Maharashtra Food and Drug Administration (FDA) has recently cancelled 13 retail licenses, 7 wholesale licenses and subsequently suspended 55 retail and 21 wholesale licenses based on 241 retail and 164 wholesale inspections. The action is part of crackdown on retailers and wholesalers in the state for non-compliance to Drugs and Cosmetics Act.

Following its ongoing surprise raids at retail and wholesale premises across the seven zones of Mumbai region, 64 retail licenses and 66 wholesale licenses have been surrendered.

Says a senior FDA official, “Cases of non-compliance have even gone on appeal to the state FDA minister and judgment on the same is based on the hearing of the concerned cases by the appellate authority.”

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.

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 cancelled 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.

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.