E pharmacy

E-PHARMACY
Abhishek S Keralli
I M.Pharm
Pharmaceutical Regulatory Affairs
Dept. of Pharmaceutics
JSSCP Ooty
J S S C O L L E G E O F P H A R M A C Y, O O T Y
An ISO 9001:2008 Certified Institution, Approved by Pharmacy Council of India,
Approved by AICTE, Accredited ‘A+' Grade by NAAC.
By:

Contents
 Introduction
 Definition
 Types
 Components of e-pharmacy
 How an e-pharmacy works
 Types of Medicines
 Regulations in India
 Suggestions from different
associations
 Amendments in e-pharmacy
 Scenario in other countries
 Opinions on e-pharmacy
 Future of e-pharmacy in
India
 Advantages
 Disadvantages
 Challenges
 References

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.
 Online Pharmacy is going to be the next big evolution that will
impact billions of lives and bring a healthy behavioural change
to safer and more convenient tomorrow.
 While many aspects of healthcare service delivery, like finding
doctors or hospitals, booking appointments, payment of fees,
booking a lab test, viewing lab test reports, have gone online,
pharmacy is one area which still lags behind.

Definition
 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”
or “Online pharmacy” or “Web pharmacy” or “Cyber pharmacy”.
 e-Pharmacies are online platforms where consumers can
purchase medicines without having to visit brick-and-mortar
pharmacies. This makes the process more convenient for
consumers and has resulted in a rising demand for the model
across the world. In addition, increasing utilization of e-
Prescriptions in the hospitals, globally, it has also led to the
growth of this industry.

History
2004
 Because of Congressional concerns over counterfeit drugs being sold
by illegitimate online pharmacies, the major online search engines
select Pharmacy Checker.com to verify the validity of online
pharmacies as a result of Congress’ concern over counterfeit drugs
being sold by illegitimate online pharmacies.
2005
 A FDA operation reveals many drugs promoted online as “Canadian”
are counterfeit and actually originate from other countries.

Contd……
2006
 To protect American from counterfeit drugs, the FDA announces new
measures that emphasize certain regulatory actions and the use of
new technologies for safeguarding the integrity of the U.S. drug
supply.
 FDA warns consumers not to buy or use prescription drugs from
various Canadian Web sites that apparently sell counterfeit products.
2007
 FDA warns consumers about counterfeit drugs from multiple Internet
sellers.
2008
 Ryan Haight Online Consumer Protection Act of 2008 passes in
Congress, banning online pharmacies from the sale of controlled
substances based on online patient consultations.

Contd……
2009
 PSM Board Member Bryan A. Liang discusses problems with
PharmacyChecker.com in the article “Searching for Safety:
Addressing Search Engine, Website, and Provider Accountability for
Illicit Online Drug Sales.”
 Report from LegitScript and KnujOn found that 80 to 90 percent of
search engine-sponsored advertisements of online drug pharmacies
(verified by PharmacyChecker.com) violate federal and state laws.
 PSM scrutinizes Google, Yahoo, and Bing for supporting illegal online
drug sales.
2010
 Google announces updated U.S. and Canada pharmacy policy and
removes PharmacyChecker.com as a certifying authority for online
pharmacies.

Key players of e-pharmacy
 Netmeds
 Medplus
 1MG
 mCHEMIST
 Medlife
 Myra
 Pharmeasy

Types
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.

Components of e-pharmacy
Technology
 Web-based and/or mobile-based application for consumers
transmits their prescriptions and place requests for medicines.
 Order that is received is verified and checked by a registered
pharmacist.
 The registered pharmacist forwards the verified prescriptions to
the pharmacy store from where the medicines are dispensed by
a licensed pharmacy.
 The web or mobile-based platform to be governed under the IT
Act 2000 and rules there under.

Pharmacy retail store
 The registered pharmacist at the store verifies the prescriptions
before dispensing.
 The medicines are dispensed from a licensed premises to the
patient or patient’s relative (Patient’s agent).
 An invoice with batch number of the medicines dispensed,
expiry date, name and address of the pharmacy with signature
of the registered pharmacist/(s) is issued online.

