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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 phone.

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 fake.

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 product certification.

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 Pvt. Ltd.

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 specifications.

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 certification body).

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 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,” Experts conclude.

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