Parliamentary Panel recommends separate legislation, National Commission On Medical Devices

The parliamentary panel presented its 138th report on 'Medical Devices: Regulation & Control' pertaining to the department of health and family welfare to the head of Rajya Sabha and Lok Sabha.

The Committee observed that the functions of the Central Drugs Standard Control Organization (CDSCO) primarily focus on the regulation of drugs as the regulatory body was originally set up to regulate pharma and other related segments. The MDR 2017 mandated the CDSCO to regulate the Medical Devices segment as well. However, 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.

In its report, 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 recommended 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.

Elaborating on its recommendations, the panel stated that the new legislation on Medical Devices should have the provisions to transform the medical devices industry and bring about a Medical Device Revolution in the country.

The Committee further suggested that 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.

It suggested that this Commission should study the aspect of centralizing the 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 a right to participate in decision making. The legal provisions should be such that citizens/experts can participate in the regulatory process & register their objections.

"The blueprint for the new legislation must also include a 10-15 year roadmap with a clear policy plan & 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 centre for manufacture & service of Medical Devices and thus also a leader in medical tourism," the panel added.

The panel also expressed that the new legislation should set up a new set of regulator at different levels for regulating 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 harmonise 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 ease of doing business.

The Committee also recommended that to undertake the regulation for all Classes of medical devices throughout the country, the proposed regulator should be adequately staffed with workforce which is technically skilled and is well-versed with the functioning of medical devices industry.

It sought the Ministry to 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 panel opined that with industry growing by leaps & bounds, the government should not afford regulation of medical devices by pharma experts and its 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 further recommended the Ministry of Health and Family Welfare to allow the new regulator to involve institutions like IISC, CSIR, DRDO and network of IITs to test medical devices for safety and efficacy. The Committee is of the firm view that these institutes have high-tech labs and thus can be used to test medical devices for their electronic, electromagnetic, biochemical-run aspects. The Committee further recommended that additional investments should be made to raise the standards of these labs as per the requirements.

The Committee noted that multiplicity of regulations exists at the component level from different departments/ ministries. It recommended that CDSCO which operates a single window clearing platform for application of license for manufacturing, export, import shall also integrate all these bodies involved in the regulation of medical devices. A single window clearance for all the department/ ministries would significantly boost investment in R&D in the field of medical devices and would also reduce the time required for obtaining approvals 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 panel stressed.

It opined that while setting the standards and benchmark of medical devices the foremost factor which should be considered is "health", the standards devised must prioritise health and wellness.

"In this regard, the Committee believes that BIS should focus on harmonising the Indian standards with world-class and globally accepted quality standards. Adapting Indian standards as per global standards would also help Indian medical device manufacturers in global market as it would make them more competitive and acceptable, which in turn would transform India into a net exporter of medical devices, spare parts and services. The Committee, therefore, recommended BIS to periodically update Indian Standards to corresponding global medical device standards as complying with Indian standards is affordable for local manufactures in comparison to global standards," it observed.

The Committee further recommended that BIS should encourage manufacturers to demonstrate/adhere to conformance to essential principles of the medical device concerned, as this would reorganise Indian products achieve greater international acceptance. This will engineer a shift towards increase in India's global share in the medical devices sector.

It also took note that the country has only 18 certified Medical Device Testing Laboratories that have been approved by CDSCO and that is grossly insufficient keeping in view the size of the country. It noted,

"The Committee is of the considered opinion that having adequate common infrastructure including accredited laboratories in different regions of the country for standard testing would significantly encourage local manufacturers to get their products tested for standards and such measures undertaken would also help in reducing the cost of production which ultimately will improve the availability and affordability of medical devices in the domestic market."

The panel also found that there is a dire need for developing a robust IT enabled feedback driven post market surveillance system for Medical Devices to evaluate the efficiency of specific Medical Devices. Thereby, it recommended;

"A medical device registry, particularly for implants should also be made to ensure traceability of patient who has received the implant in order to assess the performance of the implant and ascertain up to what extent the implant has made the life of the patient comfortable and also to seek feedback of functional capacity of medical devices. Such measures would ensure that patients get access to good quality and approved medical devices."