4 days ago
Maharashtra FDA Withdraws Cipla Licence After Bombay HC Rebuke
The Maharashtra Food and Drug Administration had cancelled the licence for one of Cipla’s medicine-handling facilities in Pune.
The regulator said inspectors found several possible rule violations involving packaging, records, storage and product recalls.
It also objected to promotional words on the packaging of Reactin Plus Tablets, a prescription medicine.
Cipla challenged the cancellation in the Bombay High Court.
The company said its hearing was set for a public holiday and that it was not given more time after asking for an adjournment.
The court said this process may have been unfair and criticised the FDA strongly.
The FDA then withdrew the cancellation order.
It will send Cipla a new notice and make another decision after reviewing the company’s response.
The Maharashtra Food and Drug Administration withdrew its cancellation of Cipla Pharma & Life Sciences Ltd’s drug-sale licences for its Wadki facility in Pune.
The Bombay High Court said the FDA appeared to have acted “high-handedly,” gone “overboard” and violated principles of natural justice.
Cipla said its hearing was scheduled for August 26, a state-declared public holiday, and that its adjournment request was denied.
The FDA cited alleged packaging, storage, stock-record, purchase-and-sale documentation and product-recall irregularities involving Reactin Plus Tablets.
The FDA will issue a fresh show-cause notice and pass a reasoned order after considering Cipla’s response.
- Who
- The Maharashtra Food and Drug Administration, Cipla Pharma & Life Sciences Ltd and the Bombay High Court, including Acting Chief Justice Ravindra Ghuge and Justice Gautam Ankhad.
- What
- The FDA withdrew its cancellation of Cipla’s drug-sale licences and agreed to restart the proceedings.
- Where
- Cipla’s carrying and forwarding facility at Wadki in Pune, Maharashtra.
- When
- The cancellation took effect on August 27, and the withdrawal was reported on August 29; the disputed hearing was scheduled for August 26.
- Why
- The FDA cited alleged regulatory irregularities, while the court questioned whether Cipla had received a fair and transparent opportunity to respond.
Cipla and Court Concerns
FDA’s Regulatory Position
Opportunity to be heard
Cipla and Court Concerns
Cipla said it had no representative available for a hearing scheduled on a state-declared public holiday and requested an adjournment. The court questioned the fairness of cancelling the licence without granting that request.
FDA’s Regulatory Position
The FDA argued that the law does not specifically provide Cipla with a right to a hearing, while agreeing to withdraw the order and restart the proceedings.
Nature of alleged violations
Cipla and Court Concerns
Cipla said the cancellation order did not allege concerns about the safety, quality or efficacy of its products and did not involve or indicate a patient-safety issue.
FDA’s Regulatory Position
The FDA cited unauthorised promotional wording on Reactin Plus packaging, stock-record discrepancies, gaps in purchase and sales documentation, and alleged non-compliance with recall directions.
Regulatory procedure
Cipla and Court Concerns
The Bombay High Court said the FDA appeared to have followed an incorrect procedure and acted in a high-handed manner contrary to natural justice.
FDA’s Regulatory Position
The FDA withdrew the cancellation and said it would issue a fresh show-cause notice before making a reasoned decision.
Key facts
- Regulator
- Maharashtra Food and Drug Administration
- Company
- Cipla Pharma & Life Sciences Ltd
- Facility
- Carrying and forwarding facility at Wadki, Pune
- Product
- Reactin Plus Tablets, described as a Schedule H prescription medicine
- Original cancellation
- The drug-sale licences were cancelled with effect from August 27
- Court criticism
- The Bombay High Court described the FDA’s approach as high-handed and overboard and questioned its compliance with natural-justice principles
- Next step
- The FDA will issue a fresh show-cause notice and later pass a reasoned order after considering Cipla’s response
Quotes
Acting Chief Justice Ravindra V Ghuge
Acting Chief Justice of the Bombay High Court
“If the court does the same thing, will it be fair? The government refuses or seeks adjournments claiming they cannot work on holidays; then how has the state’s department passed an order like this on a public holiday?”
CNBC TV 18
livemint.com
“You (FDA) are doing a laudable and appreciative job, but now you are going overboard. This is not the first time this is happening. You have wronged, and now you have to resolve the issue.”
republicworld.com
CNBC TV 18
thehindubusinessline.com
livemint.com
freepressjournal.in
+1 more
Sources
'Going Overboard': Maharashtra FDA Withdraws Order Cancelling Cipla Licence After HC Rap
Cipla Pharma license cancellation: FDA withdraws order after Bombay HC raps it for going 'overboard'
Cipla Pharma license cancellation order withdrawn as HC chides Maharashtra FDA
Cipla Pharma license cancellation: FDA withdraws order after HC raps it for going \'overboard\'
Bombay HC Slams Maharashtra FDA Over Cipla Licence Cancellation, Regulator Withdraws Order Against Pune Facility
Bombay High Court pulls up drug regulatory body over Cipla licence cancellation
Maharashtra FDA withdraws Cipla drug licence cancellation, to issue fresh notice
Cipla Drug Licence Row: Maharashtra FDA Withdraws Cancellation Order After Bombay HC Rebuke
Maharashtra FDA Withdraws Cipla Drug Licence Cancellation After Bombay HC Rebuke
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