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IMA WHITE PAPER ON ONLINE PHARMACY COUNTER

POINTS*

IMAS POINT OF VIEW


There are no well defined dedicated
laws for online pharmacies.
Pharmacies in India are governed by
the Drug and Cosmetics Act 1940,
Drugs and Cosmetic Rules 1945,
Pharmacy Act 1948 and Indian
Medical Act 1956.
Laws related to ecommerce are
defined under the IT Act 2000

According to Indian laws, a chemist


can dispense prescription drugs only
on the prescription of doctor. A
prescription requires the name of the
doctor, his /her address and
registration number besides the
name/s of the drug/s, their potency,
dosage, and duration for which the
drugs are to be supplied. The chemist
cannot dispense quantity in excess of
what has been prescribed by the
doctor. Before dispensing the drugs,
the pharmacist is expected to verify
the completeness, authenticity and
legality of the prescription.
According to Subsection 1 of section

COUNTER POINTS
Absolutely right. In 1940, forget
online, even Computers and OS were
not in place. Its time for the Indian
Govt. to design new Drugs &
Cosmetics rules & the IMA Act with
the changing medical and pharmacy
scenario.
Yes, all online businesses are defined
with this act. However online
pharmacy has to follow both the
IT Act as well as the D & C Act.
Offline or conventional pharmacies
follow only D & C Act.
Exactly.
Even online pharmacies have to
follow the same rule. Unless and
until the prescription image confirms
the required data, the online
pharmacy cannot even process the
requirement!
All prescription related queries,
wherever necessary, can be
immediately confirmed by calling the
Physician both by the offline as well
as the online pharmacy.
This rule is applicable even to the

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.
Online availability of prescription
drugs will violate provisions of
various acts like Pharmacy Act,
Drugs & Cosmetics Act.

Section 18c of the Drugs & Cosmetics


Act prohibits manufacture and sale of
any drug without a license.
Recently, an FIR was filed against
Snapdeal.com by Maharashtra FDA
for allegedly selling drugs, including
prescription drugs, online for
violating provisions of the Drugs and
Magic Remedies (Objectionable
Advertisements) Act, 1954 and
directly contravening Section 18 (c)
of the Drugs and Cosmetics Act,
1940, which prohibits manufacture
and sale of certain drugs.
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.
The prescription has to be in
duplicate, one copy of which is to be
retained by the licensed pharmacist

online pharmacies.
In fact, like offline, the online
pharmacies also have to appoint a
full-time Pharmacist.
If a person wants to play crooked,
irrespective whether it is an offline or
online, rules would be violated.
Even with conventional medical
stores, there has been in the past
violation of various rules and many
chemists were raided by the FDA for
irregularities.
Corollary to point. 4.
This is true for both offline and online
pharmacies
Snapdeal has been 1 case of utmost
negligence; however this does not
mean that every online pharmacy
does not follow the rules and
regulations.
In the past hundreds of medical
stores have been raided does it
mean that all medical stores should
be shut?
Well in such cases, online pharmacy
should be strictly told to not dispense
Schedule X drugs that require
stamping. (Not very difficult)
However, if they can devise a method
wherein they can stamp the
prescription on deliver of medicines,
it will solve problem of medicine
abuse.
Online pharmacy has all the
information of prescription, order,

for 2 years.
Schedule H1 of the Drugs & Cosmetic
Act 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 (like antituberculosis drugs), habit forming
painkillers like Tramadol and antianxiety drugs that induce sleep.
The Drugs and Cosmetics Act has no
provisions for online sale of
medicines, or home delivery of
medicines. Hence, online sale of
medicines cannot be legally
permitted.
The prescriptions submitted via
fax/email may be fake and it could
be difficult to verify their authenticity.
Online correspondence and/or
scanned copies are legally not
permitted.

Online pharmacies will promote


drug abuse, drug misuse, selfmedication etc. Any mediation
taken without the supervision of
doctors may be dangerous and even
potentially life-threatening.

dispatch data stored as soft & hard


copy.
Nearly all online pharmacies keep
records of prescription, invoice and
dispatch of medicines for their own
administrative purpose.
The real question is how many offline
medical stores keep record of all
prescriptions, make bills for every
order received and have the
complete details of every prescription
billed?

2016 is different than 1940, right?


Can we not amend or formulate rules
for the benefit of patients?

The online pharmacy can always


confirm from the Dr / Physician, if he
has seen such type of patient and
whether the prescription is legal.
The IT Act of 2000 confirms and
acknowledges the online
correspondence.
On what assumptions? Before the
onset of online pharmacies, were
there not any cases of drug abuse?
Were not the medical stores (not all,
of course) responsible for illegal
selling of Oxytocin injection to cattle
owners and many expectorants to
habitual drug users?
Where was the watchdog of IMA

Pharmacists are not allowed to


accept and dispense
prescriptions that are brought in
by children. Online pharmacies will
provide easy access to controlled
drugs or even street drugs to this
vulnerable group.
Many online pharmacies may
be operating without the
appropriate license.

when such cases were brought to


notice?
Again assumptions!!! The same rule
of conventional medical stores
applies to online pharmacies also!
Many online pharmacy give
instructions in bold about minimum
age for ordering.

