Ayurvedic drug imports remain regulated under the Drugs and Cosmetics framework, subject to testing and interim clearance conditions.

Ayurvedic drugs fall within the regulatory ambit of the Drugs and Cosmetics Act, 1940, and the import-control scheme applies to them without a carve-out. Although the import forms under Rules 23 and 24 are framed for allopathic drugs and do not fit ayurvedic products, that regulatory gap calls for amendment by the rule-making authority rather than judicial redrafting. Pending a suitable framework, import clearance may be regulated by interim conditions, including laboratory testing through a CDSCO-accredited facility, oversight by the competent licensing authority, and compliance with applicable manufacturing standards, with the importer bearing the costs.

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Issues: Whether ayurvedic drugs fall within the Drugs and Cosmetics Act, 1940 and whether their import can be cleared without an import licence under the existing rules, and what interim conditions should govern clearance of the consignment.

Analysis: Ayurvedic drugs are within the statutory definition of drugs and are expressly regulated by the Drugs and Cosmetics Rules, 1945. The import provision applies to drugs generally and contains no carve-out for ayurvedic drugs, indicating that the legislative scheme contemplates import licensing for such goods. At the same time, the prescribed forms under Rules 23 and 24 are designed for allopathic drugs and are not apt for ayurvedic drugs, creating a regulatory gap that calls for modification by the rule-making authority rather than judicial re-drafting of the scheme. In the absence of a prohibition or exemption for ayurvedic imports, the Court required the consignment to be tested by a CDSCO-accredited laboratory, with the process overseen by the licensing authority for manufacture of ayurvedic drugs and the importer bearing the costs.

Conclusion: The import of ayurvedic drugs is not exempt from regulation, but clearance of the petitioner's consignment was permitted subject to testing, certification of conformity with Indian manufacturing standards, and compliance with the applicable import conditions.

Final Conclusion: The writ petitions were disposed of with operative directions enabling release of the goods after regulatory testing and certification, while leaving the broader inadequacy of the existing import forms and rules to be addressed by the competent authority.

Ratio Decidendi: Ayurvedic drugs fall within the regulatory ambit of the Drugs and Cosmetics Act and the import-control scheme applies to them, but where the existing import forms are unsuitable, clearance may be regulated by interim conditions until the rule-making authority provides an appropriate framework.

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