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AiMeD Writes To PM For
Separate Medical Devices Dept
Urges name change from
Department of Pharmaceuticals (DoP) to Department of
Pharmaceuticals & Medical Devices
The Association of Indian Medical Device Industry (AiMeD)
on behalf of the Indian Medical Device Industry has
written to Prime Minister (PM) Narendra Modi requesting a
Department of Medical Devices and a Ministry of Life
Sciences / Healthcare Products.
Highlighting the urgent need for a separate department for
medical devices, the letter from AiMeD requested the PM to
change the name of the Department of Pharmaceuticals (DoP)
to Department of Pharmaceuticals & Medical Devices or to
have a separate Department of Medical Devices so that, the
manufacturers will be assured that the government is
taking this sector seriously as medical devices are not
pharmaceuticals, though both may be medical products. The
current name reflects the focus on the mature sector of
pharmaceuticals and the ignored 80 per cent
import-dependent sector of medical devices.
The current team needs to be supported with the required
expertise by at least four persons i.e. one each from a
background in Medical, BioMedical Engineering, Product
Development & Marketing with experience from DST / DBT /
BIRAC / DHR / MOH&FW / BCIL / NHSRC / EEPC / IBEF may be
considered, said the letter.
The remodelled department will facilitate the creation and
development of clusters for medical devices, creation of
laboratories and service centres under PPP & Skill
Development of Personnel in the field of manufacturing,
sales, service and regulations.
The letter suggested that the department could be placed
in the Ministry of Health as its extension with a Ministry
of Health Care Products or Ministry of Life Sciences.
https://www.biospectrumindia.com/news/22/21764/aimedwrites-to-pm-for-separate-medical-devices-dept.html
CDCO Releases Draft
Guidance Documents On IVD Medical Devices
To Help Transition To
License Regime
As part of its efforts to
bring all the medical devices under the licensing regime
by next year, the Central Drugs Standard Control
Organisation (CDSCO) has released draft guidance documents
on stability studies, post-market surveillance,
performance evaluation and external evaluation of In Vitro
Diagnostics Medical Devices (IVDMD) in the country.
The IVD Division of CDSCO, releasing the document on July
7, called for suggestions from interested persons on the
proposed guidance in writing within a period of 30 days.
The guidance document for stability studies is for
manufacturers in preparation of a pre market review
document for Class C and Class D IVDMD import or
manufacturing license applications, intended to aid
manufacturers in the preparation of scientific information
to be provided in support of claimed shelf life, in use
stability and shipping studies for Class C and D IVDMD
applications and post approval change application filed in
pursuant to the Medical Devices Rules (MDR), 2017.
The draft guidance document integrates global regulatory
practices within the MDR, 2017 licensing requirements and
CDSCO is looking to adopt the use of this guidance for pre
market license applications and post approval change
applications. Once implemented, all pre market in vitro
diagnostic device license applications are expected to be
prepared as specified in the guidance.
The guidance document on post-market surveillance of IVDMD,
has been prepared to facilitated and strengthen the
reporting of Adverse Events attributable to IVDMD in India
and to facilitate access to safe, appropriate and
affordable in vitro diagnostics of good quality in an
equitable manner, said the regulator.
The document provides guidance on the requirements of
reporting adverse events for IVDs falling under Class C
and D such as those for detection of HIV, hepatitis,
syphilis, malaria, dengue, cancer markers, cardiac markers
etc., Point of Care Test (POCTs) or Home-use IVD medical
devices such as glucometer and strips among others. The
guidance details the method of identifying complaints,
reporting verified complaints, responsibilities of
manufacturers and importers, corrective and preventive
actions, types of product recall and recall strategy, with
formats of recall notice, IVD complaint reporting form,
and Field Safety Corrective Action Notification, among
others prescribed.
Under the MDR, 2017, for grant of license to manufacture
or import Class B, C, or D IVDs, the applicant is required
to submit copy of performance evaluation reporting along
with application, and the CDSCO has now released the draft
guidance for an overview on performance evaluation and
external evaluation of IVDMD. In an earlier guidance
document issued on August, 2018, with the list of
laboratories for such tests to be conducted and later
issued updated lists in August 2019, February, 2020 and
May, 2022.
