Mumbai: The Food and Drug Administration (FDA) has cracked down on medical stores violating drug-sale rules, suspending 599 licences and cancelling another 141 after inspecting 2,295 retail establishments across the state between June and August.
The FDA also inspected 607 manufacturing establishments, resulting in regulatory action against 140 — 78 units had their licences suspended, while licences of the remaining 62 were cancelled.
According to an FDA release, inspections found medicines being sold without bills or prescriptions, expired drugs kept alongside saleable stock and temperature-sensitive medicines such as insulin and vaccines stored at normal temperatures instead of prescribed cold-chain conditions. Some stores were operating without direct supervision of registered pharmacists, while discrepancies were found between recorded and actual stocks.
Several retailers had also failed to maintain mandatory Schedule H1 records, while sales bills in some establishments didn’t mention batch numbers and manufacturing and expiry dates. Discrepancies were found in records of narcotic and narcotic-like drugs. Poor hygiene, dust accumulation and inadequate refrigeration were also reported.
In manufacturing units, the FDA found lapses that included inadequate technical staff, gaps in quality-control testing, incomplete batch records and manufacture of unapproved or substandard drugs.
The FDA conducted 104 search-and-seizure operations, seizing illegal drugs and cosmetics worth Rs 11.41 crore. Twenty FIRs were registered and 21 people arrested.
FDA commissioner Tukaram Mundhe said, “Inspections were being accelerated to ensure drug quality and patient safety, with strict action against violators.”
