Features Of An Online Pharmacy

An online pharmacy, at the end of the day, is a commercial enterprise. That means it must have
all the features that are common to the business.

The following features are the ones that are unique to online pharmacies.

Display clearly your must-have certifications

Firstly, you must build trust about your legitimacy. On your website, display all affiliations and
licenses clearly so that first-time visitors can easily find them.

online pharmacy business

For online pharmacies it’s important to build trust

Show complete product information

Display as much information as is required and advisable. Customers, present and potential,
should be able to spot products easily. Highlight all that information that is statutorily required
as well as information you, as a pharmacist, belief should be shared with consumers of medical
formulations.

Carry a customer credentials section

Customers base many decisions on genuine reviews. Place the reviews so newcomers can check
out what kind of service you are offering.

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Just as anywhere else, online pharmacies too benefit from positive customer feedback

Instill trust by safe payment features

Customers must feel completely safe when they may payments. Show prominently how your
payment gateway is superior in terms of ease and safety.
Consider having an app

An online store can be wonderfully complemented by an app. Customers will find an app a lot
easier to buy from. At some stage you’ll want an app, so why not earlier than later?

Highlight events

Part promotional, part social responsibility. You can have a section or run a banner dedicated to
health-related events or articles. This can include schedules of vaccinations, notifications of flu in
a particular area and so on.

pharmacy business model of online pharmacy

Online pharmacies are a good platform to advertise products

Respect privacy

Your customers buy online because they want convenience. A number of them also seek privacy
while buying from you. Make sure your systems are geared towards ensuring the privacy of your
customers. This is not only ethically appropriate but also legally required.

steps to open a pharmacy like pharma2u

Customer privacy is both important and legally required

Act responsibly and ethically

Respect the law of the land. Take every reasonable precaution that you’d take if you were a
physical store.

Offer to stay connected

An online pharmacy can offer newsletters for better engagements. In return, it will connect email
addresses to build a mailing list.

start online pharmacy like chemistwarehouse

Build a mailing list by offering newsletters

Now that you’ve understood the prerequisites and the features of an online pharmacy, it’s time
for a step-by-step guide for building an online pharmacy. This guide will help you understand the
steps, and the sequence required when you are setting up an online pharmacy.

#1 Understand The Laws Governing Online Pharmacies

Owing to all these complexities, various countries already have in place laws and guidelines
intended to regulate the sales of pharmaceutical products. However, they are almost exclusively
focused on physical stores and not on online pharmacies. Hence, there are many grey areas in
the laws of some countries. This makes setting up and running an online pharmacy a challenge.

With all this in mind, let’s take a look at the general laws governing online pharmacy stores.

There must be a registered, licensed pharmacist at the head.

The pharmacist’s license must be valid in the territory from which online pharmacy sells and the
territory to which the medicines are dispatched.

A registered, licensed pharmacist must be in charge and oversee operations, including verifying
prescriptions, storing requirements and approving of the purchase.

The pharmacy must source drugs only from legally recognized suppliers or manufacturers.
Carrying or selling counterfeit drugs is a serious offense.

start your own pharmacy

Recognition from various organizations boosts an online pharmacy’s reputation

Depending upon the country you operate in, the local drug regulating agency (e.g. the FDA in the
USA) may have put up a list of restricted items that cannot be sold without an in-person
examination.

The online pharmacy store must exercise the same caution as a physical store while selling
prescription drugs to refrain from charges of malpractices or extreme negligence.

In all likelihood, your premises will have to be approved of by the local statutory body before you
make the first sale.

#2 Select And Secure Your Brand Name And The Domain Name

This is one thing you’ll want to do as early as you can. If you’ve selected a proprietary or a
partnership structure for your business, you’ll need to separately register your brand name (for
LLC and incorporated firms, this happens by default when you register your business). What’s
important is whether a domain name is available with the desired extension; most likely you’ll
want a dot com.

#3 Decide The Structure Of Your Business And Get Licenses

If you are a registered pharmacist, great! If you aren’t, you’ll need to bring in one. The
pharmacist may be a paid employee, a business partner or a board member. Check out the laws
prevalent laws in the country you will be operating from, to see if there are any restrictions
regarding this.

Next, you’ll be fixing the legal structure of your business of your online pharmacy store. You may
structure your business as a single-owner proprietor, a partnership firm, an LLC or an
incorporated organization. The complexity of the paperwork varies from country to country.
Depending on the structure you choose and the laws of the country you plan to operate out of,
you may be able to handle the application process yourself or may need the help of an agency.

Being a sole-proprietor is not considered a safe way of doing business because all the liabilities
of the business also become the personal liability of the proprietor. An LLC or an incorporated
company, on the other hand, acknowledges that the board members and the company are two
distinct entities. That means the liabilities of the company are not considered to be the personal
liabilities of the business promoters.

Finally, go through the process of getting appropriate permits and licenses. You’ll be required to
satisfy most requirements that exist for pharmacies with the physical presence. Additionally, the
licensing authority will want to ascertain you have established the right checks and balance for
verifying the authenticity of prescriptions.

#4. Choose The Right Platform For Online Pharmacy Store

Once you have understood the regulations, it’s time to better grasp the features various
technology platforms offer.

Broadly, there are two types of technology platforms for eCommerce: Open source and Hosted
(Closed source) platforms. Here is a brief comparison of the two. (For a detailed comparison
between Magento and Shopify you may want to refer to our post-Magento vs Shopify: What
should you choose?)

Open source

Most versions are free of cost or freemium.

Great flexibility available

You take care of the domain registration and hosting

Customer support not available for the free of cost models

Shopping carts are not always included

Strong independent community of users and developers can help you in countless ways

Examples include Magento, X-Cart, Drupal, and OpenCart

#5. Identify Suppliers And Delivery Partners

Since your online pharmacy store will sell sensitive products – medicated formulations, health
supplements, OTC drugs – it’s extremely critical you select your suppliers and other partners
responsibly.

How to start online Pharmacy store similar to Netmeds

Logistics is critical to an online pharmacy’s success

There is always a huge risk that your supplier may supply you poor quality substitutes, spurious
drugs, drugs not stored as per required instructions, drugs manufactured by manufacturers with
poor quality control or drugs that are well past their expiry date. It is strongly recommended you
take a lot of care and invest a lot of efforts in identifying only recognized and reliable suppliers.
For bulk quantities, you may be able to strike a good deal with the manufacturers themselves.

If your business model is one where local pharmacy stores will directly supply the drugs to
customers based on your instructions, you need to be sure they will be following the standard
operating guidelines expected. Drugs and medical formulations being highly perishable items,
your delivery partners must follow best practices in a storage of products.
#6. Establish The Workflow And Systems For Your Online Pharmacy Store

One challenge that online pharmacies need to overcome is the way they will handle a
prescription and verify its authenticity. For instance, in the USA the National Association of
Boards of Pharmacy has come up with a program called Verified Internet Pharmacy Practice
Sites. It approves of, among other things, authentication and security procedures, and quality
assurance policies. If you’re in the US, you’ll want to have this certification. Outside of the US,
you’ll need to do a little homework to find how you will be able to authenticate various
processes.

While dispensing out medicines, you’ll need a strong system in place to make sure there are no
errors. You can consider products for pharmacy automation: they increase efficiency and let your
team more time to focus on promotional or customer-centered activities or on the CRM. For
instance, you can use automated dispensing machines, like the ones offered by Scritpro, Kirby
Lester or Parata.

how to open online pharmacy like rxcount

Pill counters such as this increase efficiency and reduce errors to almost nil

Another important component in your workflow is counter-checks. Are your technicians

checking all the information regarding the drug before preparing it for dispatch? You can build
this small check inside your pharmacy software. For instance, you have a list of checkboxes that
your technician must check individually, to show all steps are being followed. Alternatively, you
can keep certain features in the off mode as the default stage. As the technician follows each of
the steps, these features get ‘unlocked’. This way you know nothing has been omitted. Of course,
the chief pharmacist may have the master access to skip some steps that the technician has
already checked and/or are not vital.