The licensing authorities may require the performance
evaluation report for almost 19 In Vitro Diagnostics
including HIV, HBV, HCV, blood grouping reagent, cancer,
tuberculosis, malaria, dengue, chikungunia, syphilis,
typhoid, influenza, ToRCH (Toxoplasma Gondi, Rubella
virus, Cytomegalovirus, Herpes simplex virus), chlamydia,
pneumonia, methicillin-resistant staphylococcus aureus,
entero virus, sexually transmitted agents and marker for
congenital disorders.
IVDs differ from other medical devices as they perform
their function outside of the body on specimens taken from
the human body, and this must be taken into consideration
to understand the performance evaluation at independent or
external laboratories. The risks and benefits these
devices pose are related to impact
on patient management, rather than direct contact between
the device and the patient.
“A significant percentage of all healthcare decisions rely
on information provided by clinical laboratory tests and
these decisions can profoundly influence diagnosis and
management of the patient and will be influenced by the
risk to the patient of an incorrect result from the IVDs,”
said the CDSCO in the guidance document.
The guidance for performance evaluation defines various
terms and elaborates on the testing facilities,
responsibility of testing laboratory, safety measures,
procedure for dispatch of sample to testing laboratory,
procedure to be adopted by testing laboratory on receipt
of sample, storage standards of products, laboratory
testing, recording test results and interpretation of test
results, acceptance criteria and standards, cost
effectiveness, training and supervision, turnaround time
for testing, retention of samples and report,
administrative review, disposal of samples and retention
of reports, among others.
http://www.pharmabiz.com/NewsDetails.aspx?aid=151970&sid=1
To Regulate Medical Devices
In India, Govt To Create 219
Jobs For Senior Officials,
Drug Inspectors
The finance ministry has
approved the creation of posts. Industry experts, however,
have raised concerns that the government should appoint
technically competent auditors as medical devices
regulatory officers instead of hiring assistant drug
inspectors.
With the new drugs and medical devices bill recognising
medical devices as the separate domain, the government has
decided to create 219 jobs for senior officials and
inspectors to regulate the sector, News18 has learnt.
Until now, regulations for medical devices and drugs were
kept under one umbrella — the Drugs & Cosmetics Act, 1940.
But, the new upcoming Drugs, Medical Devices & Cosmetics
Bill, 2022, which replaces the previous act, recognises
medical devices as a separate entity.
“The proposal sent by the ministry of health and family
welfare for the creation of 449 posts on a regular basis
for the medical devices has been cleared by the ministry
of finance. However, the ministry has agreed to create 219
posts,” a top official at the health ministry told News18.
“The medical devices vertical will bring all the central
devices under regulation from the perspective of quality
and patient safety which will be handled by the drug and
medical devices regulator, the Central Drugs Standard
Control Organisation (CDSCO),” the official further said.
WHO WILL COME ON BOARD?
The finance ministry has cleared the creation of 85 posts
of assistant drug inspector (for medical devices) against
192 proposed positions whereas 77 jobs have been cleared
by drug inspectors (for medical devices) against 192
proposed posts. Nearly 43 posts will be created for the
assistant drugs controller against the proposed 48
positions whereas 13 jobs will be created for the deputy
drugs controller (9), joint drugs controller (4) and
additional drugs controller (1) against the requested 17
posts.
NO POSTS FOR TECHNICALLY COMPETENT OFFICERS: INDUSTRY
While the medical device manufacturers “welcome”
government’s move to recognise the industry, it noted that
the appointment of “drug inspectors” instead of
experienced medical device inspectors will again create
confusion.
“While we welcome the move to add 85 personnel to regulate
medical devices in CDSCO. However, we regret to note that
instead of appointment of technically competent auditors
as medical devices regulatory officers, the government
proposed to appoint assistant drug inspectors,” Rajiv Nath,
forum coordinator at the Association of Indian Medical
Device Industry (AIMED).
https://www.news18.com/news/india/to-regulate-medicaldevices-making-in-india-govt-to-create-219-jobs-for-seniorofficials-drug-inspectors-5704465.html
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