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.