Finally, you’ll need to establish proper systems for storing and returning drugs that have passed
their expiry date. Make sure you comply with all regulations and follow the right procedures.

As you have surely observed by now, setting up an online pharmacy store is not that difficult,
provided you have the right planning and the right agencies that can help you through the
eCommerce store development and design.
We have been specializing in eCommerce website development for a long time and we simply
love helping people! Get in touch and find out how we can help you!

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Scope

At an age where everything is going online and people are buying almost everything from
grocery to gadgets on web stores, it is time that the medical and pharmaceutical market catches
up to the trend and indeed it has. You can now fulfill all your medicinal needs online, at well, an .

Formalities to be made when opening an online pharmacy

As stated above, certain laws are to be followed while opening an online pharmacy and these
rules are quite stringent.

All laws have been well established and any online pharmacy must comply with all the rules and
regulations, however, there are many loopholes that these pharmacies are utilizing for their
profit and illegal drugs have been on the rise.

Because of its vastness, medical laws cannot be all encompassing hence causing circulation of
illegal drugs and pharmaceuticals.

Scope of Online Medicine store In India(current situation):

online pharmacy model is getting more and more attention of investors and entrepreneurs.
According to industry experts, this sector has great business potential and is believed to grow
from $18 billion markets to $55 billion by 2020.

Since Pharmacy is a healthcare sector, it comes with its own rules and norms which are to be
followed strictly to ensure the quality and safety of drugs as well as human lives. When I first
heard about this new concept of online purchasing of drugs,

The number cannot be exactly estimated, however, based on a search, around 3000 online
pharmacies were found, and half of them were based in the USA and 19% in UK and the balance
in other countries like India, Canada, etc. In another finding, B-2-B companies also offered online
pharmaceuticals of which 19% are from India.

POINTS TO REMEMBER

Online pharmacies offer drugs at low cost or at discounted prices to lure customers. If the online
pharmacy gives cheaper alternatives of drug/s prescribed, this violates the doctor-patient-
pharmacist relationship, which is based on trust.

Pharmacy laws in India do not allow a pharmacist to substitute a brand written by a doctor.

Pharmacists are also not authorized to change potency of the prescribed drug, even if the
patient asks for it.

Refilling of a prescription is not allowed by pharmacists unless authorized by the doctor. If the
doctor has prescribed a drug, e.g., 3 days, the pharmacist cannot dispense drugs for more than
this duration.

Online pharmacies may provide rebates and commissions to doctors to provide prescriptions on
the basis of online information that has been filled by the patient. This way doctors will be
vulnerable to malpractice suits. Regulation 6.4 of MCI Code of Ethics prohibits doctors from
giving

“It is largely about the interpretation of law. The Pharma Act had no clarity on electronic copy of
a prescription. However, the IT Act says that any digital copy of a document will be valid if there
is an original copy which can be presented at the time of verification,” said Bhardwaj, adding
that he launched Zigy only after getting a green signal from the law firms.

So, after considering all the possible aspects I hold consent to the whole idea of online pharmacy
and looking forward to its full-flowing and positive contribution to Healthcare sector.

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Internet pharmacy could also be called as distance pharmacy where the customers or patients
have no face to face contact with the pharmacy staff for the delivery of only special kinds of
drugs.

When it comes to awareness only few professionals know about online pharmacy stores. Yes
they know about a drug store but no idea how to operate an online version.

Before you think of stating your own online pharmacy store you need to chalk out a business
plan so you don’t fail.

The Business Model of Online Pharmacy Store

The premise sounds simple. Just like any other eCommerce business, you can sell products
online – OTC and prescription drugs in this case – and make a profit.

Online pharmacy store business models are mostly classified into two categories, based on how
they operate and make money.

The first kind is where the online pharmacy store itself stocks a huge number of medications. A
customer first submits a valid prescription for the medicines they wish to purchase. The online
store confirms the availability of the items required and the customer makes the payment. The
online pharmacy then ships the medicines to the customer.

The second kind is different in that they don’t stock the medicines themselves. Instead, they
partner with local brick-and-mortar pharmacies. When the customer makes an online request
the online pharmacy store checks which partner pharmacy is closest to the customer’s shipping
address or can best deliver the order. They collect the payment, instruct partner physically
deliver the drugs and share the revenue as per conditions agreed upon.

The online pharmacies profit is the difference in the cost versus the selling price of the items
they sell. The cost will include additional expenses like storage costs and shipping charges.

There is an opportunity to make money from featured products. Makers of OTC drugs or
cosmeceuticals (products combining benefits of cosmetics and pharmaceutical) will be willing to
pay money if the online pharmacy store agrees to display their products prominently, give top
listings during searches within the website or provide decent product reviews in blogs.

They can carry advertisements. Established stores can earn good money by accepting ads or
announcing third-party blogs and newsletters. They may choose to enroll with Google Adsense
or directly negotiate with the advertisers.

Online pharmacies may also be able to arrange video-consultations of patients with registered
medical practitioners. In return, the medical practitioners pay a certain fee to the online
pharmacy.

Tying up with institutions like retirement homes is an option worth pursuing. The residents of
such institutions may have restricted mobility. Hence, purchasing medicines online make a lot
more sense to them.

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E-pharmacies Regulation in India: Bringing New Dimensions to Pharma Sector

Priyanka VP1* and Ashok BK2

1Faculty of Pharmacy, Pacific Academy of Higher Education and Research, Udaipur, Rajasthan,
India

2Aditya College of Engineering and Advanced Studies, Aradhya, Ambawadi, Ahmedabad 380015,
Gujarat, India

Corresponding Author:

Priyanka VP

Faculty of Pharmacy, Pacific Academy of Higher Education and Research, Udaipur, Rajasthan,
India

Tel: +91 9904618308

E-mail: [email protected]

Received Date: September 28, 2016; Accepted Date: October 06, 2016; Published Date: October
10, 2016

Citation: Priyanka VP, Ashok BK (2016) E-pharmacies Regulation in India: Bringing New
Dimensions to Pharma Sector. Pharmaceut Reg Affairs 5:175. doi: 10.4172/2167-7689.1000175

Copyright: © 2016 Priyanka VP, et al. This is an open-access article distributed under the terms
of the Creative Commons Attribution License, which permits unrestricted use, distribution, and
reproduction in any medium, provided the original author and source are credited.

Visit for more related articles at Pharmaceutical Regulatory Affairs: Open Access

View PDF Download PDF

Abstract

Buying drugs/medicines online is the latest trend amongst the Indian patients and consumers.
With this increasing trend of buying medicines online, number of online pharmacies also
increase. But there is lack of proper regulatory checks and balances for exercising regulatory
control over e-pharmacies. This eventually leads to flourishing of e-pharmacies like mushrooms.
There are several other factors also which fuel the gearing up of epharmacies like increased
number of netizens, long term illness patients and increased chronic diseases. As we all know
India is the country of youngsters and they are spending more and more time on internet
through mobile or computer. Due to the advancement of technology, access of drugs through
Internet is very easy for common man. Numbers of internet users in India have been increased
continuously since 2000. This is the high time for the epharmacy model to grow with the
drastically increasing netizens, smart phone users and patients. E-pharmacies business is
growing very fast in India although its mechanism of regulation is not decided yet. The success of
the model is not guaranteed in shaky and cloudy regulatory regime but its graph is going higher
day by day. There is lack of proper and clear laws for e-pharmacies. The laws governing
Pharmacies in India are derived from Drugs and Cosmetics Act, 1940; Drugs and Cosmetics Rules,
1945; Pharmacy Act, 1948; Indian Medical Act, 1956 and Code of Ethics Regulations, 2002 etc. E-
pharmacies come under the purview of the Drugs and Cosmetics Act, 1940 and the Information
Technology Act, 2000. But current Drugs and Cosmetics Act, 1940 doesn’t distinguish between
online and offline pharmacies. It seems e-pharmacies may not abide by these regulations and
bypass them. Regulatory authorities finds it difficult to control, monitor and track sell of drugs
via internet as there is lack of clear guidelines in India regarding the same. E-pharmacy may be
proved as dangerous trend in future if not regulated properly.

