Maharahtra FDA cancels 500 licenses across state for violation of D and C Act

Mumbai, March 2016

Based on inspections done of 18,067 retail pharmacies across the state between April 2015 and January 2016, the Maharashtra Food and Drug Administration (FDA) has cancelled licenses of 500 retail pharmacies and suspended licenses of another 1,674 retail drug stores. 

The State Regulator had served 2,428 show cause notices (SCN) on the retailers based on its observation of violations of Drugs and Cosmetics Act like dispensing medicines without prescription, without proper bill and for absence of pharmacists.  The crackdown was in response to the growing trend of irrational usage of around 65 per cent of antibiotics and distribution of narcotics, MTP kits and other habit forming drugs in the last couple of years. It has also been reported that there is only five to six per cent billing on sales across Maharashtra. 

Non-compliance of Schedule H1, a senior FDA official further says attracts penalty ranging from lodging FIRs and cancellation of licenses based on the merit of the case.

During the year 2013-14, the FDA had inspected 5,469 retail stores in Greater Mumbai, 7,143 in Konkan, 11,801 in Pune, 6,855 in Nashik, 4,574 in Nagpur, 8,097 in Aurangabad and 4,147 in Amravati FDA divisions. Around 901 licences were cancelled and 693 suspended in Greater Mumbai alone. Maximum number of 1,384 cancellations were done in the Konkan division followed by Mumbai, Pune with 896 Licences, Aurangabad with 801, Nashik with 612, Amravati with 489 and Nagpur with 369.

According to FDA officials, compliance to Schedule H1 is being pursued on a war footing by educating retailers.  The Union health ministry had 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.

According to sources, it has also been reported that renewals of retail licenses in Nagpur, Pune and Nashik are also pending for the past several months giving free hand to unauthorized persons to dispense prescription medicines by evading the law of the land. Due to non-renewals, unauthorized drug retailers and wholesalers are promoting irrational usage of drugs in the name of new antibiotics by illegally selling it to quacks. Pharmabiz