'Shoot first, ask questions later' won't work in law: Bombay HC raps Maharashtra FDA
A bench of Acting Chief Justice RV Ghuge and Justice Gautam Ankhad was hearing a petition filed by Cadila challenging the FDA's recent directives to seize stocks and halt the sale and distribution of several of its medicines.
The Bombay High Court on Tuesday granted relief to Cadila Pharmaceuticals Ltd and rebuked the Maharashtra Food and Drug Administration (FDA) over its stop-sale orders against the drugmaker, saying that “shooting first and asking questions later” may be “a rule of the Wild West but does not apply in law”.
Following the court’s sharp observations, the Maharashtra FDA agreed to revoke its existing stop-sale orders against Cadila and assured the bench that it would follow due process before taking any fresh action. The FDA is headed by Commissioner Tukaram Mundhe.
A bench of Acting Chief Justice RV Ghuge and Justice Gautam Ankhad was hearing a petition filed by Cadila challenging the FDA’s directives to seize stocks and halt the sale and distribution of several of its medicines.
The bench criticised what it viewed as the FDA’s trigger-happy approach to regulatory action. “Shooting first and asking questions later is a rule of the Wild West which does not apply in the arena of law,” the court observed.
It said such an approach could not be followed in the legal and regulatory system. “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 stopped the sale and distribution of several Cadila medicines. Cadila’s lawyer, senior advocate Birendra Saraf, sought cancellation of the orders, arguing that they had caused substantial financial losses to the pharmaceutical company.
The High Court's criticism of the FDA came after weeks of high-profile inspections by the regulator, which has suspended the licences of nearly 100 food establishments across Mumbai and elsewhere in Maharashtra over hygiene and food safety violations.
Mundhe has emerged as the public face of the crackdown, drawing praise from consumers while facing criticism from sections of the hospitality industry.
The High Court said it had no doubt about the FDA’s statutory powers but questioned the manner in which they were 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,” ACJ Ghuge told FDA lawyer Neha Bhide.
The bench stressed that the issue was not whether the regulator had the authority to act, but whether it exercised that power with adequate propriety.
WHAT FDA SAID
The FDA defended its action by alleging that some Cadila products had similar branding despite containing different active pharmaceutical ingredients (APIs).
The High Court, however, said its primary concern was not the company’s financial losses but the impact 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,” ACJ Ghuge observed.
“We are concerned that the drug was not available to the patients for 20 days, effectively 32 days till today,” he added.
According to the FDA, the similarity in branding could create a serious risk of medication errors if consumers or healthcare providers confused one medicine with another.
While acknowledging the FDA’s statutory mandate to regulate medicines and protect public health, the court questioned whether the manner in which its powers were exercised was proportionate.
The bench also warned that the regulator could face heavy costs in future cases if similar orders continued to be passed without following due process.
MAHARASHTRA FDA TO REVOKE CADILA STOP-SALE ORDERS
Following the court’s observations, the Maharashtra FDA agreed to revoke the existing stop-sale orders against Cadila. The regulator also assured the bench that it would follow the statutory procedure before taking any fresh action.
This would include issuing fresh show-cause notices to Cadila, giving the company adequate time to submit written responses to the alleged violations and conducting proper hearings before passing any final orders.
The court’s intervention came after it questioned the manner in which the FDA had exercised its regulatory powers, while stressing that protecting public health must go hand in hand with following due process.
With the stop-sale orders being revoked, Cadila will get an opportunity to respond to the allegations before the regulator takes any fresh decision.
The Bombay High Court on Tuesday granted relief to Cadila Pharmaceuticals Ltd and rebuked the Maharashtra Food and Drug Administration (FDA) over its stop-sale orders against the drugmaker, saying that “shooting first and asking questions later” may be “a rule of the Wild West but does not apply in law”.
Following the court’s sharp observations, the Maharashtra FDA agreed to revoke its existing stop-sale orders against Cadila and assured the bench that it would follow due process before taking any fresh action. The FDA is headed by Commissioner Tukaram Mundhe.
A bench of Acting Chief Justice RV Ghuge and Justice Gautam Ankhad was hearing a petition filed by Cadila challenging the FDA’s directives to seize stocks and halt the sale and distribution of several of its medicines.
The bench criticised what it viewed as the FDA’s trigger-happy approach to regulatory action. “Shooting first and asking questions later is a rule of the Wild West which does not apply in the arena of law,” the court observed.
It said such an approach could not be followed in the legal and regulatory system. “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 stopped the sale and distribution of several Cadila medicines. Cadila’s lawyer, senior advocate Birendra Saraf, sought cancellation of the orders, arguing that they had caused substantial financial losses to the pharmaceutical company.
The High Court's criticism of the FDA came after weeks of high-profile inspections by the regulator, which has suspended the licences of nearly 100 food establishments across Mumbai and elsewhere in Maharashtra over hygiene and food safety violations.