Keywords

E-pharmacy; Online pharmacy; Internet pharmacy; Web pharmacy; Cyber pharmacy; Regulation;
Regulatory issues; India

Introduction

Now-a-days we witness a phase transition of buying pattern of any goods, clothes, electronics,
furniture, grocery, etc. With the advent of technology, offline shopping switches to online mode.
Buying anything online is in fashion. Then how could be our field of pharma stay untouched of
this? Buying drugs/medicines online is the latest trend amongst the Indian patients and
consumers. With this increasing trend of buying medicines online, number of online pharmacies
also increase. But there is lack of proper regulatory checks and balances for exercising regulatory
control over e-pharmacies. This eventually leads to flourishing of e-pharmacies like mushrooms.
There are several other factors also which fuel the gearing up of e-pharmacies like increased
number of netizens, long term illness patients and increased chronic diseases.
Numbers of internet users in India have been increased continuously since 2000 (Figure 1).

pharmaceutical-regulatory-affairs-internet-live-stats

Figure 1: India internet users, source: internet live stats [1].

As per Ken market research’s report [1] internet penetration (% of Population) was 0.5% in 2000
and reached to 34.8% in 2016 (estimate for July 1, 2016) [1]. From figure it is easily interpreted
that a steep upward curve in the number of net users is seen since the last few years. Same way
share of smart phone users increased continuously (Figure 2). Reliance Jio scheme will add more
number of smart phone users in India. Now move towards chronic diseases to establish
connection with e-pharmacies growth. As per Patel et al. [2] chronic diseases (e.g.,
cardiovascular diseases, mental health disorders, diabetes, cancer, etc.) and injuries are the
leading causes of death and disability in India [2]. There is also widespread presence of some
lifestyle disorders (e.g., pain, obesity, stress, dyslipidemia, diabetes, hypertension and some
cancers, etc.). Day-by-day chronic diseases and long term illness patients are increasing in India.
Thus one can say this is the high time for the e-pharmacy model to grow with the drastically
increasing netizens, smart phone users and patients.

pharmaceutical-regulatory-affairs-phone-users

Figure 2: India smart phone users, source: [email protected] 2015 [3].

As we all know India is the country of youngsters and they are spending more and more time on
internet through mobile or computer. Due to the advancement of technology, access of drugs
through Internet is very easy for common man. Same way delivery of desired drugs at desired
place (at doorstep) is possible with this. The driving forces for popularity of e-pharmacies are
time saving, money saving, 24/7 access, transparency, convenience, etc. A number of challenging
factors like cost, quality, availability, services, legality, low e-tailing penetration and high
drugstores/pharmacies market penetration, etc. will decide the success of e-pharmacies. We
expect better and quicker services from e-pharmacies and at the same time, we don’t want to
compromise with quality and safety of drugs.

There is a vast difference between the sale of common consumer goods and drugs/medicines.
Patients or consumer are not in a state to select a drug of his/her choice; which is possible in
case of other goods. Basically there is no much more difference between the online and offline
pharmacies. Both models pose similarities in operations but most noted difference between the
two is the delivery of drugs to the end users. Online stores are operated via the internet in
contrast to the offline stores. Three types of models of e-pharmacies exist in Indiaorganized,
non-organized and illegal.

Models of E-pharmacy

Organized e-pharmacy

There are two models which operate in this category.

• The market place model, where a technology company connects neighbourhood licensed
pharmacies to the end user;

• The inventory based model, where e-pharmacy is the online service of an offline licensed
pharmacy.

Non-organized e-pharmacy

In this model prescription medicines are ordered without any validated prescription. There is no
check on the genuineness of the order due to absence of qualified pharmacists. Also, improper
record keeping and no audit is a major area of concern.

Illegal international trade through e-pharmacy

In this model, drugs are shipped across the international borders without any prescription and
approval from the concerned authorities. This is generally used to order cheaper version of
drugs like Viagra [4].

E-pharmacies market is $18 billion and will grow to $55 billion by 2020. Industry experts
estimate the market to be generating 3,000-4,000 orders on a daily basis [5]. Remarkable growth
has been observed during the last five years. Investors are willing to fund the epharmacies
because they knew this model is potential enough to revolutionize the pharmaceutical industry.
This model shows promised and prominent growth in the Indian market when there is condition
of recession across the globe.

Types of Medicines

Drugs could be classified by various ways. As per Indian system of Medicines-Ayurvedic drugs,
Siddha drugs, Unani drugs, Homoeopathic drugs and allopathic drugs. It can be also classified by
level of control-Prescription drugs and over-the-counter drugs. Based on nature of origin-
synthetic or natural (Herbal drugs, Phytopharmaceuticals, Biotechnology products). Drugs could
be miscellaneously classified-Orphan drugs, Ethical drugs, Generic drugs, Lifestyle drugs,
Diagnostics, Neutraceuticals, Personal Care Products, etc. All type of drugs should be brought
under the regulatory scanner being sold online than only emphasis on allopathic drugs. The
main concerns linked to e-pharmacies in modern medicines are chances of drug abuse, misuse,
resistance, addiction due to pain killers, CNS depressants, etc. So, doctors need to check whether
the drug being prescribed is as per patients’ requirement or not? Special precautions should be
taken in case of fixed dose combination.

There is wave of opposition for e-pharmacies in India by offline pharmacists. But unfortunately
they are also not practising well their functions. Offline pharmacists don’t check prescription
properly and retain 1 copy of prescription. Sometimes they deliver and sell medicines without
prescription. Even otherwise how much control over prescription in case of offline pharmacies?
As per rules one registered pharmacist is required to run pharmacy. But many pharmacies run by
incompetent staff and owner. One pharmacist serve at more than one pharmacy store or sell
licence to other pharmacy stores for money. All these could be solved in case of e-pharmacies as
transparency is there. The problem of doctor’s bad handwriting could be solved by e-
prescription. Online model could be proved as much more beneficiary to patients. Very
expensive products like Biological products used for cancer. If drugs are available online, then
commission is less and patient gets benefit. Patients can do comparative evaluation in e-
pharmacy to find cheaper drugs. Patients can choose e-pharmacy which gives cheaper drugs.

Before discussing about e-pharmacies regulation, let’s have a look at some basic fundamentals
which help to understand regulatory mechanism easily.

E-pharmacies
The application of internet to access drugs and diagnostics which begin early in advent of info
age has matured into portals or virtual drugs stores popularly known as “internet pharmacy”.
The advent of internet pharmacy and access of drugs and diagnostics is gaining popularity due to
cost effectiveness, high speed delivery to door step of patients [6]. It is also known as Online
Pharmacy, Internet Pharmacy, Web Pharmacy or Cyber Pharmacy.

E-prescribing or electronic prescribing is a technology framework that allows physicians and

other medical practitioners to write and send prescriptions to a participating pharmacy
electronically instead of using handwritten or faxed notes or calling in prescriptions [7].

