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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.
