Industry wants the Centre to set up a stand-in medical device technical advisory board (MTAB), until constituted officially by the Centre, as proposed in the draft Bill of 2015. Highly placed sources from the sector stressed that this is utmost essential under the current circumstances to ensure proper representation of the demands of the stakeholders during the decision making process.

Experts pointed out that proxy constitution of such a board at least on a temporary basis can go a long way in addressing industry specific issues and expedite the process of making appropriate sector specific provisions for the industry as it should have been done for Bill 2015.

This demand comes in the wake of the release of the draft notification of the Drugs and Cosmetics (Amendment) Bill 2015, which proposes setting up of MTAB specifically for addressing the issues of this technical sector. While the industry is enthusiastic about this news, they stressed that no good will come from such provision if it is not put into action to address the current urgent issues at hand.

Association of Indian Medical Device Industry (AIMED) pointed out that the proposed provision should in fact be put into action as a relief, to genuinely discuss and deliberate over the representation of the stakeholders while considering the changes to be made in the draft Bill. It is understood that the industry is seriously concerned by highly misrepresented draft bill, which hardly addresses the demands or issues of the medical device sector in its current form.

In fact Rajiv Nath, forum coordinator of AIMED informed that there are many provisions which have been either unceremoniously deleted or added in the new revised bill which are against the interest of the industry. “To ensure that the benefit of constituting such board actually trickles down to help the stakeholders in effect, it is essential to set up a proxy MTAB at the earliest. We hope to see experts from the industry especially from the ICMR, department of technology to be actively involved in decision making process while re drafting the Bill, to ensure fair representation of the demands of the industry.”

He informed that ironically even for a technical sector like medical devices, parameters are set like in drugs, while experts from the pharma industry draft provisions and laws for them than from medical device sector. “This mentality has to change if the sector needs to grow and keep up with the changing market dynamics and challenges. Thus to create an act that suitably addresses the industry's demands, at least a ghost MTAB as a task force should be formed to ensure a judicious job rather than current approach of acting on comments,” Nath added.