{"id":353344,"date":"2025-07-14T17:30:48","date_gmt":"2025-07-14T12:00:48","guid":{"rendered":"https:\/\/www.scconline.com\/blog\/?p=353344"},"modified":"2025-07-19T09:36:57","modified_gmt":"2025-07-19T04:06:57","slug":"madras-high-court-on-import-of-ayurvedic-drugs","status":"publish","type":"post","link":"https:\/\/www.scconline.com\/blog\/post\/2025\/07\/14\/madras-high-court-on-import-of-ayurvedic-drugs\/","title":{"rendered":"Madras HC: Necessary to modify existing rules; prepare standards and forms for import of ayurvedic drugs"},"content":{"rendered":"
\n

Madras High Court:<\/span> The present writ petition was filed under Article 22<\/a> of the Constitution<\/a> praying for issuance of a Writ of Mandamus directing Respondents 1 and 2 to permit the petitioner to clear all goods covered by bill of entry dated 19-2-2025. A Single Judge Bench of Senthilkumar Ramamoorthy, J.<\/span>, examined the classification of the imported products as ayurvedic drugs and noted that while the statute regulated ayurvedic drugs, the existing licensing forms and procedures were tailored for allopathic medicines and not suitable for ayurvedic products. Therefore, the Court opined that it was necessary for the rule-making authority to amend existing rules and develop proper standards and forms applicable to the import of Ayurvedic drugs.<\/p>\n

The Court held that the Ayurvedic products imported by the petitioner must conform to the standards applicable to similar products manufactured in India and to ensure this, the consignment must be tested by a laboratory accredited by Central Drugs Standard Control Organization (\u2018CDSCO\u2019), under the supervision of Respondent 5-State Licensing Authority (IM). The Court directed the customs authorities to permit the release of goods upon satisfactory test report.<\/p>\n

Background<\/h3>\n

The petitioner was an authorized importer and distributor of Axe medicated oil products in India and imported these goods from a Singapore-based company. The petitioner had received notices from Respondent 5, alleging violations under Section 33EEA<\/a> of the Drugs and Cosmetics Act, 1940<\/a> (\u20181940 Act\u2019) and Rule 154 of the Drugs and Cosmetics Rules, 1945 (\u20181945 Rules\u2019). In response, the petitioner requested Respondent 1-Additional Commissioner of Customs to release the goods but was informed that the matter had been transferred to Respondent 4-Drug Controller General of India. The petitioner then filed the present writ petitions seeking directions from the Court to the respondents to allow clearance of the goods and other related reliefs.<\/p>\n

Analysis, Law, and Decision on Import of Ayurvedic Drugs<\/h3>\n

The Court held that ayurvedic drugs fall within the ambit of the 1940 Act, based on the definitions of drug and ayurvedic, siddha or unani drug under Sections 3(a) and 3(b). The Court stated that Parliament\u2019s intention to regulate Ayurvedic drugs was evident from Part XVI of the 1945 Rules. While Rule 23 of the 1945 Rules mandated an import license for drugs, no specific exclusion was made for Ayurvedic drugs. However, the forms prescribed under Rules 23 and 24 of 1945 Rules were not appropriate for Ayurvedic drugs, as they were tailored for allopathic medicines.<\/p>\n

The Court opined that there was a strong public interest element, specifically public health element, in relation to the import of drugs and the drug involved in the present case was Axe Medicated Oil and, in that context, the public health threat might not be significant. Therefore, it was necessary for the rule-making authority to amend existing rules and develop proper standards and forms applicable to the import of Ayurvedic drugs. Alternatively, Parliament might choose to amend the law to prohibit such imports, if it finds it appropriate as a matter of policy.<\/p>\n

The Court stated that the Ayurvedic products imported by the petitioner must conform to the standards applicable to similar products manufactured in India. To ensure this, the consignment in question was to be tested by a laboratory accredited by CDSCO, under the supervision of Respondent 5. The Court further stated that the petitioner was required to bear the costs of such testing.<\/p>\n

