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In order to maintain the compliance levels of close to 80,000 retail and wholesale licensees in the state, the Maharashtra Food and Drug Administration (FDA) has issued a check list to all the medical stores and wholesalers which will help them to be self -compliant before a surprise raid or routine inspection by the state regulator.
Cases detected during FDA surprise raids amounting to violation under drugs and cosmetics act included dispensing Schedule H drugs without prescription by unqualified persons to the patients leading to a surge in cases of professional misconduct.
“The checklists have been issued and we are expecting self compliance exercise to conclude in one month’s time,” says Dr Pallavi Darade, Maharashtra FDA Commissioner.
The state drug regulator canceled 607 licenses and suspended 2,620 licenses of pharmacy outlets for non-compliance of norms based on the 36,426 inspections done over a period of one year. Around 6 FIRs were lodged in cases related to non-compliance like absence of pharmacists and dispensing drugs without proper bills.
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 issuance of checklist comes close on the heels of state regulator having detected a case where medical representatives of a reputed pharmaceutical company connived with wholesalers in forging bills and procuring medicines at discounted rates twice. These medicines were then stocked and supplied elsewhere when the stocks were actually meant to be supplied to hospitals.
The state drug regulator in the past had also served 2,428 show cause notices on the retailers based on violations of D&C Act like dispensing medicines without prescription, without proper bill and for absence of pharmacists.
FDA also busted an illegal abortion drug racket and lodged an FIR with police at Parbhani in Aurangabad division which is latest in the series of such cases where offenders used to stock and sell MTP kits in a clandestine manner without a license.
Violations of D&C Act have been rampant in the last one year relating to not having proper purchase and sale bill and absence of pharmacists in the drug retail stores across the city.
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