Central regulation of medical devices is to come into effect in India as of April, it has been reported.
Once the shift has come into force at the beginning of the forthcoming fiscal year, all medical devices and equipment for the purposes of “diagnosis, monitoring, treatment, investigations and for supporting or sustaining life” will be regulated as ‘drugs’ under the Drugs and Cosmetics Act, 1940. The ostensible goal of the new regulatory framework is to improve the safety, quality, and efficacy of medical devices and equipment.
Medical devices regulation, explained
The central regulation of medical devices has been on the cards for some time. Last year, the Union Ministry of Health and Family Welfare announced its intent that the Central Drugs Standards Control Organisation (CDSCO) be the regulator of medical devices, thereby bringing them under the purview of the Drugs and Cosmetics Act and – as such – the Centre itself.
Already, some 23 medical devices are classified as ‘drugs.’ However, concerns that swathes of medical devices, equipment, and technology are “largely unregulated” has spurred plans for the enhancement of central regulation, manifesting in the switchover from April 1st. This “covers all devices, including instruments, apparatus, appliance, implant, material or other articles — whether used alone or in combination, including software or an accessory — intended by its manufacturer to be used especially for human beings or animals.”
Among the provisions of the move will be that all medical devices must be registered with the Central Licensing Authority. This registration will be voluntary for an eighteen-month period, compulsory thereafter. “[The] Central Licensing Authority may verify the documents at any point of time and investigate quality or safety related failure or complaints,” the Health Ministry explained. Registration and regulation periods will be adjusted according to the relative risks of the devices in question, in terms of when the new rules come into force. Once the rules are in place, low- and moderate-risk devices have a timeframe of thirty months; for moderate-risk and high-risk devices, the timeframe is 42 months.
The move has sparked fears from the medical devices industry itself. The impact of central regulation on small-size manufacturers falling under the bracket of micro, small and medium enterprises (MSMEs) has been cited by key players in the industry such as Rajiv Nath, coordinator of theAssociation of Indian Medical Device Industry. Quoted in Business Today, Nath opined “one can’t expect a tiny manufacturer in Bhagirath making masks or neck bracing collars or belts to hire a qualified QMS [quality management system] manager with biomedical engineering. It is not needed worldwide — these require simple basic precautions like labels for traceability and consumer protection.”
In lieu of regulation under the Drugs and Cosmetics Act, Nath and other industry players believe that it would be preferable if a separate law was introduced as government think tank Niti Aayog has proposed in the past. ‘We are highly uncomfortable to be regulated under the very rigid and prescriptive the Drugs Act as any non-conformity can be treated as a criminal offence by any drug inspector at his discretion and hauled before a court and there is no risk proportionate penalties,” Nath said. “We have been seeking assurance from the health ministry that this is a temporary measure until a Niti Aayog-drafted bill to regulate devices separately from drugs becomes a separate law. But, no meeting has been called to address these apprehensions.”
Niti Aayog itself criticised the proposal for bodies such as the CDSCO to regulate medical devices on the grounds that they lack the requisite expertise. Last year, the think tank proposed the Medical Devices (Safety, Effectiveness and Innovation) Bill, 2019 to, as Health Issues India reported at the time, “improve quality, enhance transparency, make it easier for the sector to do business, and formalise a regulatory framework as well as a framework for compensation” as well as reduce import dependency. Claims that the Union Health Ministry and Niti Aayog were at loggerheads over their differing views of medical device regulation were refuted by Minister of State for Health Ashwini Choubey.
“The purpose of the draft Bill is to ensure that medical devices in India are safe and effective,” Niti Aayog said in a statement to industry stakeholders at the time. “Further, the Bill should create an enabling ecosystem for manufacturing, research and innovation.” Among the proposals were a Medical Devices Administration (MDA) analogous to the Food Safety and Standards Authority of India (FSSAI). The MDA would consist of four divisions, in addition to a National Registry of Medical Devices. Business Standard explained at the time that the four divisions – attending to health and safety, conformity assessment, enforcement, and laboratory and medical devices testing – would operate as follows
“The health and safety division would grant permission for clinical investigation on human subjects, specify and evaluate the clinical evidence, collect and analyse results of the post-market surveillance. The conformity assessment division would issue, reject, recognise, and validate conformity assessment certificates, and also conduct audits of manufacturing sites. The enforcement division would inspect, investigate, carry out searches and seizures. The laboratories division would specify procedures for the analysis or testing of medical [devices].”
Reactions have been divided over the merits of the two proposals. While Nath’s preference, for example, rests with Niti Aayog’s proposed Bill, a different view was expressed by the Medical Technology Association of India. Their chairman and director-general, Pavan Choudhary, was quoted in Business Today as saying “we welcome the government’s decision to regulate all devices, which has also been a long-standing ask of the industry. These regulations, that are a continuation of the Medical Devices Rules 2017, which were launched after meticulous deliberations for two years, are in line with the government’s vision to provide equitable access to quality healthcare. We are also happy the health ministry is recruiting competent resources to cater to the additional workload that these new regulations will bring in.”
“AdvaMed and its member companies appreciate Indian government’s decision to regulate all medical devices under the guidelines issued by the Ministry of Health as per the Medical Devices Rules 2017 and strengthen regulations to improve safety and quality of products available in India,” Abby Pratt, Vice President of AdvaMed, commented to Health Issues India. “We believe this decision to make norms more stringent and the Ministry of Health’s investment in capacity building by recruitment of specialised auditors will benefit the medical devices industry and the patients at large.
“We congratulate the Ministry of Health and Family Welfare for its efforts to support Prime Minister Narendra Modi’s ‘Make in India’ initiative by globally harmonising India’s regulatory structure, which will enable domestic manufacturers of medical devices and IVDs to make in India for the world. It will prove pivotal in enabling a more predictable pathway for globally recognised technology to enter India and lessen the gap between India’s access to research-based medical devices and diagnostics.”
Concerns still linger, however, about the CDSCO. “We are particularly wary of the CDSCO’s competence, expertise and most importantly its commitment towards patient safety, given its dismal track record,” All India Drug Action Network co-convenor Malini Aisola was quoted as saying in The Times of India. “We urgently need comprehensive reforms to strengthen the regulatory mechanism in relation to patients’ safety. These may include guidelines for the approval of devices including clinical investigation requirements, oversight of marketing and promotion, putting in place a robust and functioning system of adverse event reporting accessible to the public, rules for voluntary and statutory recalls, and patient compensation scheme.”