2025 (7) TMI 730

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....sekaran, SPC for R3, R4 & R6, Ms.M.Sneha, Spl. Counsel for R5 COMMON ORDER By these writ petitions, the petitioner seeks a direction to the first and second respondents to permit the petitioner to clear all goods covered by bill of entry No.8438669 dated 19.02.2025 and for other remedies ancillary or incidental thereto. 2. The petitioner states that it is an authorized importer and distributor of Axe Brand Medicated Oil products in India and that it has been importing the same from the parent company, Leung Kai Fook Medical Company Private Limited, Singapore, since 2007. The petitioner received notices from the 5th respondent alleging violation of Section 33EEA of the Drugs and Cosmetics Act, 1940 (Drugs & Cosmetics Act) and Rule 154 of ....

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....judice, the Central Drugs Standard Control Organization (CDSCO) has framed guidelines permitting the import of ayurvedic drugs subject to the manufacturer's test report, samples, etc. being examined and a no objection certificate being issued. This process may be followed on an expedited basis to grant clearance. (v) The Health Sciences Authority, Singapore, has certified on 15.03.2022 that the manufacturer has maintained an acceptable level of compliance with the Pharmaceutical Inspection Convention/Cooperation Scheme Guide to Good Manufacturing Practices for Medicinal Products. (vi) The import policy provides that import of ayurvedic drugs may be undertaken "free", i.e without a licence. (vii) In response to a question in Parlia....

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....and Universal Oil is classifiable under chapter 30 of the CTH. The said judgment does not appear to have been carried in appeal and holds the field as on date. Therefore, one should proceed on the basis that the goods sought to be imported qualify as ayurvedic drugs. On examining the definition of drug and ayurvedic, siddha or unani drug in Section 3(b) and Section 3(a), respectively, of the Drugs and Cosmetics Act, it appears that ayurvedic drugs clearly fall within the ambit of the statute. Indeed, Parliament's intention to regulate this category is expressed beyond doubt in Part XVI of the Drugs and Cosmetics Rules, which expressly regulate ayurvedic drugs. Rule 23 of the Drugs & Cosmetics Rules provides for an import licence to impo....

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....ossible to discern whether licensing requirements were imposed in relation to such imports. 9. There is a strong public interest element, specifically public health element, in relation to the import of drugs. The drug involved in this case is Axe Medicated Oil and, in that specific context, the public health threat may not be significant. It is conceivable, however, that other non-allopathic medicines could have, for example, heavy metal content and, therefore, the need for regulation cannot be disregarded. As held above, the statute and rules framed thereunder apply to ayurvedic drugs. As regards import, while Rule 23 uses the expression "drugs" and not drugs used in allopathy, the forms referred to therein and in Rule 24 do not apply to....