Mundhe has emerged as the public face of the crackdown, drawing praise from consumers while facing criticism from sections of the hospitality industry.
The High Court said it had no doubt about the FDA’s statutory powers but questioned the manner in which they were 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,” ACJ Ghuge told FDA lawyer Neha Bhide.
The bench stressed that the issue was not whether the regulator had the authority to act, but whether it exercised that power with adequate propriety.
WHAT FDA SAID
The FDA defended its action by alleging that some Cadila products had similar branding despite containing different active pharmaceutical ingredients (APIs).
The High Court, however, said its primary concern was not the company’s financial losses but the impact 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,” ACJ Ghuge observed.
“We are concerned that the drug was not available to the patients for 20 days, effectively 32 days till today,” he added.
According to the FDA, the similarity in branding could create a serious risk of medication errors if consumers or healthcare providers confused one medicine with another.
While acknowledging the FDA’s statutory mandate to regulate medicines and protect public health, the court questioned whether the manner in which its powers were exercised was proportionate.
The bench also warned that the regulator could face heavy costs in future cases if similar orders continued to be passed without following due process.
MAHARASHTRA FDA TO REVOKE CADILA STOP-SALE ORDERS
Following the court’s observations, the Maharashtra FDA agreed to revoke the existing stop-sale orders against Cadila. The regulator also assured the bench that it would follow the statutory procedure before taking any fresh action.
This would include issuing fresh show-cause notices to Cadila, giving the company adequate time to submit written responses to the alleged violations and conducting proper hearings before passing any final orders.
The court’s intervention came after it questioned the manner in which the FDA had exercised its regulatory powers, while stressing that protecting public health must go hand in hand with following due process.
With the stop-sale orders being revoked, Cadila will get an opportunity to respond to the allegations before the regulator takes any fresh decision.
The Bombay High Court on Tuesday granted relief to Cadila Pharmaceuticals Ltd and rebuked the Maharashtra Food and Drug Administration (FDA) over its stop-sale orders against the drugmaker, saying that “shooting first and asking questions later” may be “a rule of the Wild West but does not apply in law”.
Following the court’s sharp observations, the Maharashtra FDA agreed to revoke its existing stop-sale orders against Cadila and assured the bench that it would follow due process before taking any fresh action. The FDA is headed by Commissioner Tukaram Mundhe.
A bench of Acting Chief Justice RV Ghuge and Justice Gautam Ankhad was hearing a petition filed by Cadila challenging the FDA’s directives to seize stocks and halt the sale and distribution of several of its medicines.
The bench criticised what it viewed as the FDA’s trigger-happy approach to regulatory action. “Shooting first and asking questions later is a rule of the Wild West which does not apply in the arena of law,” the court observed.
It said such an approach could not be followed in the legal and regulatory system. “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 stopped the sale and distribution of several Cadila medicines. Cadila’s lawyer, senior advocate Birendra Saraf, sought cancellation of the orders, arguing that they had caused substantial financial losses to the pharmaceutical company.
The High Court's criticism of the FDA came after weeks of high-profile inspections by the regulator, which has suspended the licences of nearly 100 food establishments across Mumbai and elsewhere in Maharashtra over hygiene and food safety violations.
Mundhe has emerged as the public face of the crackdown, drawing praise from consumers while facing criticism from sections of the hospitality industry.
The High Court said it had no doubt about the FDA’s statutory powers but questioned the manner in which they were 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,” ACJ Ghuge told FDA lawyer Neha Bhide.
The bench stressed that the issue was not whether the regulator had the authority to act, but whether it exercised that power with adequate propriety.
WHAT FDA SAID
The FDA defended its action by alleging that some Cadila products had similar branding despite containing different active pharmaceutical ingredients (APIs).
The High Court, however, said its primary concern was not the company’s financial losses but the impact 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,” ACJ Ghuge observed.
“We are concerned that the drug was not available to the patients for 20 days, effectively 32 days till today,” he added.
According to the FDA, the similarity in branding could create a serious risk of medication errors if consumers or healthcare providers confused one medicine with another.
While acknowledging the FDA’s statutory mandate to regulate medicines and protect public health, the court questioned whether the manner in which its powers were exercised was proportionate.
The bench also warned that the regulator could face heavy costs in future cases if similar orders continued to be passed without following due process.
MAHARASHTRA FDA TO REVOKE CADILA STOP-SALE ORDERS
Following the court’s observations, the Maharashtra FDA agreed to revoke the existing stop-sale orders against Cadila. The regulator also assured the bench that it would follow the statutory procedure before taking any fresh action.
This would include issuing fresh show-cause notices to Cadila, giving the company adequate time to submit written responses to the alleged violations and conducting proper hearings before passing any final orders.
The court’s intervention came after it questioned the manner in which the FDA had exercised its regulatory powers, while stressing that protecting public health must go hand in hand with following due process.
With the stop-sale orders being revoked, Cadila will get an opportunity to respond to the allegations before the regulator takes any fresh decision.
