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Challenges In Medical Device
Industry: From PLI Schemes To Foreign Competition
22 February, 2023
"Though there are PLI schemes available, their impact hasn’t
been as expected. Moreover, they are more focused towards big companies rather
than small companies and MSME which comprises 80 per cent of India’s
manufacturing”
India’s domestic medical devise industry constitutes just 1.6
per cent of the global medical device trade. Medical equipment used in the
nation is imported 80 per cent of the time. The Union Ministry of Trade and
Industry reports that India imported medical devices worth 63,200 crore in
2021–22, an increase of 41 per cent from 44,708 crore in 2020–21.
The PLI scheme provides a 5 per cent incentive on incremental
sale of medical equipment over the base year 2019–20. If a company generates
sales of Rs 250 crore in 2020–21 and Rs 100 crore in 2019–20, the extra Rs 150
crore in sales between the two years is referred to as incremental sales. The
incentive will take the form of a cash reimbursement to the business account.
The scheme requires that the minimum incremental sales be Rs
60 crore in the first year, Rs 120 crore in the second year, and progressively
Rs 280 crore by the fifth year.
Microbusinesses are those with yearly revenues of up to Rs 5
crore, whilst small businesses have revenues up to Rs 50 crore and medium
businesses up to Rs 250 crore.
Himanshu Baid, Managing Director and Co-Founder, Poly
Medicure expounding on PLI schemes mentioned, “Though there are PLI schemes
available, their impact hasn’t been as expected. Moreover, they are more focused
towards big companies rather than small companies and MSME which comprises 80
per cent of India’s manufacturing.”
Baid delineated, “The PLI scheme for device manufacturing is
having requisite criteria of Incremental sales worth 60 crore which the MSME
sectors are unable to fulfil. The successive PLI schemes for pharma did took
care of Incremental sale but its investment criteria are exorbitantly high which
the MSME can’t achieve.”
Underlying the Limited Access to Capital for MSME Baid
explained, “Medical device Industry being a capital-intensive industry, there is
shortage of capital because of which the medical technology sector should also
get grant for scaling up.”
Speaking on regulatory challenges faced by medical device
manufacturing industry in India, Baid stated, “Regulations too are overlapping.
The new startups are unaware of who is regulating them as there is high
ambiguity. Hence, we need to streamline regulatory environment and multiple
government department approval for medical devices should be brought under
single window clearance.
The lack of uniform regulations, the absence of a robust
regulatory framework, and lengthy approval processes, also increases the time
and costs of manufacturing medical devices.
India also faces competition from Other Countries. Although,
it is the forth largest manufacturer of medical devices in Asia, it encounters
stiff competition from other countries such as China and Taiwan, which have more
advanced infrastructure, lower costs, and more supportive regulatory
environments.
Principal Advisor, Health Policy, Confederation Of Indian
Industry (CII), Dr Shubnum Singh said, “It is important to find this sweet spot
on where lies the market need. On the other hand, there is operational safety
and efficiency with device which should also be satisfied by the devise makers.
In this cited point of care device like Glucometer used in diabetes which saves
people life.”
https://bwhealthcareworld.businessworld.in/article/Challenges-In-Medical-Device-Industry-From-PLI-Schemes-To-Foreign-Competition/22-02-2023-466506/
NPPA Fixes Ceiling Price Of Hormone
Releasing IUDs And IUDs Containing Copper
March 2, 2023
The National Pharmaceutical Pricing Authority (NPPA) has
fixed the ceiling price for two medical devices - hormone releasing intrauterine
devices (IUDs) and IUDs containing copper - under the Schedule I of the Drugs
(Prices Control) Order, 2013, which was revised to include in the National List
of Essential Medicines (NLEM), 2022.
The draft calculation sheet for these two device formulations
was released on January 12, 2023 and the same was finalised in an Authority
meeting held on February 21, after considering one representation received
against the draft working sheet, said the drug price regulator.
Accordingly, the price of hormone releasing IUD containing 52
mg of levonorgestrel is fixed at Rs. 3,456.44 per unit, which is a 19.52%
reduction from the prevailing ceiling price of Rs. 4,295.01 per one hormone
releasing IUD. The device, which has a total moving annual turnover of Rs. 15.31
crore, has two players with a market share of one per cent or more.
The Authority has considered two products, brand Emily
manufactured by public sector manufacturer HLL Life Care Ltd which had a price
per unit of Rs. 2,704.80 per unit and brand Mireya IUS manufactured by Bayer
Zydus Pharma Pvt Ltd, which has been selling at a price per unit of Rs.
3,254.58. Levodopa IUD, from Bharat Serums and Vaccines Ltd, which has a price
of Rs. 3,048.90 per unit was not considered while fixing the price of the
product. According to the NPPA draft sheet, Bayer Zydus Pharma has almost 95.85
per cent of the MAT, at Rs. 14.67 crore, while HLL Life Care has 4.15 per cent
MAT at Rs. 63.58 lakh.
The ceiling price of IUD containing copper has seen a
reduction of 21.5 per cent at Rs. 250.62 per IUD, as compared to the prevailing
ceiling price of Rs. 319.22 per IUD.
In order to fix the ceiling price, the Authority has a
considered the price of three packs from HLL Life Care - M-Care CU 250 mg (Rs.
240.24 per unit), M-Care 375 mg (Rs. 240.24 per unit) and T Care 380 mg (Rs.
159.60 per unit) - and one product TIUP CU 375 mg from Mylan with a price of Rs.
224.14 per unit. While Zydus Cadila has its brand Multiload 375 mg for the
product, with a price of Rs. 460.80 per unit price, it was not considered by the
Authority while fixing the price.
The IUD containing copper as a product has a moving annual
total of Rs. 36.71 lakh and two players with a market share of one percent or
above. HLL Life Care has brand-wise MAT of 89.29 per cent for the brand M-Care
CU and 2.66 per cent for the brand T Care, while Mylan has brand-wise MAT of
8.05 per cent. The brand-wise MAT of Zydus Cadila and U Care CU from DKT India
were zero, says NPPA.
The hormone releasing IUD and IUD containing copper were
included in the NLEM 2011 and in the subsequent lists till NLEM, 2022. However,
in the NLEM 2011, there was no specified dose for hormone releasing IUD while
under NLEM, 2015, the strength 52 mg of levonorgestrel was specified. It is also
mandatory for every manufacturer or marketer to mention the strength of
levonorgestrel for this device, as per the pharmacopoeia and national formulary.
It may be noted that the NPPA has revised the ceiling price
of 80 scheduled formulations and fixed the ceiling price of one formulation and
fixed retail prices of 74 formulations under the DPCO, 2013, based on the
decision of the Authority meeting on February 21, 2023.
http://www.pharmabiz.com/NewsDetails.aspx?aid=156629&sid=1
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