The Ministry of Health and Family Welfare has notified the Medical Devices Rules, 2017 on January 31, 2017. These new Rules have been framed in conformity with the Global Harmonisation Task Force (GHTF) framework, and conform to best international practices...
While the Indian medical devices industry supports the government’s move to help the common man get access to low-cost knee implants, it has questioned the government’s piecemeal approach, capping prices first of stents and then knee implants instead of a smooth transition.
It has recommended to the government for basic import tariff to be 10% for medical devices (whose export is over '5 crores) and duty on components to be 5% from next year and 7.5% thereafter as “Make in India” enabler, concessional duty on raw material may be retained at 2.5% for now, and to cover the devices which had not been addressed in the Jan 2016 notification.
Expedite medical devices law to regulate all devices and ensure a clear-cut definition of ‘manufacturer’ to disallow legalization of pseudo manufacturers and traders to pass themselves off as manufacturers, voluntary compliance backed by 3rd party ICMED certification to be considered as a compliance option/reduced oversight, buy Indian policy of preferential market access and preferential pricing (as per World Bank terms) for Indian medical devices for Indian public healthcare tenders and have weightage of 5% for ICMED certification, 2% for ISO 13485 certification,and 3% for design India certification for promoting quality and indigenous development.
There will be for the first time no requirement of periodic renewal of licenses
It recommends a ban on refurbished medical equipment for the next 5 years till such time we have a strong regulatory regime to ensure validated and calibrated equipment for limited access for enabling patient safety.
It has also recommended maximum retail price (MRP) to be enforced on unit of sale of medical devices. The industry suggests that no NPPA / DPCO for medical devices other than in case of stents (combination device, having drug), to introduce price cap mechanism of ex-factory / import landed price in a phased manner or bring in a 1% cess on GST to act as disincentive for putting exorbitant MRP and to incentivize ethically correct low MRP.
The Medical Devices Promotion Council – to focus on aspects of sectoral export promotion and indigenization, to address India’s 70% import dependency, 90% on medical electronics.
The Ministry of Health and Family Welfare notified Medical Devices Rules, 2017 on January 31, 2017. The new Rules have been framed in conformity with the Global Harmonisation Task Force (GHTF) framework and conform to best international practices. Only 15 categories of medical devices are, at present, regulated as drugs and to that extent, the current regulatory practices in India were not fully geared to meet the requirements of the medical devices’ sector in the country. The new Rules seek to remove regulatory bottlenecks for “Make in India” and facilitate ease of doing business while ensuring availability of better medical devices for patient care and safety.
Medical devices will, under the new Rules, be classified as per GHTF practice, based on associated risks, into Class A (low risk), Class B (low moderate risk), Class C (moderate high risk) and Class D (high risk). The manufacturers of medical devices will be required to meet risk-proportionate regulatory requirements that have been specified in the Rules and are based on best international practices.
With a view to bringing in the highest degree of professionalism in regulation of medical devices, a system of ‘Third Party Conformity Assessment and Certification’ through Notified Bodies is envisaged. The Notified Bodies will be accredited by the National Accreditation Board for Certification Bodies (NABCB). The NABCB will, before accrediting Notified Bodies, assess their competence in terms of required human resources and other requirements. These Bodies will undertake verification and assessment of Quality Management System of Medical Device Manufacturers of Class A and Class B categories, and may, as required, be called upon to render assistance for regulation of Class C and Class D medical devices also.
The Rules also seek to evolve a culture of self-compliance by manufacturers of medical devices, and accordingly, the manufacturing licenses for Class A medical devices will be granted without prior audit of manufacturing site. The manufacturer will, in such a case, be required to do selfcertification of compliance with the requirements, and based on such certification, the license will be issued. However, post approval audit of manufacturing site will be carried out by the Notified Bodies to check conformance with Quality Management System. Manufacture of Class A and Class B medical devices will be licensed by State Licensing Authorities concerned after Quality Management System audit by an accredited Notified Body. For all manufacturing sites, Quality Management System will need to be aligned with ISO 13485. Manufacture of Class C and Class D medical devices will be regulated by the Central Licensing Authority, and where required, assistance of experts or notified bodies will be sought. Import of all medical devices will continue to be regulated by the Central Drugs Standard Control Organization (CDSCO). A network of NABL-accredited laboratories will be set up by both the government and other entities for testing medical devices.
Separate provisions for regulation of Clinical Investigation (clinical trials) of investigational medical devices (i.e. new devices) have also been made on par with international practices, and like clinical trials, these will be regulated by CDSCO. Conduct of clinical investigations will, while following international practices, be conducted in a manner that ensures realization of the twin objectives of patient safety and welfare and discovery of new medical devices. Medical management and compensation will be provided to subjects of clinical investigation in accordance with predefined and objective criteria laid down by the government.
The new rules have many other unique features. There will be for the first time no requirement of periodic renewal of licenses. Accordingly, manufacturing and import licenses will remain valid till these are suspended or canceled or surrendered. Further, the entire process starting from submission of application to grant of permission/license will be processed through an online electronic platform. Timelines have been defined for most activities at the regulators’ end. The issuance of licenses for Class A medical devices on the basis of self-certification coupled with a system of checks and balances for ensuring compliance is a departure from the inspection-based regulatory regime. Risk-based audit of manufacturing units will be carried out to assess conformance with standards and quality parameters. These Rules envisage creation of a robust eco-system for all stakeholders, including innovators, manufacturers, providers, consumers, buyers and regulators.
The Rules will provide a conducive environment for fostering India-specific innovation and improving accessibility and affordability of medical devices across the globe by leveraging comparative cost advantage of manufacturing in India. The objective, transparent and predictable regulatory framework will boost confidence of investors, and as a consequence, the quality and range of products and services will improve and business burdens will be reduced. The new Rules will help in developing a quality standardization framework in India on par with international standards. The implementation of these Rules will provide assurance of best quality, safety and performance of medical devices. These Rules coupled with other measures, taken by the government in the recent past, are expected to sharpen the competitive edge and provide incentives to firms to become more efficient, innovative, and competitive. All this will support entrepreneurship, market entry and economic growth, which, in turn, will produce high-paying, highquality jobs.
The government has recently released the “Draft Pharmaceutical Policy – 2017” which has called for capping trade margins and promoting the sale of medicines using salt name instead of brand names.
The draft policy laid down several policy prescriptions that include enhancing quality standards, reining in unfair trade practices, faster approvals, boosting indigenous manufacturing, and encouraging research and development.
Disclaimer – Statements and opinions expressed in this article are those from the editorial and are well researched from various sources. The content in the article is purely informative in nature.