2026 (1) TMI 409 - HC - Customs

Provisional release of imported wellness massagers: DCGI approval and Battery Rules EPR certificate not mandatory; detention set aside.

The dominant issue was whether provisional release of imported massagers could be denied for want of DCGI approval and an EPR registration certificate ... Seeking review Of the order - provisional release release of imported goods - No approval of license/certificate by the Drug Controller General of India (‘DCGI’) for the imported massagers - Petitioner failed to provide the Extended Producer Responsibility Registration Certificate (‘EPR Certificate’) under the Battery Waste Management Rules, 2022, which is required since certain products were found to be battery operated - HELD THAT:- A perusal of the FAQs would show that, insofar as massagers are concerned, they do not require any approval under the Medical Device Rules, 2017 as they are not being used for therapeutic or alleviation of disease. They are only for wellness and soothing purposes. In addition, insofar as EPR certificate is concerned, the Public Notice: 46/2023 shows that the EPR certificate applications can also be filed even after the goods are released. One of the Petitioners has in fact filed such an application. The FAQs and the Public notice have been clearly concealed from the Court by the Customs Department. The court is clearly of the view that the Petitioners are being harassed unnecessarily, when clearly the earlier consignments of the Petitioners were cleared with objection and the consignments of various third parties were also cleared. Accordingly, the review petitions are dismissed. 1. ISSUES PRESENTED AND CONSIDERED (i) Whether the prior direction for provisional release of imported goods warranted review on the grounds that a regulatory licence/certificate from the drug regulator was required for the imported 'massagers/sex toys'. (ii) Whether non-production of an Extended Producer Responsibility (EPR) registration certificate for battery-operated products justified review and continued detention, or whether the certificate could be applied for post-release under the applicable customs public notice. (iii) Whether the review petitions disclosed any legitimate error warranting review, in light of (a) consistent clearance of similar consignments (including of third parties) and (b) the finding that relevant material had been concealed from the Court. 2. ISSUE-WISE DETAILED ANALYSIS Issue (i): Requirement of drug regulator approval for the imported massagers Legal framework (as considered by the Court): The Court examined the stated regulatory position reflected in the medical devices regulator's FAQs (as placed before it) concerning whether 'massagers intended for soothing or wellness purpose' fall under regulation as medical devices. Interpretation and reasoning: On a perusal of the FAQs, the Court accepted that massagers intended for general wellness/soothing purposes, and not for therapeutic use or alleviation of disease/disorder, do not require approval under the Medical Devices regulatory regime. The Court treated the imported items as falling in the non-therapeutic wellness category on the material before it. Conclusion: The asserted requirement of a drug regulator licence/certificate did not justify review or continued obstruction to release, because the Court found such approval not required for the goods as characterised (wellness/soothing; non-therapeutic). Issue (ii): EPR certificate for battery-operated products and timing of compliance Legal framework (as considered by the Court): The Court considered the customs public notice stating that an application for an EPR certificate can be filed even after release of goods. Interpretation and reasoning: The Court held that, consistent with the public notice, EPR compliance could be pursued post-release through filing of an application. The Court noted that an application had in fact been filed by one importer. It further found that the FAQs and the public notice had been concealed from the Court by the customs authorities. Conclusion: Absence of an EPR certificate at the time of detention was not accepted as a ground for review; the Court directed that, if not already filed, the EPR application be filed as per the public notice, and subject to that, provisional release was to be effected within two working days. Issue (iii): Maintainability/merit of review in light of prior clearances, selective treatment, and concealment Legal framework (as considered by the Court): The review jurisdiction was invoked under the Code of Civil Procedure provisions governing review; the Court confined itself to whether the earlier release order suffered from a reviewable infirmity on the grounds urged. Interpretation and reasoning: The Court relied on its earlier recorded findings that similar consignments of the importers and various third parties had already been released without objection, and that even on pointed query the customs authorities accepted that other companies were permitted to import similar products. The Court also noted the lack of a satisfactory answer in the counter affidavit to the allegation of differential treatment. In these circumstances, and coupled with concealment of relevant material (FAQs and the public notice), the Court concluded that the review attempt lacked merit and amounted to unnecessary harassment. Conclusion: The Court dismissed the review petitions, reaffirmed provisional release (subject to filing the EPR application if not already filed), and imposed costs of Rs. 25,000/- in each review petition payable by the customs department, with a direction that the amount be recovered from the salary of the concerned customs officer.