Maharashtra’s Food and Drug Administration (FDA) has taken regulatory action against 880 drug manufacturing and sale establishments after inspecting 2,902 premises across the state between June and August, according to a report carried by Loksatta. The inspections were conducted to check compliance with rules governing drug quality, manufacturing, storage and sale.
The inspected premises included 607 manufacturing establishments and 2,295 sale establishments. Action was taken against 140 manufacturing units and 740 sale establishments, with the largest share of action involving allopathic drug establishments, the report said.
Among the manufacturing establishments facing action, 58 were allopathic drug units. The licences of 13 of these establishments were suspended, while 45 licences were cancelled. Action was also taken against 31 Ayurvedic establishments, including 26 licence suspensions and five cancellations. One homoeopathic establishment had its licence cancelled and another had its licence suspended.
The FDA also acted against blood-related facilities. Of the 25 blood banks cited in the report, 21 licences were suspended and four were cancelled. Action was taken against 18 blood storage centres, including 12 licence suspensions and six cancellations. Four cosmetic manufacturing establishments were also penalised; three licences were suspended and one was cancelled. The licences of two laboratories were suspended.
The FDA said the regulatory action was undertaken after issuing show-cause notices and providing the concerned establishments an opportunity for a hearing, in accordance with applicable laws and rules. The inspections were intended to verify whether establishments were meeting requirements related to quality, production processes, storage and distribution.
The deficiencies identified during inspections included the absence of technical staff, testing conducted without the required technical personnel, failure to prepare annual reviews of product quality and inconsistencies in sterilisation records. Inspectors also found cases where medical examination reports of employees were unavailable and batch production or testing records were incomplete, according to the report.
Other reported lapses involved the manufacture of drugs not covered by an establishment’s licence, the absence of registered transfusion officers at blood facilities, blood transfusion or distribution carried out without the officer’s presence, and inadequate records for the purchase and use of empty blood bags. Some establishments were also found to lack required temperature controls or to have emergency kits containing missing or expired medicines.
At the sale and distribution level, the FDA identified instances of medicines being sold without the direct supervision of a registered pharmacist and transactions being conducted without invoices. The report also cited invoices that did not include batch numbers, expiry dates or manufacturing dates.
The FDA’s inspection programme covers both manufacturing and sale establishments across Maharashtra. The latest action, as reported by Loksatta, includes licence suspensions and cancellations following the inspection findings and the regulatory process described by the administration.
