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The
Medical Devices Sector in India; Task Force
Recommendations
Recommendations
Policy
support
1. Create
necessary bodies to drive the policies
.1.1.
Facilitating body
Set up an
independent body with a permanent office and support staff
to promote and facilitate the medical device industry with
representatives from all related government departments as
well as Industry.
1.2.
Administrative Department
Department
of Pharmaceuticals be strengthened and rechristened as
Department of Pharmaceuticals and Medical Devices.
Necessary revisions in the scope of services along with
creation of a separate post of Director in the department
to deal with issues related to the Medical devices sector.
2.
Preferential treatment in government procurement
Infrastructure
1. Set up
manufacturing hubs/ clusters in PPP mode
2. Set up Medical device parks
3. Financing support and Other support
Facilities for efficacy and safety testing
1. Medical
device testing centers should be set up preferably in the
PPP mode
2. Designate “Centers of Excellence” (CoE) for supporting
product development and validation
3. Strengthen a made in India marking (BIS) specific to
Medical devices
Skill
development
Set up a
Skill development committee with representatives from
Medical devices industry, academia (NIPERs) and Healthcare
Sector Skill Council (HSSC) under National Skill
Development Council (NSDC).
R&D
capability
1. Set up a
system for IP exchange
2. Set up/ promote Incubation centers
3. Provide requisite financing support
4. Promote industry specific “independent software vendor”
by extending similar benefits.
Policy
for pricing
1. Separate
price control order for medical devices
2. Price control body 3.Pricing & reimbursement policy
Duty
structure
Tax/ duty
structure to be designed to promote local manufacturing of
quality medical devices and diagnostic equipment.
1.
Discounts on import duties
2. Restrictions on import of second hand diagnostic
equipment.
3. Incentivize and promote exports in the medical devices
sector.
4. Taxes should be levied with reference to MRP.
Regulatory
1.
Formulate “Medical Device Regulatory Act”
1.1. Medical devices should be treated distinctly from
drugs and a separate chapter for medical devices should be
made in the existing Drugs & Cosmetics Act.
1.2. A distinct regulatory pathway to be created for
clinical trials of Medical Devices
1.3. Formulation of a risk based regulatory system for
medical devices based on justified regulatory control
mechanisms.
1.4. Harmonization with regulations guiding
radiation-emitting medical products with the help of
bodies like AERB
1.5. A policy on safety, efficacy and adverse reaction
reporting based on International quality standards
1.6. Penal provisions to be made moderate for Medical
devices
1.7. Labeling of MRP on Unit packs on imports should be
made mandatory
1.8. Design a system to restrict usage of diagnostic
equipment beyond their shelf life
2.
Designate regulatory bodies for medical devices
2.1.
Regulatory body for medical devices
2.2. Regulatory clearances to be provided by single window
2.3. Regulatory officials to be positioned across the
regulatory landscape
2.4. Continuous training of regulatory staff at centre as
well as state level
The
envisioned ecosystem
• Medical
Device Regulatory Act
• Tax discounts
• Pricing control policies
• Financing support
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