Centre To Notify Revised Schedule M III For Medical Devices By June End

Following strong representation from the medical devices industry, the Centre has agreed to align Schedule MIII with IS/ISO 13485 by delinking it from Schedule M for Pharma. The revised Schedule MIII will be notified by end of this month and is expected to attract huge investments into R&D which will enable India to emerge as a world class manufacturing hub for medical devices.

Drugs & Cosmetics Act, 1940, currently governs the Indian medical device sector, which has very different R&D, technologies, investment, production and taxation requirements from that of pharma sector. This, the industry pointed out had a detrimental impact on medical device sector Making India import dependent, leading to unfavorable business environment especially for the domestic manufacturers.

The government has been very favorable in understanding and addressing the issues of the industry, which is evident by the ground breaking decisions taken by the Centre in the last few days. Apart from this industry friendly decision, the government also recently conceded to set up separate Medical Devices regulatory framework and law for the industry with separate rules. It also agreed on the utilization of NABCB accredited third party conformity assessment bodies for QMS quality audit..