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Published: Jan 23,2018

India’s flagship institute dedicated to medical devices, Kalam Institute of Health Technology (KIHT) is all set to launch its ambitious e-auction programme.  Set up under the Andhra Pradesh MedTech Zone (AMTZ) project initiative, KIHT aims at providing critical component knowledge to relevant institutions for focused research and development.

According to KIHT, several prototypes, developed by researchers at IITs, universities and engineering colleges, are lying in these institutions. Unless they reach the prospective manufacturers, huge amounts invested for their research and development will not benefit the indigenous industry and the public at large. The e-auction programme will help resolve this issue.

The institute has a separate cell for facilitating technology transfer and scientific cooperation. It intends to connect with knowledge networks such as national and international organisations, industry associations, business councils, regulatory agencies and trade departments.

KIHT is headed by a governing board comprising Association of Indian Medical Device Industry (AiMED), Stanford-India Biodesign (SIB) Programme, Biotechnology Industry Research Assistance Council (BIRAC) and other member institutions.

Indian medical device manufacturers have been pushing for constructive measures to promote the domestic industry and reduce import dependency which would get reflected in healthcare cost.

 

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Published on: Dec 26.2017

2017 was another year that took the medical device revolution in the country to another level. Here are the most significant ‘medical device’ highlights that ensured that it remained at the top of the agenda from regulations to retaliations.

Medical Device Rules 2017
The year 2017 started with a big news in the industry when Medical Device Rules 2017 got published. The notification came a day after the Union Finance Minister mentioned during his Budget speech about forming new rules to regulate medical devices. This heeded the industry’s long standing demand to have medical device rules separate from drugs. The rules have been framed in conformity with Global Harmonisation Task Force (GHTF) framework and have enhanced clinical trial norms as per International best practices. For the first time, certified agencies would be involved to audit the manufacturing units.
Subsequently, the National Regulatory Authority, CDSCO also came up with classification of medical devices. As per the Rules, these will be classified on the basis of parameters specified in the first schedule, viz a viz low risk as Class A; low to moderate risk as Class B; moderate to high risk as Class C; and high risk as Class D. The State licensing authority will regulate Class A and Class B medical device and DCGI under the Union Government will regulate Class C and Class D medical device.
CDSCO with an aim to facilitate single window clearance for medical device and diagnostics industry, launched an online service for grant of import, manufacture, clinical investigation, sale and distribution licences of medical devices and diagnostics through ‘Sugam portal’. This shall also be in effect in line with Medical Devices Rules, 2017.

Global Forum on Medical Devices
In May 2017, WHO headquarters in Geneva hosted the 3rd Global Forum on Medical Devices represented by 85 countries and their 650 dignitaries. The delegation from India was very well represented by the industry, government and quasi government institutions who in turn presented the work of their respective domains. The biggest news came during the closing ceremony when Indian delegates were invited on stage to announce the next Global forum in India. This would certainly help the government as well as the industry to enhance the growth of the medical device industry.

Price Caps
This year most talked of topic in the industry was price cap on medical Devices. In February this year National Pharmaceutical Pricing Authority (NPPA) slashed coronary stent prices by as much as 85 percent and imposed price ceilings for all drug-eluting stents and bioabsorbable stents. The order on price caps were valid for a year and would be reviewed once again in February 2018. The matter was of grave concern for the US manufacturers, so much so that US trade representative (USTR) had to intervene and write to Union commerce minister and the Prime Minister’s principal secretary that the policy has created serious problems for US stent makers in India. The matter was also discussed during Prime Minister Narendra Modi’s visit to Washington in June. However the move was very well taken by the Indian manufacturers, it was also reported in the Economic Times that some of Private equity firms are now approaching the Indian manufacturers for investments. Later this year, continuing its agenda, NPPA capped prices for orthopaedic knee implants aswell in a move to make medical devices more affordable. Year 2018, will be a year to watch out for which would clarify further course of action to make medical devices more affordable.

Maximum Retail Price
Later this year amendments to the Legal Metrology (Packaged Commodities) Rules, 2011 took place which are also applicable to regulated medical devices effective from 1st January 2018.
It was reported that consumers at large were facing difficulty as prices of devices were sold according to the paying capacity of the consumer. Even after capping of MRP many companies were not displaying the same. Also there are important declarations other than MRP that need to be displayed, are brought into the purview of declarations to be made under the rules. Further, these rules provide that every package shall bear the name, address, telephone number, e-mail address of the person who can be or the office which can be contacted, in case of consumer complaints.

