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Medical Devices Being Marketed Without
Regulations, Safeguards In India
India still does not have a comprehensive set of rules for the manufacture and
marketing of medical devices despite their increasing therapeutic in human
bodies for several years. The Central Drugs Standard Control Organisation (CDSCO)
has been working on to frame specific standards for licensing of these products
for more than 16 months now.
In the absence of a set of rules or any guidelines, the state drugs control
authorities in the country are in total confusion with regard to the standards
for licensing the 10 medical devices notified as drugs by the Central government
in October 2005. The notified products are very much available in the market
without licence.
Senior drug control officials said that the authorities have failed to issue a
single licence for the notified products so far. Although some of the states
have commenced inspection of storage and manufacturing premises as per the
directive of a sub-committee under the CDSCO, the state authorities are groping
in the dark on the standards and guidelines for issuing product licence, they
said.
Moreover, the Drugs Controller General of India (DCGI) has issued a circular to
the state drugs controllers seeking information to take policy decisions on the
issue after the October notification came into effect and the 60 day period
allowed for manufacturers to submit application. The letter dated September 21,
2006 seeks information like number of applications received, the details of
inspection carried out jointly with CDSCO, details of guidelines followed for
such inspection and whether any experts were involved in the inspection.
"The aforesaid information is required in order to take policy decision about
the procedures, standards requirements to be adopted for grant licences to
medical devices," reveals the letter in possession with Pharmabiz. "This show
that the CDSCO itself is in confusion on the procedure to be taken. And it also
reveals that the authority has not furnished any solid guidelines even after the
period of implementation started from October 2006. Around 80 percent of these
notified products available in the markets at present doesn't have any approval
but we cannot take action because of the DCGI's guidelines," said a drug control
official from Andhra Pradesh.
"Currently the only guideline we have Schedule M and we are inspecting the
companies as per these norms. There is no other guideline with us specifically
for medical devices licensing. There are a number of players in the segment,
either as manufacturer or more as distributors and we are on the process of
inspecting the sites," said a senior official from Gujarat FDA.
"We have sent the applications to the CDSCO and are conducting inspection in
distribution and manufacturing centres according to their suggestion. But the
details for licensing are yet to be cleared by the central authority. It seems
that the central authority is on a deceleration in the issue," another official
from Kerala Drug Control Administration informed.
Though product licensing is under purview of the state drugs control
organization, the inspection are to be conducted in association with the CDSCO
zonal officers. The CDSCO with strength of 40 officials for the entire country
has to accompany the state officials in inspection simultaneously with its
existing workload.
The CDSCO West zone has conducted inspection on around 35 units in January 2007,
though the officials informed that not a single licence for the notified
products has been issued till date. The officials informed that only around
eight units would pass through approval, while all the other applicants withdrew
applications in a later stage.
(Ref : Chronicle Pharmabiz dated February 22, 2007)
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