Maha FDA cancels licenses of 5452 retailers, suspends 3178 for violation of D&C Act

Shardul Nautiyal, Mumbai Wednesday, May 14, 2014, 08:00 Hrs  [IST]

The Maharashtra Food and Drug Administration (FDA) has canceled licenses of 5452 retail pharmacies and suspended licenses of another 3178 retailers across the state in the year 2013-14 for violation of Drugs and Cosmetics Act like dispensing medicines without prescription and without proper bill. During the year, the FDA had conducted inspections on 48086 retail stores in the state. The FDA's crackdown is in line with the fact that there is irrational usage of around 65 per cent of antibiotics and cancellation of licenses is done based on the non-compliance like dispensing medicines without prescription and without bill. It has been reported that there is only five to six per cent billing on sales across Maharashtra. During the year, the FDA had inspected 5469 retail stores in Greater Mumbai, 7143 in Konkan, 11,801 in Pune, 6855 in Nashik, 4574 in Nagpur, 8097 in Aurangabad and 4147 in Amravati FDA divisions. Around 901 licenses were canceled and 693 suspended in Greater Mumbai alone. Maximum number of 1384 cancellations were done in the Konkan Division followed by Mumbai, Pune with 896 licenses, 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.  Maharashtra FDA Commissioner Mahesh Zagade convened meetings in Nagpur, Nashik earlier and in Mumbai recently to sensitise retailers about the Schedule H1 compliance. 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. Similar kind of actions have also been taken by FDA under the Drugs and Magic Remedies (Objectionable Advertisement) Act (DMR Act). Against the backdrop of several instances of violations to DMR Act last year, FDA has recently filed First Information Report (FIR) against a Mumbai based weight loss firm this year. FDA had served 1434 notices and filed 58 FIRs last year. Prosecution is going on for four cases.