Mumbai: FDA makes checklist for pharmacy outlets to promote self-compliance

Mumbai: In a yet another instance, the Maharashtra Food and Drugs Administration (FDA) issued a check-list to more than 70, 000 medical stores, retailers and wholesalers across the state to maintain the compliance levels. The official said it will help them to be self-compliant before a surprise raid or routine inspection by the state regulator.

When FDA conducted a surprise raid it was seen that there was the violation of Drugs and Cosmetic Act which included the dispensing Schedule H drugs without prescription by unqualified persons to the patients leading to a surge in cases of professional misconduct. FDA commissioner said all the medical stores, retailers and wholesalers need to self-compliance within a month.

“The checklists have been issued to nearly 77,000 retailers and wholesalers in the state. We are expecting self-compliance exercise to conclude in one month’s time,” said Dr Pallavi Darade. Darade further stated that the reason behind issuing of the checklist is because the state regulator had 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. In a year, nearly 36,426 inspections were conducted by the state drug regulator out of 607 licenses were cancelled and nearly 2,620 licenses of pharmacy outlets was suspended for violating the norms of non-compliance.

The state drug regulator in the past had also served 2,428 show cause notices on the retailers based on violations of Drugs and Cosmetic Act like dispensing medicines without a prescription, without proper bill and for an absence of pharmacists. “Violations of Drugs and Cosmetic 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,” said a senior official.

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