Cover
Story
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Government plans stricter quality control for
medical devices
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Manufacturers and
importers of medical devices will soon have to face government’s
quality control norms as mandatory pre-requisite for permit. The
ministry of health has decided to soon bring the regulatory standards
for this high-growth industry under the Drugs & Cosmetics Act. It
will seek the technical support of the Bureau of Indian Standards
(BIS) and notify as "sensitive items" a large number of such
devices/ equipment/ biological materials including in-vivo and
in-vitro diagnostic kits.
Medical devices market
in India, with an estimated size of $2,250m at present, is growing at
around 25% for the last few years. Although there are more than 120
domestic manufacturers (including about 25 big) of these items,
imports from countries like the US and Germany constitute roughly 50%
of the market. There has been no regulation on either domestic or
imported products so far in India, barring a set of optional
specifications from the BIS for medical instruments, covering only a
segment of this industry.
Major producers of
diagnostic kits and medical devices in India include Hindustan
Syringes & Medical Devices, Hindustan Latex, Dr. Reddy’s Lab,
Cadila Pharma, Lupin Laboratories, J Mitra & Co, XyCton, Bharat
Biotech. "The regulatory control will be effected by notifying
more number of items under the Schedule C1 of the Drugs Act and
concurrently bringing legislations on quality norms," drugs
controller general of India told.
[Ref: The Economic
Times – 18/9/02]
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ABSTRACT
OF THE DISCUSSIONS HELD DURING THE WORKSHOP
ON GOOD
MANUFACTURING PRACTICES &
INSPECTION OF MEDICAL DEVICES ORGANISED
BY
THE
CENTRAL DRUGS STANDARD CONTROL ORGANISATION
New
Delhi * September 19, 2002
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TOPICS
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COVERAGE
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| Introduction
to Medical Devices |
Definition;
Classification; Critical, not-critical devices; Distinction from
drugs and their role in therapy; General Characteristics; Global
& National Market position; Category-wise commercial growth,
Standards of medical devices |
| Status of
Medical Device
Manufacturing in India |
Scenario
of manufacture of medical devices in different States; Type of
devices produced; facilities provided; adoption of GMP’s;
availability of manpower, machine, raw materials, methods;
Problems faced in terms of acceptance of regulation, upgrading
knowledge through Associations & availability of reference
materials |
| International
Regulation scenario |
Background,
regulatory agencies; Distinction from Drugs; Nature of
regulation; certification; Hormonisation; pricing; import &
export |
| Quality
Control, GMP of IOL |
Introduction
to IOL, Types of IOL, Manufacturing in India and
Internationally, Classification, Manufacturing facility
requirement, Type of control expected, Quality Control. |
| Current
National Regulation Status on Medical Devices |
Background,
status of regulatory provisions covering medical devices;
comparison between GMP’s for drugs and medical devices.
Regulatory role of Central and State licensing Authorities,
Limitations, inclusion of more devices under the Drugs &
Cosmetics Act and its impact on existing Industry; import and
prices of medical devices |
| Medical
Device Packaging |
Packaging
Materials, their specifications and validation both for sterile
and non-sterile; testing; International standards on Packaging;
Customer needs; Availability of packing materials in India. |
| Medical
Device Evaluation |
Evaluation
objective, Types of testing e.g. physical, mechanical, chemical
& biological specification; Testing of Raw Materials,
In-process controls and final evaluation; sampling plans, Types
of samples, testing laboratories; Present status of testing
facilities in Govt. & Private Sector, requirement of testing
laboratories, creation of Appellate laboratory. |
| Group
Discussion |
Case
presentations, Limitations at their levels, Experience of
participants, views and comments; aspects that needs coverage on
subsequent day; specific suggestions for coverage in Medical
Device Regulation and Schedule M III revision. |
| Medical
Device Sterilization |
Objective;
Medical Device Sterilization needs; Sterilization Methods;
Effect of various methods on material & product; Shelf life;
Cost comparison; sterilization facilities in India; Sterility
Assurance. |
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