Govt to bring recruitment rules for appointment of MD inspectors to implement new MD regime from October 1

Wednesday, July 12, 2023

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 the Recruitment Rules for Assistant Drugs Inspectors (Medical Devices) in the Central Drugs Standard Control Organisation (CDSCO).

Comments were invited in June from all stakeholders in the matter within 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 bikash.mahato@nic.in,” the notice further stated.

The academic eligibility for the post is a bachelor's degree in biomedical engineering or chemical engineering or biotechnology or mechanical engineering or electrical engineering or electronics and communication or instrumentation engineering or polymer engineering or computer science engineering or a degree in pharmacy or pharmaceutical sciences or medicine with a 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 for up to five years by the instruction or orders issued by the Union health ministry.

Union health minister Dr. Mansukh Mandaviya had in May 2023 launched the Annual Capacity Building Plan (ACBP) for the capacity building of civil servants of the Ministry.

ACBP is a comprehensive strategic document envisioned to assist the development in the enhancement of capacities of individuals and of ministries/departments/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 after 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), behavioral competencies (related to behavior 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 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.

PHARMABIZ.com