The Maharashtra Food and Drug Administration (FDA) has conducted 60 workshops on good pharmaceutical practices (GPP) in the past two months. This is aimed at catering to the regulatory requirements of the drug retail supply chain towards maintaining consistent supply of quality drugs and patient safety.
Informed Maharashtra FDA Commissioner Pallavi Darade, “Through this exercise, which is the first of its kind initiative, Maharashtra FDA has served the regulatory and compliance needs of close to 10,000 medical stores in Maharashtra. The response from the pharmacists community has been overwhelming as it has dispelled several myths and misconception which were not dealt earlier.”
She added, “Prior to the workshops, a check list was issued to all the medical stores and wholesalers to help them to be self -compliant before a surprise raid or routine inspection by the state regulator.”
FDA had in the recent past detected cases related to violation of Drugs and Cosmetics Act like dispensing Schedule H drugs without prescription by unqualified persons to the patients. 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.
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.
Source : 1