Prescription drugs sold in Maharashtra without renewal of licenses in violation of Schedule H compliance
Despite the government's mandate for retail chemists to comply with Schedule H and H1, renewals of retail licenses in Nagpur, Pune and Nashik are pending for the past several months giving free hand to unauthorised persons to dispense prescription medicines by evading the law of the land. The grim scenario is that 218 licenses are pending for renewal out of the 4018 retail licensees in Nagpur alone.
Besides this, around 252 licenses are pending for renewal out of the 2798 retail licensees in Pune Zone - 3. In Nashik Zone -1, out of 2392 licensees, 281 renewals are pending and around 236 licenses are pending for renewal in Nashik Zone - 2 out of the 2012 licensees.
Due to non-renewals, unauthorised drug retailers and 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 quacks and these in turn prescribe medicines to patients irrationally with the motive of getting hefty commissions,” according to a source associated with the development.
This scenario is despite the fact that state regulator had made a massive crackdown on retail shops and cancelled licences of 5452 retail pharmacies and suspended licences of another 3178 retailers across the state for running the retail stores without a pharmacist and not maintaining proper billing records. This was based on inspections on 48, 086 retail stores in the state last year due to which around 4, 958 retail licenses were also surrendered.
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 says, will attract 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 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 cancelled 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.