and sellers in dangerous situations.

Immediate concerns involve the sale of prohibited Schedule H and X drugs. These drugs should be strictly regulated, but e-pharmacies open the door to abuse. The potential for online reuse of a prescription highlights the need for rigorous testing.

Verifying patient identities is another glitch. The online realm struggles to authenticate prescriptions, risking the sale of prescription drugs without medical oversight. And with no regulations barring sales to minors, the threat to public health multiplies.

Even as the standard rules have been around for years, brick-and-mortar establishments continue to compete with digital entrants. Reports say taking drugs home disturbs legitimate concerns and threatens their turf. But shouldn't innovation destroy outdated values for greater profit?

It is not just stereotypes that hinder progress. The lack of barcode regulation at the assembly level puts the supply chain at risk. Using barcodes for online medication delivery can improve data management and patient safety.

While e-pharmacies promise to democratize healthcare, especially in remote locations but the lack of cold-chain logistics if any, can limits accessibility, leaving this section of the population unserved.

It's time India recognizes tech's power and the potential of e-pharmacies. A solid regulatory framework is imperative, not just for progress but as a moral duty. The digital age craves modern solutions, not archaic rules. The government must champion innovation, support technological advances, and find an equilibrium between regulation and advancement. The aim is safe, efficient, and affordable healthcare for all.

Forecasts predict India's e-pharmacy sector hitting Rs 25,000 crore by 2022. The urgency for clarity prodded FICCI to push for e-pharmacy regulations, calming stakeholder jitters. Sector specialist Dr. B R Jagashetty insists the government hasten the finalization of these rules.

E-Pharmacy's Legal Framework

Few key areas for e-pharmacies include the following:

The Flawed Draft of E-Pharmacy Rules

Draft rules from 2018 cover e-pharmacy operations, like registration, distribution, and inspection. But, they're flawed.

In conclusion, e-pharmacies could reshape healthcare accessibility and affordability. Robust regulations are vital for safety and function. Stricter licensing, verification logos, digital data storage, and integration with health schemes could help. The government requires to invest more in cleaning up the current state of how the physical pharmacies operate. No pharmacy should dispense drugs without a valid prescription and all counterfeit drug operations need to be stopped.

Given our reliance on e-commerce and events like COVID-19, clear e-pharmacy rules are essential. By studying global models, India can regulate e-pharmacies smartly, reaping the benefits while securing public health and accessibility.

But unless the government acts on this draft and indulges in further meaningful deliberations, we will never be able to regularize healthcare and instead of promoting good health in the community, we might end up granting them access to dangerous drugs including narcotics and dangerous prescription drugs.

Reference:

  1. The rise of E-pharmacy in India: Benefits, challenges, and the road ahead - (https:www.ncbi.nlm.nih.gov/pmc/articles/PMC9804119/)


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