The Centre has finally released the much anticipated revised Schedule M-III notification that is aligned with IS/ISO 13485. Experts see this as a first concrete step towards adopting a separate medical device regulation in the country, an urgent need of the hour to safeguard the interest of the industry. There has been no specific regulation for medical devices and has been irrationally linked with pharma sector through common statute.

Revised Schedule M-III contains its own set of requirements for quality management systems pertaining to all notified medical devices and IVDs, plus appendices covering device master files and site master files. With this notification of Schedule M-III, the sector will now be able to explore new business opportunities as it will now open up for investments into R&D that will enable India to emerge as a world class-manufacturing hub for medical devices.

Rajiv Nath, forum coordinator of AIMED pointed out that this comes as a huge victory to that sector that was long struggling to have a foothold in this country due to lack of any government support leading to unfavourable market condition for the domestic players. He said that such neglect towards the sector had a detrimental impact on medical device industry making India import dependent.

Until now, Drugs & Cosmetics Act, 1940, governed the medical device sector, which has very different R&D, technologies, production and taxation requirements from that of phrama sector. Industry had been pushing for changes in drug rules covering regulatory quality management framework and infrastructure requirements on the lines of the BIS and international ISO 13485 standard for regulatory purposes.

Nath who is also the joint coordinator of the Indian Medical Devices Regulatory Review Group (IMDRRG) added that overseas and Indian investors were always apprehensive to invest in medical device sector since it had pharmaceutical type GMP demands imposed by regulators in an arbitrary manner. Experts stressed that the sector was always incorrectly and incompletely regulated by unsure inspectors.

“We are glad that the government has started taking strategic measures to address the issues and challenges of the industry. With the active support of the Centre we will sure be able to develop India as a manufacturing hub for medical device sector,” he added.