New Delhi : The department-related Parliamentary Committee for ministry of health and family welfare, which has looked into the medical devices regulations and recommended the way forward, has sought the Central government to bring the Department of Pharmaceuticals (DoP) under the Ministry, for better coordination. It has also pitched an idea of setting up a department of medical devices.

The Committee, in its report on Medical Devices: Regulation & Control, opined that the Covid-19 pandemic has highlighted the need to support indigenous manufacturers of medical devices. The pandemic laid bare various issues like insufficient infrastructure and fund for research and development, lack of public funding for research, dearth of skilled manpower, lack of synergy between Central-State regulatory authorities, inappropriate regulations for medical devices, lack of global-level quality standards etc plaguing the medical device industry in India.

“With the immense potential for the medical devices industry anticipated, the Ministry should focus on resolving the challenges and develop a detailed ‘Roadmap with Practical and Actionable Strategy’, it suggested.

“The Committee believes that separate legislation exclusively for the Medical Devices and bringing the Department of Pharmaceuticals (DoP) under the ministry of health and family welfare would really help solve some of the major challenges being faced by the medical device manufacturers,” it added.

The Committee felt that the mandate of the Department of Pharmaceuticals is very much related to the health sector like drugs & medical devices, their production, development, control, promotion, education, training & research.

“Hence, the Committee strongly feels that, for better coordination, the Department should be brought along with department of health and family welfare under the ministry of health & family welfare from the ministry of chemicals & fertilizers by amending the Government of India (Allocation of Business) Rules, 1961,” it averred.

It also expressed concern over the fact that the highly technical medical devices industry, having no synergy with the ministry of chemicals & fertilizers is being promoted by them instead of ministry of health and family welfare.

The Committee, therefore, recommends that since the ministry of health and family welfare is the key stakeholder and the medical devices’ being very diverse in range with respect to technology and material sciences, inter-ministry co-ordination is required between various departments, which should be done by the ministry of health and family welfare only.

Pitching in for a new department for the medical devices industry under the Ministry, it added, “The Committee, accordingly, recommends that to nurture the nascent medical devices industry, the government should consider creation of a separate department of medical devices for playing the role of a policy maker, facilitator as well as regulator”.

The new department of medical devices can co-ordinate with the Ministries connected with the industry to perform the key functions including catalyze growth of the Indian medical device sector; define priority devices to fight priority diseases in consultation with national and international bodies; implement strategy to shift India’s import dependency from around 80% to less than 30% in next 5 years for priority devices and next 10 years for all devices; facilitate creation and development of clusters for medical devices; facilitate creation of laboratories and service centers under PPP; facilitate skill development of personnel in the field of manufacturing, sales, service and regulations of medical devices; create a forum for close cooperation between user, developers, manufacturers and academia; and create and manage a Special Purpose Vehicle Fund for long gestation R&D projects under Made by India and Make for India projects for enterprises, it added.

The Committee added that for a strong regulator it needs to be supported with required expertise from the backgrounds of medical, biomedical engineering, product development and marketing. There is utmost requirement of training programmes for regulatory officials (both Central and state level) as well as for industry persons for effective implementation of the rules and regulations. It may be noted that the Committee has opined that the existing structure and expertise (which is more pharma centric) of the workforce in Central Drugs Standard Control Organisation is falling short in effectively regulating the medical devices industry.

Developing skilled and trained manpower possessing technical know-how of the medical devices is essential for smooth implementation of the regulations. This could be done through long-term, short-term and crash courses on medical device manufacturing and quality control in institutes like IITs, NITs and medical colleges for new regulatory officers.

The ministry of skill development may also be requested to formulate courses related to medical devices, manufacturing, use and maintenance.

“There is a need for devising a mechanism to pre-empt exigencies and provision for “emergency use authorization” of medical devices in case of emergencies, it said.

The Committee also opined that the Ministry should lower high fee charged by notified medical devices testing laboratories like NIB particularly for Class C&D devices. The Committee observes that there is lack of co-ordination between academic institutions and industrial requirements. The Committee recommends that the innovators and scientists at research institutions should be made aware of the required standards and regulations, otherwise it’s difficult to commercialize their innovation/creation.