Following crackdown by Maharashtra Food and Drug (FDA) on retail shops running without a pharmacist and not maintaining proper billing records, around 4, 958 retail licenses have been surrendered in the year 2013-14. During the year, the FDA had conducted inspections on 48086 retail stores in the state and cancelled licences of 5452 retail pharmacies and suspended licences of another 3178 retailers across the state.
Maharashtra FDA Commissioner Mahesh Zagade says surrendering of licences is the outcome of stringent action taken by FDA which has helped create discipline amongst the chemists to comply with the provisions of the Drugs and Cosmetics Act. Giving reference of the protests done by Maharashtra Chemists and Druggists Association (MSCDA) last year in the month of December over the stringent action for non-compliance, he says, “we could see the desired effect by imposing Maharashtra Essential Services and Maintenance Act (MESMA) in order to ensure that consistent supply of essential medicines is not curtailed in the interest of patient safety”.
The FDA's crackdown is in line with the fact that there is irrational usage of around 65 per cent of antibiotics. It has been reported that there is only five to six per cent billing on sales across Maharashtra.
Most of the chemists across Maharashtra are also yet to follow the newly amended Schedule H1 effective from March 1, 2014 due to lack of awareness and cumbersome record keeping. Non-compliance of Schedule H1, a senior FDA official says, will attract penalty ranging from lodging FIRs and cancellation of licenses based on the merit of the case.
Argues Ashok Khandelwal from Healthcare Advocacy group Chikitsasansar, "Today non-compliance to Schedule H1 will have serious implications as drug wholesalers are promoting irrational usage of drugs in the name of new antibiotics by illegally selling it to quacks. Drug Controller General of India (DCGI) needs to take appropriate action as it has been found that medical representatives appointed by drug companies in order to meet their targets promote antibiotics to unqualified allopaths and these in turn prescribe medicines to patients irrationally with the motive of getting hefty commissions."
During the year 2013-14, 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 licences 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 licences, Aurangabad with 801, Nashik with 612, Amravati with 489 and Nagpur with 369.