How does an e-pharmacy operate?
Capture
Prescription
Receive your
order at
doorstep
Fill your order
with
prescription
Search nearby
Pharmacies
Pay OnlineCheck
Availability of
Medicines
E-pharmacy
Customer

Interconnection
Pharmacies CustomersE-pharmacy

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.

Regulation in India
Drugs and Cosmetics act 1940
 Sale of Schedule H and Schedule X drugs.
 Doesn’t differentiate between medicines sold online or offline.
Indian Medical Council act 1956
 Pharmacists and doctors should work together. If e-
pharmacies are allowed, then this relationships will be lost.
 MCI code of ethics prohibits from giving or receiving any
rebates or commissions. e-pharmacies may provide.
 The health ministry and CDSCO are working together on
working on e-pharmacy regulation policy, which is expected
to streamline the online sales of medicines.

Contd……
The Pharmacy Act 1948
 “No person other than a registered pharmacist shall
compound, prepare, mix or dispense any medicine on
the prescription of a medicinal practitioner.”
Information Technology Act 2000
 Governs some of the legal issues pertaining to online
dealings but it is silent on the aspect of e-pharmacy.

Suggestions from different associations
 The association gave a detailed presentation on
advantages of online mode of sale and also advocated
that the market place and electronic platforms are in line
with the provisions of the Information Technology Act,
2000 and Pharmacy Practice Regulation 2015. They also
reiterated that the sale of medicines does not violate
prevailing provisions of the Act.- Indian Internet
Pharmacy Association (IIPA)
 The Pharmacy Practice Regulations have been made by
Pharmacy Council of India, with approval of the Central
Government, as powers conferred under Section 10 and
18 of the Pharmacy Act, 1948. While dispensing the
medicines whether online or offline, the provisions under
these regulations have to be considered.- Pharmacy

 FICCI gave a detailed presentation on advantages of this
mode of sale and also advocated that the market place
and electronic platforms are in line with the provisions of
the Information Technology Act, 2000 and Pharmacy
Practice Regulation 2015. They also reiterated that the
sale of medicines through online mode do not violate
prevailing provisions of the Act.- Federation of Indian
Chambers of Commerce & Industry (FICCI).

Indian Pharmaceutical Association(IPA)
Draft guidelines(April 2018) that are being prepared on e-pharmacies have the
following Lacunae and these should be rectified before the guidelines are
implemented
 A background note explaining why the Government views that e-
pharmacies are necessary is missing. Such a note is essential to
understand the need and purpose of e-pharmacies in this country. At
the same time, clear cut safety measures that would be implemented
need to be listed.
 A clear procedure of how medicines will be dispensed by an e-
pharmacy needs to be laid down for proper functioning of e-
pharmacies.
 Simplified procedure is currently going on with the e-pharmacies
currently going on with the e-pharmacies currently functioning in
India and we believe that no where in the world such a model is

 Where would the accountability rest if anything goes wrong, such as
if a wrong medicine is dispensed or sub-standard medicine is
dispensed . Would the web portal be held accountable or the
pharmacy or both needs to be finalised. In an ideal situation, we feel
that both should be held accountable.
 Is it not compulsory to dispense medicines online only from their
own brick and mortar pharmacy?
 Definition of an e-prescription need to be made more unambiguous.
 Precaution and care while transporting the medicines is not
specified.
 Precautions or restrictions on orders and supply of temperature-
sensitive medicines were not laid down.
 Validity checks for prescriptions are not mentioned.

 Preventive measures for uploading of prescription on multiple web
portals are not specified. In addition, what if the same prescription is
used to purchase at a brick and mortar pharmacy? Such precautions
are not considered.
 Adhaar linking of patient/pharmacist in this process is required.
 Validity period of a prescription needs to be specified, one week or a
month?
 What is the logo, authentication for a website in which one can
purchase medicines online?
 Physical address of the owner and pharmacy need to be specified. In
case of complaints, to whom should the consumer complaint? This
also need to be specified.
 How do consumers recognise which are genuine e-pharmacy sites?

