The Food and Drug Administration (FDA) officials have cancelled the licences of 107 chemists and suspended the licences of 402 chemists in the Pune division found violating the Drugs and Cosmetics Act, 1940 while carrying out inspections from April 2022 to March 2023.
The 107 errant chemists include 73 wholesalers, distributors, and 34 retailers. Of them 30 chemists are from Pune district, Pune city, Pimpri-Chinchwad and Pune rural, said the officials.
Also,402 licences were suspended for violations, including a major chunk of 250 chemists from the Pune district. The report for the same has been sent to the state government, said the FDA officials.
According to the officials the violations include, operating without a pharmacist or qualified staff, poor record keeping, dispensing medicines without a valid prescription, improper storage of temperature-sensitive drugs, and non-maintenance of records of scheduled drugs amongst others.
Inspection of chemist shops, wholesalers and retailers was conducted between April 2022 to March 2023 by the officials. During this, 867 pharmacies in the Pune division were inspected and 509 errant pharmacies were identified.
A senior FDA official requesting anonymity said, licences are cancelled only in case of serious violations, for example; a pharmacist unavailable for a couple of days or during the inspection is less serious in comparison to Pharmacist unavailable for several months.
“If a chemist is unavailable during a visit, the licence can be suspended; however, if the pharmacy is operating without qualified personnel, the consequences are serious.” In such circumstances, severe action, such as licence cancellation, is taken’, he explained.
The action was taken per the FDA Commissioner’s guidance, according to SV Pratapwar, Joint Commissioner of FDA, (Drug), Pune region, and the inspections are part of routine inspections.
“We are ensuring that all rules are strictly followed. Initially, show cause notices were issued to these pharmacies, requesting an explanation. We took further action, such as suspending or cancelling their licences, after receiving their explanation. However, they cannot function until then since they have been handed orders to halt the sale, but they can file an appeal,” Pratapwar explained.
The FDA employee in Pune discovered a discrepancy in the records of Scheduled pharmaceuticals such as sleeping pills and habit-forming medications. At three chemists, the record of a popular pharmaceutical, Mephentermine sulphate injections among gym enthusiasts to grow more muscle swiftly was found to be mismatched and unmaintained.
According to officials, such errors are made on purpose to sell the injections on the black market at excessive prices. As a result, the licences of all three chemist shops were revoked, and they later filed an appeal.
Sushil Shah, president of the Chemists Association of Pune District (CAPD), stated that the organisation regularly informs its members to respect the norms and do business. “FDA officials will visit shops and conduct inspections.
“It is their responsibility. Chemist shops should follow the rule while on duty because it is our responsibility. Only when violations occur is an action taken. The organisation never supports someone who breaks the law. The association holds monthly workshops and meetings where they are instructed on how to respect the guidelines. Even if some of them do not obey the rules and suffer punishment, it must be acknowledged,” Shah stated.