3. India's medical devices sector is regulated by the Drugs and
Cosmetics Act of 1940 primarily..
The industry has been asking for a specific policy on
medical devices
In February 2020, the Centre notified changes in the Medical
Devices Rules, 2017 to regulate medical devices on the same
lines as drugs under the Drugs and Cosmetics Act, 1940.
INTRODUCTION
3
This was actually necessitated after revelations about faulty
hip implants marketed by Johnson & Johnson, exposing the
lack of regulatory teeth when it came to medical devices.
4. 4
The Union Cabinet on Wednesday approved the medical devices policy to promote industry in a
"holistic manner" from the current size of $11 billion to $50 billion over the next five years.
Policy set to facilitate an enabling ecosystem for manufacturing and innovation, a streamlined
regulatory framework and skill building in line with industry requirements.
The policy aim is to achieve a 10-12 per cent global market share in the next 25 years with
the immediate short term goal is to be $50 billion industry by 2030.
IDEA
PROCESS
SUCCESS
Skilling, Reskilling and up skilling of professionals in the medical device sectors by
ministry of Skill Development.
Making partnerships with foreign academic institutes and industry growing
the med-tech Branding positioning and awareness creation through
dedicated export promotion council.
The National Medical Devices Policy 2023 will be in addition to the existing PLI
schemes that are underway.
National Medical Devices Policy will promote R&D here, establish
Centre of excellence in academic and research institutions, promote
innovation hubs, ‘plugs and play’ infrastructures and support start-ups.
5. Need Of Medical Device Policy ?
5
As per estimates, some 80-85% of the medical devices
currently sol in India, mostly high end ones, are imported.
While the Indian Players and manufactures have centered
their offspring's in the low cost and low tech products, like
consumables and disposables
With the new policy in place, the Centre Aims to reduce
India’s import dependence to nearly 30% in the next
couple of years and become one of the top five global
manufacturing hubs
The policy push is to look at an export driven manufacturing
of high end offerings which are also affordable to Indian
hospitals and labs, while reducing import dependence
significantly.
The policy also aims to increase India per capita spend
on medical device. India has one of the lowest per capita
spend on medical devices.
Apart from import reduction, the policy will also look to
make now costly medical devices affordable and also easily
accessible. This ensure larger use across hospitals and
provide better quality healthcare and affordable treatment
7. Advantages Of Medical Device Policy
7
Significantly lower than the per capita
consumption of developed nations like the
US at $415 and Germany at $313.
The policy also aims to increase
India's per capita spend on medical
devices.
The policy will also look to make now costly
medical devices affordable; and also easily
accessible.
India has one of the lowest per capita spend on
medical devices at $3, compared to the global average
of per capita consumption of $47.
The policy push is to look at an export driven
manufacturing of high end offerings, which are
also affordable to Indian hospitals and
laboratories, while reduce import dependence
significantly.
This will ensure larger use across hospital
and provide better quality healthcare
and affordable treatment.
8. 8
PLANNED
DEVIATIONS
DEVIATIONS
UN-PLANNED
DEVIATIONS
Any deviation from established procedures should be documented and
explained. Critical deviations should be investigated, and the
investigation and its conclusions should be documented.
ICHQ7A
A deviation is any unwanted event that differs from the approved
processes, procedures, instructions, specifications, or established
standards. Deviations can occur during the manufacturing, packing,
sampling, and testing of drug products
Planned deviations are temporary deviations from an existing
protocol or process that have been pre-approved. They are limited to
a specific time period or a number of batches.
Organization makes these changes to avoid a potentially hazardous
situation. Deviations are planned in such a way that they do not
compromise the safety and efficacy of your products.
Unplanned deviations are also known as uncontrolled events,
unplanned events, or incidents. Unplanned deviations are non-
compliances from your designed protocols or systems at any stage of
the lifecycle of a product manufacturing, testing, holding, packaging,
or storage.
Pharmaceutical Deviation’s
GMP requires
deviations to be
documented.
↓
Assists With
Continuous
Improvement
9. Deviation Classification Categories
9
CRITICAL DEVIATION
Significant impact on the
production quality or GMP
system.
MINOR DEVIATION
not have any direct impact
on the quality of the product
or the GMP system
MAJOR DEVIATION
Moderate to a considerable
impact on product quality or
GMP system.
DEVIATION MANAGEMENT
(eQMS)
Electronic Quality Management
System
10. Out Of Trend (OOT) & Out-of-
Specification (OOS) Process
Identification
Determination
Verification New Time Point
Data
Stability
Prediction
10
