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India imports between 70 and 90 per cent of its medical devices. And while these products may have regulatory certifications in other countries, the reality is that a considerable number of them are not covered by a domestic regulation.
For the over ₹30,000-crore imports of medical devices last year, there exists no local regulation or quality checks, save some products that are governed by the AERB (Atomic Energy Regulatory Board) for radiation safety. Only 23 devices are regulated by the Ministry of Health through its Central Licensing Authority and the State Licensing Authorities under the Drugs and Cosmetics Act (DCA).
The recent incidents of faulty implants supplied by Johnson & Johnson point to a deeply entrenched malaise in the system besides laying bare the inadequacies and inequities in the DCA that is clearly not suited to regulate medical devices. Devices are engineering products, not drugs or medicines. As a result, patient safety concerns have compounded in the absence of a regulatory framework that is clearly defined for medical devices.
We are in the business of providing healthcare products to save patient lives, yet our policy-makers are surprisingly undecided and seem to be in no urgency to usher in a “Patient Safety Medical Devices Law” to protect patients, even after the recent J&J incident.
In India, most implantable devices are unregulated, including pacemakers, defibrillators, continuous monitoring glucose monitors, etc. It is strange that the over $10-billion domestic medical devices market is not governed comprehensively by any regulatory framework, guidelines or distinct laws. Manufacturers need to know the legal requirements, rules and role that every stakeholder in the system needs to follow, and in a predictable manner. This will attract overseas and Indian investments. Presently, investors shy away from an unpredictable, incomplete and incorrect regulatory environment for medical devices. In the absence of regulations, domestic manufacturing suffers as a surgeon is unsure on trying an unregulated device from a startup entrepreneur on a live patient.
To be effective and industry-friendly, we need a regulatory framework with a clear demarcation of roles of the regulator, of the supervising accreditation body that assists the regulator, and that of certification bodies who audit the manufacturer. And to be able to effectively check and control the industry and yet be able to unleash its true potential, the underlining principle of any regulatory framework should be “Minimum Government – Maximum Governance”.
Until recently, there was no onus on manufacturers to demonstrate compliance. There is a need for manufacturers to voluntarily use accredited third-party conformity assessment bodies to verify and certify their compliance level to regulations. This will ensure better quality and also create greater international acceptance for Indian Products. Emphasis on market surveillance and monitoring with a system for necessary systemic action to prevent reoccurrence of J&J type incidents will ensure greater patient safety.
A beginning has been made in this direction with the recent Medical Device Rules, which became effective from January 1 2018. However, these rules are applicable only on the 23 devices notified as Drugs under DCA. Clearly, an ultrasound machine or an X- Ray machine is not a Drug.
India needs to regulate all medical devices and not item by item as is the constraint under DCA. In the absence of sector-specific technical regulations for medical devices, the BIS (Bureau of Indian Standards) Act can be used to regulate all devices at one go, for starters.
The National Accreditation Board of Certification Bodies is already accrediting certification bodies for Voluntary Quality Assurance Indian Certification for Medical Devices (ICMED) certification. Incentivising ICMED certification by the Quality Council of India will help manufacturers in capacity building for voluntary compliance to quality, thereby ensuring global competitiveness to enable the smooth transition to mandatory compliances under a Patient Safety Medical Devices Law. A strong and fair regulatory environment will help the Make in India campaign by encouraging the growth of this industry.
Rajiv Nath is Forum Coordinator for the Association of Indian Medical Device Industry. Views expressed are personal
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