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The Union ministry of health and family welfare has designated the 22 drugs inspectors (medical devices) it has appointed in the beginning of June this year, as medical devices officers (MDOs) under the Medical Devices Rules (MDR), 2017.
The notification is in continuation with the government's efforts to strengthen manpower in the drug regulatory system for the medical devices sector.
The ministry, through a notification dated June 3, appointed 22 individuals as inspectors for the whole of India under Section 21 of the Drugs and Cosmetics Act, 1940, for implementation of the Medical Devices Rules (MDR), 2017.
Section 21 of the Drugs and Cosmetics Act states, "The Central government or a state government may, by notification in the Official Gazette, appoint such persons as it thinks fit, having the prescribed qualifications, to be Inspectors for such areas as may be assigned to them by the Central government or state government, as the case may be".
According to the MDR, the Central and state governments may designate an inspector appointed under Section 21 of the Act, as medical devices officer. The medical device officer and the medical device testing officer, while exercising powers and duties under the Act and the rules, shall be deemed to have been appointed as the government analyst and the inspector, respectively, added the Rules.
It may be noted that the Union ministry of health and family welfare has also recently initiated efforts to strengthen manpower in the drug regulatory system for the medical devices sector, by calling for applications from eligible candidates to fill 43 posts of drugs inspector (medical devices) in the Central Drugs Standard Control Organisation (CDSCO).
The gazetted, non-ministerial posts at the pay level 8 (Rs. 47,600-1,51,100) of the 7th Central pay commission, will be on deputation basis across all the zones/sub-zones including head quarter under the CDSCO.
As reported earlier, the Parliamentary Panel on Health and Family Welfare has called for urgent and time-bound measures to fill the vacant posts in the CDSCO, observing that there is significant vacancy position in the regulatory workforce under the drugs and medical devices verticals, particularly at the level of drugs inspectors and assistant drugs nspectors.
While the sanctioned strength under the Drugs Vertical stands at 613 posts, as many as 257 posts remain vacant, including 186 vacancies of drugs inspectors. In the medical devices vertical, only 24 personnel are in position against a sanctioned strength of 249 posts, observed the Panel.
"The Committee is of the view that such a large number of vacancies could adversely affect regulatory efficiency, quality surveillance and enforcement activities," said the Panel headed by Member of Parliament Prof. Ram Gopal Yadav.
"The Committee, therefore, recommends that the Department take urgent and time-bound measures, in coordination with the Union Public Service Commission, to expedite the recruitment process and fill the vacant posts," it added.
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