Despite just two months left for the much-awaited Medical Devices Rules — to regulate and ensure quality of all the medical gadgets — to come into effect, the Government is yet to recruit the requisite manpower to ensure the smooth implementation of the new legislation which was framed in pursuance of Prime Minister Narendra Modi’s Make in India initiative. The new Rules will be effective from January 1, 2018.
Sources said that the file for the recruitment of the manpower for implementation of the rules that aims to regulate and ensure quality of all the medical gadgets, local or imported, is tossing between the UPSC and the Union Health Ministry with both sides sticking to their stand on the procedure of appointment of the staff.
“So far no post has been created in the Drug Controller General of India (DCGI) to handle voluminous regulatory/testing works relating to the medical devices. The UPSC and Health Ministry have agreed to disagree over the appointment procedure,” said the sources.
Presently, only 22 of the over 10,000 types of medical gadgets in use in the country are regulated. Once, the rules are enforced all the medical gadgets will come under regulation.
However, in the present scenario, the Ministry is faced with a situation where on one hand, rolling out of the regulatory framework is critical for growth of the domestic medical device sector and on the other there is no staff to regulate the registration, licensing and monitoring of the devices.
While the Health Ministry is insisting on direct recruitment of the officers (35 posts) at various levels such as assistant drug inspector(medical devices), drug inspector, assistant drug controller and deputy drugs controller to execute the licensing and monitoring under the new regime, the UPSC has favoured vacancies to be filled through deputation and direct recruitment, apparently to avoid issues like promotions.
However, the Health Ministry has argued that deputation-based recruitments will not only delay appointments but also compromise qualifications.
“We are seeking direct recruitment as this will ensure quick appointment as well as qualified officers. As far as promotion issue is concerned, we have told them that if all the initial vacancies at various grades are filled by direct recruitment, the officers in various levels are required to complete the qualifying years of services allocated to them to become eligible for promotions,” the officials said.
Thus the sanctioned number of posts at various levels would increase substantially and the career progression of the officers at various levels would be taken care of prescribing promotion as a method for filling up the subsequent additional vacancies, he added.
It is hoped that the Rules would give the local industry the ‘Make in India’ platform as presently, most of the gadgets are imported.