In a strategic move that would give a huge thrust to the medical device sector, the DTAB sub-committee that was set up by the Centre to deliberate over the possibilities of formulating and aligning the good manufacturing practice (GMP) guidelines for the sector with the globally accepted ISO standards, recently submitted its detailed report to the CDSCO.
 
It is understood that experts from the government and the industry had been brainstorming over working towards balancing and aligning the GMPs for medical devices and in vitro diagnostics with the ISO 13485 quality management system standard, which is focused on quality system requirements.
 
Rajiv Nath, forum coordinator of AIMED, who was also part of the sub-committee, informed that he is hopeful that the government will take cognizance of this recommendation and will act upon it for the best interest of the industry. He further added that aiming to give reprieve to the sector, the government has also assured the industry to remove the medical device sector from the ambit of Schedule M, which is primarily applicable to pharma industry.
 
It is important to note that if enacted, this will fall under the Drugs and Cosmetics Act. Currently, there are only 14 medical devices that are regulated and recognised as drugs in the country based on the parameters of GMP requirements as followed for the pharma industry. Experts from the medical device sector have been demanding the government to recognise and set separate standards that are in lines with the globally accepted standards rather than that of GMP, as the industry dynamics of both the sectors vary greatly.
 
Nath pointed out that if the government aligns its GMP requirements for the sector with that of the internationally accepted standards, it will become easier for the manufacturers to register their devices in India.
 
ISO 13485:2003 is an international quality standard specifically designed for medical device companies. Using it to guide medical device design, development, and manufacturing is the most common approach for companies that wish to enter the regulated European, Japanese, Australian and Canadian markets. Design control, process controls, device traceability, and customer feedback are just a few of the key areas that ISO 13485 governs.