E-commerce or electronic commerce is the buying and selling of goods and services, or the
transmitting of funds or data, over an electronic network, primarily the internet. These business
transactions occur either as business-to-business, business-to-consumer, consumerto- consumer
or consumer-to-business. The terms e-commerce and ebusiness are often used interchangeably.
The term e-tail is also sometimes used in reference to transactional processes for online
shopping [8]. Interaction between communication systems, data management systems and
security, which because of them exchange commercial information in relation to the sale
products or services, will be available, so the definition, the main components of electronic
commerce are: Communication systems, data management systems and security [9].

Overview of e-pharmacies regulation in India

First we will understand drug regulation of India. Currently regulatory powers have been
distributed between the centre and the state governments. Central Government is responsible
for licensing of drug imports and the state governments are responsible for the manufacture,
sale and distribution of drugs. Central Government exercises regulatory control over drugs by
New Delhi based Central Drugs Control Organisation headed by the Drugs Controller General
India. State authorities’ exercises regulatory control over drugs by state based Drugs Control
Administration headed by the State Drugs Controllers. Every state has its own Drugs Control
Administration.

The laws governing Pharmacies in India are derived from Drugs and Cosmetics Act, 1940; Drugs
and Cosmetics Rules, 1945; Pharmacy Act, 1948; Indian Medical Act, 1956 and Code of Ethics
Regulations, 2002, etc. These all laws were written before the era of computer has been started.
So, basically there are no laws related to internet and ecommerce. The Information Technology
Act, 2000 governs all activities and issues related to internet. When e-pharmacies regulation is
concerned, there is lack of accurately and unambiguously stated laws and clear-cut guidelines to
regulate, control and monitor e-pharmacies. For ensuring efficient and legitimate running of e-
pharmacies, it is a need of the hour to make hassle free rules for e-pharmacies.

E-pharmacies come under the purview of the Drugs and Cosmetics Act, 1940 and the
Information Technology Act, 2000. But current Drugs and Cosmetics Act, 1940 doesn’t
distinguish between online and offline pharmacies. So amendments are required to Drugs and
Cosmetics Act, 1940 to bring e-pharmacies within the scope of Drugs and Cosmetics Act, 1940.

E-pharmacy players make interpretation of laws and rules as per their convenience for taking
advantage for their business when there is uncertainty on the applicability of these laws to this
model. It seems that online players do not abide to these regulations and try to bypass them.
There is a big misconception of believing that rules applied for offline pharmacies could be easily
applied to the online pharmacies too. This may lead to dangerous consequences and may be
proved as dangerous trend in future. There are not clear provisions regarding sale of drugs from
internet, it seems very difficult to control, monitor and track sell of drugs through e-pharmacies.

Rules and Acts

Drugs and Cosmetics Act, 1940

• Section 18 (c) of the Drugs and Cosmetics Act prohibits manufacture and sale of any drug
without a license. As per the Section 18 (c) of Drugs and Cosmetics Act, 1940 to be read with
Rule 65, only a licensed retailer is entitled for the sale of drugs and that too on the basis of
prescription of a doctor only.

• Section 27 of Drugs and Cosmetics Act has provisions for penalty for manufacture, sale, etc., of
drugs in the form of imprisonment and monetary fine. It very clearly states in subsection “b (ii)
without a valid licence as required under clause (c) of section 18” [10].

• Section 10 of the Drugs and Cosmetics Act prohibits import of any drug that is not of standard
quality, any misbranded, adulterated or spurious drug or any drug for requires a license for
import. It also does not permit import of “any drug which by means of any statement, design or
device accompanying it or by any other means, purports or claims to cure or alleviate any
disease.” Imported medicines may be fake, mislabelled and unsafe.

• The Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945, have clear
guidelines on the sale of Schedule H and Schedule X drugs, which are ‘restrictive drugs’ and can
be sold only on the prescription of a registered medication practitioner. Schedule X drugs include
narcotics and psychotropic substances. Chances of drug abuse and addiction are higher with
these drugs. They also require meticulous storage and dispensing records. The prescription has
to be in duplicate, one copy of which is to be retained by the licensed pharmacist for 2 years.

Drugs and Cosmetics Rules, 1945

• Rule 65 of Drugs and Cosmetics Rules, 1945 stipulates sale of drug under the supervision of a
registered pharmacist which also involves signing of the bill and stamping of the prescription by
the pharmacist and the doctor. Rule 65 of Drugs and Cosmetics Rules, 1945 prescribes the
procedure to be adopted by the medical stores while selling the prescription drugs and under
which the prescription from the registered medical practitioner is necessary for sale of Schedule
H drugs under the Act [11].

• Schedule H1 of the Drugs and Cosmetics Rules, 1945 mandates a licensed pharmacist to
maintain a separate register for sale of drugs that are specified in Schedule H1 with details of the
patient, doctor and the name of the drug/s including quantity; it is to be kept for three years and
is open to inspection by regulatory authorities. Schedule H1 mainly includes potent antibiotics,
habit forming painkillers and anti-anxiety drugs that induce sleep.

• Schedule H1 drugs are also required to have special labelling, with symbol Rx in red to be
clearly displayed on the left top corner of the label and a box warning with a red border-“It is
dangerous to take this preparation except in accordance with the medical advice. Not to be sold
by retail without the prescription of a registered medical practitioner.”

• The objective of Schedule H1 was primarily to check the indiscriminate use of antibiotics in
India, in view of the rising incidence of multi-drug resistant bacteria, a serious public health issue
worldwide. Easy access to antibiotics via e-pharmacies will defeat this very purpose.

Indian Medical Council Act, 1956 and code of ethics regulations, 2002

• Regulation 5.3 of MCI Code of Ethics stipulates that pharmacists and doctors should work
together. If e-pharmacies are allowed, then this relationship will be lost.

• Regulation 7.14 of MCI Code of Ethics 2002, also does not allow a registered medical
practitioner to disclose the secrets of a patient that he/she may have been learnt in the exercise
of his/her profession. Declaration (g) given to doctors at the time of registration states: I will
respect the secrets which are confined in me.

• Regulation 6.4 of MCI Code of Ethics prohibits from giving or receiving any rebates or
commissions. E-pharmacies may provide rebates and commissions to doctors to provide
prescriptions on the basis of online information that has been filled by the patient. This way
doctors will be vulnerable to malpractice suits [12].

• Not only doctors, Pharmacists too have a role in ethical dispensing of prescription medicines.
Safe and effective use of medicines is a complementary effort and subsequent amendments
have some provisions in it that are of relevance to the pharmacists.

• Regulation 1.9 of MCI Code of Medical Ethics Regulations, 2002 requires all doctors to abide by
the laws of country that regulate the practice of medicine. Neither the doctor nor the
pharmacist should be a party to helping others evade these laws.

• Regulation 7.19 of MCI Code of Medical Ethics Regulations, 2002 does not allow doctors to use
touts or agents for procuring patients. So, a pharmacist should not indulge in such activities [13].

Narcotic Drugs and Psychotropic Substances Act, 1985

There is chance of misuse of unmonitored and uncontrolled sale of narcotic drugs listed under
the Narcotic Drug and Psychotropic Substances Act, 1985 [14].

Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954

The Drug and Magic Remedies (Objectionable Advertisement) Act and Rules 1954 mentions a list
of ailments for which no advertising is permitted. It also prohibits false or misleading
advertisements that end up making wrong claims. Indian population is being increasingly
exposed to advertising for prescription drugs despite legal prohibitions [15].

Section 3: Prohibition of Advertisement of Certain Drugs for Treatment of Certain Diseases and
Disorders

Section 4: Prohibition of Misleading Advertisements Relating to Drugs [16].

