Maha FDA cancels 8 licenses, suspends 30 during surprise raids for non-compliance to D&C Act
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Shardul Nautiyal, Mumbai
May 26 , 2016
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In its ongoing drive of surprise raids at retail and wholesale premises
across the seven zones of Mumbai region, the Maharashtra FDA has
canceled eight licenses and suspended another 30 from May 1, 2016 till
May 23, 2016 for non-compliance to Drugs and Cosmetics Act, 1940.
Out
of the eight canceled, six were retail licenses and two were wholesale
licenses. Out of 30 suspended, 23 were retail licenses and 7 were
wholesale licenses.
Stop sale notices were earlier issued while
the state regulator made surprise checks at 11 such drug retail stores
and found that pharmacists were absent in two of the stores of Mumbai
region in violation of Rule 65(2) of the D&C Act which attracts
penalty both under Pharmacy Act and Drugs and Cosmetics Act for
professional misconduct.
Meanwhile, the state regulator has also
received 4 letters from Maharashtra State Pharmacy Council (MSPC)
stating suspension of 4 such pharmacy registrations under the Pharmacy
Act, 1948 referred by the state FDA. Over 200 such cases of professional
misconduct of pharmacists were referred to MSPC for action. MSPC is a
quasi-judicial body which can act against the errant pharmacists by way
of either issuing warning letters or suspending or canceling their
registrations.
The quasi-judicial body had in the past canceled
registrations of 10 such pharmacists referred by FDA for professional
misconduct from across the state.
Cases detected during surprise
raids amounting to violation under D&C Act included not furnishing
proper billing details during surprise inspections at retail drug stores
and dispensing of Schedule H drugs without prescription by unqualified
people to the patients.
The regulator had over the past two months seized stocks of medicines worth Rs.
3 lakh from a Mumbai-based firm and canceled licenses for violation of
Section 18(C) of D&C Act. An FIR was also filed against a firm in
Maharashtra which was found violating the D&C Act, Narcotic Drugs
and Psychotropic Substances Act, 1985 (NDPS Act) and sections under
Indian Penal Code (IPC). Under the NDPS Act, it is illegal for a person
to produce, manufacture, cultivate, possess, sell, purchase, transport,
store, and/or consume any narcotic drug or psychotropic substance.
Licenses
of 500 retail pharmacies were canceled and of another 1,674 retail drug
stores were suspended as a part of inspections done on 18,067 retail
pharmacies across the state between April 2015 and January 2016. The
state drug regulator in the past had also served 2,428 show cause
notices (SCN) on the retailers based on violations of D&C Act like
dispensing medicines without prescription, without proper bill and for
absence of pharmacists.
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