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Union
Government Appoints 172 Drugs Inspectors As Medical Device
Officers
The Central
Drugs Standards Control Organisation (CDSCO), which is
functioning across the country in six zones, has appointed
172 drug inspectors as medical device officers (MDO) under
the new Medical Device (MD) Rules 2017 to regulate
manufacture, import, sale and distribution of medical
devices. Medical Device Rules 2017 were notified vide GSR
78 (E) dated January 31, 2017 under the Drugs and Cosmetic
(D&C) Act, 1940 and the said rules are effective from
January 1, 2018. As per the new Rules, state licensing
authority (SLA) has to send applications to the notified
bodies appointed by the Central government for inspections
and auditing of Class A and Class B category medical
devices for compliance.
Class C and
Class D categories are audited by the CDSCO. As per the
latest Union Health Ministry notification, “In pursuance
of the powers conferred under sub-rule (2) of Rule 18 of
the Medical Devices (MD) Rules, 2017, the CDSCO inspectors
appointed by the Central government under Section 21 of
the D&C Act, 1940 (23 of 1940) are hereby designated for
the whole of India as medical device officers for the
purpose of the said Rules with immediate effect and until
further orders.” The Union Health Ministry has also
notified eight bodies which are registered with CDSCO
under provisions Medical Devices Rules, 2017 to carry out
audit of manufacturing sites under the provisions of the
said Rules. The notified bodies have been registered with
CDSCO include Intertek India Pvt Ltd, TUV Rheinland India
Pvt Ltd, TUV Sud South Asia Pvt Ltd, Dnv GI Business
Assurance India Private Limited, BSI Group India Pvt Ltd,
BSCIC Certifications Pvt Ltd, TUV Intercert SAAR India
Private Limited, Zenith Quality Assessors Pvt Ltd. The
West Zone of CDSCO consists of Chhattisgarh, Goa, Daman &
Diu, Silvassa, Madhya Pradesh and Maharashtra.
The Zonal
head is Deputy Drugs Controller (India) while there are
two Assistant Drugs Controllers (India). In all, 15 Drugs
Inspectors for Chhattisgarh and Maharashtra are working as
CDSCO DIs. Following the notification, issues related to
postgrant compliance, data protection, product recalls and
product liabilities among others will be implemented
effectively towards device or product safety. As of today,
37 medical device categories have been notified. Earlier,
26 medical devices were notified between 2005 and 2017
which has under its ambit 364 products. In December, 2018
three new devices like nebuliser, glucometer and surgical
gowns were notified. New MD Rules 2017 covers not only
medical devices but also in vitro diagnostics,
disinfectants, surgical sutures, ligature, condoms,
bandages, etc. It sets new standards for manufacturing and
useof medical devices.
https://www.thehitavada.com/Encyc/2021/7/2/Union-Government-appoints-172-drugs-inspectors-as-medicaldevice-officers.html
, 02-Jul-2021
Med Tech
Industry Asks NPPA To Rationalize Trade Margins For
Imported And Indigenous Medical Devices
As per Para
25(3) of DPCO 2013, every retailer, dealer, hospital and
institution shall display price list and the supplementary
price list, as furnished by the manufacturer, on a
conspicuous part of the business premises in a manner so
as to be easily accessible to any person wishing to
consult the same.
Domestic
medical device industry has asked the National
Pharmaceutical Pricing Authority (NPPA) to rationalize
trade margins from first point of sales (POS) that is when
GST is charged initially in case of imported medical
device industry and for indigenous ones based on
ex-factory discounted prices.
This
representation comes in the wake of NPPA recently capping
prices of Pulse Oximeter, Blood Pressure Monitoring
Machine, Nebulizer, Digital Thermometer and Glucometer in
wake of increase in demand due to pandemic through a
Gazette Notification dated July 13, 2021.
“On many
medical devices the trade margins over import landed
prices have been found to be 10-20 times higher upon
investigation. We had been seeking the Maximum Retail
Price (MRP) to be capped at 2 to 4 times the imported
landed price which is the first POS and not the price to
distributor (PTD) which can be the second POS if the
government wishes to protect consumers while seeking to
arrest the increasing import bill which crossed Rs 45000
Crore last year,” according to Rajiv Nath, Forum
Coordinator, Association of Indian Manufacturers of
Medical Devices (AiMeD).
NPPA has
collected data regarding the trade margins for these five
medical devices from the manufacturers, marketers,
importers and noted that margins ranging up to 709% from
PTD to MRP level have been reported.
https://www.financialexpress.com/lifestyle/health/med-techindustry-asks-nppa-to-rationalize-trade-margins-for-importedmedical-devices-and-indigenous-medical-devices/2290984/,
July 17, 2021
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