Drugs and Cosmetics Rules Do Not Apply To Import Of Ayurvedic Drugs; Madras High Court Calls for Modification of Existing Rules

The Madras High Court observed that the Drugs & Cosmetics Rules do not apply to the import of ayurvedic or non-allopathic drugs. Therefore, it is necessary for the rule making authority to modify existing rules, prescribe standards and prepare appropriate forms in which applications may be made and import licenses granted to persons importing ayurvedic drugs.

The Madras High Court considered the issue related to import of ayurvedic drugs without license.

The Bench of Justice Senthilkumar Ramamoorthy observed, “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…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 the import of ayurvedic or non-allopathic drugs. Therefore, it is necessary for the rule making authority to modify existing rules, prescribe standards and prepare appropriate forms in which applications may be made and import licenses granted to persons importing ayurvedic drugs. In the alternative, as a policy measure, it is always open to Parliament to amend the law and prohibit the import of ayurvedic or other classes of drugs, if deemed fit.”

Advocate Hari Radhakrishnan represented the Petitioner, while Advocates Revathi Manivannan, ARL. Sundaresan and M. Sneha represented the Respondents.

Case Brief

It was the case of the Petitioner that it is an authorized importer and distributor of Axe Brand Medicated Oil products in India and that it has been importing the same since 2007. However, he received notices from the State Licensing Authority alleging violation o provisions of the Drugs and Cosmetics Act, 1940 and Rule 154 of the Drugs and Cosmetics Rules, 1945 (Drugs & Cosmetics Rules).

It was the contention of the Petitioner that products imported by the Petitioner have been held to be classifiable as ayurvedic drugs by the Customs Excise and Service Tax Appellate Tribunal. Further, the provisions of Drugs and Cosmetics Act in relation to import of drugs are inapplicable to ayurvedic drugs. Thus, the Petitioner contended that it should be allowed to import goods without a licence.

While the Respondents contended that import of ayurvedic drugs is prohibited without license.

Court’s Analysis

The Court opined that from the material on record, it is not possible to discern whether licensing requirements were imposed in relation to such imports.

The Madras High Court emphasised that it is necessary for the rule making authority to modify existing rules, prescribe standards and prepare appropriate forms in which applications may be made and import licenses granted to persons importing ayurvedic drugs. In the alternative, as a policy measure, it is always open to Parliament to amend the law and prohibit the import of ayurvedic or other classes of drugs.

The Court directed the Central Drugs Standard Control Organisation (CDSCO) to test the Petitioner’s consignment to determine whether the imported products conform to the standards prescribed for similar products manufactured in India. If a satisfactory report is received, accordingly, the release of petitioner’s goods will be permitted.

Accordingly, Writ Petitions were disposed of.

Cause Title: M/s.Axeon Marketing India V. The Assistant Commissioner of Customs (Group 2), Import Commissionerate & Ors. (Neutral Citation:2025:MHC:1467 )

Appearance:

Petitioner: Advocate Hari Radhakrishnan

Respondent: Advocates Revathi Manivannan for R1 & R2, ARL.Sundaresan, Assisted by V.Chandrasekaran, SPC for R3, R4 & R6 M.Sneha, Spl. Counsel.

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