The Union health ministry will bring recruitment rules for the appointment of medical device inspectors as the country is on its course to implement the new medical device (MD) regulations, informed Drugs Controller General of India (DCGI) Dr Rajeev Singh Raghuvanshi to Pharmabiz adding that the MD Rules 2017 will govern all the medical devices categories or risk based classes of A, B, C and D from October 1, 2023.
Manufacturers of Class A and B medical devices are currently being regulated as they have registered under the new regime before September 2022. From October 1, regulations will be in place for Class C and Class D medical devices.
The Union health ministry is also currently in the process of amending Recruitment Rules for Assistant Drugs Inspector (Medical Devices) in the Central Drugs Standard Control Organisation (CDSCO).
Comments were invited in the month of June from all stakeholders in the matter within a period of thirty days following the Union health ministry notice.
“The comments may be furnished to undersigned Room No.434-C, ‘C Wing, Nirman Bhawan, New Delhi-110011 or may kindly be sent to firstname.lastname@example.org,” the notice further stated.
The academic eligibility for the post is bachelor’s degree in biomedical engineering or chemical engineering or bio-technology or mechanical engineering or electrical engineering or electronics and communication or instrumentation engineering or polymer engineering or computer science engineering or degree in pharmacy or pharmaceutical sciences or medicine with specialization in clinical pharmacology or microbiology from a recognized university or equivalent.
There shall be mandatory induction training of at least two weeks duration for successful completion of probation for Direct Recruits as prescribed by the Central government. The eligible age limit should not exceed 30 years. It is relaxable for government servants upto five years in accordance with the instruction or orders issued by the Union health ministry.
Union health minister Dr Mansukh Mandaviya had in the month of May, 2023 launched the Annual Capacity Building Plan (ACBP) for capacity building of civil servants of the Ministry.
ACBP is a comprehensive strategic document envisioned to assist the development in enhancement of capacities of individuals, and of ministry/department/organizations (MDOs).
The plan has been developed by the Capacity Building Commission in close coordination and consultation with the Mission Karmayogi Cell of the Health Ministry, all divisions in the department and subsequent to a detailed Training Needs Analysis (TNA) for the Union health ministry.
The Annual Capacity Building Plan envisages the systematic development of Domain Competencies (related to knowledge and expertise related to the sector, division, and the respective focus areas), behavioural competencies (related to behaviour and soft skills), and functional competencies (related to functional aspects of the division) among civil servants.
The Maharashtra Food and Drug Administration (FDA) has also sent a proposal to the state government in the month of May for manpower upgradation taking into account that only 80 drug inspectors are serving as the field force in Maharashtra. This manpower is today constrained to keep an oversight on around 90,000 drug retail stores and 900 plus manufacturing units towards maintaining compliance levels.
There are 161 sanctioned posts of drug inspectors in Maharashtra and 21 in Mumbai.