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Import Of Medical Devices Up By 41% In
Fy22
India imported medical devices worth Rs 63,200 crore in 2021-22, up 41 per
cent from Rs 44,708 crore in 2020-21, as per a report by AiMeD.
The Commerce Ministry data analysed by the Association of Indian Medical Device
Industry (AiMeD) has shown that the imports of medical devices are up by record
41 per cent at Rs 63,200 crore in 2021-22 from Rs 44,708 crore in 2020-21.
Speaking on the rise in imports of medical devices, Rajiv Nath, forum
coordinator, AiMeD, said, “NITI Aayog and the Department of Pharmaceuticals
recognise that Indian manufacturers have a 12-15 per cent disability factor in
manufacturing medical devices in India. We urge the government to neutralise
this disability for reduction of medical devices imports in India as was in the
case of consumer electronics, including mobile phones and even in the
toy industry.
At present, the duty on Chinese imports ranges mostly from zero to 10 per cent,
but the bulk of the items are in the 7.5 per cent category and one item at 25
per cent.
AiMeD urged the government to expedite steps to end the 80 per cent import
dependence and an ever-increasing import bill of over Rs 63,200 crore, expedite
steps for patients’ protection, stronger quality and safety regulations, price
controls to make medical devices and quality treatment accessible and affordable
and ethical indigenous manufacturing viable.
CHINA TOP IMPORT SOURCE FOR INDIA
Despite the government’s efforts to slow imports from China, the neighbouring
nation remained the top import source for India as imports from China grew 48
per cent from Rs 9,112 crore in 2020 -21 to Rs 13,538 crore in 2021-22.
The medical device imports from the USA also increased steeply by 48 per cent to
Rs 10,245 crore in 2021-22 from Rs 6,919 crore in 2020-21.
The value of medical devices from China was nearly the same as the combined
value of imports from Germany, Singapore, and the Netherlands in 2021-22.
RISING IMPORT AND ITS IMPACT ON DOMESTIC UNITS
AiMeD said India's rising medical devices imports has hurt small and medium
units.
With the government’s push to make India ‘Aatmanirbhar’ in medical device
manufacturing, during the pandemic, several local units making masks, PPE kits,
thermometers, and gloves mushroomed as there was very high demand.
AiMeD said from 1,200 units, the numbers had gone up to 1,800 during the peak of
the Covid-19 pandemic. Slowly, units started to shut down as imports from China
kept on rising. Now, it is estimated that there are around 1,500 such units, and
many more are on the verge of closing down.
For the beleaguered domestic industry, capacity utilisation had dropped by the
October-December quarter of 2021-22. From the peak utilisation levels of 100 per
cent, by November 2021, around 33 per cent, or one-third of India’s medical
devices making capacity, was estimated to be lying idle. This is even higher
currently, as per AiMeD, an umbrella organisation of domestic medical device
manufacturers.
AiMeD’s analysis shows India’s top five medical device import sources -- China,
USA, Germany, Singapore and the Netherlands --together account for Rs 37,519
crore, or 68 per cent, of the total value of imports.
AiMeD pointed out that among the six major categories of medical devices like
Consumables, Disposables, Electronics and Equipments, Implants, IVD Reagent &
Surgical Instruments that are imported, the growth has been the highest in the
‘electronics and equipment’ category.
India imported Rs 40,649 crore worth of medical devices that come under this
category in 2021-22 against an import worth Rs 4,569 crore in 2016-17.
The import of surgical instruments went up to Rs 1,260 crore from Rs 243 crore
during this period. The other categories of products fared like this: IVD
reagent (from Rs 361 crore in 2016-17 to Rs 6,564 crore in 2021-22), consumables
(from Rs 5,249 crore in 2016-17 to Rs 8,488 crore in 2021-22), implants (from Rs
384 crore to Rs 3,155 crore) and disposables (from Rs 2,061 crore to Rs 3,084
crore).
AiMeD also analysed the top 50 medical device import items from China to
identify the areas of greater dependence for India. A bulk of the imported
medical devices from China (in value terms) fall in the ‘other items’
sub-sections under various major categories, it finds. AiMeD urged that the
government should consider shifting from an 8 Digit HS Code to a 10 Digit HS
Code as done by USA and Europe to give more granular data for enabling better
analysis and policy making.
"The government needs to take policy decisions as done for Mobile Phone &
Consumer Electronic Industry to give level playing field, if not a strategic
advantage to domestic manufacturers, while safeguarding consumers or India will
remain 80 per cent import dependent which is a high healthcare security risk,"
Rajiv Nath said.
https://www.indiatoday.in/business/story/import-of-medical-devices-up-by-41-per-cent-2021-2022-1978761-2022-07-22
(July 22, 2022)
CDSCO Issues Alert On Baxter’s Blood Purification Device
Hemoperfusion Cartridge
The Central Drugs Standard Control Organisation (CDSCO) has issued a medical
devices alert on Baxter Healthcare’s Absorba Hemoperfusion Cartridge 300 C and
Absorba 300 C, devices used in blood purification, due to presence of
particulate matter within the cartridge.
Baxter has informed the CDSCO that it “is issuing an urgent medical device
recall for the Adsorba Hemoperfusion Cartridge 300 C and Adsorba 300 C due to
the presence of particulate matter within the cartridge”. If the particulate
matter is not detected before use, the particles may reach the vascular system
of the patient with potential serious adverse health consequence, it added.
However, there have been no complaints or patient injury associated with this
issue, said the company in a regulatory filing. The company has also released
the batches/lots which were affected, with expiration date ranging between
February and October, 2024.
Hemoperfusion is to complement existing blood purification technologies, if the
patient has taken life threatening amounts of adsorbable drugs, or is in a deep
coma and symptoms such as hypo ventilation, hypotonia, hypothermia, worsening of
the clinical state despite conservative medical management, among others.
If the patient has taken drugs of which the amount, composition and kind are
unknown and the patient is deeply comatose, hemoperfusion can be considered. The
Adsorba has been proven a high degree of efficacy for the drugs including
barbiturates, organophosphates, bromo carbamide, paracetamol, ethchlorvynol,
paraquat, meprobamate, salicylate, among others.
The use of hemoperfusion as a supplementary treatment does not mean that other
conventional methods of treatment should be omitted. Measures such as gastric
lovage, establishment of free airway and assisted respiration, controlled
electrolyte and water balance, and forced dieresis should be administered
whenever indicated. Furthermore, it might be necessary to monitor carefully the
blood levels of vital substances or drugs which also could be adsorbed during
the hemoperfusion treatment. Access to blood stream for hemoperfusion treatment
can be obtained by normal hemodialysis methods.
The company said that any person who has used an affected Adsorba Hemoperfusion
Catrdige 300C and Adsorba 300 C, may be affected. CDSCO has said that it has not
received any complaints from the market on this issue.
Baxter has sought the customers to return the product to the company directly,
if purchased directly from the company, by completing the customer reply form
and sending it through email to Baxter. If it has been purchased form a
distributor, the company advises the customers to contact the distributor for
return and credit.
http://www.pharmabiz.com/NewsDetails.aspx?aid=152253&si=1
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