The Pharmacy Act, 1948

According to Subsection 1 of section 42 of Indian Pharmacy Act 1948, “no person other than a
registered pharmacist shall compound, prepare, mix, or dispense any medicine on the
prescription of a medical practitioner.” Section 42 (2) also states, “whoever contravenes the
provisions of sub-section (1) shall be punishable with imprisonment for a term which may
extend to six months, or with fine not exceeding one thousand rupees or with both.”

Information Technology Act, 2000

The Information Technology Act 2000 governs some of the legal issues pertaining to online
dealings but it is silent on the aspect of epharmacy. As a result, illegal e-pharmacies have been
increasing in India [17].

There is no legislation specific to data privacy in India as yet. The laws that deal with data
protection or privacy in India are Section 43A of the Information Technology Act, 2000 and the
Information Technology (Reasonable Security Practices and Procedures and Sensitive Personal
Data or Information) Rules 2011.

There is a proposed Privacy (Protection) Bill, 2013 (“Bill”), which focuses on the protection of
personal and sensitive personal data of persons. If passed and enacted, it will override all
existing provisions directly or remotely related to privacy under section 3, which provides that
“no person shall collect, store, process, disclose or otherwise handle any personal data of
another person except in accordance with the provisions of this Act and any rules made
thereunder.”

There is ambiguity in the Indian law whether a pharmacy is allowed to take money prior to
delivery of medicines. Certain provisions of the law mandate, money to be collected from the
customer only after medicines are physically handed over to the customer [18].

Pharmacy Practise Regulations, 2015

It appears that electronic prescriptions should be valid especially in the light of the Pharmacy
Practise Regulations of 2015 declared by Pharmacy Council of India in January 2015. In these
regulations, “Prescription” is defined by regulation 2. (j) “Prescription” means a written or
electronic direction from a Registered Medical Practitioner or other properly licensed
practitioners such as Dentist, Veterinarian, etc. to a Pharmacist to compound and dispense a
specific type and quantity of preparation or prefabricated drug to a patient.12 On basis of
existing regulations it appears that a scanned copy of prescription will be perfectly considered as
a valid prescription. However, whether such electronic prescriptions can be used to buy
medicine from epharmacies has been questioned [18].

Good Distribution Services

The drug distribution is currently being regulated at the state level by the health departments for
detecting such cases and taking action. FDA officials, however, pinpoint that there is a need for a
proper regulatory mechanism for e-pharmacy. This will help, according to the drug regulators, in
curbing the currently prevalent illegal practice of irrational use of drugs through self-medication,
more so, as it has become a global phenomenon [19].
Techno- legal requirements

Online pharmacies operating in India are abided to follow certain techno legal requirements of
Indian laws which they fail to comply with are as below:

• Privacy

• Data protection

• Encryption

• Cyber law due diligence

• Internet intermediary obligations

• Cloud computing [14]

In absence of knowledge of cyber law due diligence requirements and Internet intermediary
liabilities some e-pharmacies stores, websites and individuals breach the provisions of
Information Technology Act, 2000.

E-pharmacies operate assuming that offline medico-legal requirements can be used for online
requirements, which is actually misbelieving as both have different legalities and array of
questions. If they follow it will lead to chain of legal consequences and liabilities. Strict
adherence to compliance with Indian laws is required for successful operation of any e-
pharmacy.
Government’s move towards the issue

Sale of medicines through e-pharmacies has been banned by the Drugs Controller General of
India (DCGI) on 30th December, 2015. All the drug control administrations of state governments
and union territories are informed to take necessary action against the epharmacies selling
medicines as pending submission of the report prepared by the expert committee to the Centre.
The Drugs Controller General of India (DCGI) emphasized to keep eye on the online sale of
medicines to stop breaching rules and regulations. Hence all epharmacies operating in India are
under the regulatory scanner.

Drugs Consultative Committee had constituted a seven-member subcommittee to study the

issue of sale of drugs on the internet and associated risks and concerns. Sub-committee review
recommendations to formulate guidelines on the use of information technology in e-pharmacy
and authorise its legal validity.

Federation of Indian Chambers of Commerce and Industry (FICCI) has been appointed as nodal
agency by the Drugs Controller General of India (DCGI) to consolidate and frame guidelines for
online sales of medicines through e-commerce channels in June, 2015. To oppose central
government’s move to regularise sale of medicines through the internet, All India Organisation
of Chemists and Druggists (AIOCD) went on one day’s strike in October, 2015.

Indian Medical Association (IMA) wrote a white paper which shows that Indian Medical
Association (IMA) strongly oppose e-pharmacies. But objection of white paper could be
improved if concerned authorities study it in detail and proper steps will be taken. Traditional
pharmacies owners also oppose online model. So, concerned authorities should think about
existing models interest and benefit while drafting new rules for online model. It would not hurt
business of existing model’s players. New model will be such that it integrate and augment the
business of existing model rather than harming it. It should open horizon of new opportunities
for the existing model. Both models should be operated, worked and regulated in harmonized
and synchronised manner. It would be served as a platform to bridge the gaps of existing offline
pharmacies and connect the patients with existing offline pharmacies.

Glimpses of federation of Indian chambers of commerce and industry (ficci) report

Earlier there was shaky and cloudy regulatory regime for epharmacy model in absence of well-
defined laws. If this persists for long time, unregulated e-pharmacy may be proved as dangerous
trend in future. To overcome this situation, regulatory authorities have started to frame laws and
guidelines for the same. Sub-committee is ready to release a report of recommendations to
regulate e-pharmacies after extensive deliberations with experts, industry persons and stake
holders. As per S. Eswara Reddy (Joint Drugs Controller-CDSCO), “This report will mainly accept
online pharmacies only with respect to e-prescriptions.”

They emphasize on e-prescriptions and recommended a standardised format for these

prescriptions. They defined terms related to online medicine retail, including e-prescriptions,
online pharmacies, and Over-The-Counter (OTC) drugs. The report has suggested amendments
to drug rules and a “negative list” which specifies drugs prohibited to sell to ensure the safe
running of online pharmacies. It has suggested integrating AADHAR Number into the overall
epharmacy framework to make the retail process more transparent.

What should do to improve regulation?

Design a website for checking legality of e-pharmacy.

Make guidelines for consumers for safely accessing e-pharmacies and explains how to buy
medicines safely from e-pharmacies.

Specific and clear-cut rules should be made for selling, prescribing, dispensing, and delivering
prescription drugs through e-pharmacies.

List of illegal and blacklisted e-pharmacies should be provided to help out consumers and stop
them using such fake websites.

Government should make a common logo for legally operating epharmacies to distinguish them
from illegal one.
Make guidelines for online drugs importation and re-importation for legislators and consumers.

It is mandatory for e-pharmacies dealing with online drugs importation and re-importation to be
registered and to get licence for the same from regulating body.

As the power of drug regulation is distributed between Central and State government, role of
Central government and State government should be well defined.

E-pharmacies’ should not use the data generated from online business for commercial purpose.

Using public-private tie-ups leveraging characteristics of internetbased technologies and

engaging private sector service providers can be the basis of an encyclopaedic policy to address
this planetary public health concern.

Government schemes like National Rural Health Mission can aid in promoting proper procedures
to acquire drugs, prevent selfmedication through campaigns on television, radios and social
media [20].

Watch should be kept on importation of banned drugs through epharmacies outside India which
don’t come under Indian jurisdiction.

Each and every activity and transactions made through epharmacies must be under regulatory
scanner to prevent it from underworld and smuggling.

E-pharmacy must establish its server in India as if it is outside the boundaries of India, it is
difficult to control and regulate it.

