CESTAT Allahabad Upholds Provisional Release of Imported Medical Gloves

Aadrikaa Legal Services (ALS) – IDT Tax I Arbitration I Litigation

Date: 30.05.2026

CESTAT Allahabad Upholds Provisional Release of Imported Medical Gloves

The Customs, Excise & Service Tax Appellate Tribunal (CESTAT) Allahabad recently delivered a significant order regarding the provisional release and classification of imported medical gloves by M/s Rajat International. This case highlights the complexities of customs regulations, medical device compliance, and the interplay between various regulatory authorities in India.

Background of the Case

M/s Rajat International, a proprietorship engaged in importing gloves, brought in ‘Non-sterile non-measurable powdered latex examination gloves (Class A)’ from Malaysia. The goods were detained by Customs at ICD Dadri due to concerns over port notification, product classification, and regulatory compliance. The importer sought clarification and faced multiple rounds of legal and administrative proceedings, including writ petitions before the Allahabad High Court.

Key Issues in Dispute

1. Product Classification
   • The importer classified the gloves under CTH 40151900, while Customs argued they should fall under CTH 40151200, which specifically covers medical, surgical, dental, or veterinary gloves.
   • Customs alleged misclassification was intended to avoid obtaining a No Objection Certificate (NOC) from the Assistant Drug Controller (ADC).
2. Labelling Requirements
   • Customs cited a test report indicating missing batch numbers, manufacturing dates, manufacturer’s name, and expiry dates on the samples, which are mandatory under the Medical Devices Rules (MDR), 2017.
   • The importer countered that labels were present on bulk packaging, as confirmed by a re-examination and panchnama dated 15.04.2026, which Customs failed to disclose in their appeal.
3. Import Through Non-Notified Port
   • Customs objected to the import at ICD Dadri, a non-notified port under Rule 43A of the Drugs and Cosmetics Rules, 1945.
   • The importer argued that the actual port of discharge was Nhava Sheva (a notified port), and ICD Dadri was only for clearance. This interpretation was supported by previous tribunal judgments.

Tribunal’s Analysis and Findings

• Classification Dispute: The tribunal noted that even if Customs’ classification was accepted, there was no differential duty or financial implication, as all duties had been paid. The issue was deemed academic and not relevant to the provisional release.
• Labelling Compliance: The tribunal found that labels were indeed affixed on the bulk packaging, and there was no requirement to label individual gloves. The department’s suppression of the panchnama confirming this was criticized.
• Port Notification: The tribunal agreed with the importer that the goods entered India through a notified port (Nhava Sheva), and clearance at ICD Dadri did not violate port restrictions. Previous similar imports had been cleared without issue.
• Risk to Public Health: Customs failed to provide evidence that releasing the goods would pose a health risk. The gloves were classified as Class-A (low risk) devices, and all statutory requirements were met.
• NOC Requirement: The tribunal held that once statutory requirements are fulfilled, the absence of an NOC from CDSCO cannot be a ground to withhold goods, especially when previous imports were cleared.

Final Order and Implications

• The tribunal dismissed the Customs department’s appeal, upholding the provisional release of the goods subject to bond and bank guarantee conditions.
• Customs was directed to release the goods within seven days of the order.

What This Means for Importers

1. Accurate Classification: Importers must ensure correct classification of goods but can defend their position if there is no revenue implication.
2. Labelling: Proper labelling on bulk packaging is generally sufficient for Class-A medical devices.
3. Port of Import: Goods entering through a notified port and cleared at an inland depot are compliant if supported by documentation.

Regulatory Compliance: Registration under MDR, 2017 and fulfillment of statutory requirements are crucial for smooth clearance.

Source: CESTAT Allahabad

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