Respondent 5, upon receiving a satisfactory test report, shall certify that the manufacturing process complied with the process in India. The same shall be forwarded to Respondents 1 and 2, who on receipt, shall permit the release of the goods. The Court accordingly disposed of the petitions on the said terms without imposing any costs.<\/p>\n

[Axeon Mktg. India v. Commr. of Customs, 2025 SCC OnLine Mad 3245<\/a>, decided on 26-6-2025<\/span>]<\/p>\n

\n

Advocates who appeared in this case:<\/p>\n

For the Petitioner:<\/span> Hari Radhakrishnan, Advocate<\/p>\n

For the Respondents:<\/span> Revathi Manivannan for R 1 & R 2, Arl Sundaresan, assisted by V. Chandrasekaran, SPC for R 3, R 4 & R 6 and M. Sneha, Spl. Counsel for R 5.<\/p>\n

Buy Constitution of India \u00a0HERE<\/a><\/h3>\n

\"Constitution<\/a><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

“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.”<\/p>\n","protected":false},"author":67526,"featured_media":353349,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[3,10],"tags":[30064,85271,32707,15001,85268,2567,3518,85270,85269,14591],"class_list":["post-353344","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-casebriefs","category-highcourts","tag-ayush","tag-central-drugs-standard-control-organization","tag-drugs-and-cosmetics-act","tag-drugs-and-cosmetics-rules","tag-justice-senthilkumar-ramamoorthy","tag-Madras_High_Court","tag-public_health","tag-rule-154-drug-cosmetic-rules","tag-rule-23-drug-cosmetic-rules","tag-writ-of-mandamus"],"yoast_head":"\nMadras HC on import of Ayurvedic drugs | SCC Times<\/title>\n<meta name=\"description\" content=\"Madras High Court opined that it was necessary to develop proper standards and forms specifically applicable to import of Ayurvedic drugs.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.scconline.com\/blog\/post\/2025\/07\/14\/madras-high-court-on-import-of-ayurvedic-drugs\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Madras HC: Necessary to modify existing rules; 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The fee\u2026","rel":"","context":"In "Legislation Updates"","block_context":{"text":"Legislation Updates","link":"https:\/\/www.scconline.com\/blog\/post\/category\/legislationupdates\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2017\/09\/Parliament_Colour.jpg?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2017\/09\/Parliament_Colour.jpg?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2017\/09\/Parliament_Colour.jpg?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2017\/09\/Parliament_Colour.jpg?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2017\/09\/Parliament_Colour.jpg?resize=1050%2C600&ssl=1 3x"},"classes":[]},{"id":329450,"url":"https:\/\/www.scconline.com\/blog\/post\/2024\/08\/27\/sc-stays-notification-omitting-rule-170-drug-rules-which-prohibited-ads-ayurvedic-drugs\/","url_meta":{"origin":353344,"position":2},"title":"Supreme Court stays Ayush Ministry’s Notification omitting Rule 170 of Drug Rules which prohibited ads of Ayurvedic, Siddha or Unani drugs without approval","author":"Editor","date":"August 27, 2024","format":false,"excerpt":"Vide notification dated 01-07-2024, the Ministry of Ayush amended Drug Rules, 1945, omitting Rule 170.","rel":"","context":"In "Hot Off The Press"","block_context":{"text":"Hot Off The Press","link":"https:\/\/www.scconline.com\/blog\/post\/category\/news\/hot_off_the_press\/"},"img":{"alt_text":"Rule 170 of Drug Rules","src":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2024\/08\/Rule-170-of-Drug-Rules.webp?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2024\/08\/Rule-170-of-Drug-Rules.webp?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2024\/08\/Rule-170-of-Drug-Rules.webp?