Explainer / Draft rules for e-pharmacies

Online pharmacies cannot stock drugs and will have to operate through retail chemist shops for doorstep supply of medicines just like food delivery platforms, according to revised draft regulations for the online sales of drugs.

The draft regulations also make retail pharmacies eligible to deliver medicines at a customer’s residence.

Some retail pharmacies deliver drugs to houses in their respective areas, but if the revised regulations get enforced, they would be allowed to do so in a formal manner, said a senior health ministry official.

The health ministry is in the process of finalising the draft regulations even as the Drugs Controller General of India (DCGI) has asked all regulators in states and Union Territories to prohibit the sale of medicines by online pharmacies as per the Delhi High Court order.

While hearing a PIL by Zaheer Ahmed in December 2018, the HC had ordered a ban on the sale of illegal or unlicensed online sale of medicines till the government drafts rules to regulate e-pharmacies.

The DCGI order, issued last week, asked all drug regulators in states / UTs to take “necessary action” to enforce the HC directive.

The health ministry in its earlier draft had allowed the online sale of drugs barring narcotics and psychotropic drugs, by a licensed online medical store.

Currently, online pharmacies are operating without a drug licence as there are no rules framed for the sector. Officials say around 50 such pharmacies currently operate in India.

There are an estimated 8 lakh retail pharmacies and wholesalers registered.

“The changes were being made following consultation with the stakeholders after retail pharmacists expressed concern over their business going to loss with online medical stores getting official recognition,” said the health ministry official. “According to them, online pharmacies will offer huge discounts and provide customers with the option of plethora of brands of drugs because of which more and more people will opt for them.”

In September, the government, in an affidavit submitted to HC, said it is in the process of finalising the draft rules for regulating e-pharmacies after going through representations of all stakeholders.

In his PIL, Ahmed had said that the online illegal sale of medicines would lead to a drug epidemic, drug abuse and misuse of habit forming and addictive drugs.

He also moved a contempt plea in April, contending that the e-pharmacies continue to “blatantly” violate the HC directive and the central government was not doing anything to stop it, following which the court issued notices to the Centre and some e-pharmacies.

In response, e-pharmacies in July told the court that they do not require a licence for the online sale of drugs and prescription medicines as they do not sell them, instead they are only delivering the medications.

Ahmed claimed that the health ministry, Central Drugs Standard Control Organisation and an expert committee appointed by the drug consultative committee have already concluded that the online sale of medicines is in contravention of the provisions of Drugs and Cosmetics Act, 1940, and allied laws.

Still, lakhs of drugs are being sold on the Internet every day, it said, adding that some of the drugs / medicines contain narcotic and psychotropic substances and some can even cause antibiotic-resistant bacteria, which is a huge threat to patients and humanity at large.

Risks in buying drugs online

* Supply of fake and illegal drugs.

* Abuse on account of fake or forged or no prescriptions.

* Lack of verification of the ultimate user.

* Unhealthy competition.

* Abuse of critical health data generated online.

* Mishandling during transport.

Highlights of the draft rules

* All e-pharmacies have to be registered with the Central Drugs Standard Control Organisation.

* Psychotropic substances, habit-forming medicines like cough syrup and sleeping pills, schedule x drugs will not be sold online.

* The application for registration will have to be accompanied by a sum of Rs 50,000 while asserting that an e-pharmacy registration holder will have to comply with the provisions of the IT Act, 2000.

* The details of patients shall be kept confidential and shall not be disclosed to any person other than the central or the state government concerned, as the case may be.

* The supply of any drug shall be made against a cash or credit memo generated through the e-pharmacy portal and such memos shall be maintained by the e-pharmacy registration holder as record.

* Both state and central drug authorities will monitor the data of sales and transactions of e-pharmacies. In case of rule violations, the registration of e-pharmacies will be suspended, and it can be cancelled too.

* Every two years, the central licencing authority will inspect the premises from which an e-pharmacy operates.

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