1st World Conference on Access to medical products and International Laws for trade and health

In the context of 2030 agenda for Sustainable development, Ministry of Health & Family Welfare, Indian Society of International Law and World Health Organisation hosted the 1st World Conference on Access to Medical Products and International Laws for Trade and Health. The conference was inaugurated by the Union Health Minister himself. The objective of the conference was to exchange knowledge and expand understanding on contemporary issues in international trade law, research and innovation for access to medical products. The conference came up with recommendations for possible policy coherence on international trade laws and health, including intellectual property covenants for access to medical products.

Kalam Institute of Health Technology
Named after the 11th President of India, an institute dedicated for medical technology came up in Vishakhapatnam. The institute is funded by the Department of Biotechnology, Government of India with the aim to identify critical gaps in medical technology and suggest the government to do focused spending on such areas. It shall also help bridge the gap between academic research and industrial market access, by auctioning of patents and prototypes available with government funded academic research institutions. KIHT shall broadly function on Innovation & Market Access, Enabling Technology Transfer, and Research & Development Support.

Accomplishments under National Health Mission (NHM)
As per the achievements of Ministry of Health & Family Welfare during the year 2017 published under Press Information Bureau, many technology intensive programs have flourished. In order to increase access to better healthcare services, some of these programs have been implemented under Public Private Partnership (PPP) mode.
Under the Pradhan Mantri National Dialysis Program, access to Dialysis services have been increased to 219 districts with 2039 dialysis machines. These dialysis services are free for patient Below Poverty Line (BPL) and at a subsidised rate to other patients. Under NHM’s Free Diagnostic services Rs. 759.10 Crore have been approved to 29 sates/UTs to provide these services free for all. Free Diagnostic services broadly includes free pathology and radiology services. In order to ensure a sustainable model, Government of India is also supporting states for Biomedical Equipment Maintenance Program (BMMP) and for provisions for radiation safety. BMMP, which is one of the biggest medical equipment maintenance program globally, which takes care of 7,56,750 number of equipment in 29,115 health facilities across the country, costing approximately Rs. 4564 Crores.

Asian Harmonisation Working Party
This year India embraced the opportunity to host the 22nd conference on Asian Harmonisation Working Party (AHWP) at New Delhi. The five day conference conducted by Central Drug Standard Control Organisation (CDSCO) under Ministry of Health & Family Welfare and Federation of Indian Chambers of Commerce and Industry (FICCI) focussed on Capacity Training, technical Workshops, technical committee meeting and the 22nd AHWP Annual Meeting. This year’s edition of the programme focussed on ways to harmonize the medical device regulations in the Asian and other regions. It also focussed on major regulatory and policy updates in the medical device sector and the initiatives taken by the Government of India in the Medical Device Sector. The conference brought together all the stakeholders of the Indian Medical Device Industry and key international players on one platform with an aim to evolve a pragmatic roadmap for medical device sector development.

Standards and Quality
With Medical Device Rules (MDR), 2017 notified, accreditation bodies under Quality Council of India have also become very active in the domain of medical device. NABCB has been identified as an accreditation body for the certification bodies which will be designated as the Notified bodies (NB) by the Central Licensing bodies. These NBs will undertake assessment of Quality Management System for manufacturers of Class A and B category devices. In this regard NABCB has formulated a task force to finalise the audit requirements based on MDR, 2017.
Meanwhile, National Accreditation Board for Testing and Calibration Laboratories (NABL) under Quality Council of India has also announced a national level awareness program on accreditation of Medical Device Calibration to be held on 11th and 12th of January 2018 at AERB campus, Mumbai. NABL would also launch ‘specific criteria for Medical devices calibration discipline’ at this event.
Joining the league, Medical Equipment & Planning Division of Bureau of Indian Standards (BIS) is also organising a seminar on “Standardization on Medical Electrical Equipment” on 19th January 2018 at the premises of Atomic Energy Regulatory Board (AERB), Mumbai.

Medical Device Parks
After Andhra Pradesh, this year Telangana too inaugurates a medical device park with a claim to be country’s biggest. On the day of inauguration itself, the Telangana government had handed over land to about 14 medical devices manufacturing companies. The Telangana Park would work closely with Indian Institute of Information Technology Hyderabad (IIIT-Hyderabad) for medical technology. To weed out the financial constraints for the development in the park, an accelerator seed fund has also been proposed.
With Medical Parks also planned in Gujarat and Maharashtra; emphasis on excellence in Research and Development (R & D), the medical devices industry in India is poised to grow.

