The document discusses India's lag in manufacturing medical devices despite being a major exporter of pharmaceuticals. It notes that India imports many basic medical devices like hospital beds and monitors. The secretary cites the example of linear accelerator machines used for cancer treatment, which cost over Rs. 5 crore to import but could cost Rs. 1.5 crore if manufactured in India, allowing more hospitals to offer cancer treatment. Recent duty hikes on medical device imports are aimed to boost domestic manufacturing over time by correcting inverted duty structures that currently favor imports. The government is also working to develop its own quality standards for medical devices rather than relying only on international ones like USFDA.

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‘Pharmacy to the world can’t make diapers, hospital beds’
By Dr.Mahboob ali Khan Phd
Citing the example of linear accelerator machines used in radiation therapy for
cancer patients, the secretary said these devices cost over Rs.5 crore so the 1.5
million new cancer patients every year in India can only go to ‘corporate hospitals’
for treatment.
New duty structure to create ecosystem where even large medical devices will be
made in India
India is lagging in manufacturing medical devices and the recent increase in import
duties on such devices are a ‘corrective step’ to create an ecosystem for
manufacturing them locally, according to a top government official.

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While India is known as the pharmacy of the world, exporting to over 200
countries, it is falling behind in medical devices whose regulation was recently
entrusted with the Department of Pharmaceuticals, “We are producing so many
things, sending even satellites to Mars in a very cost-effective way. But we are not
able to produce ordinary medical devices. You go to any hospital you will find that
all the equipment is coming from other countries, even the ordinary monitors,
hospital beds. Can’t we produce hospital cots and beds here?”I reiterate.
Citing the example of linear accelerator machines used in radiation therapy for
cancer patients, the secretary said these devices cost over Rs.5 crore so the 1.5
million new cancer patients every year in India can only go to ‘corporate hospitals’
for treatment. “If you manufacture such a technology within India, and it is
available, it will cost Rs.1.5 crore.
But we don’t manufacture in India. We all think only foreign equipment will work
that are available only in topmost tertiary care hospitals.
“Suppose you manufacture them here, even district hospitals can have this
equipment and treat cancer,” he said. Imports from Ireland or China are not only
convenient but also cheaper owing to inverted duty structures that hamper
domestic manufacturing activity, he said referring to the decision to hike duties on
several medical devices in January.
“Recently, we initiated correction of duty structures. If you import the equipment
as it is, it is cheaper, it is convenient to get (them) into the hospital from Ireland or
China.
“If you manufacture the same thing in India, duty is there. So it is convenient for
all of us, but we want to rectify this… It wouldn’t happen overnight,” I know.I
think this approach will help in manufacturing medical devices in India over time.
“You will be surprised baby diapers used by the millions of babies born in our
country, are also called a medical device.
“We import Rs.200 crore of diapers, (but) now, a few companies have come into
India. We will create an ecosystem that even large medical devices are made in
India over a period of time,argubly there was no reason why India should import
ordinary medical devices, including hospital beds and even diapers.

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I think said the government is working on standards for medical devices rather
than rely on USFDA norms currently prescribed in government procurements for
medical equipment. He was speaking at an event to introduce a voluntary
certification process for domestically-produced medical devices organised by the
Quality Council of India with the Association of Indian Medical Device Industry.
I think such a certification would help create confidence among doctors and
consumers about the reliability of locally manufactured products.
The government is also prodding all pharma producers to adapt World Health
Organisation (WHO) standards to reassure the world that Indian drugs are not only
cost-effective but are also of good quality.
“Whatever be the quality constraints that people keep complaining of (in pharma
products), that’s not a major issue. Our own people undermine our own products,”
I think.
Though Indian standards are sufficient, the move to WHO standards would help
bolster quality perception.
According to India Ratings, a Fitch company, the Indian pharmaceutical industry is
estimated to grow at 20 per cent compound annual growth rate over the next five
years.
The Indian pharmaceutical industry, which is expected to grow over 15 per cent
every year between 2015 and 2020, will outperform the global pharmaceutical
industry, which is set to grow at an annual rate of five per cent between the same
period.
Presently the market size of the pharmaceutical industry in India stands at U.S. $
20 billion. As on March 2014, Indian pharmaceutical manufacturing facilities
registered with the U.S. Food and Drug Administration (FDA) stood at 523,
highest for any country outside the U.S.
By 2020, India is likely to be among the top three pharmaceutical markets by
incremental growth and sixth largest market globally in absolute size. India’s cost
of production is significantly lower than that of the US and almost half of that of
Europe. It gives a competitive edge to India over others, according to a report by
the Indian Brand Equity Foundation.