The Bombay High Court on Tuesday granted relief to Cadila Pharmaceuticals Ltd and criticised the Maharashtra Food and Drug Administration (FDA) over its stop-sale orders against the drugmaker. The court observed that “shooting first and asking questions later” might be a rule of the Wild West, but it has no place in the legal system.
Following the court’s strong remarks, the Maharashtra FDA agreed to withdraw its existing stop-sale orders against Cadila and assured the bench that it would follow due process before initiating any further action. The FDA is headed by Commissioner Tukaram Mundhe.
A bench comprising Acting Chief Justice RV Ghuge and Justice Gautam Ankhad was hearing a petition filed by Cadila challenging the FDA’s directions to seize stocks and suspend the sale and distribution of several of its medicines.
The bench questioned what it considered an overly aggressive approach by the FDA. “Shooting first and asking questions later is a rule of the Wild West which does not apply in the arena of law,” the court remarked.
The judges said such a method could not be adopted within the legal and regulatory framework. “Even when it comes to hotels, you shoot first, then ask questions. The same is happening in this case,” the court said.
The FDA had seized stocks and ordered a halt to the sale and distribution of multiple Cadila medicines. Senior advocate Birendra Saraf, representing Cadila, sought the cancellation of the orders, arguing that the action had resulted in significant financial losses for the pharmaceutical company.
The High Court’s criticism came after several weeks of high-profile inspections by the regulator, which has suspended the licences of nearly 100 food establishments across Mumbai and other parts of Maharashtra for alleged hygiene and food safety violations.
Mundhe has become the public face of the crackdown, receiving praise from consumers while also drawing criticism from parts of the hospitality sector.
The High Court said it did not question the FDA’s statutory authority but raised concerns about how those powers were being exercised. “We have no doubts about your powers. You only display your powers, but the problem is you have the power to use the sword, but you use it to kill a mosquito,” Acting Chief Justice Ghuge told FDA lawyer Neha Bhide.
The bench emphasised that the question was not whether the regulator possessed the authority to act, but whether it exercised that authority appropriately and proportionately.
WHAT FDA SAID
The FDA defended its action by claiming that some Cadila products had similar branding even though they contained different active pharmaceutical ingredients (APIs).
However, the High Court said its main concern was not the company’s financial losses but the effect of the stop-sale orders on patients. “The drug was not sold for 20 days. We are not concerned with the loss of Senior Advocate Saraf’s client,” Acting Chief Justice Ghuge observed.
“We are concerned that the drug was not available to the patients for 20 days, effectively 32 days till today,” he added.
The FDA argued that similarities in branding could pose a significant risk of medication errors if patients or healthcare professionals mistakenly confused one medicine with another.
While recognising the FDA’s statutory responsibility to regulate medicines and safeguard public health, the court questioned whether the regulator’s exercise of power had been proportionate.
The bench also cautioned that the FDA could be burdened with substantial costs in future cases if it continued issuing similar orders without adhering to due process.
MAHARASHTRA FDA TO REVOKE CADILA STOP-SALE ORDERS
Following the court’s observations, the Maharashtra FDA agreed to withdraw the existing stop-sale orders against Cadila. The regulator also assured the bench that it would comply with the prescribed statutory process before taking any further action.
This would involve issuing fresh show-cause notices to Cadila, allowing the company sufficient time to submit written responses to the alleged violations and conducting proper hearings before issuing final orders.
The court’s intervention followed its concerns over the manner in which the FDA had exercised its regulatory powers, while reiterating that public health protection must be balanced with adherence to due process.
With the stop-sale orders being withdrawn, Cadila will have an opportunity to respond to the allegations before the regulator makes any further decision.
