Reproduced
from India Legal, Published May 6, 2019, pg. 29
With hospitals and pharma
companies charging heavily for medical devices, a PIL in the Delhi HC seeks
direction to cap lens prices
Medical devices have often
come under the scanner for being overpriced. A PIL filed in the Delhi High
Court late last year challenged such overpricing with a specific plea that
intraocular lenses, among the essential medical devices, be listed under the
National Pharmaceutical Pricing Authority.
India has for long been known
as the “blind capital” of the world. Around 15 million people here are blind,
which is 50 percent of the world’s blind population. According to the data
published by the National Programme for Control of Blindness and Visual
Impairment, cataract alone accounts for 62.6 percent of all causes of curable
blindness in India.
The cataract surgery rate is
pinned at above one percent of the total population of the country every year.
That means millions of people are getting intraocular lenses implanted each
year. But there is a huge gap between the cost of procuring these lenses and
the price a patient has to pay for correcting his vision.
The PIL came up for hearing in
the Court last week and there was talk of the need for incorporating
implantation of intraocular lenses into the definition of a “drug” in the
National List of Essential Medicines (NLEM) and price capping it in the
interest of public health. The National Pharmaceutical Pricing Authority (NPPA)
was set up in August 1997 to act as an independent regulator for the pricing of
drugs and ensure availability and accessibility of medicines at affordable
prices. The Drug Price Control Orders (DPCO) are issued by the government to
declare a ceiling price for essential and lifesaving medicines (as per a
prescribed formula) so as to ensure that these medicines are available at a
reasonable price to the general public.
The criteria for inclusion of
a drug in NLEM includes, among other things—it should be approved/licensed in
India; it should be useful in case of a disease which is a public health
problem in India; it should have proven efficacy and a safety profile based on
valid scientific evidence; it should be cost effective; and it should be stable
under storage conditions in India.
The Union Ministry of Health
and Family Welfare prepared and released the first NLEM in 1996, consisting of
279 medicines. This list was subsequently revised in 2003 and included 354 medicines.
Later in 2011, the list was further revised and had 348 medicines. Till June
2018, 851 medicines (including four medical devices—cardiac stents, drug
eluting stents, condoms and intra uterine devices) are regulated under the
revised schedule.
Currently intraocular lenses,
which fall under the ambit of notified devices and are widely used in cataract
surgeries, are being priced ten times higher than the market at the point of
care. Consumers are charged Rs 8,000 for a brand of intraocular lens which has
a landing cost of Rs 800.
Medical experts have been
insisting that intraocular lenses, catheters, orthopaedic implants, dental
implants and ophthalmic medication be brought into the NLEM in order to make
them affordable for the common man.
It is now the High Court’s
turn to take a call.
Dr KK Aggarwal
Padma Shri Awardee
President Elect Confederation of
Medical Associations in Asia and Oceania
(CMAAO)
Group Editor-in-Chief IJCP Publications
President Heart Care Foundation of
India
Past National President
IMA
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