The author is the Senior Consultant, Healthcare Technologies (Medical devices) at National Health Systems Resource Centre, Ministry of Health & Family Welfare, Government of India which is a WHO collaborating center for priority medical devices & health technology policy.

 

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Published on: Nov 13, 2017

The Kalam Institute of Health Technology (KIHT), which held its first Governing Body meeting on November 10 this year at Delhi, is working towards building a robust system for innovation in the medical devices sector in the country, experts said.

The Governing Body, led by Prof Vijay Raghavan, hailed the uniqueness of the KIHT model in bringing academia and industry together. The Governing Body members applauded the conceptualisation and idea of KIHT to support the Government of India for focussed R&D policy in the medical devices sector through its Cell for Research and Development (CRD).

KIHT’s Cell of Technology Transfer (CTT) will facilitate academia with rapid technology transfer and product certifications, while the Cell for Innovation and Market Access (CIM) will enable industry with technology access and drive innovation of next generation of medtech products.

The Cell for Market Intelligence and Trade (CMT) will work with respective department or ministry towards elimination of trade barriers. CMT will also undertake research and analysis of relevant data to help in developing long term strategies for the medical device industry.

KIHT is working towards hosting a first of its kind congregation of innovators, investors and manufacturers for technology transfer from academia to industry for commercialisation.

KIHT’s proposition is further strengthened through its partnership with Association of Indian Medical Device Manufacturers (AIMED) which brings access to technical bandwidth from the industry and opportunities for deeper collaboration with the medical device industry.

The Governing Body acknowledged that KIHT presented a successful template for continuous innovation which could be replicated in other domains.

KIHT is being guided by stalwarts of the scientific community like Dr R Chidambram, Principal Scientific Advisor to Government of India as President.

The Governing Body members include: Prof Vijay Raghavan, Secretary Department of Biotechnology as Chairperson; Dr Poonam Malakondaiah, Principal Secretary (HM&FW), Government of Andhra Pradesh; Dr Renu Swarup. Senior Advisor, Department of Bio-technology and MD, Biotechnology Industry Research Assistance Council (BIRAC); Rajiv Agarwal, Joint Secretary, Department of Industrial Policy & Promotion (DIPP), Government of India; Dr Swati Basu, Scientific Secretary, Office of Principal Scientific Adviser to Government of India; Rajiv Nath, Forum Coordinator, Association of Indian Medical Device Manufacturers (AIMED), New Delhi; Prof B Ravi, Institute Chair Professor, IIT Bombay, Mumbai; Prof Balaram Bhargava, Executive Director, School of International Bio-Design, AIIMS, New Delhi; and Dr Jitendar Sharma, Managing Director & CEO, Andhra Pradesh MedTech Zone, Visakhapatnam as Executive Director

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Published: Nov 10,2017

Kalam Institute of Health Technology (KIHT)  formally launched today, November 10^th, 2017 at New Delhi with their 1^st Governing Body meeting. KIHT, known for its unique model of bringing academia & industry together discussed the way forward for innovation and growth of Medical Devices Industry in India.

Major announcement at 1st Governing Body meeting were:

•              Approval accorded for technology e-auction
•     KIHT identified as nodal point for medical technology program support cell for national biopharma mission
•            KIHT accepted as the facilitator for DBT/BIRAC funded innovations for helping them with certifications

The Governing body led by Prof. Vijay Raghavan applauded the conceptualization and idea of KIHT to support Govt. of India for focussed R&D policy in the medical devices sector through its Cell for Research and Development (CRD).
Lalit Mahajan, Chairman, Mitra Industries representing (AiMeD), Association of Indian Medical Device Industry said, “Aimed is indeed a proud team member of KIHT team and emphasized that AiMeD will lead the Prioritized indigenous development of Medical Devices in India for addressing Priority Diseases in the country.”

Congratulating KIHT on its formal launch, Rajiv Nath, Forum Coordinator, AiMED said, “We are extremely happy that the 1st Governing Body meet of KIHT is a major step towards   making India a Global Manufacturing Hub for medical device sector and to build a robust system for innovation in the medical devices sector in the country.”

KIHT’s Cell of Technology Transfer(CTT) will facilitate academia with rapid technology transfer and product certifications, while the Cell for Innovation and Market Access (CIM) will enable industry with technology access and drive innovation of next generation of medtech products. The Cell for Market Intelligence and Trade (CMT) will work with respective department/ministry towards elimination of trade barriers. CMT will also undertake research and analysis of relevant data to help in developing long term strategies for the medical device industry.

