Improved regulation of medical devices
will ensure safety, quality (The Hindu)
Mains Paper 2: Health
Prelims level: Medical Devices Rules
Mains level: Importance of the regulation of medical devices
The Centre brings virtually “all” medical devices under regulation for
quality and safety.
A gazette notification was issued to this effect on February 11,
bringing all devices under the scope of Section 3 (b) of the Drugs and
Cosmetics Act, 1940, which pertains to medical devices.
At present, over 35 devices are regulated or notified under the Medical
Devices Rules, which came into force two years ago.
The new categories of devices are likely to be notified from April this
year. They will come under regulation after a period of 30-42 months.
The domestic industry in particular has been given this window of
adjustment to meet the required standards, the grace period rising with the
levels of risk of the device.
The nebulisers, blood-pressure monitoring devices, glucometers,
disinfectants and insecticides, and digital thermometers, notified earlier
as low risk devices, are likely to come under regulation from January 1,
The high risk devices such as implants, CT scan equipment, MRI
equipment, X-Ray machines, dialysis machines, also notified earlier, may
come under the new regime from April 2021.
Boosting domestic medical equipment sector:
In another boost to the domestic medical equipment sector, many of whom
are MSMEs, the Centre has imposed a health cess on imported medical devices,
with exceptions in the case of life-saving equipment.
Any cess is, in principle, to be opposed, a levy in this case, coupled
with the application of the Medical Devices Rules across the board, is
expected to improve the competitiveness of the domestic industry.
About 70 per cent of India’s ₹70,000-crore medical devices market is
dominated by imports, with US and EU being key suppliers.
Enhance capabilities in regulation:
A NITI Aayog Bill is in the works for effective regulation of medical
devices, in the process removing them from the Drugs and Cosmetics Act.
This might be necessary in view of the fact that drugs and devices are
quite dissimilar in nature. It is also worth looking at whether quality
certification of imported devices is to be accepted under all circumstances,
without subjecting them to trials in the Indian context.
The Johnson and Johnson hip transplant episode is instructive here.
Norms for operational trials should be defined, and a sample size that is
too small may not be reliable.
The penal provisions should be applied with respect to the risk of a
product, and not across the board. The most serious issue with regulating
medical devices pertains to the lack of data.
This is despite a ‘materio-vigilance programme’ having been in force
since July 2015 to collect data through ‘material device adverse event
A move to create a ‘national registry’ of surgeons, as in the UK, should
be expedited, with the Centre taking the lead.
Q.1) With reference to the Public Enterprises Survey 2018-19, consider the
following statements: 1. It was released by NITI Aayog.
2. ONGC, Indian Oil Corporation and NTPC were the top three profitable PSUs in
Which of the statements given above are correct? (a) 1 only
(b) 2 only
(c) Both 1 and 2
(d) None of the above
Q.1) What are the steps needed to improve regulation of medical devices will
ensure safety, quality?