Maharashtra Cancels 200 Licences Over Substandard Medicines

Maharashtra’s Food and Drug Administration (FDA) has cancelled more than 200 licences of medical retailers and wholesalers for supplying low-grade medicines, Minister of State for FDA Narhari Zirwal informed the state assembly on Wednesday.

The action follows a statewide inspection drive aimed at identifying substandard pharmaceutical products circulating in the market.

Zirwal, responding to questions raised by legislators including BJP MLA Amit Satam, stated that licences of 176 retailers and 39 wholesalers were revoked after they were found selling medicines that failed quality standards. The FDA had issued show-cause notices before initiating cancellations. During the drive, inspections were carried out on 136 retailers and 93 wholesalers across multiple districts.

Also Read: Zydus Introduces Zyrifa Biosimilar to Ease Cancer Bone Treatment

As part of the exercise, samples of cough syrups and other commonly used drugs were collected from ten locations in the Mumbai, Thane, Pune, Aurangabad and Nagpur divisions. Of the 36 samples tested, 34 did not meet prescribed quality benchmarks. The failed samples included medicines used for hypertension, diabetes, tuberculosis, cardiac conditions and blood purification. Six samples of a paediatric cough syrup brand were also found to be substandard.

The minister noted that an earlier FDA operation in October 2024 had detected fake cough syrups stocked by certain pharmacies and supplied by some manufacturers. Following this discovery, the department instructed doctors, pharmacists and clinical establishments not to prescribe or dispense medicines containing propranolol. Authorities also found instances of altered formulations being sold under new names, and reports indicated that unapproved firms had supplied fake medicines to government hospitals.

Zirwal acknowledged that a shortage of drug inspectors, with several sanctioned posts vacant, has hindered routine inspections and testing. Recruitment efforts and upgrades to drug-testing laboratories are underway to strengthen regulatory oversight. The cancellation of licences marks one of the most extensive enforcement actions by the FDA as the state works to curb the distribution of substandard medicines.