The Bombay High Court on Tuesday provided relief to Cadila Pharmaceuticals Ltd and criticized the Maharashtra Food and Drug Administration for its stop-sale directives against the company. The court stated that acting without prior inquiry follows rules of the Wild West rather than legal standards.
After the court’s remarks, the Maharashtra FDA consented to withdraw its current stop-sale directives against Cadila and confirmed it would observe proper procedures ahead of any future measures.
A bench comprising Acting Chief Justice RV Ghuge and Justice Gautam Ankhad examined a petition from Cadila contesting the FDA instructions to confiscate stocks and suspend sales of multiple medicines.
The bench condemned the FDA’s hasty regulatory steps. It noted that such methods cannot apply within the legal framework. The court added that similar hasty actions occur even with hotels.
The FDA, led by Commissioner Tukaram Mundhe, had confiscated stocks and halted distribution of several Cadila products. Cadila’s counsel argued the orders led to major financial harm for the firm.
The High Court acknowledged the FDA’s legal authority but questioned its application. It compared the use of power to employing a sword against a mosquito.
The bench clarified the core issue was not the existence of authority but its proportionate exercise.
The FDA justified its steps by claiming some Cadila items shared branding despite differing active ingredients. The court emphasized concern over effects on patients rather than company losses, noting medicines remained unavailable for weeks.
The FDA highlighted risks of medication mix-ups from similar branding. While recognizing the regulator’s duty to safeguard public health, the court examined whether actions were measured.
It cautioned the FDA about potential heavy penalties in future similar cases.
Following the observations, the Maharashtra FDA agreed to lift the stop-sale orders. It pledged to issue fresh notices, allow time for responses, and conduct hearings before final decisions.
The court’s action followed scrutiny of the FDA’s methods, stressing that health protection requires adherence to due process. With orders revoked, Cadila can address claims before any new regulatory choice.
