Horiba Is Working On The Biggest Medical
Factory In India: Dr Jai Hakhu, Chairman And CEO, Horiba
In near future healthcare will have monitors, electronic
sensors at home and the doctors will know proactively that what is going on.
Some kind of predictive health messages will be sent ahead of time. The devices
which we make, in the future, will have wifi connectivity or Bluetooth, so you
don't have to visit a doctor to find out what happened, it can simply be done by
Shahid Akhter, editor, ETHealthworld, spoke to Dr Jai Hakhu,
Chairman and CEO, Horiba, Instruments Incorporated (U.S),
President of Horiba, to know more about Horiba's contribution in the field of
blood analyzers and their plans to scale up manufacturing in India.
Global healthcare technology: Trends
The key thing now is remote connectivity because the next
step in healthcare will be that you will have monitors, electronic sensors at
your home and the doctors will know proactively that what is going on. For
example, in diabetic people where you must have seen that they can have
continuous monitoring and that is monitored by a doctor's office. There is no
point that people will get a big shock or stroke as some kind of predictive
messages will be sent ahead of time. Big data is going to be very important in
the medical field. The devices which we make, in the future, will have wifi
connectivity or Bluetooth, so you don't have to visit a doctor to find out what
happened, it can simply be done by phone. Hence. these trends are emerging.
Global healthcare technology: Market
People get sick in both poor or rich countries, so our job is
to reduce the cost per test. As far as India is concerned, I want to reach every
corner of the country. We have about 12 acres of land in Nagpur and the building
is being built right now. The idea is to reach every place at affordable cost
and also our goal is to help the society.
Global/Indian healthcare technology: Horiba Medicals
Horiba is not the biggest in healthcare, there are many other
big companies, but Horiba has the analyzers right from the Founder. If you look
at the broad cross-section of Horiba, there is a common thing called analyzers.
In healthcare, you are analyzing the blood and we are focusing on the analysis
part of the healthcare.
For example, we introduced the Helo product for healthcare.
It is a track system that was introduced around two-three months back in India
and it was accepted by Zeimens as a standard product. They will be using our
product globally, so it's not only what we do, but also what we can do with
others. Therefore analyzing is the key part.
I started Horiba India Healthcare around eight-nine years
back. We were two people and our position through distributors was number fifth.
Our goal to be number three and team of Horiba India achieved it. Now, we are
almost number one in the field of blood analyzers.
Global healthcare delivery system: Your views
Different countries have different health systems. For
example, in the US healthcare system is not that good. It depends on how much
money you make. Similarly, if you go to Canada everybody gets healthcare or even
in England, but we have to do a lot of work. In China, I visited hospitals and
was very disturbed to see that healthcare does not reach the poorest section. We
have a tremendous disparity, even in India. We need to work on that as to how we
can normalise it and reduce the cost per test so that we can serve the masses.
Therefore it's not in the great state globally.
Horiba Medicals: Future plans for India
We are building twelve acres complex in Nagpur and it will
have a capacity for us to serve for the next ten to fifteen years. We have also
invested in Haridwar and Pune. It's going to be the biggest medical factory in
India. My personal goal is to reach the masses at an affordable cost, but we
have to make money to keep on investing.
Make in India: Ease of doing business
We need to have manufacturing in India, not only that but
also the supply chain as manufacturing alone is simply not the answer. As what
happens in the labour for manufacturing is only ten percent, you don't gain much
as you have to develop the infrastructure.
Indian Market Full Of
Unauthentic Certificates For QMS In Medical Devices: Experts
Even as concerns have been raised globally about counterfeit
or unsafe medical devices, accreditation experts in India say that a large
number of certificates of certification for quality management system (QMS) as
per international standard, ISO 13485, in medical devices are unauthentic or
In India, certification bodies should be accredited by
National Accreditation Board for Certification Bodies (NABCB) for undertaking
certification as per ISO 13485 which is an international standard for QMS in
medical devices and accepted by many regulators around the world.
