Mumbai: The Maharashtra Food and Drug Administration (FDA) has cancelled 318 retail licenses and suspended 1,642 licenses across the state for non-compliance to the Drugs and Cosmetics Act. This action is an outcome of the state drug regulator’s routine inspections on 72,000 drug retail shops and 25,000 wholesale inspections.
FDA officials said the highest raids were conducted in April when the pandemic curve was at its peak and people were struggling for life-saving drugs.
This comes after FDA received several complaints regarding medical stores that were black marketing essentials generic medicines and were also overcharging.
DR Gahane, Joint Commissioner, FDA Maharashtra, said there are 72,000 medical retail shops and 25,000 wholesalers in the state and every year they conduct raids on medical stores that failed to follow the Drugs and Cosmetic Act. They were receiving many complaints following which they conducted surprise inspections and learnt the medical stores were black-marketing the medicines at that time when patients' relatives were running from door to door to get those medicines.
“During its inspections, we detected the violations to Good Pharmaceutical Practices (GPP) like dispensing Schedule H drugs without prescription, absence of proper purchase and sale bills and non-availability of pharmacists in the drug retail stores across the state. Following which we served the regulatory and compliance needs of close to 318 medical stores in Maharashtra. A checklist was issued to all the medical stores and wholesalers to help them to be self-compliant before a surprise raid or routine inspection by the state regulator before conducting workshops,” Gahane said.
According to the data, there are 6,496 medical shops and 4,500 wholesalers in Mumbai. During the ongoing pandemic, FDA revoked the licenses of 33 medical practitioners. In addition, the licenses of 230 medical shop owners have been suspended for a few days.
Officials said chemists need to strictly adhere to the norms laid down under the Drugs and Cosmetics Act, 1940. "A qualified pharmacist is a must. Besides, chemists have to maintain the sale of records of all scheduled H1 drugs and keep a register to record names and addresses of doctors and patients," he said.
Senior FDA officer said It is mandatory to be a pharmacist in medical stores, it is illegal to run a medical business without a pharmacist. A surprise inspection of the medicals revealed that most of the shops did not have pharmacists. In addition, they have taken action against those who dispense medicine without a prescription, do not pay the bills to the customers and tamper with the account of the goods purchased and violate other rules. “Some were caught selling medical sleeping pills and other scheduled drugs which should not be given without a prescription. Some medical friends have been caught making a mistake for the third time, so their license has been cancelled,” said an officer.
A chemist from Mumbai, who didn't wish to be named, said, "Earlier, we used to help customers understand regimen of drugs prescribed to them by doctors. Now, since we are compelled to do a lot of clerical work, we hardly find time to help them. We have to keep sales records of drugs dispensed. We have to write down the name and address of the doctor and patient in a register every time any higher antibiotic is sold."