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Maha FDA issues show cause notices to hospitals for reuse of catheters, overcharging patients
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Shardul Nautiyal, Mumbai
August 24 , 2017
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Against the backdrop of increasing number of cases of reuse of catheters
across hospitals in Mumbai, Pune and Nashik, Maharashtra Food and Drug
Administration (FDA) has flagged this issue with the central government
and served show cause notices (SCN) to around 8 corporate hospitals
which were involved in the unethical practice of reusing catheters and
overcharging patients subsequent to its reuse at the point of care.
These hospitals are reported to have charged patients as much as 77% of
the retail price.
Catheters are used to manage urinary
incontinence which includes standard catheter which is a thin, flexible,
hollow tube that is inserted through the urethra into the bladder and
allows the urine to drain out. A catheter is used for draining a
person's bladder and is ordered by a physician for many different
medical purposes.
Informs Maharshtra FDA Commissioner Pallavi
Darade, “Hospitals have been given 15 days time to reply to the SCNs
failing which they will face prosecutions as per the provisions of the
law.”
A letter on the same has also been sent to the central
government, state health ministry and state medical education department
as well to apprise them of the unethical practice so that a policy
decision could be taken forward jointly on the same and actions can be
taken based on the current set of rules as provisioned under the law
with reference to each department and jurisdictions.
After
coronary stents, around 14 more medical devices that were rampantly sold
at inflated rates in hospitals, could see a price regulation in the
coming months. The list includes orthopedic implants, intraocular lenses
and artificial heart valves to consumables such as syringes, needles
and catheters.
The drug pricing regulator National
Pharmaceutical Pricing Authority (NPPA) is also planning to collect data
on pricing and availability of orthopaedic implants and other medical
devices from different sources to help notify their ceiling prices soon.
Against
the backdrop of rampant practices of overcharging of coronary stents at
the point of care, NPPA had fixed prices of coronary stents after
bringing it under National List of Essential Medicines (NLEM) following
adverse market reports of unethical markups at every stage of the supply
chain.
Maharashtra FDA had in the past seized orthopaedic implants worth Rs.
2.31 crore from a Mumbai based manufacturer who was manufacturing,
stocking and supplying products in a clandestine manner without a
license. The implants were illegally manufactured, stocked and supplied
in Bhiwandi in violation of Drugs and Cosmetic Rules. Further to this,
orthopaedic implants were also seized from Akola worth Rs. 4.40 lakhs.
Orthopaedic
implants is one such product which is subject to unethical markups in
the supply chain and it has been given to understand and patients are
fleeced at the point of care through the hospital - dealer nexus.
Section
18(c) prohibits stock, distribute and sale of the medical devices,
except Licence issued under Drugs and Cosmetics Rules, 1945. This is an
offence attracting penalty of imprisonment of 3 to 5 years and fine of
minimum Rs. 1 lakh, as prescribed under Section 27(b)(ii) of the said Rules.
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