Madras High Court: Ayurvedic Imports Subject to Drug Import Rules

In a landmark ruling that may reshape the regulatory landscape for ayurvedic medicine imports, the Madras High Court in W.P.Nos.8920, 8924 & 8928 of 2025 allowed Axeon Marketing India to import Axe Brand Medicated Oil—but only after the consignment passes rigorous testing under Indian ayurvedic manufacturing standards. The Court held that ayurvedic drugs are subject to drug import rules. This order was pronounced by his judgment was pronounced by Justice Senthilkumar Ramamoorthy on June 26, 2025.

Facts of the Case

Axeon Marketing, an authorized Indian distributor of Axe Brand Medicated Oil (Singapore), had their consignment blocked by Customs and Drug Control authorities.

They were accused of importing proprietary items under the guise of Ayurvedic medicines allegedly violating the Drugs & Cosmetics Act, 1940 and Rules, 1945.

The company argued that ayurvedic drugs were not subject to standard drug import licensing and cited favorable tribunal precedent (SMA Trading Company, 2022).

The Court’s Ruling

Ayurvedic drugs fall within the definition of “drug” under the Drugs & Cosmetics Act, and the import rules do apply, even if current licensing forms are ill-suited for non-allopathic products.

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.

2025:MHC:1467

There’s no exemption or blanket prohibition on importing ayurvedic medicines—hence, conditional import is legally feasible.

CDSCO guidelines offer a viable interim route: if the product meets Indian standards (e.g., heavy metal testing, labeling norms), clearance may be granted.

The Court directed that the consignment must undergo testing by a CDSCO-accredited lab. If results show compliance with Indian ayurvedic manufacturing standards, the State Licensing Authority (SLA) must certify the same.

On such certification, Customs must release the goods. The entire process should be completed in 6–8 weeks, and costs borne by the petitioner.

The Court urged regulatory reform, noting that current rules lack specific forms or procedures for ayurvedic imports, even though the law applies to them.

Parliament or the Ministry of AYUSH must consider creating dedicated import licensing provisions or formally prohibiting such imports, if that’s the intent.

This judgment affirms that non-allopathic medicine imports are not a free-for-all. Importers of ayurvedic drugs must ensure full conformity to Indian health safety standards, including heavy metal content and proper labeling.

It highlights the regulatory gray zone in India’s drug import laws—and the need for clear, updated rules for AYUSH products.