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MTaI Demands Removal Of Additional 5% Cess On Imported Devices & Reduction Of
Custom Duties In Budget 2023-24
The Medical Technology Association of India (MTaI) has recommended reduction in
custom duties at the minimum to 2.5% and removing additional 5% health cess
imposed on imported medical devices among others as part of budget 2023- 24
recommendations.
This will help in ensuring patients get long-term access to quality medical
devices especially as more than 86% of medical devices are imported.
Another important area of focus is to have a predictable pricing policy for the
medical device industry. This should follow with the proven and predictable
pathway of trade margin rationalization as adopted successfully during the
pandemic for certain medical devices, MTaI has suggested.
“In order to give the much required fillip to the industry, the Public
Procurement Order (PPO) should be backed by empirical studies, labeling
requirement under Legal Metrology (Packaged Commodities) Rules, 2011 and Quality
Control (QC) Orders which add redundant compliance burden to the Medical
Technology industry should be done away with”, said Pavan Choudhary, director
general, MTaI.
“We are constantly in consultation with the government in order to improve the
ease of doing business in the country, particularly in the MedTech sector. Some
of the key recommendations we have made to the government are regarding the ease
of starting a business, the registration procedure, the regulatory regime,
business credit availability, taxes and cross-border trade. While India has done
well in many areas, propelling its EODB rankings to 63 in 2022 from 142 in 2014,
according to a World Bank report,” he added.
“There are still several improvement areas that need urgent resolution. These
are high taxes and tariff rates, which are the highest among all neighbouring
countries. The public procurement policy also needs a relook, as in the current
form it is very restrictive which is a big concern as 86% of India’s medical
devices are imported,” he further added.
In India, medical devices or equipment are regulated by the Drugs Controller
General of India (DCGI). All medical devices are mandated to conform with ISO
13485 post September 30, 2021, which ensures that products and services are
safe, reliable and of good quality. The MedTech industry also has to comply with
Quality Control Orders (QCOs)/Compulsory Registration Orders (CROs) issued by
various ministries from time to time.
However, these QCOs/CROs add to the compliance burden without any additional
value addition to the already regulated medical devices. Furthermore, it affects
local manufacturing, R&D, service and maintenance of installed medical devices
in the country impacting their uptime for patient diagnosis and timely
treatment. Therefore, MTaI has recommended a broad exemption for regulated
medical devices from additional QCOs/CROs.
MTaI currently represents 47 research based medical device and equipment
companies with global experience in innovation and manufacturing. Many of them
have made remarkable investments by setting up a large number of R&D centres and
manufacturing plants in India. Together they serve patients across many areas of
care like cardiology, oncology, ophthalmology, diagnostics, orthopaedics, etc.
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