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India Developing Federal Medical Device
Surveillance System
The Indian government is developing a system of medical
device surveillance and adverse event reporting, dubbed the Materio-vigilance
Programme of India.
It will be run out of 10 Indian medical schools, led by the
Sree Chitra Thirunal Institute of Medical Sciences and Technology in the South
Indian city of Thiruvananthapuram, according to Indian news outlet Pharmabiz.com.
The Indian Pharmacopoeia Commission, located near New Delhi, will play a
coordinating role, as well as the Central Drug Standard Control Organization,
the country’s equivalent to the FDA.
In addition, a proposed World Health Organization center for
crucial medical devices and health technology policy would provide technical
support, according to the article.
Currently, a committee formed to implement the program is
designing adverse event reporting forms and studying how to do to causality
assessments.
The government has devoted about $15 million to setting up
surveillance programs for pharmacovigilance, biovigilance, and haemovigilance,
as well as medical device monitoring, or materiovigilance.
Among emerging markets, India is one of the most accepting of
new devices because it has many modern, privately run hospitals, and lacks a
strict process for device regulation or approval.
But this move shows the Indian government is looking to
increase its oversight of a med tech market worth $3.1 billion annually. The
information gained from the monitoring system will help regulators’ make
decisions and recommendations based on domestic use of devices. China is also
implementing systems to gather domestic data in the form of more invasive local
clinical trials, which would be required as a condition for device approval.
The article alludes to the global metal-onmetal hip debacle,
which left a stream of injured patients in its wake, and demonstrates the
dangers of other countries’ reliance on the FDA and European regulators.
The plan to create an adverse event reporting and post-market
monitoring system comes in the context of a federal proposal to create a
separate medical device regulatory regime. In India, they are currently
regulated as drugs, in spite of the myriad differences between the two sets of
products.
Mr. Varun Saxena
FierceMedicalDevices
25 May 2015
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http://novamedica.com/media/theme_news/p/
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(Ref:
http://novamedica.com/media/theme_news/p/2579)
Medical Devices Industry In India Underinvested: WHO
NEW DELHI: The ambitious ‘Make in India’ campaign of Prime
Minister Narendra Modi throws up opportunities for growth of domestic medical
devices industry, which is not only “underinvested” but heavily import-oriented
at present, the World Health Organisation (WHO) has said.
“There is a need for appropriate and applicable health care
technology in India. Our medical devices industry is underinvested and heavily
import-driven at present.
“But with the current ‘Make in India’ campaign, there is a
huge opportunity for growth and expansion of the medical device industry. This
would highly improve the access of essential medical devices and health care
technology to patients in India,” WHO Representative to India, Nata Menabde, was
quoted as saying in a Health Ministry statement.
She said this during an event to formally announce the
commencement of National Health Systems Resource Centre (NHSRC), as the WHO
collaborating centre for Priority Medical Devices and Health Technology Policy.
This was announced by the WHO Country office for India in
collaboration with the Health Ministry and NHSRC yesterday. This is the first
WHO collaborating centre in South East Asia Region, the Health Ministry
statement said.
Menabde also handed over the designation of WHO collaborating
centre commencement at NHSRC to Health secretary B P Sharma.
Noting that prioritising medical devices and health
technology in the country is an “important agenda” item, Sharma said that it is
critical to have the specifications in place for the medical devices and
equipments that are already procured and used in the system.
“There is also need for dedicated medical devices testing
laboratories to ensure the safety and efficacy of these devices,” he said.
The division of healthcare technology and innovation at NHSRC
has been working in the area of health technologies and related policy
interface.
Its works includes framing of technical specifications for
technologies procured under National Health Mission, best practices for
technology life-cycle management and maintenance, secretariat for assessment and
uptake of innovations into public health systems among others, the statement
said.
PTI Mar 21, 2015, 08.40PM IST
(Ref:
http://articles.economictimes.indiatimes.com/2015-03-21/news/60346504_1_health-ministry-nationalhealth-mission-nata-menabde)
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