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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..
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