Maharashtra Food and Drug Administration (FDA) has cancelled 25 licenses of drug retail stores in areas of Santacruz, Vile Parle and Andheri for failing to appoint a full time qualified pharmacist over the past six months in violation of Rule 65(2) of the Drugs and Cosmetics (D&C Act) Act.

Cases of professional misconduct like absence of pharmacists and pharmacists not furnishing proper billing details during surprise inspections at retail drug stores over the past six months have been rampant. Cases have also been detected where unqualified people have sold Schedule H drugs to the patients.

While inspecting such drug retail stores in Greater Mumbai in the past, state regulator had issued stop sale notices for violating Rule 65(2) of the D&C Act. Meanwhile, the state regulator also suspended 21 licenses and cancelled a total of 47 licenses in contravention to provisions of Drugs and Cosmetics Rules.

Maharashtra FDA has also till date referred 212 such cases of professional misconduct of pharmacists to the Maharashtra State Pharmacy Council (MSPC) for appropriate action. MSPC is a quasi-judicial body which can act against pharmacists by way of either issuing warning letters or cancelling their registrations.

There are 1,307 drug retail shops at Santacruz, Vile Parle and Andheri. FDA has maintained that there is a need to keep strict vigil on employed pharmacists and repeat offenders.

Violations also relate to not having proper purchase and sale bill and absence of pharmacists. Cases detected during surprise raids amounting to violation under D&C Act included even dispensing Schedule H drugs without prescription by unqualified people to the patients.

Licenses of 500 retail pharmacies were cancelled 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.

The state regulator had in the past cancelled eight licenses and suspended another 30 during the period between May 1, 2016 and May 23, 2016 for non-compliance to D&C Act.

Out of the eight cancelled, six were retail licenses and two were wholesale licenses. Out of 30 suspended, 23 were retail licenses and 7 were wholesale licenses.

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. MSPC had in the past cancelled registrations of 10 such pharmacists referred by FDA for professional misconduct in the state.