 Do’s and Don’ts for consumers using online pharmacies need to be
listed and popularized.
 Digital data protection of patient information? There are no
precautions mentioned.
 Is aggressive marketing with discounts permitted?
 Delivery by a courier permitted? Please note that dispensing or final
handling of the medicines to be done by the pharmacist only. How
this can be ascertained in case of an internet pharmacy? Do the only
packaging of dispensed medicines? This needs to be looked into
from the prospective of Section 42 of Pharmacy Act.
-Date: August 13, 2018

Latest Amendments for e-pharmacy in India
 Online pharmacies have to register with CDSCO.
 They are not allowed to supply drugs under the
narcotics, psychotropic & tranquiliser categories
according to the draft rules.
 E-pharmacy registration holders will also have to
establish and maintain a portal for the management of
business.
 The portal will have details of logistic service providers,
a written policy of supplied drugs and their contact
details, as per draft rules.
 There should also be a mechanism in place to enable
customers to lodge their grievance.

Contd……
 The main is aim to monitor the sale of drugs through e-
pharmacy and also the genuineness of the supply of
medicines.
 E-pharmacy registration holders would have to provide
24×7customer support.
 The Drug Controller General of India will issue licenses
for three years and e-pharmacies will be regulated under
the Drugs and Cosmetics Rules 1945 as well as the
Information Technology Act 2000.

Contd……
■ Application for grant of registration of E-pharmacy service
providers: Application for grant of Registration for carrying
out e-pharmacy shall be made in to the Licensing Authority,
as defined under Rule 21(A), and shall be accompanied by
 an fee of rupees one lakh
 constitution details of the applicant
 Address proof of the applicant (Aadhar /Passport/ Driving
license)
 Information about role and responsibilities of E-pharmacy
service provider.
 Name, qualification, registration number of the registered
pharmacist whose services are employed.

Contd……
 List of retail sale licensees, with whom contract has been
made to supply drugs.
 Lists of the States /UTs where the applicant intend to offer
the service.
 Details of the licenses issued by the SLA to the applicant in
the respective State where they intent to offer the services.
■ Application for grant of registration of chemist and
carryout E-pharmacy: Application for grant of Registration
carrying out e-pharmacy shall be made to the Licensing
as defined under Rule 21(B), and shall be accompanied by
 an fee of rupees ten thousand
 Details of the licenses issued by the State Licensing
Authority.

Scenario in other countries
■ Presently purchase and sale of medicines over the internet is
increasingly being popular worldwide. Some countries have stringent
rules and regulations while some countries are still in process to
make the framework. However developed countries like Japan, Italy,
Ireland, Spain, Korea, Thailand, Turkey and Russia Federal do not
permit sale of medicines through online pharmacies.
Canada
■ The main features of the regulatory regime in Canada are:
 E-pharmacy must be a brick and mortar pharmacy with a physical
physical street address to dispense drugs over internet.
 There is no national license, it happens at the provincial level.
 Any licensed pharmacy that offers internet services must meet the
meet the standards of practice within its own province.

Contd……
USA
■ The main features of the regulatory regime in USA are:
 It is permitted in US but the pharmacy must be domiciled within the
within the US.
 Online pharmacies must be registered with the Drug Enforcement
Enforcement Administration (DEA) to dispense ‘controlled
substances’, must be compliant with Federal food, Drug and
Cosmetic Act, Federal Controlled Substances Act and cannot
dispense medications that are not approved by the FDA.
 USA has a programme called Verified Internet Pharmacy Practice
Practice Sites (VIPPS) certification which is given to pharmacy
pharmacy websites that practice the defined rules and standards set
standards set by the VIPPS programme.

 VIPPS does not allow the pharmacy to dispense based on
scanned prescription or an image of prescription.
 E- prescription or original paper prescription is the only
allowable form of prescription for a VIPPS pharmacy.
 FDA Guidelines suggest that a legal, regulated ‘online
pharmacy’:
– Requires a valid prescription
– Provides a physical address in the United States
– Is Licensed by the state board of pharmacy in the state
state where the pharmacy is operating
– Has a state- licensed pharmacist to answer your question.

Opinions on e-pharmacy
 “This problem cannot be solved without technology,”
believes Aziz, chief executive, Myra, despite weathering a
strong lobby of brick-and-mortar medicine retailers that
has.
 “Clicking a picture of the prescription is easy”, said
Prashanth Tandon, co-founder of 1MG.
 This is a tricky sector, says, co-founder of Zigy.
 The terms and conditions are the same for both online and
offline players, says co-founder of 1MG.

