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Observing the delay in recruitment process for manpower to regulate the medical devices sector, the Department-related Parliamentary Standing Committee on Chemicals and Fertilisers has asked the Department of Pharmaceuticals (DoP) to ensure that the process would be completed within the prescribed timeline without fail.
It also recommended that more training programmes, workshops and interactive sessions should be conducted for the state licensing authorities and medical devices industry on the Medical Device Rules, 2017.
The Committee in its recent report on promotion of the medical device industry, noted that the Department in 2022 informed that 236 Medical Device Officers (MDO) have been notified in Central Drugs Standard Control Organisation (CDSCO) and States have also notified MDO’s as per Medical Device Rules, 2017.
In addition, 219 new posts at various levels from the lowest level of medical device officer to the supervisory level officer, joint medical device officer and additional drug controller level officers have been created by the Department of Expenditure on July 13, 2022.
In its report submitted at both the houses of Parliament, the panel said, "The Committee are of the opinion that the recruitment process for 236 notified and 219 created posts, which is pending for more than a year, would have serious implications on regulation as well as issuing licenses to manufacturers."
The Committee expressed its desire that the DoP would impress upon the ministry of health and family welfare (MoHF&W)/CDSCO to expedite the process of recruitment and appointment on aforesaid posts and keep them apprised of the same.
"Further, the Committee would like to be ensured that the recruitment of a specialized cadre of medical device officers for performing the crucial task of regulation and audit of medical devices would be done within the prescribed timeline without fail. Moreover, CDSCO should also follow up recruitment of medical device officers with States that have notified such posts as per Medical Device Rules, 2017," recommended the Committee headed by Lok Sabha member Dr Shashi Tharoor.
It also took note of the appointment of 23 Drugs Inspector (Medical Devices) and three Assistant Drugs Controllers (Medical Devices) with engineering background in the medical device division.
The Committee noted that the MoHF&W has been imparting training to State Licensing Authorities for an effective implementation of Medical Device Rules, 2017. However, it learnt from the representatives of the medical device industry during an informal discussion that much more handholding and training is required for all stakeholders in the medical device ecosystem for proper understanding of the recently announced rules, regulations and procedures in this regard.
The Committee recommended that more training programmes, workshops, interactive sessions should be conducted with concerned States Licensing Authorities and representatives of the medical device industry for clear understanding and effective implementation of Medical Device Rules, 2017.
In the wake of implementation of licensing regime to all medical devices, the health ministry has been receiving applications from the industry for issuance of licenses. At the time of the panel's communication with the ministry, it was informed that out of the 3413 manufacturing license applications received till then, 2,262 applications were approved and all those manufacturers whose applications are pending will still be allowed to sell their products for the next six months without any penalty.
The panel said that it would like to ensure that all the necessary arrangements will be made to complete the process for the issuance of license to the manufacturers of all kinds of devices in a time-bound manner.
Taking note of the government's initiative to establish the National
Institute for Medical Device Education and Research (NIMERs) on lines of National Institutes of Pharmaceutical Education & Research (NIPERs), the panel said that it trust the initiatives so taken will be implemented in letter and spirit and utmost care will be taken to ensure that they do not face any resource crunch.
It may be noted that one of the major issues being faced by the medical device industry in the country is the lack of skilled manpower. Four among the seven NIPERs at Mohali, Hyderabad, Guwahati and Kolkata have started M Tech (Medical Devices) courses in addition to M Pharma (Medical Devices) and PhD (Medical Devices) courses already running at NIPER Ahmedabad.
The DoP has announced a new Scheme on ‘Human Resource Development in Medical Devices Sector’ with an outlay of Rs. 480 crore for a period of three years for financial assistance to government institutions for running multi-disciplinary dedicated courses in medical devices. It has recently accepted the nomination from the Life Science Sector Skill Development Council (LSSSDC) as project management agency for the scheme and is in the process of signing a memorandum of understanding with the council for the same.
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