In order to enhance enforcement for compliance amongst retailers, wholesalers and manufacturers of pharmaceutical products, Maharashtra Food and Drug Administration (FDA) conducted 122 raids in the year 2013-14 as compared to only 49 in the year 2012-13. The raids revealed rampant violations of Drugs and Cosmetics Act, 1940 and Rules, 1945 as offenders stocked drugs without a license and sold them without purchase bills.
As a part of FDA's crackdown to discourage irrational usage of of antibiotics, it had canceled licenses of 5452 retail pharmacies and suspended licenses of another 3178 retailers across the state in the year 2013-14 for violations like dispensing medicines without prescription and without proper bill. During the year, the FDA had conducted inspections on 48086 retail stores in the state.
To ensure compliance to the conditions of wholesale licence and Drug Price Control Order (DPCO-2013), FDA has also filed FIRs against stockists for refusing to supply medicines in contravention to DPCO and Essential Supplies Maintenance Act (ESMA). Such cases were detected by the state regulator since it intensified its drive last month against errant wholesalers. FDA has intensified the crackdown on the errant wholesalers considering the fact that until last year unfair practice of constraining the supply of medicines by a handful of drug dealers was rampant. Stockists were being inspected for compliance to schedule 65 of Drugs and Cosmetics (D&C) Act, 1940 and Schedule 5 of Drug Price Control Order (DPCO) - 2013.
The state as of today has 18000 wholesalers including those who export and import. Out of which, there are around 4000 stockists who supply to the retail trade. According to FDAs findings, there is irrational usage of around 65 per cent of antibiotics and cancellation of licenses is done based on 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.
Former Maharashtra FDA Commissioner Mahesh Zagade had also convened several meetings across the state 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.