On Wednesday i.e. 12.12.2018,
the Hon’ble Division Bench of Chief Justice of Delhi High Court has
directed the Central government and the Delhi government to restrain the online
sale of medicines by e-pharmacies, as the same it is not permitted under the Drugs
and Cosmetics Act, 1940 and the Pharmacy Act, 1948 in
a petition filed by one Dermatologist Dr Zaheer Ahmed.
The petition claimed that
lakhs of medicines are being sold online through e-pharmacies, in spite of a
direction of the Drug Controller General of India to the State Drug
Controllers, “to put a strict vigil on online sale of medicines in violation
of the Drugs and Cosmetics Act and Rules thereunder, to protect the interest of
public health”, thus violating the citizens’ Right to Life guaranteed
under Article 21 of the Constitution.
The petition also highlights
the serious consequence that misuse or abuse of drugs can have on human health:
“A large number of
children/minor or people from uneducated rural background use internet and can
be victims of wrong medication while ordering medicines online which are
operating without a drug license…The unregulated sale of medicines online will
increase the risk of spurious, misbranded and substandard drugs being sold.
Some drugs have psychotropic substances and can be easily ordered on internet
and misused for criminal activities or drug abuse.”
Earlier in the month of
October, 2018 the Hon’ble Madras High Court had granted
an injunction restraining the sale of medicines and drugs online, on a plea
moved by the Tamil Nadu Chemists and Druggists Association (TNCDA).
One more petition is pending
before the Hon’ble Delhi High Court
which is also seeking closure of online pharmacies that are
offering drugs and prescription medicines through websites.
The above
decisions of both the Hon’ble High Courts are welcome particularly as an online pharmacy sounds convenient; there is no waiting
in queues, no rushing to the chemist shop before it shuts shop for the day,
placing the order is easy, moreover, the order can be placed any time of the
day and the medicines are conveniently delivered via courier at your doorstep.
Yet, this convenience comes at a price. Not only there may be financial
implications for the patients, their safety may even be endangered at times.
Indian
Medical Association (IMA) has never been in favor of online sale of medicines
and had raised this issue during my tenure first as Honorary Secretary and
later as National President IMA.
The need of the
hour is to come out with a defined policy for both online consultations and
online pharmacy. In an earlier judgement, the Supreme Court has said no to
telephonic consultation, unless it is an emergency.
So, if telephonic
consults are not allowed, then how can online consults or online pharmacy be
permitted for patients with no established doctor-patient relationship?
After much persuasion and
objections, the Central Government has introduced some draft rules to
amend the Drugs and Cosmetics laws to regulate and allow only
licensed e-Pharmacies.
Online sale of medicines has
several ill-effects, such as:
· 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 Information Technology
Act, 2000.
· The major issue of concern is that prescription drugs cannot be sold online as there
is no provision in any law for sale of prescription drugs online.
· Online pharmacies may not abide by regulations and rules
relating to scheduled drugs as mentioned in Schedule E1, G, H, H1 and X and
bypass them. 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 online pharmacies will defeat this very purpose.
· 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, self-medication etc. Any mediation taken without the
supervision of doctors may be dangerous and even potentially life-threatening.
· 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.
· Regulation 5.3 of MCI Code of Ethics stipulates that pharmacists and doctors should work
together. If online pharmacies are allowed, then this relationship will be
lost.
· Many online pharmacies may be operating without the appropriate license. This
increases the chances that drugs sold by such unlicensed pharmacies maybe counterfeit, substandard, or adulterated and
therefore risky to the patient. There are no checks in place to make sure
that the drugs sold by online pharmacies are not spurious.
· If online pharmacies are allowed, the National
Pharmacovigilance Program, initiated by Central Drugs Standard Control
Organisation (CDSCO) under the Ministry of Health and Family Welfare, will
become a futile exercise. This program is not only meant for doctors but also
for pharmacists.
· Medicines have to be stored properly as recommended by
the manufacture. Exposure of medicines to high temperatures in storage or in
transit could diminish their efficacy and are a potential health risk. There 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.
· Breach of confidentiality is another major concern. Online pharmacies may
misuse personal and financial information of the patient as well as of doctors
leading to cases of identity thefts and fraud.
· 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 or receiving any rebates or commissions.
· Similar to the online search service Justdial.com, online
pharmacies may also promote doctor substitution, which
is unethica
Dr KK
Aggarwal
Padma Shri Awardee
President
Elect Confederation of Medical Associations in Asia and Oceania (CMAAO)
Group Editor-in-Chief IJCP Publications
President Heart Care
Foundation of India
Immediate
Past National President IMA
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