New Delhi : The Department Related Parliamentary Standing Committee on Health and Family Welfare has reiterated its stand that the inter-ministry coordination for promotion of the medical devices industry should be done by the ministry of health and family welfare (MoHFW).
The panel, in its 146th report on the action taken by the government on its recommendations in the 138th report on the ‘Medical Devices: Regulations and Control’ made the recommendation after considering the responses shared by the Ministry on the recommendations in the 138th report.
In its 138th report, the panel 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 the ministry of health and family welfare.
The Committee recommended that since the MoHFW is the key stakeholder and the medical devices being very diverse in range with respect to technology and material sciences, inter-ministry coordination is required between various departments, which should be done by the ministry of health and family welfare only. The Department of Pharmaceuticals (DoP) is under the ministry of chemicals and fertilisers.
The ministry informed the panel following this recommendation that the regulatory body CDSCO has a vertical on Medical Devices with 23 Drugs Inspectors (Medical Devices), 236 Medical Device Officers (MDO) and 03 ADC (Medical Devices) working in CDSCO. Further, recently the Government has created additional 219 dedicated posts at various levels to strengthen CDSCO in medical device regulations.
The DoP has also suggested that there may not be any need for creation of a separate department for medical devices, however the medical device division can be strengthened with more manpower to address the growing needs of the sector.
It is also informed that the DoP has taken various initiatives for the last 7 years for the medical devices sector.
In the latest 146th report, the panel reiterated, “The Committee appreciates the steps taken by the government for strengthening of CDSCO (Central Drugs Standard Control Organisation), however it feels that since the ministry of health and family welfare is the key stakeholder of medical devices, the inter-ministry coordination for promotion of the industry should be done by the ministry of health and family Welfare only”.
It also reiterated its recommendations to incorporate suitable provisions in the new Drugs, Medical Devices and Cosmetics Bill so as to overcome the shortcomings in the Medical Devices Rules (MDR), 2017, adding that the action by the ministry may be initiated at the earliest.
The Committee accepted the response from the ministry regarding its earlier recommendation on creation of bone banks, which are meant to facilitate easy availability of bones for grafting.
The ministry said that creation of Bone Banks may be considered by appropriate institutions or entities after consultation with stakeholders and such activities are not usually part of a regulation. Responding to the Committee’s recommendation to make the biocompatibility studies mandatory to prevent poor quality products from entering the market, the ministry said that it is already mandatory for implantable devices under the MDR, 2017.