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Centre to notify revised Sch M III for medical devices by June end

Suja Nair Shirodkar
Monday, June 20, 2016, 08:00 Hrs  [IST]

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.

Delinking Schedule M III from pharmaceutical sector, has been a long standing demand of medical device industry. They have been steadfastly 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.

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 phrama sector. This, the industry pointed out had a detrimental impact on medical device sector making India import dependent, leading to unfavourable business environment especially for the domestic manufacturers.

Rajiv Nath, forum coordinator of AIMED pointed out that the irrational linking of medical device sector with pharmaceutical through common statute and regulatory regime has been a big stumbling block in unlocking the full potential of this critical sector and had contributed to India’s humungous import dependency, while scaring away investment.

“We are elated by this decision as finally things are being set in motion to put the industry in the progressive growth path as envisioned by the prime minister in his make in India dream. This strategic move will certainly open huge market opportunity, as it will finally be a viable and profitable decision to invest in India,” added Nath who is also the joint coordinator of the Indian Medical Devices Regulatory Review Group (IMDRRG).

The government has been very favourable 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 utilisation of NABCB accredited third party conformity assessment bodies for QMS quality audit.


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