KIHT is being guided by stalwarts of the scientific community like Dr. R. Chidambram, Principal Scientific Advisor to Government of India as President and the Governing Body members include: Prof. Vijay Raghavan – Secretary Department of Biotechnology as Chairperson; Dr. (Smt.) Poonam Malakondaiah – Principal Secretary (HM&FW), Govt. of Andhra Pradesh; Dr. Renu Swarup – Senior Advisor, Dept. of Bio-technology, & MD, Biotechnology Industry Research Assistance Council (BIRAC); Shri Rajiv Agarwal – Joint Secretary, Department of Industrial Policy & Promotion (DIPP), Govt. of India; Dr. Swati Basu – Scientific Secretary, Office of Principal Scientific Adviser to Govt. of India; Shri Rajiv Nath – Forum Coordinator, Association of Indian Medical Device Manufacturers (AIMED) will  bring access to technical bandwidth from the industry and opportunities for deeper collaboration with the medical device industry; Prof. B. Ravi – Institute Chair Professor, IIT Bombay, Mumbai; Prof. Balaram Bhargava – Executive Director, School of International Bio-Design, AIIMS, New Delhi and Dr. Jitendar Sharma – Managing Director & CEO, Andhra Pradesh MedTech Zone, Visakhapatnam as Executive Director

 

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As a young citizen of India,armed with technology, knowledge and love for my nation,

I realize, small aim is a crime

1st stanza of Song of Youth by Dr. A.P.J. Abdul Kalam
In true spirit of the lines above Dr. A.P.J. Abdul Kalam, fondly known as the People’s President and the Missile Man, had envisioned a Developed India through his India Vision 2020 document. Healthcare was identified as a key focus area to achieve this vision of a Developed India. Indigenous, focused R&D to solve for healthcare problems in India was and is the need of the hour. Addressing a gathering in Bangalore on January 10, 2010, Dr.Kalam stressed on the need of affordable healthcare for all in India.

Kalam Institute of Health Technology (KIHT), named after this visionary scientist cum statesman, was setup with the support of Biotechnology Industry Research Assistance Council (BIRAC), a Public Sector Undertaking of Department of Biotechnology to bring increased access to affordable health products to citizens and a thriving medical devices manufacturing sector in India. KIHT works towards enabling the medical device industry in India which is largely import dependent leading to high costs of healthcare. KIHT works on 3 core areas of a) Facilitating focused R&D b) Technology transfer enabling upscale of prototypes c) Market access which will lead to access to healthcare for patients. Inspired by the vision of Dr.Kalam making healthcare affordable and available is at the core of the KIHT philosophy.

KIHT will facilitate focused research on Critical Technology Links(CTLs) of medical devices. As a country, it is imperative that investments into R&D are made in areas where there is maximum benefit for the Indian society. KIHT organizes regular workshops where expertsfrom industry and academia meet to brainstorm of key areas of research where India isdependent on Imports. The findings of these sessions are then shared with funding agencies

to ensure funds reach critical research areas.The Kalam-Raju stent which was developed indigenously by Dr.Kalam and his team in collaboration with Dr. B. Soma Raju of the Care Foundation is a great example of industry-academia collaboration. India’s import dependency for cardiac stents was making such stents unaffordable. This Kalam-Raju stent brought the cost of stents down by almost 75%. KIHT will be facilitating focused research on technologies based on burden of disease and which are high import dependent through their Cell for Research & Development (CRD). Facilitating focused and target oriented R&D by providing critical knowledge to relevant institutions.

R&D towards new product development needs to move from prototypes to full-fledged products which can then actually reach patients. KIHT through its Cell for Technology Transfer (CTT) works towards enabling this technology transfer. Research organizations, individual innovators, start-ups, academic institutes can identify and partner with appropriate companies with the help of the CTT team at KIHT for commercialization of their innovations. The financial consideration received for such innovations through commercialization can then be funnelled back to enable further innovation thus creating an ecosystem which fosters innovation. Dr.Kalam in an address on the occasion of Technology Day 2006, identified technology transfer as a key stage in affecting economic competitiveness of a product. The CTT team aims to achieve successful technology transfers in the field of medical devices.