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2024\/08\/Rule-170-of-Drug-Rules.webp?resize=700%2C400&ssl=1 2x"},"classes":[]},{"id":270224,"url":"https:\/\/www.scconline.com\/blog\/post\/2022\/07\/16\/ccpa-issues-advisory-to-e-commerce-platforms-on-sale-of-ayurvedic-siddha-and-unani-drugs\/","url_meta":{"origin":353344,"position":3},"title":"CCPA issues Advisory to e-commerce platforms on sale of Ayurvedic, Siddha and Unani drugs","author":"Bhumika Indulia","date":"July 16, 2022","format":false,"excerpt":"\u00a0 \u00a0 The Central Consumer Protection Authority (CCPA) has issued an Advisory to e-commerce entities concerning the sale of Ayurvedic, Siddha and Unani drugs containing ingredients listed in Schedule E (1) of the Drugs and Cosmetics Rules, 1945. E-commerce platforms have been advised that the sale or facilitating the sale\u2026","rel":"","context":"In "Hot Off The Press"","block_context":{"text":"Hot Off The Press","link":"https:\/\/www.scconline.com\/blog\/post\/category\/news\/hot_off_the_press\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2019\/03\/consumer-protection.jpg?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2019\/03\/consumer-protection.jpg?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2019\/03\/consumer-protection.jpg?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2019\/03\/consumer-protection.jpg?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2019\/03\/consumer-protection.jpg?resize=1050%2C600&ssl=1 3x"},"classes":[]},{"id":207283,"url":"https:\/\/www.scconline.com\/blog\/post\/2018\/12\/27\/madras-hc-suspends-operation-of-order-banning-sale-of-medicines-by-e-pharmacies\/","url_meta":{"origin":353344,"position":4},"title":"Madras HC suspends operation of order banning sale of medicines by e-pharmacies","author":"Bhumika Indulia","date":"December 27, 2018","format":false,"excerpt":"Madras High Court: Petitioner had approached this Court before a Single Judge Bench of Pushpa Sathyanarayana, J., with a prayer to block the link of all websites involved in online sale of Schedules H, H1 and Schedule X medicines which is in violation of Rules 65 and 97 of the\u2026","rel":"","context":"In "Case Briefs"","block_context":{"text":"Case Briefs","link":"https:\/\/www.scconline.com\/blog\/post\/category\/casebriefs\/"},"img":{"alt_text":"","src":"","width":0,"height":0},"classes":[]},{"id":265166,"url":"https:\/\/www.scconline.com\/blog\/post\/2022\/04\/08\/application-for-renewal-of-license-to-be-made-within-18-months-of-expiry-vide-drugs-4th-amendment-rules-2022\/","url_meta":{"origin":353344,"position":5},"title":"Application for renewal of license to be made within 18 months of expiry vide Drugs (4th Amendment) Rules, 2022","author":"Bhumika Indulia","date":"April 8, 2022","format":false,"excerpt":"On April 04, 2022, the Central Government has notified the Drugs (4th Amendment) Rules, 2022 to further amend the Drugs Rules, 1945. This has come into force on April 4, 2022. \u00a0 Key points: In Rule 153 and 153 A which deals with\u00a0 'Application for licence to manufacture Ayurvedic (including\u2026","rel":"","context":"In "Legislation Updates"","block_context":{"text":"Legislation Updates","link":"https:\/\/www.scconline.com\/blog\/post\/category\/legislationupdates\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2022\/04\/MicrosoftTeams-image-161.jpg?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2022\/04\/MicrosoftTeams-image-161.jpg?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2022\/04\/MicrosoftTeams-image-161.jpg?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2022\/04\/MicrosoftTeams-image-161.jpg?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2022\/04\/MicrosoftTeams-image-161.jpg?resize=1050%2C600&ssl=1 3x"},"classes":[]}],"amp_enabled":true,"_links":{"self":[{"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/posts\/353344","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/users\/67526"}],"replies":[{"embeddable":true,"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/comments?post=353344"}],"version-history":[{"count":0,"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/posts\/353344\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/media\/353349"}],"wp:attachment":[{"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/media?parent=353344"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/categories?post=353344"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/tags?post=353344"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}