Mumbai: In a concerted effort to fortify pharmaceutical compliance and ensure the highest standards in the industry, the Maharashtra Food and Drug Administration (FDA) has initiated a massive crackdown, replete with license revocations, seizures, and legal actions. The regulatory body has cancelled a total of 320 licenses, encompassing 134 retail and 186 wholesale licenses, spanning the period from April to October. This decisive move comes in the wake of an exhaustive series of 6,779 inspections carried out by the FDA.
The comprehensive inspections laid bare a spectrum of non-compliance issues plaguing the pharmaceutical drug supply chain, ranging from the absence of qualified pharmacists to the improper storage of medicines and the neglect of maintaining accurate sale and purchase records. Responding resolutely, the Maharashtra FDA has suspended 892 retail licenses and 1033 wholesale licenses.
According to Abhimanyu Kale, commissioner, Maharashtra FDA, “During the investigative period from April to October, 2023, the Maharashtra FDA orchestrated 53 targeted raids, culminating in the confiscation of pharmaceuticals valued Rs. 2.85 crore within the clandestine drug supply chain. Significantly, 28 FIRs have been filed, addressing violations pertaining to the peddling of spurious drugs and the unauthorized sale of prescription medications.”
Kale further informed that the regulatory crackdown has not only resulted in more than 30 arrests but has also seen the initiation of 3,102 prosecutions against individuals involved in the illicit trade of spurious drugs. Simultaneously, quality control measures have been heightened, with approximately 120 samples declared as not meeting standard quality out of the 3,200 samples subjected to scrutiny by state drug controllers (SDCs).
In recognition of the need for reinforced compliance measures, the Maharashtra FDA is actively augmenting its workforce. Of the 200 sanctioned posts, only 82 drug inspectors (DIs) are presently active, prompting a concentrated effort to bolster manpower particularly in the Marathwada and Vidarbha regions, currently grappling with a pronounced shortage.
Additionally, the regulatory body faces a substantial shortage of Assistant Commissioners, with 38 out of the 66 sanctioned posts vacant. In terms of manufacturing units, Maharashtra today has 940 allopathic, 466 ayurvedic, 24 homoeopathic, and 395 cosmetics manufacturing units. Furthermore, the state boasts 57 public testing labs distributed strategically across its regions.
This expansive crackdown by the Maharashtra FDA underscores its commitment to upholding pharmaceutical compliance, safeguarding public health, and fortifying the integrity of the pharmaceutical supply chain in the state.