The Kalam-Raju tablet developed again by Dr.Kalam and Dr. B Soma Raju served delivery of the right medical aid through technology coupled with access to a knowledge platform. The tablet enabled primary level healthcare workers to make informed decisions thus improving healthcare access and quality. Drawing a parallel in the medical device space the Cell for Innovation and Market Access (CIM) aims at enabling creation and adoption of medical device specific industry standards, technology upgrades in manufacturing, skill development programs which will lead to Indian products being at par with global competitors and thus enabling economic viability and improved delivery of healthcare.

CIM will also work towards addressing concerns like trade barriers, technical barriers, operational challenges which can impair the manufacturing and trade of

medical devices.

KIHT is working towards the goal of affordable and accessible healthcare for all as set in the India Vision 2020 document. However, this cannot be achieved by one entity. In the health care sector the consumers, healthcare providers, insurance providers all need to invest in building the ecosystem across best practices, knowledge sharing and empowering the patient to make informed decisions. Sustaining, evolving, maturing the entire healthcare system in India is a project for all stakeholders to drive cohesively.

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Association of Indian Medical Device Industry (AiMED) has been invited to be on the governing board of Kalam Institute of Health Technology (KIHT), a project initiated under AMTZ (Andhra Pradesh MedTech Zone).ETHealthWorld  |  July 31, 2017, 13:47 IST

New Delhi: Kalam Institute of Health Technology (KIHT), India’s first institute dedicated to medical devices under the AMTZ (Andhra Pradesh MedTech Zone) project initiative, will be headed by a governing board comprising AiMED, Stanford-India Biodesign (SIB) Programme, Biotechnology Industry Research Assistance Council (BIRAC) and seven other member institutions.

The KIHT governing board includes Dr R Chidambaram, Principal Scientific Advisor to the Prime Minister, as President; Dr K Vijay Raghavan, Secretary, Department of Bio-Technology, as Chairperson; and Dr Jitendar Sharma, Director & CEO of AMTZ, as Executive Director.

The governing body, comprising 8-10 member institutions, will monitor the progress made by the institute, review the annual reports and add value through its advices. “The members are the original founding members of the society, which was created as a formal institution to oversee the industry and work with the government for utilisation of the funds in a proper manner for desired objectives,” said Rajiv Nath, Forum Coordinator, AiMED.

The two functions that the body aims to fulfil are re-identification and medical technology transfer.

Dr Jitendra Sharma, executive director, KIHT, added, “One major function of KIHT will be to guide the Government of India on what to fund for R&D. The second major function will be pooling all the medical devices which are lying in prototype stage in the institutional labs like IIT and auction them to the industry. The money gained out of the auction will reach back to the investors, as thousands of crores have been invested on thousands of research work on medical technology with no benefits to the industry and patients because the prototypes have only been kept in the lab.”

Citing an example, Nath said, “We will be coordinating with Indian Institute of Science to compile a list of patents that have already been filed for various technologies and then we will seek the government’s permission to auction them. So that the devices can be utilized by Indian entrepreneurs at low cost and can be put into promotional use. The second task is to have coordinated strategies to decide the priority diseases in the country and see the unavailable technologies overseas. These unavailable technologies can be illustrated for R&D purposes in India. We hope that India will take off as a manufacturing base for medical devices in the world.”

The formal launch of the institute is yet to be done. “The work has already started with all the approvals and funding. The union government is yet to announce the date of launch which is keenly awaited,” said Dr Sharma. He added, “First set of priority is the listing of technology that requires R&D in India. Applications will be requested from academic and research institutions, who are interested to do R&D on the priority list for which the department of biotechnology, Government of India, will provide financial support. Application form is being designed while the first set of technology transfer prototype auctions is being formulated. Lots of things are in process. The institute may also come up with short term courses, workshops or seminars on technology transfer. KIHT is supposed to be the brain of medical technology policy in India.”

Dr Sharma stated that Indian medical technology industry has a growth rate of 16%, which is highest in the world. “But the cost of manufacturing medical device, which is very high, has been a major challenge as we didn’t have any scientific facility until AMTZ was announced. As part of the AMTZ initiative, 11 huge industrial labs will be set up for the cost of almost Rs 300 crore. Around 240 factories will be created so that the industry can manufacture the devices with the minimal investment.”

AiMED is also advocating for the development of more medical devices parks across the country, and is in talks with the state governments of Telangana, Haryana and Gujarat. “Our first focus is to create the required ecosystem and policies to support medical devices manufacturing in India. The most important one is the current duty structure which varies from 0 to 7.5 %, and needs to be at least 10% to make manufacturing of devices viable in India. As long as duty remains low, people will keep on importing goods in the country and will not give much incentive to manufacturing.