To ensure efficient running of e-pharmacies great compliance and strict adherence to laws is
required. So, regularly check whether epharmacies follow it or not.
Advantages

• Time saving

• Money saving

• 24/7 access possible

• Convenience increased

• Easy accessibility to medicines

• Increased availability of medicines

• Refund possible

• Easy comparison of medicines in terms of cost

• Increased consumer information and information exchange

• Privacy

• Fast distribution
• Increased choice as wider variety of medicines available.

• Convenient for some patients and old age people who can’t leave their home.

• Delivery of medicines at desired place at desired time possible

Disadvantages

• Chances of drug resistance

• Chances of drug interaction

• Chances of drug abuse

• Chances of drug misuse

• Chances of misdiagnosis

• Promote self-medication

• Purity and quality of drugs not assured

• Financial privacy issues

• Medical privacy is a major concern

• Electronic health records security and privacy concerns

• Easy availability of illegal substances

• Encourage direct to consumer advertising of prescription drugs which is illegal

• Risks associated with online purchasing of drugs

• Sale of drugs without prescription by some e-pharmacies which lead to harmful consequences

• Online prescription without consulting a doctor

• Doctor’s prescription may not be honoured

• Doctor- Pharmacist- Patient: This trio trust evaporates

• Affect business of offline pharmacists

• Access to illiterate and poor population difficult

• Authentication of physicians and pharmacist online is unclear

• Labelling and packaging related issues

• Tough to distinguish between legitimate and illegitimate websites for e-pharmacy

• No control on purchasing drugs by minors from e-pharmacies

• Tough to transport temperature sensitive drugs

Challenges

• Absence of concrete laws for e-pharmacies in India

• To take money before delivery of drugs/medicines is questionable

• Selling or shipment of drugs to minors

• Reach of technology driven model to illiterate people due to lack of knowledge about internet

• Speed of internet

• Prescription related issues

• Legality of electronic signature

• Identity and reliability of legal e-pharmacy

• Protection of consumer rights

• Security and confidentiality of information exchanged

• Security of financial transactions

• Regulatory control over e-pharmacies operating outside the jurisdiction of India

• Unclear laws on inter-state transfer of drugs/medicines.

• Drug importation and re-importation issue

Conclusion

Regulatory authorities finds it difficult to control, monitor and track sell of drugs via internet as
there is lack of clear-cut guidelines in India for regulating e-pharmacies. Although the model is
promising great opportunity for the business, it have some drawbacks also and number of
regulatory hurdles in its way of success. It will promote selfmedication, drug abuse, drug
addiction, drug resistance. It will also encourage patients to self-report the medical history. E-
pharmacy may be proved as dangerous trend in future if not regulated properly. Regulatory
authorities and government of India should think about existing pharmacy system and
pharmacists while framing the rules for e-pharmacies. Patients’ safety and quality of drug should
paramount whilst framing rules.

References

Ken Research (2015)India online healthcare products market outlook to 2020-infusion of online
marketplaces and healthcare awareness to shape future growth. Market Research Report 121.

Patel V, Chatterji S, Chisholm D, Ebrahim S, Gopalakrishna G, et al. (2011) Chronic diseases and
injuries in India, India: Towards Universal Health Coverage. Lancet 377: 413-428.

https://ihealthcomms.wordpress.com/tag/health-app/

Verma N (2015) Legal Procedures that every pharmacy must follow, traditional or online,
mCHEMIST.
Sahay P (2016) Will online pharmacies work in India, and are they even legal? Live Mint.

Joy J, Nagappa A (2016) Internet pharmacy regulations on marketing drugs directly to

customer.Pharmtutor.

http://searchhealthit.techtarget.com/definition/e-prescribing

http://searchcio.techtarget.com/definition/e-commerce

Nanehkaran YA (2013) An introduction to electronic commerce.Int J Scientific TechnolRes 2:4.

Pillai MA, Aggarwal KK(2016) IMA White Paper: IMA White Paper on online pharmacy. IMA.

Nautiyal S (2015) DCGI to study global regulations to frame rules on online pharmacy
soon.Pharmacy and Trade

Pharmacy Practice Regulations (2015) Pharmacy Council of India, Government of India.

IMA (2015) White Paper: Every pharmacist must know certain MCI Rules. Indian Medical
Association.

PTLB (2014) Laws for opening of online pharmacy store in India.Cyber Laws in India and
Technology Laws and Regulations in India.

Ghia1 C, Jha R, Rambhad G (2014) Assessment of the impact of pharmaceutical advertisements

on patient’s drug consuming behaviour: A questionnaire based survey. Journal of Young
Pharmacists6:2.

The Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 (21 of 1954).

Unnikrishnan CH, Arathoon M (2008) Lax regulation sees India becoming a haven for illegal
online pharmacies. Live Mint.

Malvai E (2015) Legality of selling medicines online in India. iPleaders.

Nautiyal S (2015) Online pharmacy rules must align towards understanding pharmacist
role.Pharmabiz.com.

Nagaraj A, Tambi S, Shravani G, Biswas G, Kumawat H, et al. (2014) Counterfeit medicines sale on
online pharmacies in India. JRes Pharm Pract3: 145-146.

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An online pharmacy, internet pharmacy, or mail-order pharmacy is a pharmacy that operates

over the internet and sends the orders to customers through mail or shipping companies.

Online pharmacies might include:

Pharmacy benefit manager – A large administrator of corporate prescription drug plans

Legitimate Internet pharmacy in the same country as the person ordering

Legitimate Internet pharmacy in a different country than the person ordering. This pharmacy
usually is licensed by its home country and follows those regulations, not those of the
international orders.

Illegal or unethical internet pharmacy. The web page for an illegal pharmacy may contain lies
about its home country, procedures, or certifications. The "pharmacy" may send outdated
(expired shelf life) or counterfeit medications and may not follow normal procedural safeguards.

Contents

1 Home delivery

2 Risks and concerns

3 Discussion

4 International consumers

5 U.S. consumers

5.1 Overseas online pharmacies and U.S. law

5.2 Enforcement

5.2.1 Mail fraud

6 Bulgarian consumers

7 Canadian online pharmacies selling to United States customers

8 Indian consumers

8.1 Legal status in India

9 Pakistani consumers
10 UK consumers

11 See also

12 References

13 External links

Home delivery

Conventional stationary pharmacies usually have controlled drug distribution systems from the
manufacturer. Validation and good distribution practices are followed. Home delivery of
pharmaceuticals can be a desirable convenience but sometimes there can be problems with
uncontrolled distribution.

The shipment of drugs through the mail and parcel post is sometimes a concern for
temperature-sensitive pharmaceuticals. Uncontrolled shipping conditions can include high and
low temperatures outside of the listed storage conditions for a drug. For example, the US FDA
found the temperature in a mail box in the sun could reach 136 °F (58 °C) while the ambient air
temperature was 101 °F (38 °C)[1]

Shipment by express mail and couriers reduces transit time and often involves delivery to the
door, rather than a mail box. The use of insulated shipping containers also helps control drug
temperatures, reducing risks to drug safety and efficacy.

Risks and concerns

Illegal or unethical pharmacies sometimes send outdated, substituted, or counterfeit

medications[2][3][4][5]

Sometimes an online pharmacy may not be located in the country that is claimed. For example,
one study of drug shipments claiming to be from Canada revealed many actually originated in
several different countries and were often bogus medications[6]

Minors or children can order controlled substances without adult supervision

Other concerns include potential lack of confidentiality, improper packaging, inability to check
for drug interactions, and several other issues[7]

Discussion
Canisters containing pharmaceuticals are loaded into an automatic dispensing machine at a mail
order pharmacy.

