The Maharashtra Food and Drug Administration inspected 2,902 drug manufacturing and sales establishments between June and August and initiated regulatory action against 880 units for alleged violations of quality, storage, documentation and operational requirements.
Mumbai | September 8, 2026
The inspections covered 607 manufacturing establishments and 2,295 sales establishments across Maharashtra, according to information attributed to the FDA. Action was taken against 140 manufacturing units and 740 sales establishments during the three-month period.
The FDA said the inspections were conducted to verify compliance with rules governing drug quality, manufacturing processes, storage and sales. The department said ensuring the quality of medicines and the safety of residents remained its priority.
Among the manufacturing establishments facing action, 58 were allopathic drug units. The licences of 13 of these establishments were suspended and 45 were cancelled. Action was also taken against 31 Ayurvedic establishments, with 26 licences suspended and five cancelled. One homoeopathic establishment had its licence cancelled, while another had its licence suspended.
The inspections also covered blood banks and blood storage centres. Of the 25 blood banks that faced action, 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 proceeded against. Licences of three were suspended and one was cancelled. The licences of two laboratories were suspended, according to the FDA’s account.
The department said the regulatory action was taken after the establishments were issued show-cause notices and given an opportunity for a hearing. The suspensions and cancellations were carried out under the applicable laws and regulations, the FDA said.
The deficiencies identified during inspections included the absence of technical staff, testing carried out without the required technical personnel, failure to prepare annual reviews of product quality, inconsistencies in sterilisation records and the absence of medical examination reports for employees. Inspectors also found incomplete batch production and testing records and instances of medicines allegedly being manufactured without approval under the relevant licence.
At blood-related facilities, the FDA cited the absence of registered transfusion officers or transfusions and distribution carried out when the designated officer was unavailable. Other issues included the storage of empty blood bags without proper purchase and usage records, inadequate temperature control and missing or expired medicines in emergency kits.
At sales establishments, the reported deficiencies included the sale or distribution of medicines without direct supervision by a registered pharmacist, transactions without bills, and invoices that did not include batch numbers, expiry dates or manufacturing dates.
The FDA’s inspection drive covers both manufacturing and distribution points in the medicine supply chain. The latest figures show that action was taken against roughly three in ten establishments inspected during the period, although the department’s statement did not provide a consolidated breakdown of the final penalties by type of violation or establishment location.
The FDA said regulatory proceedings followed the prescribed notice and hearing process. The department’s statement did not specify the names of the establishments involved or announce a further statewide inspection deadline.
