Based on the inspections on 24,193 retail drug stores across the state, the Maharashtra Food and Drug Administration (FDA)'s report reveals violation of Drugs & Cosmetics Act related to dispensing medicines without prescription and absence of a registered pharmacist as the reason behind cancellation of retail licenses in the state.
As many as 2,241 retail licenses were canceled and 1,857 licenses suspended following the show cause notices issued to 4503 medical stores across the state between April 2014 and February 2015, a senior FDA official explained.
The FDA's crackdown is in line with the fact that there is irrational usage of antibiotics and cancellation of licenses is done based on the non-compliance like dispensing medicines without prescription and absence of a pharmacist. This comes as a welcome change more so as cases of online sales of prescription drugs has come to light with the growing trends of self medication especially in tier -1 cities across the country.
The Union health ministry had also amended the D&C Rules to insert Schedule H1 to regulate the use of antibiotics in the country, and had placed 46 antibiotics under this category.
Maharashtra FDA has also referred over 200 cases related to professional misconduct of pharmacists to the Maharashtra State Pharmacy Council (MSPC) for action. Officials maintain that there is a growing trend of absence of pharmacists due to renting out pharmacy certificates to the drug retail stores and doing employment elsewhere.
MSPC is a quasi-judicial body which can act against the errant pharmacists by way of either issuing warning letters or cancelling their registrations. A senior FDA official pinpoints that most of the cases referred for MSPC action relate to the absence of pharmacists at the drug stores due to the unethical practice of doing dual employment.
An expert however argues that mere absence of a pharmacist during an FDA inspection does not amount to a professional misconduct. It has to be backed by circumstantial evidence which proves that the absence was due to a pharmacist doing dual employment, in an incident of he being found forging bills and in an event of prescription medicines or Schedule H drugs selling without a bill in his/her absence.