Medical device cos ask DoP to
reduce threshold investment limit to Rs. 75 to 90 crore from Rs. 180 crore under
Medical device manufacturers have urged the
Department of Pharmaceuticals (DoP) to consider reducing threshold investment
limit in range of Rs. 75 to Rs. 90 crore from Rs. 180 crore for domestic
manufacturers in the Production Linked Incentive (PLI) Scheme for promoting
domestic manufacturing of medical devices.
This, according to the Association of Indian
Medical Device Industry (AiMeD), will also widen the scope of eligibility to
cover COVID-19 utility medical devices.
The Government of India through its flagship “Make
in India” initiative relied heavily on the Indian manufacturers to meet the
rising demand of essential healthcare equipment for the country pushing the
Indian medical devices sector to become self-reliant especially for essential 39
COVID-19 medical devices.
DoP had notified PLI Scheme for promoting domestic
manufacturing of medical devices through a gazette notification dated July 21,
2020. Total financial outlay of the Scheme is Rs. 3,420 crore.
According to Rajiv Nath, Forum Coordinator, AiMeD,
“The threshold investment limit of Rs. 180 crore over 3 years is palatable for
those manufacturers with turnovers of over Rs. 800 to Rs. 1,000 crore which
hardly anyone can bear. That is why, we have sought DoP to consider reducing
this in the range of Rs. 75 crore to Rs. 90 crore for domestic manufacturers.
As per the PLI Scheme for medical devices, the
incentive per company will be applicable on incremental sales of manufactured
goods over base year subject to ceilings as decided by the empowered committee
(EC). This has been done to address disability in manufacturing of medical
devices in India vis-ŕ-vis other major manufacturing economies.
AiMeD has worked with Quality Council of India (QCI)
to expedite finalization of Indian Certification for Medical Devices (ICMED)
Scheme Plus Certification as well as with consultants consortium to provide
online training on quality management system (QMS) certification to new
entrepreneurs who had ventured into medical devices manufacturing towards
capacity building to meet QCIs ICMED certification and regulatory compliance so
that they could develop confidence to seek global certification of CE and US FDA
compliance for enabling global competitiveness.
Under the PLI scheme, financial incentives shall be
given to selected companies based on threshold investment and incremental sales
(over Base Year) of medical devices covered under target segments.
Under the Scheme, financial incentive shall be
given to selected companies at the rate of 5% of incremental sales (over Base
Year) of goods manufactured in India and covered under Target segments, for a
period of five years i.e. from FY 2021-22 to FY 2025-26.
The PLI scheme, however, is applicable only for
greenfield projects. Financial incentive under the scheme shall be provided only
to companies engaged in manufacturing of goods covered under target segments in
Eligibility shall be subject to thresholds of
investment and incremental sales of manufactured goods (covered under Target
Segments) over Base Year. An applicant must meet all the threshold conditions to
be eligible for disbursement of incentive. Eligibility under Production Linked
Incentive scheme shall not affect eligibility under any other Scheme and
vice-versa. The tenure of the scheme is from FY 2020-21 to FY 2026-27.
The application window for receiving the
applications shall be 120 days. Financial Year 2019-20 shall be treated as the
base year for computation of incremental sales of manufactured goods.
Assessment of threshold investment and incremental
sales of manufactured goods shall be based on details furnished to the
departments/ministries/agencies and statutory auditor certificates. Application
under the Scheme can be made by any company registered in India.
Medical device park to come
up in Uttar Pradesh
Simultaneously, it is also setting up an
electronics park, apparel park, handicraft park and toy park
A dedicated medical device park is proposed to be
developed over 350 acre in Yamuna Expressway Industrial Development Authority ‘s
(YEIDA) Sector-28 along Yamuna Expressway in Uttar Pradesh.
A memorandum of understanding (MoU) has been signed
with the Kalam Institute of Health Technology to prepare a detailed project
report (DPR) for the project.
The government is focusing on industries such as
bulk drug and medical device manufacturing, for which the state government is in
touch with the Centre for development of dedicated industrial parks.
Simultaneously, it is also setting up an
electronics park, apparel park, handicraft park and toy park in the YEIDA area.
Moreover, an integrated township is also planned along the proposed heritage
city at Raya Urban Centre and a logistics hub at Bajna Urban Centre.
The industrial development authorities have
allotted almost 740 acre under 1,097 plots for projects with an investment of
around Rs 9,700 crore in 2020-21. These projects will create employment
potential for nearly 1,95,990 people. Out of this, YEIDA has allotted 566 acre
land parcel in 871 plots for projects worth Rs 7,006 crore.
Allotment of 124 plots has been made for an apparel
park, 76 plots for a handicraft park, 516 plots for MSME park and 111 plots for
a toy park in Sectors 29 and 33.
The Uttar Pradesh State Industrial Development
Authority (UPSIDA) has allocated nearly 52 acre in 123 plots for projects worth
Rs 588 crore, followed by Noida which has allotted 92 acre in 101 plots for
projects worth Rs 1,341 crore.
The major investments in these areas include a data
centre by Hiranandani Group worth Rs 750 crore, an integrated food processing
unit by Britannia Industries worth Rs 300 crore, yeast manufacturing by
Associated British Food worth Rs 750 crore, consumer electronics by Dixon
Technologies worth Rs 200 crore, footwear manufacturing by Von Wellex of Germany
worth Rs 300 crore, grain infrastructure equipment by Ekagrata Inc of Canada
worth Rs 746 crore, wiring harness and components by Japan’s Yazaki worth Rs
2,000 crore and electric vehicles unit by Edison Motors of South Korea worth Rs
Moreover, post covid-19, seven projects with an
investment of around Rs 8,500 crore have commenced commercial operations, while
19 projects with an investment of around Rs 6,400 crore have entered active