1 week ago
Bombay High Court Backs FDA Crackdown, Questions Enforcement Methods
The Maharashtra FDA checks restaurants, warehouses and medicine companies for safety problems.
The Bombay High Court said this work is important.
However, the court said the FDA sometimes acted too harshly or skipped required steps.
In several cases, businesses had fixed most or all of the problems, but their licences were not restored quickly.
The court said immediate closure should usually happen only when there is a serious public health danger.
It also told the FDA to give businesses notices and chances to explain themselves.
The court criticized actions involving Amazon Retail India and Cadila Pharmaceuticals for being too sweeping.
But it did not give urgent relief to a restaurant whose paneer was found unsafe.
This means the court supports safety enforcement but wants it to be fair and carefully carried out.
The Bombay High Court supported Maharashtra FDA action against food and drug safety violations but criticized disproportionate enforcement and due-process lapses.
In at least nine June and July cases, courts stayed or reversed licence suspensions when no public health emergency was shown or defects had been corrected.
The court ordered the FDA to pay Rs 5 lakh to Gurunanak Dairy and Sweets after delaying licence restoration despite 98 per cent compliance.
It criticized FDA action involving Amazon Retail India and Cadila Pharmaceuticals, urging systematic enforcement and proper hearings.
The court denied urgent relief to Udupi Swaad Restaurant after an inspection found its paneer sample unsafe and substandard.
- Who
- The Maharashtra Food and Drug Administration, the Bombay High Court, and affected businesses including Gurunanak Dairy and Sweets, Amazon Retail India, Cadila Pharmaceuticals and Udupi Swaad Restaurant.
- What
- The High Court reviewed FDA suspensions, recalls and other enforcement actions, supporting the safety objective while questioning proportionality and due process.
- Where
- The cases involved Maharashtra, including Mumbai, Nagpur, Aurangabad, Pune, Navi Mumbai, Thane and Bhiwandi.
- When
- The cases were heard during June, July and August, with key observations and orders issued between July 29 and August 21.
- Why
- The FDA was acting against alleged food and drug safety violations, while the court examined whether the enforcement methods were justified and legally proper.
FDA’s Safety Enforcement
Court and Businesses’ Due-Process Concerns
Need for strong action
FDA’s Safety Enforcement
The FDA pursued alleged food and drug safety violations, including expired or damaged food at an Amazon warehouse and potentially confusing medicine branding at Cadila Pharmaceuticals.
Court and Businesses’ Due-Process Concerns
The court said the safety objective was laudable but warned that enforcement must be systematic, proportionate and based on the circumstances of each case.
Immediate licence suspension
FDA’s Safety Enforcement
The FDA suspended or acted against businesses and suppliers where it identified safety deficiencies or suspected risks.
Court and Businesses’ Due-Process Concerns
The court said Section 32 generally requires an improvement notice before suspension, with immediate suspension reserved for exceptional cases involving a recorded public health risk.
Food safety standards
FDA’s Safety Enforcement
The FDA’s actions were intended to prevent unsafe food and medicines from reaching consumers.
Court and Businesses’ Due-Process Concerns
The court ordered or considered relief where businesses had corrected deficiencies, but refused urgent relief for Udupi Swaad after finding the paneer sample unsafe and substandard.
Key facts
- Court
- Bombay High Court
- Regulator
- Maharashtra Food and Drug Administration
- Cases reviewed
- At least nine cases in June and July involved stays or reversals of licence suspensions.
- Compensation
- The FDA was directed to pay Rs 5 lakh to Gurunanak Dairy and Sweets.
- Gurunanak compliance
- A reinspection found 98 per cent compliance, but licence restoration was delayed for more than 30 days.
- Park Inn inspection
- The court restored the hotel’s licence after finding that two insects did not justify continued suspension alongside 95 per cent compliance.
- Udupi Swaad finding
- The restaurant’s licence was suspended after a June inspection found its paneer sample unsafe and substandard.
Quotes
Bombay High Court bench
The bench hearing Amazon Retail India’s challenge to FDA action
“You are going overboard… This is plain and simple perversity, absolutely strange policies. You corner people. Once you clear 98 per cent compliance you say, now, go and file an appeal. What is this? Torturing citizens?”
indianexpress.com
“We appreciate your (FDA’s) action and this is a laudable object and you deserve compliment. But go systematically,”
indianexpress.com
Sources
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