Analyzing the Draft E-Pharmacy Rules

[Akash Santosh Loya and Pratik Joshi are Final Year B.A. LL.B. (Hons.) students at the National University of Advanced Legal Studies, Kochi]

While the advent of e-commerce has introduced several advantages, it has also raised various concerns. These are evident in the pharmaceutical sector in India wherein e-commerce is making great strides in helping consumers avail of drugs at their door-step through online portals. Due to the constant increase of e-pharmacies, the apprehension of distribution of illegal and low quality medicines has been raised, one that requires the immediate attention of the legislators. However, in order to address these concerns, there is no concrete regulatory framework in India except for the Draft Rules that are pending approval. To the relief of consumers, there are orders passed by the Madras High Court that can be found here and here and by the Delhi High Court that can be found here. The Madras High Court has directed the Central Government to notify the rules by 31 January, 2019, but allowed the e-pharmacies to function until then, whereas the Delhi High Court has imposed a ban on all e-pharmacies in India that are functioning without a license. This post seeks to suggest some changes that can be made in Draft Rules before adoption by making a cross-jurisdictional comparison.

Model of E-Pharmacies and its Types

E-pharmacy is a web portal through which the medicines can be ordered. If the medicines are prescription drugs, then a valid prescription should be uploaded on the web portal. Certain e-pharmacies also provide the facility of granting prescriptions. Once the order is placed and processed, the medicines will be delivered to the address of the consumer-patient. The medicines are generally delivered through the physical pharmacies that are registered with the e-pharmacy.

There exist three kinds of e-pharmacies. The first type is generally termed as ‘traditional e-pharmacy’. This type of online pharmacy provides medication to the public only on the receipt of valid prescription. In the absence of a valid prescription from a doctor, no medicines are provided. The customers have to generally upload the prescription on the web portal of the e-pharmacy.

The second type of e-pharmacy provides a facility of receiving prescriptions through the web portal of the online pharmacist. Generally, the consumer-patient has to fill up a questionnaire on the basis of which a prescription is given by the doctor of the online pharmacist. Under this model, there is no physical check-up of the customer-patient before the provision of medication.

The last type of e-pharmacy is one of major reasons for the growing necessity to regulate e-pharmacies across the world. In this type, the customer-patient is given the drugs without showcasing of a valid prescription.

Indian Regime

Current Regime

In India, the primary legislation dealing with the import, manufacture, sale or distribution of medicines is the Drugs and Cosmetics Act, 1940 (the “D&C Act”) and rules framed under the same. Under the D&C Act, a complete prohibition has been imposed not only on the manufacture, sale or distribution but also on the exhibition and offering for sale, of the drugs that are misbranded, adulterated or do not meet the standards of quality laid down under the legislation.[1] The e-pharmacies do fall within the ambit of this provision as they are involved in nothing but exhibiting and offering for sale various drugs. Therefore, an e-pharmacy can be held liable for promotion or sale of any illegitimate drugs.

Further, in order to exhibit or offer the drugs for sale, a license is required. In order to obtain this license, a person is compulsorily required to have premises where the drugs can be stored safely and properly.[2] In addition to the aforesaid requirement, in case of prescription drugs[3] and certain other types of drugs, the aforesaid license will be issued only if the pharmacy is under the charge of a person who is a registered pharmacist and the prescription drugs are being dispensed under such pharmacist’s supervision.[4] Therefore, proper premises that is under the charge of a registered pharmacist are the two broad conditions for issuance of license.   

Thus, under the present regime, an e-pharmacy can operate only if it owns a premises that is safe to store drugs. No drugs can be offered for sale through an e-pharmacy web portal if it does not own physical premises in India.

Proposed Draft Rules for Regulation of E-Pharmacies

According to the Draft Rules, any person wishing to undertake sale of drugs through a web portal or electronic method is compulsorily required to seek a registration certificate from the licensing authority by filing an application in Form 18AA. An e-pharmacy will be granted a registration certificate and allowed to hold it only if:

  1. the web portal of the e-pharmacy is located in India;
  2. the e-pharmacy is under the charge of a registered pharmacist; and
  3. the e-pharmacy is not offering for sale drugs that are covered under categories of the Narcotic and Psychotropic Substances Act, 1985 or under Schedule X of the Rules.

Further, in order to protect the interest of consumers, the e-pharmacy is obligated to publish certain information like the details of the owners of e-pharmacy, details of the registered pharmacist and logistics service providers. This will certainly help the consumers to verify whether the e-pharmacy is a legitimate one or not.

One of the progressive steps suggested under the Draft Rules is the localization of the consumer data collected by the e-pharmacy. The e-pharmacies are not only required to ensure that the data collected by consumers is not disclosed but also ensure that such data is not sent outside the India.

Comparison and Analysis

United States

The two primary legislation dealing with medicines in the U.S. are the Federal Food, Drugs and Cosmetics Act, 1906 (the “FD&C Act”) and the Controlled Substances Act, 1970 (the “CSA”). The former is a general legislation that deals with all kinds of medical drugs. The latter is concerned with certain specific drugs.[5] These drugs, termed as ‘controlled substances’, are prescribed in five schedules of the CSA.[6] There is a further categorization of these ‘controlled substances’ into prescription drugs and non-prescription drugs.[7] The determination as to whether a controlled substance is a prescription drug or a non-prescription drug is made on the basis of rules specified under the FD&C Act.

