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New medical device regulations may
affect patent filings for medical device inventions in India
The medical device sector is one of the fastest
growing industries in India and has witnessed a steady double-digit growth. A
study conducted by Deloitte in association with the Indian Health Care
Federation revealed that the Indian medical device market is expected to reach
the market size of $50 billion by 2025.
The two primary laws governing the quality and
safety of medical devices in India are the Drugs and Cosmetics Act (1940) and
the Medical Devices Rules (2017). The term ‘medical devices’ comes under the
definition of ‘drugs’ under the Drugs and Cosmetics Act. Until very recently,
the medical device sector was largely unregulated in India, with a mere 37
medical devices subject to regulation. However, in order to better monitor this
sector and widen the scope of medical devices that are regulated, the definition
of ‘drugs’ was amended on 11 February 2020, at the same time as the Medical
Devices Rules were updated. The combined effect of these changes has been that
as of 1 April 2020, all medical devices imported into or manufactured in India
must be regulated under the Drugs and Cosmetics Act and the Medical Devices
Rules.
The amended definition of ‘drugs’ under the Drugs
and Cosmetics Act is as follows:
All devices including an instrument, apparatus,
appliance, implant, material or other article, whether used alone or in
combination, including a software or an accessory, intended by its manufacturer
to be used specially for human beings or animals which does not achieve the
primary intended action in or on human body or animals by any pharmacological or
immunological or metabolic means, but which may assist in its intended function
by such means for one or more of the specific purposes of ? (i) diagnosis,
prevention, monitoring, treatment or alleviation of any disease or disorder;
(ii) diagnosis, monitoring, treatment, alleviation or assistance for, any injury
or disability; (iii) investigation, replacement or modification or support of
the anatomy or of a physiological process; (iv) supporting or sustaining life;
(v) disinfection of medical devices; and (vi) control of conception. (Newly
notified medical devices)
Further, the updated Medical Devices Rules make the
registration of all the newly notified medical devices compulsory before the
Drugs and Controller General of India before 1 October 2021, with the exemption
of the earlier 37 notified devices. Manufacturers and importers of medical
devices must now register their products on the Central Drugs Standard Control
Organisation’s (CDSO) online portal, along with an ISO 13485 standard
(accredited by the National Accreditation Board for Certification Bodies or
International Accreditation Forum in respect of medical devices) and a freely
available sale certificate from the country of origin for importers.
Appropriate licences are now compulsory under the
Medical Devices Rules for newly notified devices that fall under Class A (low
risk devices) and Class B (low to medium risk devices) by 11 August 2022 and for
newly notified devices falling under Class C (medium to high risk devices) and
Class D (high risk devices) by 11 August 2023. However, it will not be necessary
to register the 37 medical devices that were notified prior to the amendments in
2020, with the CDSO.
The huge potential of the medical devices sector in
India is a lucrative opportunity for innovators and they should take care to
protect their inventions under the Patents Act (1970). A study by two Indian
authors revealed that some of the top applicants for medical devices patents in
India have been Philips, Ethicon and Sanofi. While the Act contains no blanket
prohibition on the patentability of medical devices, a patent application
directed at a medical device may be met with objections under Sections 3(f),
3(i), and 3(k).
Section 3(f) prohibits patenting inventions that
are a mere arrangement or rearrangement of known devices, each functioning
independently with their functions being already known. Thus, in order for a
medical device invention to avoid an objection under Section 3(f), it is
necessary to show that the medical device is more than a mere workshop
improvement and the combination of the known devices must be shown to result in
a better and cheaper alternative. Section 3(i) may present an obstacle where the
claims in the patent application describe the invention as a method of treatment
for human beings and animals rather than as a medical device. Therefore,
inventions must not be directed towards monopolising any method of diagnosis or
treatment of a medical condition on the human body or animals and instead be
directed towards a medical device, which functions independently of a human or
animal. Lastly, Section 3(k) may affect a patent for a medical device involving
the use of computer software, as it prohibits patenting of computer programmes
per se. However, this objection can be circumvented by demonstrating precisely
how the computer software is interrelated to the working of the medical device.
A few examples of medical devices employing software technologies are CT scan
machines and in vitro diagnostic devices, among other things.
Comment
.For patent applicants filing for medical devices
in India, it is advisable that claims be drafted in such a way that they
suitably circumvent aspects of Section 3. Further, the timely amendment of the
Drugs and Cosmetics Act and the Medical Devices Rules is a welcome opportunity
to strengthen the regulation and commercialisation of medical devices in India
so as to more fully exploit the huge potential of the medical device sector.
For further information contact:
Neetika Gandhi
Chadha & Chadha
View website
Email:
neetika.gandhi@iprattorneys.com
This is a co-published article whose content has
not been commissioned or written by the IAM editorial team, but which has been
proofed and edited to run in accordance with the IAM style guide.
On track to produce 177.6 million auto-disable syringes for
government by March: HMD
Synopsis
"The front runner COVID vaccines being launched in India would need a 0.5ml AD
syringe for intramuscular drug delivery we are informed. In addition to the
annual procurement of 300-350 million of these syringes by GoI for the Universal
Immunisation Programme, additional orders have been placed on us by the Ministry
of Health and Family Welfare," HMD MD Rajiv Nath said.
NEW DELHI: Hindustan Syringes & Medical Devices (HMD) on Monday said it is on
track to produce 177.6 million 0.5 ml KOJAK auto-disable syringes for the
government by March 2021. The company has also shipped over 100 million pieces
of KOJAK AD syringes to Covax stockpile facility, as the COVID-19 vaccines are
showing promising results across the globe, HMD said in a statement.
The World Health Organization (WHO) and United Nations Children's Fund (UNICEF)
have recommended that auto-disable syringes should be used for administering
vaccines, particularly in mass immunisation programmes, it added.
"The front runner COVID vaccines being launched in India would need a 0.5ml AD
syringe for intramuscular drug delivery we are informed. In addition to the
annual procurement of 300-350 million of these syringes by GoI for the Universal
Immunisation Programme, additional orders have been placed on us by the Ministry
of Health and Family Welfare," HMD MD Rajiv Nath said.
HMD is on track to produce 177.6 million 0.5 ml KOJAK AD syringes for the union
government by March 2021 and 60 million are already in the company's stock,
awaiting dispatch instructions, he added.
"We have requested the government to provide us clarity on the various kinds of
syringes required for the vaccine candidates under development as some of these
would be by intradermal delivery or intra nasal delivery or possibly oral
delivery. Each type would require a matching specialised syringe type. We need
early intimation for boosting the capacities further," Nath said.
As India gets ready for COVID-19 vaccine, the government should be well equipped
with a secured stock of syringes in advance to administer a vaccine when it is
ready, he added.
"The estimated demand in India would be around 900 million of different kinds of
syringes for just one shot of vaccine, considering 60-70 per cent of the country
is being vaccinated. The number would amplify to 1.8 billion if the vaccine
India chooses, needs two shots," Nath said.
He also appealed to the government on behalf of the Indian syringe manufacturers
to increase the import duty on syringes to enable a level playing field.
https://economictimes.indiatimes.com/industry/healthcare/biotech/healthcare/on-track-to-produce-177-6-million-auto-disable-syringes-for-government-by-march-hmd/articleshow/79491373.cms
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