4 days ago
FDA Withdraws Cipla and MCA Eatery Actions After HC Rebuke
The Maharashtra FDA took action against a Cipla facility and five restaurants linked to the Mumbai Cricket Association.
The Bombay High Court said the FDA had acted too quickly and had not followed a fair process.
In the Cipla case, the FDA had cancelled a drug-sale licence after alleged problems involving Reactin Plus tablets.
The court also objected to the FDA scheduling a hearing on a government-declared public holiday.
In the restaurant case, the FDA questioned why the licences were in MCA’s name while another company operated the eateries.
The court said the law did not necessarily prohibit that arrangement and told the FDA to take a practical view.
A new inspection found the restaurants 88 per cent compliant with food-safety rules.
The FDA agreed to reconsider the matter after giving MCA a fresh notice and hearing.
The Bombay High Court criticised the Maharashtra FDA for undue haste, a high-handed approach and violating natural justice.
The FDA withdrew its order cancelling Cipla Pharma and Life Sciences’ drug-sale licence for its Pune unit.
The FDA agreed to withdraw suspension orders covering five restaurants at Mumbai Cricket Association premises.
A fresh inspection found the eateries 88 per cent compliant with food-safety rules, allowing them to reopen under the court’s order.
The FDA agreed to issue MCA a fresh notice and hear its position on the contract with Shirke Infrastructure after the court warned of possible contempt action.
- Who
- The Bombay High Court, Maharashtra Food and Drug Administration, Cipla Pharma and Life Sciences Limited, Mumbai Cricket Association and Shirke Infrastructure were involved.
- What
- The FDA withdrew or agreed to withdraw a Cipla drug-sale licence cancellation and suspension orders affecting five MCA-premises restaurants.
- Where
- The Cipla facility was at Wadki in Pune, while the restaurants were at MCA premises in the Bandra-Kurla Complex in Mumbai.
- When
- The report was dated August 29; the Cipla licence cancellation had taken effect on August 27.
- Why
- The High Court found that the FDA had acted with undue haste, used an incorrect or overly rigid approach and failed to follow principles of natural justice.
High Court’s concerns
FDA’s enforcement position
Cipla licence cancellation
High Court’s concerns
The court said the FDA followed the wrong procedure, acted high-handedly and violated natural justice, including by scheduling a hearing on a state government holiday.
FDA’s enforcement position
The FDA had cancelled Cipla’s drug-sale licences after alleged violations were detected during a follow-up investigation into the packaging and recall of Reactin Plus tablets.
Restaurant licensing arrangement
High Court’s concerns
The court said the FDA should take a pragmatic view and give the Mumbai Cricket Association a proper hearing about its contract with Shirke Infrastructure.
FDA’s enforcement position
The FDA objected that the restaurants were operated by Shirke Infrastructure even though the licences were issued in MCA’s name, and agreed to reconsider the issue after receiving a fresh response.
Restaurant reopening
High Court’s concerns
The court held that the suspension order stood vacated because a fresh inspection found the eateries 88 per cent compliant, allowing services to reopen.
FDA’s enforcement position
The FDA had initially suspended the restaurants as part of its enforcement action; the reports contain conflicting wording about whether the licences remained suspended pending the fresh hearing.
Key facts
- Court
- Bombay High Court
- Regulator
- Maharashtra Food and Drug Administration
- Cipla facility
- Cipla’s carrying and forwarding facility at Wadki, Pune
- Cipla action
- The FDA cancelled the drug-sale licences effective August 27 before withdrawing the order
- Restaurants affected
- Five restaurants at Mumbai Cricket Association premises
- Inspection result
- The eateries were found 88 per cent compliant with food-safety rules
- Next step
- The FDA said it would issue MCA a fresh notice, provide a hearing and pass a reasoned order
Quotes
Bombay High Court bench
The bench hearing the Maharashtra FDA cases, comprising Acting Chief Justice Ravindra Ghuge and Justice Gautam Ankhad.
“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 and officers 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.”
rediff.com
theprint.in
“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.”
rediff.com
Sources
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