NABCB provides accreditation to certification and inspection
bodies based on assessment of competence as per the applicable international
standards and guidelines.
It is internationally recognised and represents the interests
of the Indian industry at international forums through membership and active
participation with the objective of becoming a signatory to international
multilateral / mutual recognition arrangements (MLA/MRA).
It is also a member of International Accreditation Forum (IAF),
International Laboratory Accreditation Cooperation (ILAC) and Asia Pacific
Accreditation Cooperation (APAC) as well as signatory to its MRAs for QMS and
Experts reason out that there is no ban on foreign
accreditation bodies which might be members of IAF operating in India. IAF is
the only international system of equivalence of certifications but is voluntary
in nature and not obligatory. Therefore, there is no regulatory oversight on
unauthentic or fake certificates.
There are many certifying bodies in the Indian market which
are either not accredited or are accredited by accreditation bodies which are
not members of IAF and are issuing unauthentic certificates. They are also
issuing certificates for CE mark, which is the European regulatory mark, without
any accreditation or authorisation while only notified bodies of European
Commission can issue such certificates.
“There is no law which requires certification bodies to go
for accreditation or be under the IAF system. That is why there are
certification bodies which claim accreditation from some accreditation body
which is not part of IAF. NABCB is member of IAF and has signed MRAs for
different schemes,” informs Anil Jauhri, former CEO, NABCB. NABCB is a MRA
signatory for ISO 17021 which covers QMS for medical devices under a broader
framework, Jauhri further explains.
List of NABCB-accredited certification bodies for ISO 13485
for Medical Devices Quality Management Systems (MDQMS) are International
Certifications Services Private Ltd, TUV SUD South Asia Pvt Ltd, Intertek India
Pvt Ltd , TUV Rheinland (India) Pvt Ltd, DNV GL Business Assurance India Pvt
Ltd, BSI Group India Pvt Ltd, TUV India Pvt Ltd, BSCIC Certifications Pvt Ltd,
TUV InterCert Saar India Pvt Ltd, Zenith Quality Assessors Pvt Ltd and SGS India
CDSCO notifies certification bodies under Medical Device
Rules (MDR) -2017 based on NABCB accreditation only and only 6 of the above have
been notified till now.
The world market is full of private certification bodies
issuing certificates to industry and it is important to distinguish an authentic
certificate from many unauthentic, fake or fraudulent certificates going around.
An authentic certificate should contain the following like
name and address of the organisation certified, scope of certification
describing its activities under certification, standard (or sometimes scheme or
regulation) against which certification is granted e.g. ISO 9001 or ISO 22000
(standard) or AS 9100 or FSSC 22000 (scheme). In general guidance standards are
not amenable to certification. These have to be formal requirement standards or
The authentic certificate should also include date of issue
and expiry of certificate, unique identification number of the certificate, name
and address of the certification body (CB), logo of the certification body,
accreditation symbol indicating the name of the accreditation body (AB) which
has accredited the certification body (in most countries,
in the absence of any law requiring certification bodies to register,
accreditation is the only way of recognizing a competent, authentic
It should also include IAF Mark – indicating that the
certificate is covered under the Multilateral Mutual Recognition Arrangement
(MLA) of the International Accreditation Forum (IAF) and hence is
internationally equivalent and acceptable in the market.
In order to judge authenticity, the names of member ABs of
IAF can be seen on its website www.iaf.nu. It also gives information on which
accreditation bodies are signatories to IAF MLAs for specific schemes – QMS or
EMS or FSMS.
Once manufacturer locates the AB in a country, he can go to
its website from the link given on IAF website and then on AB’s website to
verify if the CB is accredited.
“Then from the CB, you can verify the certificate because
under international norms, CBs are obliged to help verify certificates issued by
them. In case the certificate is issued under a scheme like IATF 16949 or AS
9100, it is possible to verify the certificate through the scheme owners also,”