How is it possible? Any pharmacy


that opens shop has to have a valid
license. Are they (IMA) implying that
the Govt. FDA is not doing its duty?
This increases the chances that drugs Like offline pharmacy, even the
sold by such unlicensed pharmacies
online pharmacies can be searched
maybe counterfeit, substandard,
for stocking of substandard or
or adulterated and therefore risky
counterfeit medicines. By the way,
to the patient. There are no checks in substandard relates to manufacturing
place to make sure that the drugs
practices and is not a problem of
sold by online pharmacies are not
pharmacy.
spurious.
If online pharmacies are allowed, the A very illogical statement indeed!!!
National Pharmaco-vigilance
How is the government program of
Program, initiated by Central Drugs
pharmaco-vigilance going to be
Standard Control Organisation
affected by online pharmacies?
(CDSCO) under the Ministry of Health
and Family Welfare, will become a
Even online pharmacies have
futile exercise. This program is not
Pharmacists and they would very
only meant for doctors but also for
much like to be a part of all
pharmacists. In March this year, the
Government programs of Ministry of
Health Ministry approved a Materio
Health & Family.
Vigilance Programme of India to
monitor adverse events associated
with medical devices.
Medicines have to be stored properly Does it mean that the local FDA
as recommended by the
officials are going to give license to
manufacture. Exposure of medicines
anyone who puts paper for online
to high temperatures in storage or in pharmacy?
transit could diminish their efficacy
and are a potential health risk. There Repeat all online pharmacy

is no way to check the storage


conditions of the drugs sold by the
online pharmacies.
Regulatory authorities continue to
monitor a drug for any adverse effect
even after it has been on the market.
If the safety/quality of the medicine
comes under question or, if it is
potentially contaminated, mislabeled
or is improperly packaged, then they
may recall or withdraw a
prescription or OTC drug from
the market even after it has been
approved. Sometimes, the
manufacturer may voluntarily recall a
drug. If online pharmacies are
permitted, the drug recalls become
very, very difficult, almost next to
impossible.

have to follow all the guidelines


deemed fit for an offline
pharmacy.
On the contrary, it is very easy to
recall the medicines (marked by
FDA) supplied through online
pharmacies since they have the
entire data of their patients
name, address, billed date and
quantity billed.

The offline medical stores do not give


receipt/bill of every prescription and
if the recall of particular medicine
happens, these conventional medical
stores can only provide data of the
stocks lying at their shops.
Even today all drug recall is limited to
stocks available at the distributors
and the medical stores only since,
very few medical stores maintain the
data of their patients.
Breach of confidentiality is
How innocent! All online commerce
another major concern. Online
companies are governed by IT Act
pharmacies may misuse personal and 2000, that specifically prohibits
financial information of the patient as companies to sell, use, transfer the
well as of doctors leading to cases of financial or personal details of their
identity thefts and fraud.
customers unless and until agreed by
the customers.
Online pharmacies offer drugs at
The online pharmacies receive stocks
low cost or at discounted prices
from the same distributors or
to lure customers.
companies that supplies stocks to the
medical stores. The online pharmacy
also receives the same discount or
commission as offline medical stores.
If the online pharmacies are happy
with passing some of their
commission to the patients, what
stops conventional medical stores to
give the same to their patients. In

If the online pharmacy gives cheaper


alternatives of drug/s prescribed, this
violates the doctor-patientpharmacist relationship, which is
based on trust.

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 or receiving any rebates
or commissions.

Similar to the online search service


Justdial.com, online pharmacies may
also promote doctor substitution,
which is unethical.

The service of online pharmacy will


be utilized by affluent and educated

fact, medical stores also receive


schemes from the company / sales
personnel which online pharmacies
are not entitled.
If the same content and composition
of the prescribed medicine is
available at a cheaper cost, why not
let the patients get the benefit. Of
course, this should be done only after
the confirmation from the Physician.
Nothing can be a bigger joke
than this!!!
How can the doctors be vulnerable to
malpractices unless and until they
themselves decide?
All know that the doctors are
sponsored by Pharma companies
not only for Medical conferences, and
symposia but also for their personal
trips. And of course, there is
complimentary gifts and cash in kind
as well. Dont the Drs also have a
share or own medical stores in their
premises? Arent Doctors vulnerable
to such unethical practices?
The IMA should first instill ethics in
their members before shooting in the
dark.
Can medical knowledge be
substituted?
Online pharmacies are merely
provider of medicines. How can they
substitute Drs?
On the other hand, conventional
medical stores have always been
substituting Drs. by way of providing
medicines to patients for small
illness.
On the contrary, online pharmacy
services provide more patient benefit

people. Hence online pharmacy has


no public health benefits or
implications;

in terms convenience and economy


not only to the educated but even to
town B & Town C population at their
doorstep.

*The above page of IMA White Paper on Online Pharmacy appears


on www.ima-india.org

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