How Indian E-pharmacies Operate? Rules & Regulations Governing Them

1
How Indian E-pharmacies Operate? Rules
Regulations Governing Them
2
The Different Models Of E-pharmacies

• 1) Online Only Pharmacy

2) A digital twin of Brick-and-Mortar pharmacy

• 3) E-pharma marketplace

To start an online pharmacy, you need to
understand relevant rules and regulations and
follow 7 steps
3
1. Drugs and Cosmetics Act, 1940 (DC Act)
Defines the pharmacies and lays fundamental
guidelines for the operation of drugs and
cosmetics. It also mandates a retail license to
sell the drugs on the basis of a valid
prescription.
4
2. Drugs and Cosmetics Rules, 1945 (DC Rule)
Regulates manufacturing, sale, distribution,
import and advertisements of drugs and
cosmetics. Prescribes and ensures product
and labelling standards.
5
3. Pharmacy Act, 1948

• Regulates the pharmacy profession as a
  whole and sets rules and extent of punishment for
  an offence.

6
4. Drugs and Magic Remedies (Objectionable
Advertisement) Act, 1954
Regulates advertisements of drugs relating
to certain conditions and diseases.
7
5. Narcotic Drug and Psychotropic Substances Act,
1985
Regulates operations, including sales,
relating to narcotic drugs and psychotropic
substances and provides stringent punishments for
matters related thereof.
8
6. Information Technology Act, 2000 (IT Act)
Regulates the bodies or persons who deal
with sensitive data of all kinds. Implements
measures to ensure data privacy and penalizes
disclosure of personal information without
consent. It was further amended in 2011 as
Information Technology (Reasonable security
practices and procedures and sensitive personal
data or information) Rules, 2011 to include
medical records and history, biometric
information, physical, physiological and mental
health condition and other such sensitive data.
9
7. Indian Medical Council Code of Ethics
Regulations, 2002 (MCI Code)
Regulates professional conduct of registered
medical practitioners in India, prescribes
acceptable medical practices and provides penalty
for the violation of these regulations.
10

• Central Drug Standard Control Organisation
  (CDSCO)

• State Drug Standard Control Organisation

• The Drug Controller General of India (DCGI)

11
Some of the noteworthy revisions suggested in the
draft rules are as follows
12

1. Definition of e-pharmacy

For the first time, the term e-pharmacy
was defined It was accurately defined as a
business of distribution or sale, stock, exhibit
or offer for sale of drugs through a web portal
or any other electronic mode.
13
2. Registration of e-pharmacy
The rules require that any person intending
to conduct e-pharmacy business needs to
mandatorily apply for registration to the central
licensing authority by filling the form 18AA
along with furnishing required documents and
making a payment of INR 50,000. The validity
of the registration would be three years from the
date of issue. After the expiration, the
pharmacist is required to renew the license.
14
3. Audit
The draft rules also make clear provision
for a periodic inspection of the business. The
e-pharmacy registration holder must allow the
inspection by the authorized team of central
licensing authority every two years.
4. Data Localisation
According to the draft, e-pharmacies are
required to establish the e-pharmacy portal
through which they conduct business in India and
shall keep the data generated localised.
These rules also specify that the data generated
or mirrored through the e-pharmacy portal shall
not be sent or stored outside India.
15
5. Confidentiality of the Information
The e-pharmacies are required to keep all
the details of its customers discreetly. Further,
they are also required to disclose these details
to the concerned government for public health
purposes.
16
6. Helpline and Grievance Redressal
The e-pharmacy registration holder will have
to set up a support and grievance redressal
mechanism for a minimum period of 12 hours a day
for the 7 days of a week, and a registered
pharmacist is required to answer the customer
queries.
17
7. Central License
The draft rules mentioned a provision of
central license from the countrys apex drug
regulator, to allow them to operate across the
country.
18
8. Regulatory Authority
These draft rules propose to appoint a central
licensing authority i.e. Drug Controller General
of India (DCGI) to replace state drug regulators.
DCGI will be the sole authority for granting
approvals with a validity of three years.
19
Want Guidance For e-Pharmacies?

• Contact EMed Pharmatech, an indigenous pharma IT
  company and a global leader in pharma application
  development services. We, at EMedstore provide
  state-of-the-art iOS app, Android app and a
  website to enable you to sell medicines online.
  So far, we have made more than 450 such projects
  and we have our presence in 32 countries. To see
  why clients across the globe are relying on our
  services, get your free demo here.

20
Get in Touch
91 720 209 7862, 91 973 771 2429
CALL -
info_at_emedstore.in
MAIL ID -
A/707, Mondeal Heights, Beside Novotel Hotel, Nr.
Iscon Square, S.G. Highway, Ahmedabad, Gujarat-
380015
ADDRESS -