The draft notification of the Drugs and Cosmetics (Amendments) Bill 2015 comes as a huge set back for the medical device industry, which has been anticipating some major regulatory reforms for the sector. Far from addressing their long-standing demand for recognition of devices from that of drugs, the new draft fails to incorporate even some of the key demands essential for the sector's growth.

Experts pointed out that though there are many technical improvements in layout, legalese and structure, recommendation on key issues made in the D&C (Amendment) Bill 2014 to the joint secretary K L Sharma have been overlooked. Association of Indian Medical Device Industry (AIMED) stressed that while the sector does need regulations, they do not want it to be as a part of the drugs, but separate and unique from that of D&C Act.

While the industry is okay with the Centre’s plan to remove separate provision relating to in vitro diagnostics for medical devices, by including it in the definition of medical device, they are shocked with the deletion of certain key provision essential for the growth of the sector.

Rajiv Nath, forum coordinator, AIMED informed that the draft does not mention anything on having medical device officer independent from that of drugs, a well-appreciated and positive point in the previous Bill that was deleted in this draft.  Though it does mention about a provision that states that central licencing authorities shall have exclusive power to issue a licence for the manufacturing for sale or distribution of any medical device.

It is understood that the previous draft Bill of 2014 had a provision to have medical device officer separate from drugs, with distinct competency. Shockingly, some of the important definitions related to medical devices have also been deleted like that of notified body, quality management system, custom made device and performance evaluation etc. This may further complicate matters for the stakeholders especially since these terms are being referred in the Bill, said Nath.

He further pointed out that optimum assurance of medical device safety has several essential elements that Indian law makers need to consider before trying to regulate this engineering and scientific sector.

“Unfortunately for the industry, the decision makers in the country always make regulatory decisions, through the prism of a drug-based regulatory framework, than with demands of medical device sector in mind. Time and again the industry had been keen on pressing the need for adopting regulations for medical devices that are at par with current internationally accepted standards than with that of drugs,” he said.

It is understood that the association has already raised their concerns with the Centre on the draft in its present form with the hope that the government will take note of the same.