Health ministry to upgrade manpower on priority as CDSCO plans to regulate all medical devices under D&C Act
With the central
drug regulator now planning to regulate all medical devices under Drugs and
Cosmetics (D&C) Act in a phase wise manner, the Union health ministry is
planning to upgrade manpower at Central Drugs Standard Control Organisation
(CDSCO) towards effective licensing and enforcement activities to ensure
safety, quality and performance of medical devices.
Considering that bringing all medical devices into regulatory control will lead to increase in work load considerably, a total of 754 CDSCO regulatory officers and laboratories staff will be inducted into the existing manpower of 119 regulatory and lab staff at CDSCO before implementation of the second phase. As per the road map outlined till 2020, the ministry has set out to upgrade CDSCO manpower by creating additional 1,195 new posts, including 64 experts, and additional 4,300 personnel for new laboratories, mobile drug testing labs, e-governance and training. CDSCO has been facing acute manpower crunch as the workload has been increasing at an average of 20% to 25% over the past few years. Considering the increase in work load, the regulatory infrastructure including manpower need to be strengthened proportionately for licensing as well as enforcement activities, as per the Drugs Technical Advisory Board (DTAB) report which recommends for creation of a new team under CDSCO. The team under drugs controller general of India (DCGI) would be led by an additional drugs controller (ADC-India). As per the recommendation, there should be four Joint Drug Controllers (JDC-India) to assist the ADC-India, one each for specific function like invasive medical devices, non-invasive medical devices, in-vitro diagnostic medical devices, Materiovigilance Programme of India (MvPI), enforcement, legal and training. There should be 12 deputy drugs controllers (DDC -India), 48 ADCs, 192 each of drugs inspectors (DI-Medical Device) and assistant drugs inspectors (ADI-Medical Device). Before implementation of second phase, the vertical should have the necessary manpower in line with the roadmap for bringing all medical devices under regulation. It is also envisaged to recruit 71 data entry operators (3 for office of ADC (I), 2 each for JDC(I), 1 for each for DDC(I), ADC(I) and 71 office assistants which may be hired through outside agency. There should be 31 experts on deputation/contractual basis - 3 orthopaedicians, 2 dermatologists, 3 surgeons, 20 biomedical engineers, 1 biocompatibility expert and 6 cardiologists. There should be 20 research associates having post graduate qualification in areas of biomedical engineering/biotechnology/ microbiology to assist in developing various guidelines and review of materiovigilance data which may be hired through outside agency. Further, the list of panel experts from various clinical fields including specialists in In-Vitro Diagnostics evaluation shall be utilized on the basis of need for medical devices including In-Vitro Diagnostics (IVDs). In addition to the above, following cells also need to be established utilising permanent staff lead by DDC (I) and some outside expert on need basis namely materiovigilance cell, IT cell, field vigilance cell and enforcement cell, training cell, information & public education cell In order to accommodate the manpower of medical device vertical, minimum of 60,000 square feet additional space is required at CDSCO headquarters. The committee also recommended that 5 laboratories should be set up within a span of five years for testing of various medical devices and in-vitro diagnostics (IVDs) medical device. Considering that each laboratory should have 1 director, 4 deputy directors, 8 senior scientific officers (SSOs), 16 junior scientific officers (JSOs) and 32 scientific associates (SAs), the committee recommended that there should be total 5 directors, 20 deputy directors, 40 SSO, 80 JSO and 160 SAs with adequate supporting staff. |
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