Contd……
 Faizan Aziz, founder Myrameds, said mandatory
registration with the central licensing authority will bring
legitimacy to the industry.
 “People will have more transparency to access prescription
medicine through e-pharmacies by company and pricing to
patients,” says Atul Sharma, founder and CEO, Health
scape Business Solutions, a healthcare consulting firm.

Retail Pharma
Market 1. Only 6% of the market currently falling in
the organized segment.
2. The market is expected to reach a value
of INR 2.9 Billion by 2022
3. Presently dominated by the unorganized
segment
4. The market is expected to shift towards
an organized nature
5. As consumer preferring to buy medicines
online and from pharmacy retail chains
SOURCE: Pharmacy Retail Market in India 2017

Future of e-pharmacy in India
 The growth of the Internet has given rise to various
technology driven models, to access and serve
consumers in a fast paced and most efficient way.
 One of the progressive technology models that have
evolved in the last few years is telemedicine that has
enabled accessibility to the finest doctors at the click of
a button.
 Another recent innovation that has positioned itself as
an attractive model in the healthcare space is E-
pharmacy.

Contd……
 E-Pharmacy is one of the technology advancements
which is likely to bridge this gap by providing easy and
affordable access of medicines to the consumer at their
doorstep at a mere finger click. Moreover, the concept
will also provide proper awareness to the buyer
regarding the appropriate medicinal remedies.
 Buying medicines online is a different culture altogether.
These are still early days for Online Pharmacy in India,
which means that potentially there is immense place for
growth.

Contd……
 Currently, secure web-based platforms are available with
few providers to support enhanced pharmacy services
and public health initiatives. The wide use of these will
increase and also web platforms will be used as a
communication portal to make information available to
pharmacists.
 Following the recent protest against online sales of
medicines, Government of India is considering to take
measures to regulate it.
 The 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.

What should do to improve regulation?
 Specific and clear-cut rules should be made for selling,
prescribing, dispensing and delivering prescription
drugs through e-pharmacy.
 Government should make a common logo for legally
operating e-pharmacies to distinguish them from illegal
one.
 As the power of drug regulation is to be distributed
between Central and State government, role of Central
government and State government should be well
defined.
 List of illegal and blacklisted e-pharmacies should be
provided to help out consumers and stop them using

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
 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 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

Contd……
 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
 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
 Prescription related issues
 Legality of electronic
signature
 Identity and reliability of
legal e-pharmacy
 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-

References
■ https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/why-governments-new-draft-
rule-could-make-or-break-e-pharmacies-like-netmeds-pharmeasy/articleshow/63690489.cms
■ https://timesofindia.indiatimes.com/business/india-business/health-ministry-to-bring-new-set-of-rules-for-e-
pharmacies/articleshow/63912863.cms
■ https://www.fortuneindia.com/enterprise/new-policy-to-authenticate-e-pharmacies/101800
■ http://www.mondaq.com/india/x/637554/food+drugs+law/Regulatory+Guidelines+For+EPharmacy+StartUps
■ https://www.thehindubusinessline.com/economy/policy/soon-a-new-set-of-rules-for-e-
pharmacies/article23672052.ece
■ https://www.quora.com/What-is-the-future-of-online-pharmacy-in-India
■ https://www.omicsonline.org/open-access/epharmacies-regulation-in-india-bringing-new-dimensions-to-
pharmasector-2167-7689-1000175.php?aid=80341
■ https://www.safemedicines.org/history-of-online-pharmacy-regulations
■ http://www.cdsco.nic.in/writereaddata/Sub-Committee%20Report%20on%20e-pharmacy.pdf
■ https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/until-government-releases-
rules-e-pharmacies-to-self-regulate-iipa/articleshow/55555554.cms
■ https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/e-commerce-players-brace-for-
big-battle-over-online-pharma/articleshow/65062615.cms
■ https://www.fortuneindia.com/enterprise/new-policy-to-authenticate-e-pharmacies/101800
■ http://blog.emedstore.in/Post/The-Future-of-Online-Pharmacy-in-India/32
■ https://www.linkedin.com/pulse/future-e-pharmacy-india-keerti-bhardwaj
■ file:///C:/Users/Admin/Downloads/Internet%20Pharmacies%20IPA%20views%2013.08.2018%20(1).pdf

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