Legitimate mail-order pharmacies are somewhat similar to community pharmacies; one primary
difference is the method by which the medications are requested and received. Some customers
consider this to be more convenient than traveling to a community drugstore, in the same way
as ordering goods online rather than going to a shop.[8]

While many internet pharmacies sell prescription drugs only with a prescription, some do not
require a pre-written prescription. In some countries, this is because prescriptions are not
required. Some customers order drugs from such pharmacies to avoid the cost and
inconvenience of visiting a doctor or to obtain medications their doctors were unwilling to
prescribe. People living in the United States and other countries where prescription medications
are very expensive may turn to online pharmacies to save money. Many of the reputable
websites employ their own in-house physicians to review the medication request and write a
prescription accordingly. Some websites offer medications without a prescription or a doctor
review. This practice has been criticized as potentially dangerous, especially by those who feel
that only doctors can reliably assess contraindications, risk/benefit ratios, and the suitability of a
medication for a specific individual.[9] Pharmacies offering medication without requiring a
prescription and doctor review or supervision are sometimes fraudulent and may supply
counterfeit—and ineffective and possibly dangerous—medicines.

International consumers

Main article: Consumer import of prescription drugs

International consumers sometimes purchase drugs online from online pharmacies in their own
countries, or those located in other countries. Some of these pharmacies require prescriptions,
while others do not. Of those that do not require prescriptions, some ask the customer to fill in a
health questionnaire with their order. Many drugs available at legitimate online pharmacies are
produced by well-known manufacturers such as Pfizer, Wyeth, Roche, and generic drugmakers
Cipla and Ranbaxy of India and Teva Pharmaceutical Industries of Israel. However, it remains
difficult for a patient to ascertain whether an online pharmacy is legitimate. Medicines obtained
from rogue online pharmacies come with no guarantees with regard to their identity, history and
source. A study in three cities in the Netherlands found that over 60% of the consumed sildenafil
was obtained from illegal sources.[10] The work of Roger Bate from the American Enterprise
Institute, in which he has tested hundreds of prescription drug orders purchased over the
Internet, shows that properly credentialed online pharmacies, ones selling domestically and
internationally, only sell lawfully-manufactured medicines.[11]
U.S. consumers

An attraction of online pharmacies is drug prices.[12] Shoppers can sometimes obtain 50 to 80

percent or more savings on U.S. prices at foreign pharmacies.[13] The Washington Post reported
that "...millions of Americans have turned to Mexico and other countries in search of bargain
drugs...U.S. Customs estimates 10 million U.S. citizens bring in medications at land borders each
year. An additional 2 million packages of pharmaceuticals arrive annually by international mail
from Thailand, India, South Africa and other points. Still more packages come from online
pharmacies in Canada."[14] According to a Wall Street Journal/Harris Online poll in 2006, 80
percent of Americans favor importing drugs from Canada and other countries.[15] Factors
independently associated with importation by U.S. residents are age greater than 45 years, south
or west region of residence, Hispanic ethnicity, college education, poor or near poor poverty
status, lack of U.S. citizenship, travel to developing countries, lack of health insurance, high
family out-of-pocket medical costs, trouble finding a healthcare provider, fair or poor self-
reported health status, filling a prescription on the Internet, and using online chat groups to
learn about health.[16] President Obama’s budget supports a plan to allow people to buy
cheaper drugs from other countries.[17] A 2016 study suggested that providing health insurance
coverage may significantly reduce personal prescription drug importation and the subsequent
risk of exposure to counterfeit, adulterated, and substandard medications.[12] Further, health
insurance coverage is likely to be particularly effective at reducing importation among persons
who were Hispanic; born in Latin America, Russia, or Europe; and traveled to developing
countries.[12] A report in the journal Clinical Therapeutics found that U.S. consumers face a risk
of getting counterfeit drugs because of the rising Internet sales of drugs, with worldwide
counterfeit drug sales, offline and online, projected to reach $75 billion by 2010.[18]

Independent research published by the National Bureau of Economic Research demonstrates

that online pharmacies, U.S. and foreign, verified by certain credentialing entities, sell genuine
medication and require a prescription.[19] In that study, all tested prescription drug orders were
found to be authentic when ordered from online pharmacies, international and U.S.-only,
approved by PharmacyChecker.com [20], as well as U.S. online pharmacies approved by the
National Association of Boards of Pharmacy (NABP) Verified Internet Pharmacy Practice Sites
(VIPPS) program or LegitScript, and Canadian-based online pharmacies approved by the
Canadian International Pharmacy Association. Nine percent of tested products ordered from
non-credentialed online pharmacies were counterfeit.[19]

There are two verification programs for online pharmacies that are recognized by the National
Association of Boards of Pharmacy (NABP). One is VIPPS, which is operated by the NABP and was
created in 1999.[21] The Food and Drug Administration refers Internet users interested in using
an online pharmacy to the VIPPS program.[22] The other is LegitScript, which as of September
2010 had approved over 340 Internet pharmacies as legitimate and identified over 47,000
"rogue" Internet pharmacies.[23] Canadian and all non-U.S. online pharmacies that sell
prescription medication to Americans, regardless of credentials, are not eligible for approval in
the VIPPS and LegitScript programs.[24]

Overseas online pharmacies and U.S. law

Legality and risks of purchasing drugs online depend on the specific kind and amount of drug
being purchased.

The FDA believes that many selling illegal pharmaceutical products without prescriptions are
controlled by organised criminal networks.[25] In 2014, The U.S. FDA, in partnership with other
federal and international agencies and technology companies like Google, took action against
websites, some based in India, that were selling drugs to U.S. consumers.[26] Mail Order
pharmacies are regulated by the federal laws of the US [27] and hundreds of them operate
legally in the US.

The U.S. Food and Drug Administration believes that ICANN should do more to block and seize
what the agency views as illegal online pharmacy websites. [28] ICANN has articulated the
position that it does not have the organizational mandate to take down online pharmacies,
stating in one post on its website, "that ICANN is not a court and is not empowered to resolve
disputes when parties disagree over what constitutes illegal activity in multiple countries around
the world."[29] The Electronic Frontier Foundation, a non-profit organization defending civil
rights on the Internet, views the influence of the pharmaceutical industry on the Internet as a
form of censorship that threatens the ability of American consumers to access medicines in
other countries purchased from online pharmacies that sell legitimate medicines.[30]

Enforcement

It is illegal to purchase controlled substances from an overseas pharmacy. A person purchasing a

controlled substance from such a pharmacy may be violating several federal laws that carry stiff
penalties.

Any package containing prescription drugs may be seized by US Customs and Border Protection.
The package may be held and eventually returned to the sender if the addressee does not
respond and provide proof that they are allowed to receive these drugs (e.g., a valid
prescription).[31] In practice, the number of packages containing prescription drugs sent to
United States on a daily basis far exceeds CBP's capabilities to inspect them.[32] In the past,
packages often passed through customs even if they were not sent from Canada or otherwise
didn't meet the requirements of section 844 of 21 USC. In 2006, some Canadian pharmacies
reported that "as much as 5 percent" of orders from American consumers were being seized.[33]

DEA and FDA[34] generally do not target consumers unless drugs are imported in large
quantities (suggesting intent to distribute) or represent a perceived danger to public health
(opiates, amphetamines).

Rarely, drug importation laws are enforced on the local level. For example, in June 2005 in Baton
Rouge, Louisiana, a number of customers of online pharmacies were arrested by local law
enforcement officers and charged with possession of a controlled substance without
prescription.[35]

The act of importation of the controlled substance from overseas violates 21 USC, Section 952
(up to 5 years in prison and $250,000 fine for importation of non-narcotic Schedule III, IV, or V
drugs; possibly more for narcotics and Schedule I and II drugs). The act of simple possession of a
controlled substance without a valid prescription violates 21 USC, Section 844 (up to 1 year in
prison and $1,000 fine). FDA does not recognize online prescriptions; for a prescription to be
valid there must be a face-to-face relationship between the patient and the health-care
professional prescribing the drug. What exactly constitutes a "face-to-face" relationship is
considered by many online pharmacies to be a subjective definition that would allow them to
operate as an adjunct to the patient's own physician if the patient submits medical records
documenting a condition for which the requested medication is deemed appropriate for
treatment. Sections 956 and 1301 provide exemptions for travelers who bring small quantities of
controlled substances in or out of the country in person, but not by mail.

