India
oi-Swastika Sruti
In a shocking development, the Maharashtra FDA has revoked its order to cancel the drug sale license of Cipla Pharma and Life Sciences Ltd’s Carrying & Forwarding (C&F) unit at Wadki, Pune following criticism of its conduct from the Bombay High Court.
Maharashtra FDA revoked its license cancellation order for Cipla Pharma’s Pune drug unit following Bombay High Court criticism of illegal procedures and violation of natural justice. The FDA will now issue a fresh show-cause notice, consider Cipla’s response, and issue a reasoned order.
The Bombay High Court held that the FDA had adopted an illegal procedure and violated the principles of natural justice by cancelling the license.
FDA To Issue Fresh Show-Cause Notice To Cipla
During the hearing, the FDA informed the Bombay High Court that it would withdraw the cancellation order with immediate effect.
The regulator also said it would issue a fresh show-cause notice to Cipla, consider the company’s response and then pass a reasoned order.
The original cancellation had taken effect from August 26.
Why Did FDA Cancel Cipla’s Licence?
FDA action had been brought against the C&F factory of Cipla after an inspection carried out in June. Several issues had been identified about the packaging, stocking and recalling of Reactin Plus tablets, which are prescription drugs, falling under the category of Schedule H.
As per the FDA report, the packaging included the description “analgesic and antipyretic”, which was unauthorised promotional language, according to the regulatory agency.
The department believed that use of such language on a prescription drug would lead to consumer abuse and self-medication.
FDA Also Flagged Stock And Recall Records
The regulator’s inspection also reportedly identified discrepancies between the facility’s physical and computerised stock records.
Other issues cited by the FDA included gaps in purchase and sale records and alleged non-compliance with directions relating to the recall of Reactin Plus tablets.
These findings led the regulator to cancel the drug sale licence of the facility.
However, Cipla challenged the order before the Bombay High Court.
Cipla Says It Was Denied A Proper Hearing
Senior counsel Aabad Ponda, appearing for Cipla, told the court that the FDA had asked the company to appear for a hearing on August 27.
However, August 27 was a public holiday declared by the Maharashtra government.
Since no company representative was available on the holiday, Cipla sought an adjournment. According to the company’s submissions, the FDA nevertheless proceeded to cancel the licence on the same day without providing another opportunity for a hearing.
The FDA’s lawyer, Additional Government Pleader P P Kakade, argued that the law did not provide the company with a right to a hearing.
Bombay HC Questions FDA’s ‘High-Handed’ Approach
The divisional bench headed by Acting Chief Justice Ravindra Ghuge and Justice Gautam Ankhad took issue with the scheduling of the hearing on a public holiday by the FDA, followed by the cancellation of the license once Cipla requested more time.
According to the judges, the FDA had “gone overboard” in its actions.
The divisional bench characterized the behavior of the FDA as “highhanded,” adding that the procedure of cancellation was contrary to the principles of natural justice.
The judges wondered whether it was justifiable to ask the company to come for a hearing on a holiday declared by the government.
Court Says FDA Must Correct Its Procedure
The bench acknowledged the FDA’s broader role in enforcing drug and food safety standards but said regulatory action must follow a fair process.
The court observed that government departments themselves often seek adjournments because they cannot function on public holidays.
Following the court’s observations, the FDA agreed to withdraw its cancellation order and restart the process.
Cipla Says No Product Safety Concern Was Alleged
Cipla had announced on Friday that it had approached the Bombay High Court against the FDA’s action. The company clarified that the cancellation order did not allege any concern regarding the safety, quality or efficacy of its products.
Cipla also said the order did not involve or indicate any patient-safety issue.
The FDA will now issue a fresh notice, consider Cipla’s response and take a fresh decision through a reasoned order.
