Even as the Centre has indicated its plans to have a single Act for pharmaceuticals, medical devices, and cosmetics through a new draft Bill, the Department-Related Parliamentary Standing Committee (DRPSC) on health and family welfare has strongly recommended separate legislation for the medical devices industry.
The Committee, in its 138th report on ‘Medical Devices: Regulation & Control’ pertaining to the department of health and family welfare, presented to the heads of Rajya Sabha and Lok Sabha on September 12, said:
“The Committee, while welcoming, the initiative of the Ministry to set up a panel to make the new Drugs, Medical Devices and Cosmetics Bill with separate provisions for medical devices, strongly recommends that instead of drafting a combined legislation for drugs, medical devices, and cosmetics, the Ministry should appreciate the potential of the medical device industry and formulate a separate legislation for medical devices.”
The new legislation on medical devices should have the provisions to transform the medical device industry and bring about a medical device revolution in the country.
Instead of the panel, the government should come up with a “National Commission on Medical Devices’ to examine all aspects of the industry in detail and bring forth a comprehensive law supported by a holistic policy and institutional infrastructure for the purpose.
This Commission should study the aspect of centralizing medical device licensing with the central regulator so as to make the approval process easy.
The Ministry should also focus on guaranteeing transparency by designing this legislation so that the citizens/experts get the right to participate in decision-making.
The legal provisions should be such that citizens or experts can participate in the regulatory process and register their objections.
“The blueprint for the new legislation must also include a 10-15 year roadmap with a clear policy plan and targets.”
“The Committee strongly believes that with a 15-year roadmap with annual targets for the medical device industry, India would emerge as the world’s biggest center for manufacture and service of medical devices and thus also a leader in medical tourism,” it added.
While the Medical Devices Regulation, 2017 mandated the Central Drugs Standard Control Organisation (CDSCO), which has a primary focus on the regulation of drugs, to regulate the medical devices segment as well, the existing structure and expertise (which is more pharma-centric) of the workforce in CDSCO is falling short in effectively regulating the medical devices industry.
The new legislation should set up a new set of regulators at different levels to regulate the medical devices industry.
Unlike the present structure, the proposed regulator should license the manufacturing of all classes of medical devices, i.e., Class A, B, C, and D.
This would help harmonize the regulation process throughout the country as it would do away with different regulating procedures employed by different states.
This step would greatly help the manufacturers and will reduce the time required to start a manufacturing unit, thereby facilitating the ease of doing business.
The Committee also recommended that to undertake the regulation of all classes of medical devices throughout the country, the proposed regulator should be adequately staffed with a workforce that is technically skilled and well-versed in the functioning of the medical devices industry.
The Ministry should work in synergy with state governments and impart the necessary skills to the local medical device officers and also devise a mechanism to regularly designate state medical personnel as medical device/medical device testing officers so that the mandate of the legislation can be implemented effectively.
“The Committee believes that with the industry growing by leaps and bounds, the government should not afford regulation of medical devices by pharma experts and it is time that at ground level the medical device regulations are dispensed with by qualified and well-trained medical device officers to give a fillip to the medical device industry in the country,” it said.
The Ministry should allow the new regulator to involve institutions like IISC, CSIR, DRDO, and a network of IITs to test medical devices for safety and efficacy. Additional investments should be made to raise the standards of these labs as per the requirements.
Taking into account the potential growth and independent development of Indian medical devices in the country, the separate Act on medical devices should have rules and regulations with clearly defined roles and responsibilities of regulating bodies; supportive policies like predictive tariff policy, refurbished imports to enable the spread of unavailable medical devices at a low cost for deeper penetration in the smaller cities and rural areas; and preferential public procurement to boost domestic manufacturing.
A single window clearance for all the departments/ministries would significantly boost investment in R&D in the field of medical devices and would also reduce the time required for obtaining approval from different departments/ministries.
The Ministry must incorporate such an all-encompassing “single window clearing/approval system” in the proposed new separate Act for the regulation of medical devices.
The interface between ministries dealing with Medical Device Rules, 2017 should be organized to carve out road maps for the growth and development of the medical device industry in the country.
The Committee is of the considered view that the development of more medical device parks in different spaces would operationalize linkage along with lending support to an ancillary industry that can proliferate the medical device industry in the country.
It further observed that the law to regulate medical devices needs to have provision for risk-proportionate regulatory controls and a risk-proportionate penal system and provide clarity of exemptions or diluted regulatory requirements for very low-risk nonsterile surgical instruments and other non-sterile medical devices.
The new legislation’s regulatory controls need to be shared between the Centre, State and Conformity Assessment Notified Bodies in Law and there should not be any duplication of state and central government regulations.
There needs to be accountability fixed on the State Regulator to the Central Licensing Authority (or a National Regulator) to ensure harmonious enforcement).
To avoid a multiplicity of regulations at the component level from different departments/ministries, it is recommended that CDSCO, which operates a single window clearing platform for the application of licenses for manufacturing, export, and import, also integrate all these bodies involved in the regulation of medical devices.
The report added that there is a dire need to develop a robust IT-enabled feedback-driven post-market surveillance system for medical devices to evaluate the efficiency of specific medical devices.
A medical device registry, particularly for implants, should also be set up to ensure traceability of the patient who has received the implant in order to assess the performance of the implant and ascertain to what extent the implant has made the life of the patient more comfortable and also to seek feedback on the functional capacity of medical devices.
Such measures would ensure that patients get access to good quality and approved medical devices, it added.
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