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Indian GMP Requirements For Medical
Devices Could Soon Resemble ISO 13485
India’s regulatory body, the Central Drugs Standard Control
Organization (CDSCO), recently put forth a proposal to align the country’s good
manufacturing practices (GMPs) for medical devices and in vitro diagnostics with
the ISO 13485 quality management system standard. Manufacturers compliant with
ISO 13485 may now find it easier to register their devices in India..
ISO 13485:2003 is an international quality standard
specifically designed for medical device companies. Recently, India’s CDSCO
drafted a proposal to align its GMP requirements with ISO 13485. CDSCO is
currently soliciting comments on the proposed changes and is accepting comments
through December 17, 2014. The proposed changes are focused on quality system
requirements and, if enacted, will fall under the country’s Drug and Cosmetic
Act.
If the changes are adopted, it may be easier for ISO
13485-compliant companies to enter the Indian market. Because the latest
standard will intimately follow ISO 13485, manufacturers with quality systems
that are already in line with the standard will have fewer regulatory hurdles
when registering a new medical device in India. ISO 13485 is currently
undergoing extensive revisions, and the updated version is projected to be
released in 2015. ISO 13485 has not been updated in over a decade, however, and
manufacturers should be prepared to adjust to changes that are certain to arise.
http://www.meddeviceonline.com/doc/indian-gmp-requirements-for-medicaldevices-could-soon-resemble-iso-0001
NPPA Issues Notices To Medical Devices
For monitoring of price movement of notified medical devices
as drugs under DPCO, 2013, the National Pharmaceutical Pricing Authority has
asked the manufacturers and importers of medical devices in the country to
urgently produce a slew of documents to examine the extend of price variations
of medical devices in the domestic market. The NPPA’s knee-jerk action in this
regard comes in the wake of recent media reports that the prices of medical
devices regulated as drugs under the Drugs and Cosmetics Act and Rules there
under are sold at exorbitant prices with high profit or trade margins,
particularly the prices of cardiac stents, drug eluting stents, orthopaedic
implants, etc.
NPPA is of the view that because of over dependency on
imported medical devices, prices of these products have gone up stupendously in
past few years. Moreover, in the absence of price regulation, doctors, hospitals
and retailers allegedly make money as commission for prescribing expensive
stents or branded medicines. The idea is to bring such practices under scrutiny
through the new policy.
The medical devices market in India was estimated at $6.3
billion in 2013 and growing annually at 10-12%. Most of it is dominated by
imported products. According to a recent report by the Boston Consulting Group (BCG),
around 70% of the medical devices used in India are imported. The NPPA has
issued letters to all concerned manufacturers/importers including Abbott
Healthcare, Boston Scientific India, Zimmer India, Edwards Life Sciences,
Johnson & Johnson, India Medtronic Corporate, B Braun Medical India, 3M India,
Harsoria Healthcare and Roche Products India.
http://www.pharmabiz.com/NewsDetails.aspx?aid=85500&sid=1
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