Asia & Australia

December 17, 2018

Madras & Delhi High Courts ban online sale of medicines


Medicines

Buying medicines online is the latest trend among Indian patients and consumers as online pharmacies allow people to buy medicines conveniently and privately. However, in addition to the convenience and privacy, two Indian High Courts have also considered the risks associated with the online sale of medicines.

Madras High Court Order:
On December 17, banning the online sale of drugs and medicines, the Madras High Court ordered the Centre to notify the statutory rules related to such sale by January 31, 2019 and stated that pharmacies in the country would be entitled to sell medicines online only after obtaining licences under the rules that were now in the draft stage and yet to be finalized.

This order arose on a writ petition filed by Tamil Nadu Chemists and Druggists Association seeking a ban on websites that facilitate online sale of drugs until the Centre brings into effect a legal framework for permitting such sales.

According to the Association, the issue of the online sale of drugs listed in Schedule H, H1m and X of the Drugs and Cosmetics Act of 1940 was rampant in the country though there was a specific legal bar on selling such medicines without the prescription of medical practitioners was of serious concern.

The Association further added, “The Drugs and Cosmetics Act was enacted during the colonial era and much before the advent of online trade. Though several amendments had been made to the law over the last 78 years, so far no provision had been introduced in it permitting online sale of drugs and medicines.”

It then said, “As per the Drugs and Cosmetics Rules of 1945, it is not permitted to ship, mail, or provide door delivery of the prescribed medicines... Yet, drugs of scheduled and non scheduled category are available online on different websites and distributed across the country. As on date, there are more than 3,500 such websites.”

As per the Association, “While so, online sale is being happily carried on by several websites in violation of existing statutory rules... Despite repeated representations made to the Centre and drug control authorities, the online sale of drugs has not been restrained. There are even advertisements in leading newspapers with heavy discounts.”

The Association had in October 2018 said, “Although online shopping might be convenient to consumers, purchasing medicines from unlicensed online stores can be risky as they may sell fake, expired, contaminated, unapproved drugs, or otherwise unsafe products that are dangerous to patients and which might put their health at risk.”

Earlier, in September, the Union Health Ministry had come out with draft rules on the sale of drugs by e-pharmacies with an aim to regulate online sale of medicines across India and provide patients accessibility to genuine drugs from authentic online portals. The draft rules on "sale of drugs by e-pharmacy" stated that no person will distribute or sell, stock, exhibit or offer for sale of drugs through e-pharmacy portal unless registered.

Drugs Controller General of India Eswara Reddy had in September said that rules have been proposed to ensure accessibility and availability of drugs to the people across India, further adding that "After the rules are finalized, people will be able to get genuine drugs through these online pharmacies. These pharmacies will be purchasing directly from the drug manufacturer so they will also be able to give 20-30 per cent discounts, thus benefiting the patients."

Delhi High Court Order:
On December 12, a bench of Chief Justice Rajendra Menon and Justice V K Rao of the Delhi High Court ordered a ban on the sale of online medicines by e-pharmacists across the country and directed the Centre and the AAP government to immediately implement the order.

The order arose on a PIL filed by one Zaheer Ahmed, a Delhi-based dermatologist who complained that lakhs of medicines were being sold on the Internet every day without much regulation, posing a huge risk to patients and doctors alike.

Ahmed stated that the online sale of medicines is not permitted under the Drugs and Cosmetics Act, 1940 and Pharmacy Act, 1948 and highlighted that even though the Drug Controller General of India in 2015 clearly directed all state drug controllers to protect the interest of public health by restraining such sale online, lakhs of medicines continue to be sold online, often even without prescription.

According to Ahmed, the government was unable to supervise the issue and has thus failed in its responsibility to protect public health, which is its constitution obligation under Article 21.

He added, “Unlike common items, drugs are highly potent and its misuse or abuse can have serious consequences on human health, not just for the person consuming it but for humanity at large as some drugs can be addictive, habit forming and harmful to the body. A large number of children/minor or people from uneducated rural background use internet and can be victims of wrong medication while ordering medicines online.”

Ahmed then stated that online pharmacies are operating without a drug licence and cautioned that “unregulated sale of medicines online will increase the risk of spurious, misbranded, and substandard drugs being sold... Some drugs have psychotropic substances and can be easily ordered on Internet and misused for criminal activities or drug abuse.”

Earlier Reports by WHO and EAASM:
According to an earlier report by WHO, considering a worldwide scenario, “The range of counterfeit products reaching markets has also broadened with the increased commercial use of the Internet to provide a dizzying array of both branded and generic drugs. In more than 50% of cases, medicines purchased over the Internet from illegal sites that conceal their physical address have been found to be counterfeit.”

Also, according to earlier reports by the European Alliance for Access to Safe Medicines (EAASM), “In a shocking development, it was discovered that counterfeit versions of lifesaving prescription medicines for cancer and serious cardiovascular diseases are also being sold to consumers online.”

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