BioSpectrum India Magazine November issue BioSpectrum India Magazine | Page 25

www.biospectrumindia.com
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November 2017
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COVERStory
BioSpectrum
with international practices and, like clinical trials,
these will be regulated by CDSCO. Conduct of clinical
investigations will, while following the international
practices, be conducted in a manner that ensures
realization of the twin objectives of patient safety and
welfare and discovery of new medical devices. Medical
management and compensation will be provided to the
subjects of clinical investigation in accordance with
the predefined and objective criteria laid down by the
fovernment.
The new Rules have many other unique features. It
will be for the first time that there will be no requirement
of periodic renewal of licences. Accordingly,
manufacturing and import licences will remain valid
till these are suspended or cancelled or surrendered.
Further, the entire process starting from submission
of application to grant of permission/licence will be
processed through online electronic platform. Timelines
have been defined for most activities at the regulators
end. The issuance of licences for Class A medical
devices on the basis of self-certification coupled with a
system of checks and balances for ensuring compliance
is a departure from the inspection based regulatory
regime. Risk based audit of manufacturing units will
be carried out to assess conformance with standards
and quality parameters. These Rules envisage creation
of a robust eco-system for all stakeholders including
innovators, manufacturers, providers, consumers,
buyers and regulators.
Reacting to the notifications of the health ministry
Anil Jauhri, CEO, National Accreditation Board
for Certification Bodies (NABCB) said, “The Rules
will provide a conducive environment for fostering
LIST OF NOTIFIED
MEDICAL DEVICES
1. Disposable Hypodermic Syringes
2. Disposable Hypodermic Needles
3. Disposable Perfusion Sets
4. In vitro Diagnostic Devices
for HIV, HBsAg and HCV
5. Cardiac Stents
6. Drug Eluting Stents
7. Catheters
8. Intra Ocular Lenses
9. I.V. Cannulae
10. Bone Cements
11. Heart Valves.
12. Scalp Vein Set
13. Orthopedic Implants.
14. Internal Prosthetic replacements
15. Ablation Devices
In addition to the above medical devices,
the following substances are also regulated
as ‘Drugs’ under Drugs & Cosmetics Act,
1940 & Rules, 1945 there under:-
1. Blood Grouping Sera
2. Skin Ligatures, Sutures and Staplers
3. Intra-uterine devices (Cu-T)
4. Condoms
5. Tubal Rings
6. Surgical Dressings
7. Umbilical Tapes
8. Blood/ Blood Component Bags
Source: http://www.nishithdesai.com
India specific innovation and improving accessibility
and affordability of medical devices across the
globe by leveraging comparative cost advantage of
manufacturing in India. The objective, transparent
and predictable regulatory framework will boost the
confidence of investors and, as a consequence, the
quality and range of products and services will improve
and business burdens will be reduced. The new Rules
will help in developing a quality standardization
framework in India at par with international standards.
The implementation of these Rules will provide the
assurance of the best quality, safety and performance
of medical devices.”
These Rules coupled with other measures, taken
by the government in the recent past, are expected to
sharpen the competitive edge and provide incentives
to firms to become more efficient, innovative, and
competitive. All this will support entrepreneurship,
market entry and economic growth that, in turn, would
produce high-paying, high-quality jobs.
Reacting to the announcement of the Medical
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