Krupali Wgahela, ASMSOC

Module 2
Health and Education
No fresh announcements although allocation has been hiked
Healthcare professionals expressed disappointment with Finance Minister Nirmala
Sitharaman’s maiden Budget, which, while raising the annual outlay by almost ₹10,000
crore, made no direct mention of the crucial sector.
The proposed overall allocation for health has risen to ₹64,999 crore this year, from a revised
estimate of ₹55,949 crore last year.
“Through the budget, there has been no direct reference to the health sector at a time when
India has been plagued by child deaths and stressed health infrastructure,” remarked Dr.
Harjit Singh Bhatti, a member of the Resident Doctors’ Association, All India Institute of
Medical Sciences (AIIMS). “There is an urgent need to address the multiple issues that are
plaguing the system,’’ he added.
The government has to revisit the unfinished agenda such as ‘priority sector’ status to the
health sector to ensure smooth credit flow, mandatory universal health insurance, tax
incentives for capacity building, creation of a dedicated infrastructure and innovation fund,”
said H. Sudarshan Ballal, president, NATHEALTH, an apex healthcare industry body.
The Association of Indian Manufacturers of Medical Devices (AiMeD) too expressed
anguish over the ‘continued neglect’ of domestic medical devices manufacturers by the
government.
“We are shell shocked to see that no action has been taken by the government to stem the
tsunami of imports... that is crushing the Indian manufactures,” commented Rajiv Nath of
AiMED.
Silver lining
Lamenting the lack of any fresh commitments to healthcare, Shankar Narang, COO, Paras
Healthcare, however, saw a silver lining in the announcement relating to support for research.
“One of the most notable announcements in the budget has been the pledge to establish a
National Research Foundation to boost research in all areas,” said Dr. Narang.
Swati Deshpande, Director (Operations) at Datar Cancer Genetics Limited, said while the
move to set up a National Research Foundation was certainly a positive, the government had
“completely ignored” the bio-medical sector, which has the potential to be a global research
hub for fields like genetic research, bio-informatics and artificial intelligence.
The budgetary proposal to provide sustained support to the start-up sector, however, won
plaudits.
“This year promises to be a healthy growth for the sector,” asserted Vivek Tiwari, founder
and CEO of Medikabazar, an e-commerce site for medical devices and hospital supplies.
“The Central government is planning to set up more than 1.5 lakh Health and Wellness
Centres by 2022 under the Ayushman Bharat Yojana and plans to provide healthcare cover of
₹5 lakh to around 10.74 crore families across the country,” he noted.
 Krupali Wgahela, ASMSOC

New Delhi: In a bid to ensure quality, all imported as well as locally manufactured medical
devices sold in India will have to be certified by the Central Drugs Standard Control
Organization (CDSCO) before they enter the market.
Government’s think tank Niti Aayog has prepared a roadmap on medical devices, suggesting
that all medical devices clear specific safety and quality standards.
A meeting was held on 25 July between Niti Aayog, Department of Pharmaceuticals (DoP),
Ministry of Commerce, Bureau of Indian Standard (BIS), CDSCO, Department of Industrial
Policy and Promotion (DIPP) and it was decided to implement the roadmap without any
further delay, two people aware of the matter said.
“An inter-ministerial consultation was held and everybody agreed on the roadmap prepared to
regulate the medical devices. The ministry of health and family welfare is likely to come out
with the draft notification soon to this effect," said the first person quoted above, requesting
anonymity.
Once notified, import, manufacture and sale of all medical devices will need to be certified
by the Central Drugs Standard Control Organisation (CDSCO). Manufacturers will also have
to seek licences from the Drug Controller General of India (DCGI) before their product enters
the Indian market.
As of now, only 23 devices are regulated. “There is no system of assuring the quality of non-
notified devices. Indigenous manufacturers of non-notified devices are not able to participate
in public tenders, which affects the growth of industry," said the second person.
The government has suggested regulating the medical devices in a phased wise manner.
Earlier the health ministry committee had formed a committee, which recommended that all
manufacturers should register details on a special portal to be developed for this purpose.
“Such registration shall initially be voluntary basis upto 18 months from the date of
notification and thereafter it shall be made mandatory,"suggests the roadmap on medical
devices. Mint has reviewed copy of the presentation.
The manufacturers and importers will also have to report serious adverse events to CDSCO
so that these reports could be analysed to assess the safety and performace of the devices and
appropriate regulatory interventions can be taken to ensure patients safety.
Medical devices are already classified on the basis of the risks they pose. Low-risk devices
are classified as ‘Class A’; devices with low to moderate risk are classified as ‘Class B’;
devices with moderate risk are classified as ‘Class C’; and devices having high risk are in
‘Class D’ category.
 Krupali Wgahela, ASMSOC

According to public health experts, the medical device industry is ridden with loopholes;
regulation thus is extremely important. “The regulation will help ensure safe and tested
medical devices reach the end user," the first person cited above said.
As per the roadmap after receiving such incident, the CDSCO shall investigate quality, safety
related failure, complaints and suspend or cancel the registration based on the findings.
Earlier this year in February, the government put implantable medical devices, CT scan
equipment, MRI equipment, defibrillators, dialysis machine, PET equipment, X-Ray
machines and bone marrow cell separator under purview of The Drugs and Cosmetics Act,
1940. The matter of regulating medical implants was first discussed on 16 May 2018. It has
now been decided that these devices will be regulated with effect from April 2020.
In India, most implantable medical devices are unregulated.
Both import and export of medical devices grew at more than 10% between 2011-12 and
2014-15, according to a report by the department of pharmaceuticals under the ministry of
chemicals and fertilizers. The medical devices industry has grown from $2.02 billion in 2009
to $3.9 billion in 2015, at a compounded annual growth rate (CAGR) of 15.8%.

Further reading
https://www.business-standard.com/article/companies/import-of-medical-devices-from-us-
on-the-rise-here-s-all-you-need-to-know-118061000756_1.html

https://economictimes.indiatimes.com/industry/healthcare/biotech/healthcare/india-145th-among-
195-countries-in-healthcare-access-quality/articleshow/64282199.cms?from=mdr

https://thewire.in/health/india-healthcare-system-inequality