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‘E-pharmacies’ are in quandary after the decisions taken by country’s two High Court’s over the issue of online sale of medicines. The Hon’ble Delhi High Court deferred the hearing on the matter and extended its interim stay on the online sale of medicines through e-pharmacies. However, the Hon’ble Madras High Court temporarily suspended the ban on online sale of medicines that was imposed last week by a single judge bench of the High Court. The petitioners in both the cases have sought a complete ban on the sale of drugs including prescription medicines and psychotropic substances on internet by online pharmacies (E-Pharmacies) in absence of any regulations notified by the Government of India.
E-Pharmacies (The Convenient Option)
E-Pharmacies made access to medicine highly convenient, all medicines general or specific are available just on one click , a patient need not have to hop from one shop to another in search of a particular medicine. This E- pharmacy industry has become a lucrative sector in the past few years, with surge in cheap data usage and widening reach of e-commerce. It has been estimated that more than 250 online pharmacies have sprung up in India in recent years, cornering Rs1,000 crore of the Indian drug market. Leading Startup Netmeds has recently secured $35 million of funding from Daun Penh Cambodia group. Similar investments have been on rise in other online pharmaceutical companies as well such as LifCare, Pharmeasy, 1mg and others.The sector have been offering services like telemedicine at affordable prices and free delivery of prescribed medicines by connecting brick-and-mortar pharmacy stores with the consumers through mobile applications. However, the many organizations have been protesting against proliferation of e-pharmacies, the traditional pharmacies see them as competitors eating their pie whereas human rights groups have raised concerns over the unregulated sale of medicines leading to potential health epidemic .
Position in India
Further, on the legal standards the petitions argue the online sale of medicines to be in contravention with the existing legal requirements that are must for the sale, prescription, storage and transportation of medicines . In India, the sale of medicines is mandated only in accordance with the Drugs and Cosmetics Act, 1940 (“DCA”) and Drugs and Cosmetics, Rules 1945 (“DCR”). The fixed retail shops must obtain license under Section 18 of the DCA and Rule 61 of the DCR to carry sale of prescribed medicines. Further, the sale shall be done only against a valid prescription of a medical practitioner in accordance with Section 42 of the Pharmacy Act ,1948. Lastly only a registered pharmacist is authorized to dispense medicines under Rule 65(2) of the DCR and Rule 9.1 of the Pharmacy Practice Regulations, 2015. The petitioners have argued that the ‘e-pharmacies’ have been openly flouting these rules and thus playing with the health of millions of patients.
It cannot be debated that E-pharmacy cannot be equated with normal e-commerce platform. It would be a serious concern if medicines can be bought or sold in a similar manner that of other goods on Amazon or Flipkart. The same was accepted by a sub-committee that was constituted by Drugs Technical Advisory Board (DTAB) entrusting responsibilities to examine the issue of regulating the sale of drugs over internet under the Drugs and Cosmetics Rules, 1945 (D&C Rules). The sub-committee has also proposed recommendations on the matter and lately these recommendations have been published as ‘Draft-Rules’ by Ministry of Ministry of Health & Family Welfare (MOH&FW). Thus a new Part VI- ‘Sale of Drugs by E-Pharmacy’ has been proposed to be added to the D&C Rules. Though the DRA and DRC were silent on the online sale of medicines,it is imperative to examine the proposed legal structure with existing legal regime governing the pharmaceutical industry.
|Legal Issues||Existing Framework||Proposed Rules|
Section 18 of the DRA and Rule 61 of the DRC makes mandatory for fixed retailers to obtain a license for sale of the medicines.
Proposal to create a National Portal, that shall act as the nodal platform for transacting and monitoring online sale of drugs.
Rule 61 of the DRC impose geographical restrictions at the licensed premises.
Sale of medicines shall take place only in the respective state from where the order has been placed.
A valid prescription is mandatory for sale of prescription under Section 42 of the DCA.
The sale of online medicines is to be carried through proposed Electronic Prescription Exchange.
Dispensing medicines by registered pharmacist
Medicines shall be dispensed under the personal supervision of a pharmacist as per Rule 65(2) of the DRC and Rule 9.1 of the Pharmacy Practice Regulations.
The drugs are required to be prescribed by registered medical practitioner and sold through licensed professional only.
Storage and Transportation
Rule 64 of the DRC ensure that the license is granted only after the authority ensures the premises are adequately equipped for storage of medicines and the medicines sold are to be given to the patient by hand.
the e-pharmacy is an intermediary its functions, responsibilities, procedure for registration need to be fixed under DRC.
Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002; and Pharmacy Practice Regulations, 2015 makes strong provisions for patient confidentiality.
It is critical to ensure personal data of the patients confidential in accordance with the IT Act.
Supervision by Drug Inspector or Drug Controller
The premises where drugs are sold, stocked, exhibited can be inspected by Drug Inspector as per Section 22 of the DCA.
provisions relating to supervision shall be followed as per existing laws.
In a country where almost no-compliance is being followed with respect to sale of prescription drugs by the brick-and-mortar stores, e-pharmacies have a potential to alter the existing practices. Sale through an Electronic Prescription Exchange (EPE) would be a step in containing overuse and unscrupulous of medicines especially ones contributing to antibiotic resistance across the country. It will also provide a check on to rampant mal-practices done by Doctors and Brick and Mortar Pharmacies like passively forcing patient buy medicines from their preferred Pharmacist in the greed of getting commission on sale.
Furthermore, Doctors also prefer to prescribe costlier medicine to generic medicines to gain more commission as a result of which these Brick and Mortar Pharmacies rarely give any discount because they need to pay the doctors commissions for prescribing their medicines leaving the poor patient at the suffering end. In fact, there are various tie-ups entered upon by Private Hospitals and Pharmacies for conducting the above described mal- practices which everyone of us have experienced at some point of time. Therefore, I strongly advocate the concept of E- Pharmacies however, same can only be made effective after a proper framework of laws governing the industry. In absence of the same there are huge chances of a greater mis-happening, as sectors of great importance like that of pharmacy cannot be left unchecked and unregulated.
India could also widen the scope of industry by following best practices across the world such as Displaying Internet Pharmacy Logo in UK over all the web-pages and prohibiting advertisement of medicines especially ones stored through computer cache. However, lurking the online pharmaceutical industry for regulations is serious blow to the same cause. The legal mechanism must be put in place at the earliest.
Author: Mr. Shubham Borkar, Senior Associate – Litigation and Business Development and Gursimran Narula – Intern, at Khurana & Khurana, Advocates and IP Attorneys. In case of any queries please contact/write back to us at email@example.com or at www.linkedin.com/in/shubhamborkar.