E- Pharmacy In India (Ban Or No Ban)

‘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.[1]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.

Recommendations

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
License
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.
Geographical Restriction
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.
Prescription
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.
Patient Confidentiality
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.

Conclusion

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 shubham@khuranaandkhurana.com or at www.linkedin.com/in/shubhamborkar.

References: 

[1]https://qz.com/india/1494451/delhi-high-court-bans-e-pharmacies-like-netmeds-medlife-1mg/

Leave a Reply

Archives

  • October 2021
  • September 2021
  • August 2021
  • July 2021
  • June 2021
  • May 2021
  • April 2021
  • March 2021
  • February 2021
  • January 2021
  • December 2020
  • November 2020
  • October 2020
  • September 2020
  • August 2020
  • July 2020
  • June 2020
  • May 2020
  • April 2020
  • March 2020
  • February 2020
  • January 2020
  • December 2019
  • November 2019
  • October 2019
  • September 2019
  • August 2019
  • July 2019
  • June 2019
  • May 2019
  • April 2019
  • March 2019
  • February 2019
  • January 2019
  • December 2018
  • November 2018
  • October 2018
  • September 2018
  • August 2018
  • July 2018
  • June 2018
  • May 2018
  • April 2018
  • March 2018
  • February 2018
  • January 2018
  • December 2017
  • November 2017
  • September 2017
  • August 2017
  • July 2017
  • June 2017
  • May 2017
  • April 2017
  • March 2017
  • February 2017
  • January 2017
  • December 2016
  • November 2016
  • October 2016
  • September 2016
  • August 2016
  • July 2016
  • June 2016
  • May 2016
  • April 2016
  • March 2016
  • February 2016
  • January 2016
  • December 2015
  • November 2015
  • October 2015
  • September 2015
  • August 2015
  • July 2015
  • June 2015
  • May 2015
  • April 2015
  • March 2015
  • February 2015
  • January 2015
  • December 2014
  • November 2014
  • October 2014
  • September 2014
  • August 2014
  • July 2014
  • June 2014
  • May 2014
  • April 2014
  • March 2014
  • February 2014
  • January 2014
  • December 2013
  • November 2013
  • October 2013
  • September 2013
  • August 2013
  • July 2013
  • June 2013
  • May 2013
  • April 2013
  • March 2013
  • February 2013
  • January 2013
  • December 2012
  • November 2012
  • September 2012
  • August 2012
  • July 2012
  • June 2012
  • May 2012
  • April 2012
  • March 2012
  • February 2012
  • January 2012
  • December 2011
  • November 2011
  • October 2011
  • September 2011
  • August 2011
  • July 2011
  • June 2011
  • May 2011
  • April 2011
  • March 2011
  • February 2011
  • January 2011
  • December 2010
  • September 2010
  • July 2010
  • June 2010
  • May 2010
  • April 2010