With the various controversies relating to medical devices taking the limelight, the Government is looking forward to recruiting 754 officers to exclusively regulate the sale of medical devices and monitor their efficacy in India. It has been planned to constitute a medical device with respect to manpower and infrastructure to be established in the Central Drugs Standard Control Organisation(CDSCO.
Acting on the same, the Government has proposed to constitute a vertical body under CDSCO and hire officers to regulate the manufacture and sale of Medical Devices in the country. The proposal came during a Drugs Technical Advisory Board (DTAB) meeting held earlier this month. The DTAB proposal approved for the Government to place 754 officers. These officers will be distinct from the existing drug regulatory office. Besides Medical Devices, these drug regulatory officers primarily monitor medicines and functions under the CDSCO.
Out of these 754 officers, around 449 of these officers will be responsible to deal with regulatory affairs including affairs such as audit manufacturing sites, granting approvals for imports, cancellation and approval of trade licenses among others. The remaining 305 are to be laboratory personnel who would check the effectiveness and safety of devices besides cross-checking the claim made by the manufacturers.
The DTAB has also proposed that the new body should be led by an additional drugs controller who will be assisted by four joint drugs controll — one each for invasive medical devices, non-invasive medical devices, in-vitro diagnostic medical devices and legal enforcement and training. “There should be 12 deputy drugs controllers, 48 assistant drugs controllers, 192 inspectors and 192 assistant inspectors for medical devices,” DTAB proposal reads.
Besides, the proposal has further states the recruitment of 31 experts including orthopaediacians, dermatologists, surgeons, biomedical enginee biocompatibility experts, and cardiologists on deputation or on contractual basis for advice on medical devices pertaining to their specialisation. Moreover, the board agreed that CDSCO should be strengthened with respect to manpower and infrastructure to regulate all medical devices also recommended to include dentists and ophthalmologists in the category of experts to be recruited and manpower and infrastructure in States should also be strengthened and an advisory may be issued to all the States in this regard.
According to The Print, these regulatory officers would be recruited via a written examination conducted by the Union Public Service Commission(UPSC). Commenting on the proposal, a bureaucrat from the Ministry of Health and Family Welfare, which oversees the DTAB told “The idea is do fresh recruitments and create a separate vertical altogether.”
[Courtesy: https://business.medicaldialogues.in/cdsco-to-hire-754-regulatory-officers-especially-to-regulate-medical-devices-in-countrydtab/