Now You Are Going Overboard: HC Slams Tukaram-Led Maharashtra FDA, Withdraws Cipla Licence Cancellation
Mumbai: The Maharashtra Food and Drug Administration (FDA) has withdrawn its order cancelling the drug sale licence of Cipla Pharma & Life Sciences Ltd's Carrying and Forwarding (C&F) unit at Wadki in Pune after the Bombay High Court pulled up the regulator for allegedly acting in a 'high-handed' manner and going 'overboard' in its action against the company.
A bench comprising Acting Chief Justice Ravindra Ghuge and Justice Gautam Ankhad questioned the procedure followed by the FDA in cancelling Cipla's licence and observed that the order was against the “principles of natural justice.”
The FDA informed the High Court that it would withdraw the licence cancellation order forthwith and issue a fresh show cause notice to Cipla, following which a reasoned order would be passed.
The dispute arose after the Maharashtra FDA cancelled the drug sale licence of Cipla Pharma & Life Sciences Ltd's C&F facility at Wadki, Pune, with effect from August 27, citing alleged irregularities concerning the packaging, storage, stock records and recall of Reactin Plus Tablets, a Schedule H prescription medicine.
Cipla challenged the regulatory action before the Bombay High Court.
During Saturday's hearing, senior counsel Aabad Ponda, appearing for Cipla, submitted that the FDA had sent an email directing the company to appear for a hearing on August 26, which was a public holiday declared by the state government.
According to Ponda, the company did not have a representative available on the holiday and had sought an adjournment. However, the FDA proceeded to pass the cancellation order on the same day without granting the company an opportunity of hearing.
Additional government pleader P.P. Kakade, appearing for the FDA, submitted that the law did not provide the company with a right to a hearing.
The bench questioned the FDA's decision to call the company for a hearing on a public holiday and then proceed with the cancellation.
“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,” the High Court observed.
The bench further criticised the manner in which the FDA proceeded against Cipla, observing that the regulator had acted in a “high-handed” manner and followed an incorrect procedure.
“The order is against the principles of natural justice,” the court said.
The High Court also questioned whether it was “fair and transparent” for the FDA to send an email asking the company to send a representative for a hearing on the same day, particularly when that day was a state-declared public holiday.
“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,” the bench questioned.
Following the court's observations, the FDA agreed to withdraw the cancellation order and initiate the process afresh by issuing a fresh show cause notice to Cipla.
What Led To Cipla Licence Cancellation?
The FDA had earlier cancelled the drug sale licence of Cipla's C&F unit after inspections reportedly revealed several deficiencies relating to Reactin Plus Tablets.
During an inspection conducted in June, FDA officials allegedly found unauthorised promotional text on the packaging of Reactin Plus, a Schedule H prescription medicine. The packaging reportedly described the medicine as an “analgesic and antipyretic.
The regulator had alleged that the use of such promotional language on a prescription medicine was unauthorised and could encourage self-medication.
The FDA also reportedly identified discrepancies between physical and computerised stock records, gaps in purchase and sale records and alleged non-compliance with directions concerning the recall of Reactin Plus.
The regulator subsequently cancelled the drug sale licence of the Pune C&F unit with effect from August 27.
However, the High Court's intervention has now resulted in the withdrawal of that order, with the FDA required to follow the process afresh.
Cipla Says No Product Safety Concern
Cipla had earlier stated that it challenged the FDA's action and clarified that the regulatory order did not allege any concerns regarding the safety, quality or efficacy of its products.
The company also said that the matter did not involve or indicate any patient safety issue.
Cipla reiterated its commitment to maintaining high standards of quality, regulatory compliance and patient safety while stating that the matter was under judicial consideration.
Also Read: Maharashtra FDA Cancels Cipla Pune Unit's Drug Licence Over Reactin Plus Lapses
Court's Broader Criticism Of FDA
During the same proceedings, the Bombay High Court also expressed strong displeasure over the Maharashtra FDA's approach in a separate matter concerning the suspension of licences of five restaurants operating at the Mumbai Cricket Association (MCA) premises.
While that matter was separate from the Cipla proceedings, the bench questioned the FDA's broader approach to enforcement and its alleged haste in passing orders.
The court asked the regulator:
“Do you feel you are a Lord and you can do anything?”
The bench also questioned how many times it would have to intervene to ensure that the department balanced enforcement with fairness.
“How many times should we try to convince and balance equities so that the department does not feel discouraged? Why do we say, 'Don't kill a mosquito with a sword'? Do you feel you are a lord and you can do anything?” the High Court questioned.
In the MCA matter, the court had earlier directed the FDA to take a pragmatic approach after a fresh inspection reportedly found the eateries to be 88 per cent compliant with food safety requirements.
PTI reports that the court criticised the department for allegedly disregarding its earlier direction and adopting what it described as a “pedantic instead of pragmatic” approach.
“However, despite clearly saying this, the FDA has disobeyed our order and taken a pedantic view instead of a pragmatic view. We are tired of scolding the department all the time. It is now time to pass stinging orders. We will issue contempt action against the concerned officers. Let them convince us or go to jail,” the bench said.
The FDA subsequently agreed to withdraw the suspension order concerning the eateries and issue a fresh notice to the MCA, provide it an opportunity to respond regarding its contractual arrangement with the third-party operator and thereafter pass a reasoned order.
The High Court's observations in the Cipla matter, however, centred specifically on the procedure adopted by the FDA before cancelling the company's drug sale licence and the requirement to follow the principles of natural justice.
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