FDA turns on heat, acts against 334 pharmacies for violating rules
| Date :03-May-2023 |
By Rutu Borkar
Food and Drugs Administration (FDA) took action against 334 pharmacies in Nagpur district for violation of guidelines pertaining to selling prescribed drugs and medical instruments. The action was initiated after finding various irregularities by the chemists. Among the 334 chemists, the major breach documented by FDA was pharmacies running sans licence, non-renewal of licence, shifting of shops and godowns without permission, or not sharing crucial information with the concerned authority, and substandard material quality. During the checks, the FDA team also found that some of the chemists are engaged in sale of medical devices for which a separate licence has to be procured.
Selling drugs in absence of a registered pharmacist at a chemist store, storing expired products, and selling physician samples to consumers are some of the factors that contributed to subsequent actions by the FDA. Many a time, banned drug contents are found to be stored at the pharmacies. Government issues directions from time to time regarding ban on sale of medicines or combinations which have been determined harmful for humans. So, when such contents are found during examination of the pharmacies, action is bound to follow, a source in the FDA said.
In the search conducted for the period from April 2002 to March 2023, FDA issued 159 show cause notices, suspended 160 licences and cancelled 15 licences. The material seized by FDA is collectively valued at Rs 72,79,452. In the previous year for the period from April 2001 to March 2022, FDA had issued 136 show cause notices, suspended 104 licences and cancelled 16 licences. The material seized by FDA during this period was collectively valued at Rs 48,77, 236. "Once we seize the material we have to store it at our office premises. We have to keep them under our custody until the courts direct further action. The seized material is destroyed only if the expiry date is crossed. Also, the time taken for the court ruling is not definite,” said Pushpahas Ballal, Assistant Commissioner, Food and Drugs Administration, Nagpur Division. Explaining why such actions had to be taken, Ballal said that the irregularities may not always be related to the content of medicines. It was observed that the stipulated guidelines prescribed by FDA were not observed.
According to a senior official at FDA Nagpur division, the Drug Inspectors posted at Nagpur office undertake, on an average, six to seven surprise checks every month. The officials also act on the complaints received online on its website while they pursue the written complaints received at its office. The checks ensure that the actions are not meant to harass or create hurdles in the business, but FDA is duty-bound to ensure that those tasked with sale of life-saving drugs are acting in accordance with the framed laws. FDA officials have requested all citizens to mandatorily take bills for any drug purchased from the pharmacies. This ensures that the patients or their relatives have a window to act against the wrong doing on part of the pharmacy.