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The Medical Device Regulation Bill, 2006
But these are precisely the reasons why
some licenses are being held back.
The Act has also burdened an already overwhelmed
regulatory system. Companies are in queue for a year or
more, waiting for licensing inspection. At the DCGI’s
office, half the 80 available positions are vacant. State
administrations, which help regulate the thousands of drug
manufacturers in the country, are also over-burdened. An
official in the DCGI’s office in New Delhi, whom this
reporter was directed to speak to, points out under
condition of anonymity that one state food-and-drugs
inspector operating from a district-level office would
have to oversee local manufacturers, pharmacies,
investigations, and pending court cases. Medical devices
are just the latest addition. “The shortage is acute,” he
says. “If 50 manufacturers apply from one district, it is
bound to take months to complete inspections.” The DCGI
could not be reached for comment.
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Imports : Ironically, imports are being approved on the
basis of documentation, minus factory inspections. “We are
getting implants even from China but there is no rule to
inspect their factories,” says Dr Sancheti. Even imports
from the developed world need some kind of audit, says
Sankaran Valiathan, former director of Kerala’s Sri Chitra
Tirunal Institute of Medical Sciences and Technology,
where the heart valve that TTK markets was developed. “How
do you know that it is not a rejected device that is being
dumped here?”
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The DCGI’s website lists 303 import registration
certificates issued this year, till July 2007. But there
is no list of approved local manufacturers, or even a list
of applicants. This lack of information has other
side-effects. End-users such as doctors cannot check on
the manufacturers’ approval status, and there is no
incentive for producers to apply for a licence as there is
no way of knowing who has applied and who hasn’t. “Many
companies don’t even know they are being regulated,”
admits the official.
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Exports may be hit too. Importing countries need evidence
- called a free sale certificate - that a device is
approved for use in the exporting country. Until the DCGI
licenses a unit, a free sale certificate is out of the
question. “I hope the issue is resolved soon,” says Sunil,
who is presently forced to tell potential customers that
TTK is awaiting certification.
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Compounding matters is the fact that the industry has not
banded together to influence policy. “They could achieve a
lot more if they joined hands,” says Dilip Shah, secretary
general of the Mumbai-based Indian Pharmaceutical
Alliance, a grouping of top drug makers that has been
successful in shaping policy. The way the medical devices
industry is structured, that’s next to impossible.
Products range from CT scanning machines, ECG and MRI
apparatus on the one hand, to knee and heart implants on
the other. Even sutures are medical devices.
Each market segment has addressed its own issues so far.
Drug-coated stent producers are one example. It was
illegal trials of an imported stent in a government
hospital in Mumbai that led to a High Court order for
regulation of medical devices in 2005. This was after the
importer and a local stent company, both of which were
shut down by the state, went to court drawing attention to
the absence of rules.
Since then, stent producers such as Bangalore’s Vascular
Concepts (which went to court), and Ahmedabad’s Sahajanand
Medical Technologies (SMT), have got their licences.
Dhirajlal Kotadia, SMT’s chairman, says the process took
almost a year. “There may be some negative impact in the
short term, but the move is positive.” Companies that make
hydrocephalus shunts and pacemakers are not included in
the regulated categories as yet. Indeed, they may prefer
to work quietly.
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