The Goa Food & Drugs Administration (FDA) has commenced a massive crackdown on retailers for non-compliance of some key provisions of the Drugs & Cosmetics Act.
Goa FDA has detected cases of absence of pharmacists, improper maintenance of records and even multiple violations by pharmacists in retail drug stores. Says Goa FDA director Salim A Veljee, "We have been registering 3 to 4 cases of non-compliance every month. Licences have been suspended and even cancelled for violating various provisions of D&C Rules during the past few months. In some cases, violators have been booked for multiple charges for non-compliance to D&C Act."
Violators were found involved in not only selling drugs without prescription but were also involved in other violations, like running the pharmacy without pharmacist, not maintaining relevant statutory purchase and sales records for scheduled or prescription drugs. "There were billing irregularities like not recording proper names of the prescriber or patient details on the cash memos, stocking of expired drugs, among others," he said.
Actions were taken in the past with reference to increasing possibility of pharmacies supplying psychotropic substances as an alternative to narcotics in the tourist coastal belt.
The Goa 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.
During the last financial year, 22 licences of retailers were suspended after 558 inspections and issuing 130 show cause notices. The last fiscal saw 92 retailers being warned. Of the 22 suspended licences, six were from the coastal belt. This was done after conducting 312 inspections and issuing show cause notices to 60 retailers, of whom 45 were left with a warning.
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.
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.