Cos should only accept
e-prescriptions, doctors must assume more responsibility
A high-level government
committee, which was constituted last year by the Drug Consultative Committee
under the health ministry to regulate the sale of medicines through online
pharmacies, has recommended the creation of a national portal that will act as a
nodal platform for monitoring sale of drugs via internet. Online pharmacies
will need to mandatorily display the portal link on their homepage for
authenticity verification by patients or consumers.
The committee, that submitted its
report to the central drug regulator recently , stated that only
e-prescriptions or electronically generated and digitally-signed prescriptions
should be considered by online pharmacies to check misuse.
A significant share of the
responsibility for the sale of medicines through online pharmacies will now be
on doctors. As per the committee report, doctors will have to create electronic
prescriptions or paper prescriptions that can be scanned and uploaded to cloud
by the doctor or patient through the intermediary link. These prescriptions may
be linked with the Aadhaar card.
The prescriptions will
necessarily have a unique identification number, name of the patient, phone
number of the patient, name and dosage of the medicine, compounding and drug
formularies and information on how many refills can be allowed.
As part of the broad framework,
the committee has outlined that “all e-pharmacies that plan to sell, offer or
exhibit for sale of medicines over the internet, will need to be registered
with Central Drugs Standard Control Organisation (CDSCO) under the Drugs and
Cosmetics Rules, 1945.“ It added: “No unregistered entity shall be permitted to
undertake online sale of medicines.“ The fee for registration of an online
pharmacy has been fixed at `1 lakh.
Besides, it said online sale of
drugs may be permitted only on e-prescriptions that are in compliance with the
provisions of the I-T Act, 2000, and other rules under the said Act. Electronic
prescriptions, the report added, are medical prescriptions generated via the
electronic mode, gadgets, devices that are verifiable, printed and transmitted.
Integrity and authenticity of prescription will be crucial in any online sale
of medicines.
“The entire audit trail,
including the name and address of the patient, physician and pharmacy shall be
digitally stored to prevent abuse and ensure tracking in case of any adverse
events,“ the report said.
The committee, headed by the
Maharashtra FDA commissioner Harshdeep Kamble, along with regulators from a few
states such as Karnataka, Odisha, Goa and Madhya Pradesh, considered
submissions from over 300 stakeholders to finalise its recommendations.The
committee also studied systems followed in countries such as the US, the UK,
Canada and Australia to reach its conclusions.The committee quoted Transparency
Market Research to point out that the e-pharmacy market globally is expected to
reach $128 billion by 2023, growing at 17.7% from $29.3 billion in 2014,
asserting that growth is expected from the Asia-Pacific market at the back of a
surge in mobile phone usage. A Boston Consulting Group (BCG) report cited by
the committee put China's online pharmacy market at $1.1billion in 2014.
The recommendations come in the
backdrop of heightened oppo sition from the powerful chemists' body -the All
India Organisation of Chemists and Druggists -that a few weeks ago threatened a
nationwide bandh alleging indiscriminate proliferation of internet-based
pharmacies and misuse of medicines that were meant to be dispensed strictly via
prescriptions.
To counter the uproar, a select
group of online pharmacies led by Netmeds, PharmEasy , 1 mg and mChemist vowed
to adhere to a self-regulatory mechanism by following a common code of
conduct.Although online pharmacies form a minuscule part of the distribution
system of the growing Indian pharmaceutical market, they are expected to see a
surge in revenues as policies evolve and the market reach expands into rural
areas.
The committee report has
suggested curbs on drugs that are habit-forming and could be misused. It has
excluded certain categories of drugs such as narcotic and psychotropic drugs,
tranquilisers, habit-forming drugs and Schedule X drugs that are prone to
misuse via online pharmacies.
The 121-page report will now be
studied by the ministry and suitable changes in the legislative provisions may
be considered.
Source: THE ECONOMIC TIMES-29th November,2016.
http://epaperbeta.timesofindia.com/Article.aspx?eid=31818&articlexml=Panel-Suggests-Portal-to-Monitor-e-Drug-Sales-29112016008032#