In the U.S., a framework for regulation of e-pharmacies was provided by enactment of the Ryan Haight Online Pharmacy Consumer Protection Act, 2008 (“Ryan Haight Act”). The event that triggered this enactment was the death of school boy named Ryan Haight due to the consumption of drugs provided by an online pharmacy without prescription. The Ryan Haight Act has only amended the CSA. Therefore, its scope is limited to the sale and distribution of ‘controlled substances’ by e-pharmacies.

By virtue of these amendments, all the e-pharmacies that are dispensing or distributing medicines in US (irrespective of their web portal location) are required to ensure that no ‘controlled substance’ that is categorized as a prescription drug is dispensed without a valid prescription.[8] It also provides for criteria in order to determine if the prescription is a valid one. Accordingly, every prescription that is signed by a registered medical practitioner is not by itself a valid one. It is only when a prescription is granted after an in-person examination of the consumer-patient that it will be considered a valid prescription.[9] Thus, e-pharmacies have been prohibited from distributing or dispensing any prescription controlled substance if the customer-patient was not personally examined by a medical practitioner. Further, e-pharmacies are also required to provide complete details of the pharmacies that will be dispensing or distributing medicines through it on its website.[10]

Under the Draft Rules, a valid prescription needs to be uploaded for dispensation of prescription drugs. However, ‘prescription’ is defined in a very loose manner to merely include a written note or an electronic document given by a registered medical practitioner.[11] This gives rise to the possibility of prescriptions being provided even without physical examination of a consumer-patient. In fact, such practices are undertaken by most of the e-pharmacies in India where a consumer-patient can get a prescription from the doctor appointed by e-pharmacies themselves, by merely filling a questionnaire online. No in-person examination is undertaken before the issue of a prescription. This clearly leads to low quality of medical examination before the prescription of drugs which may have varied life-threatening side-effects. Therefore, in order to curb such practices and ensure protection of health of consumer-patients, stringent requirements as followed in U.S. should be adopted. A prescription should be considered a valid one only if it is provided by a registered medical practitioner after undertaking in-person examination of the consumer-patient.       

Canada

Canada has adopted an interesting and unique model to regulate the practice of pharmacy. Pharmacy, amongst others, is one of the self-regulating professions: the federal and the provincial governments have delegated the power to regulate the profession to certain external bodies. These bodies are tasked with the responsibility of developing standards that guide the profession in ethical, technical and educational matters. They issue licenses to individuals which allows them  to practice in a particular premise, whether it be a conventional pharmacy or a pharmacy offering services online. The external regulatory authorities have formed a national association known as the National Association of Pharmacy Regulatory Authorities (“NAPRA”) which, among other things, acts as the primary body to dispense the public with information and awareness about the pharmacy regulation in Canada. It also has the responsibility of creating national model standards and guidelines on behalf of its members.

In this regard, NAPRA approved the “Model Standards for Canadian Pharmacists Offering Pharmacy Services Via the Internet in 2001” (“Model”) in response to the ushering in of the information age and era of the internet. Canadian online pharmacies have to ensure that their delivery service complies with all the standards of practice enlisted in the document. This compliance is in addition to the mandatory compliance with provincial legislation dealing with the conventional practice of pharmacy. By virtue of this document the pharmacist can only accept prescriptions if they are ordered verbally or via facsimile transmission by the prescriber.[12] The pharmacist must provide specific information like the license obtained by the pharmacy, physical location, telephone number, names and particulars of the manager, etc. on the pharmacy home page. It states that the pharmacist must ensure the confidentiality and the privacy of the patient’s medical information is protected in every manner.[13]

Most of the Draft Rules are comparable and analogous to the Canadian model standards when put alongside each other. However, unlike the Indian counter-part, the Canadian model does not impose a blanket ban on advertisement of drugs and pharmacy services. It merely states that the pharmacy website must be in compliance with federal and provincial regulations regarding the advertising of drugs and pharmacy services.[14] The Model further prohibits pharmacists from entering into disclaimer agreements or obtaining releases with an objective to exempt the pharmacy operation from compliance with applicable rules and standards of practice.

Conclusion

The Indian regime proposed for regulation of e-pharmacies is certainly progressive in nature. By providing data localization, it has ensured that the personal information provided by the consumer-patient is protected and is not subject to misuse and exploitation. This does protect the right to privacy of individuals. Further, the standards of disclosure to be made by the e-pharmacies to consumer-patients are in consonance with the general global practice. This ensures that consumer-patients have sufficient information before exercising their choice of ordering medicines from a particular e-pharmacy.

However, along with these positive and progressive aspects, there is a shortcoming in relation to the dispensation of prescription medicines as stated above which should resolved by the Government before notifying the Draft Rules.

Akash Santosh Loya & Pratik Joshi

[1] Drugs and Cosmetics Act, 1940, section18.

[2] Drugs and Cosmetics Rules, 1945, rule 64.

[3] According to the Drugs and Cosmetics Rules, 1945, rule 65(9), substances specified in Schedule X and Schedule H cannot be sold without prescription.

[4] Drugs and Cosmetics Rules, 1945, rule 65(2).

[5] 21 U.S.C. §811

[6] 21 U.S.C. §812.

[7] 21 U.S.C. §829.

[8] 21 U.S.C. §829(e)(1).

[9] 21 U.S.C. §829(e)(2).

[10] 21 U.S.C. §831.

[11] The Medical Council Regulations, 2002 also are widely worded.

[12] Model Standards For Canadian Pharmacists offering Pharmacy Services via the internet approved By Napra Council November 2001- Point No. 3, available at https://napra.ca/sites/default/files/2017-08/Model_Standards_of_Prac_for_Cdn_PharmTechs_Nov11.pdf.

[13] Model Standards, at point no. 6.

[14] Model Standards, at Point no. 4.

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