Importation of an unapproved prescription drug (not necessarily a controlled substance) violates

21 USC, Section 301(aa), even for personal use.[34] The Food, Drug, and Cosmetic Act does allow
for the importation of drug products for unapproved new drugs for which there is no approved
American version. However, this allowance does not allow for the importation of foreign-made
versions of U.S. approved drugs.

The law further specifies that enforcement should be focused on cases in which the importation
by an individual poses a threat to public health, and discretion should be exercised to permit
individuals to make such importations in circumstances in which the prescription drug or device
imported does not appear to present an unreasonable risk to the individual.[36]

It is also illegal to import non-approved drugs (21 USC sections 331(d) and 355(a)); however, FDA
policies suggest that, under certain circumstances, patients may be allowed to keep these drugs.
[37]
Individual U.S. states may implement their own laws regulating importation, possession, and
trafficking in prescription drugs and/or controlled substances.[citation needed]

For several years, the states of Nevada,[38] Minnesota, Illinois and Wisconsin have run official
state programs to help their residents order lower-cost drugs from abroad to save money.

Mail fraud

All online pharmacies sell through the internet but must ship the product usually via the mail.
The selling of many class (schedule)[39] drugs without a valid prescription (also called Rx-only
drugs or legend drugs) is illegal and companies shipping them by mail can be prosecuted for mail
fraud (Postal Inspection Service) as well as investigations and Federal charges by the DEA, IRS,
Homeland Security, Food and Drug Administration’s Office of Criminal Investigations,
Department of Justice, INTERPOL,[40] and the U.S. Immigration and Customs Enforcement (ICE),
[41] and it is common practice for many agencies to jointly investigate alleged crimes.[42]

Bulgarian consumers

All Bulgarian online pharmacies must be registered with the Bulgarian drug agency (BDA). BDA
controls the trade with medicines and makes analysis when doubting the quality and safety of
drugs. A special BDA logo and a certificate for registration of pharmacy proves the accreditation
and the legitimacy of the store. When clicking on the logo, the consumer will be taken to the
official page of the Bulgarian drug agency. The web page must deliver information about the
pharmacy's name, address, registration number and its manager.

Canadian online pharmacies selling to United States customers

Buying prescription drugs from even the most well respected internet pharmacies in Canada
often results in a prescription filled from drugs sourced not from Canada but rather Caribbean
nations or from eastern Europe. The Canadian online pharmacy that sells the drugs offers a
Canadian price but buys at a still cheaper rate from third parties overseas. This has led to
problems with prescriptions being filled with counterfeit drugs, which sometimes have no
activity whatsoever. Some pharmacists have exited this business because of the ethical problems
involved, and some less-established Internet sites may be knowingly selling fake drugs. In 2014,
the largest online Canada drug retailer was forbidden by Health Canada from selling wholesale
drug. Of the three primary entrepreneurs of online Canadian drugs sold to the United States,
one is in jail, one exited the industry entirely, and the third is under investigation for criminal
wrongdoing.[43][44][45] The same errors have occurred in US pharmacies, notably CVS. For
more about this see "Canada Drugs' history and closure".
Indian consumers

Online pharmacies in India have significantly increased due to growing E-commerce in India and
little regulation of the industry.[46]

There is "no regulatory control over drug advertisements on television or the Internet".[46]

Technology can help in meeting the healthcare objective of India.[47][48][49] Indian government
is planning to spend Rs 500 crore on computer literacy project for 50 lakh people over a period
of 3 years. This would help Indian citizens to access government services in the fields of e-
education, e-health and e-governance.[50] Healthcare providers in India are also expected to
spend $1.1 billion on IT products and services in 2014.[51]

Legal status in India

Main article: Online pharmacy laws in India

There is no specific law to deal with online pharmacies in India but multiple laws govern online
pharmacies in an indirect manner. The Drugs and Cosmetics Act, 1940, and the Drugs and
Cosmetics Rules, 1945, have guidelines on the sale of Schedule H and Schedule X drugs. These
can be sold only on prescription and there are specific rules, including for labelling and bar
coding.[52]

It appears that electronic prescriptions should be valid especially in the light of the Pharmacy
Practise Regulations of 2015 declared by Pharmacy Council of India in January 2015. In these
regulations, “Prescription” is defined by regulation 2 (j)[3] ‘means a written or electronic
direction from a Registered Medical Practitioner.’[53] On basis of existing regulations it appears
that a scanned copy of prescription will be perfectly considered as a valid prescription. However,
whether such electronic prescriptions can be used to buy medicine from online pharmacies has
been questioned.[54]

The Maharashtra Food and Drugs Administration (FDA) raided 27 online pharmacies located in
Mumbai, Thane and Pune and seized drugs worth Rs. 2 Crore.[55]

Pakistani consumers
in 2015, the Drug Regulatory Authority of Pakistan Act passed[56] for the registration of
homeopathic, herbal, unani, allopathic, and nutraceutical products. This has also implied that
only registered retail pharmacies can sell such items, along with OTC and Prescription
medication, to the public.[57][58]

The sale of all drugs in Pakistan is subject to the Drugs Act of 1976.[59]

UK consumers

In the UK more than 2 million people buy drugs regularly over the Internet from online
pharmacies; some are legitimate but others have "dangerous practices" that could endanger
children.[60] In 2008, the RPSGB introduced a green cross logo to help identify accredited online
pharmacies (from 2010 the internet pharmacy logo scheme is run by the GPhC).[61]

European registered pharmacists have reciprocal agreements allowing them to practice in the UK
by getting registered with the General Pharmaceutical Council.

The first internet pharmacy in the UK was Pharmacy2U, which started operating in 1999.[62] The
UK is a frontline leader in internet pharmacy since a change to NHS pharmacy regulations in
2005 that made it legal for pharmacies to fill NHS prescriptions over the internet.[63] Drugs
supplied in this way tend to be medicines which doctors refuse to prescribe for patients, or
would charge a private prescription fee, as all patients treated under the National Health Service
pay either a flat price or nothing for prescribed medicine (except for medicine classed as lifestyle
medicine, e.g. anti-malarials for travel), and medical equipment.[citation needed] Since July
2015 the Medicines and Products Regulatory Agency (MHRA) has required online sellers of
medicines to adopt an EU wide logo and maintain an entry in the MHRA medicines sellers
registry.[64]

In the UK, online pharmacies often link up with online clinic doctors. Doctors carry out online
consultations and issue prescriptions.[65] The company employing the doctors must be
registered with the Care Quality Commission. Online clinics only prescribe a limited number of
medicines and do not replace regular doctors working from surgeries. There are various ways
the doctors carry out the online consultations; sometimes it is done almost entirely by
questionnaire. Customers usually pay one fee which includes the price of the consultation,
prescription and the price of the medicine.
As of April 2016, there were 46 registered online pharmacies in England. In April 2017 the Care
Quality Commission suspended the registration of Doctor Matt Ltd – trading as
theonlinesurgery.co.uk because of inadequate medical assessment of prescription requests. Six
have been warned after inspections.[66]

Pharmacy2U claimed in June 2018 that online dispensing could save the NHS up to £400 million
a year, a claim disputed by other pharmacy organisations.[67]

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