LexM/S BHAGWATI MEDICAL HALL & ANR. versus CENTRAL DRUGS STANDARD CONTROL ORGANIZATION & ORS
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[2024] 12 S.C.R. 2102 : 2024 INSC 1048 M/s Bhagwati Medical Hall & Anr. v. Central Drugs Standard Control Organization & Ors. (Civil Appeal No(s). 14735-14736 of 2024) 19 December 2024 [Vikram Nath and Prasanna B. Varale, JJ.] Issue for Consideration Whether District Magistrate’s order prohibiting sale of 'aromatic tincture of cardamom' on the ground of it containing a high level of alcohol was correct and in accordance with the statutory framework of Drugs & Cosmetics Act, 1940. Headnotes† Drugs and Cosmetics Act, 1940 (D&C Act) – District Magistrate (DM), Agra issued orders prohibiting sale of “alcohol mixed tinctures” – Drug Inspector acted on said orders and prevented Appellants from selling “aromatic tincture of cardamom” on the ground that it was an alcohol mixed tincture – Appellants, being licensed distributor of “aromatic tincture of cardamom” under D&C Act objected to such prohibition and challenged said actions of Respondents before High Court – Dismissed; review petition also dismissed by High Court – Appellants approached Supreme Court: Held: The Court held that under D&C Act, power to ban or categorize any drug as prohibited article in public interest vests solely with the Central Government under Section 26A of the D&C Act – Such legislative scheme of centralised decision-making is deliberate to prevent fragmentation of drug regulatory regime in India and to ensure uniformity and avoid inconsistent local measures. [Paras 7-9] On facts, the Court found no notification issued by Central Government prohibiting / restricting trade of “aromatic tincture of cardamom” – It also referred to the list of prohibited drugs issued by the Ministry of Health and Family Welfare through their gazette notifications that was attached as Annexure P17 with the special leave petition. [Para 10] [2024] 12 S.C.R. 2103 M/s Bhagwati Medical Hall & Anr. v. Central Drugs Standard Control Organization & Ors. Thus, the directions issued by the DM was held to be against the legislative scheme of D&C Act. – Respondents’ reliance on Section 22(1)(d) of D&C Act to justify their actions was rejected by the Court for the reason that the said provision was procedural in nature and was limited to inspecting, sampling, seizing non-compliant drugs, and in all enforcing the existing statutory framework and could not be a substitute for Central Government’s prerogative under Section 26A of D&C Act. [Para 11] The Court found that High Court failed to appreciate the distinction between general regulatory authority and the special, centralized power to prohibit drugs under D&C Act; that also adversely impacted the rights of the Appellants in this case who were a duly licensed trader. [Para 13] List of Acts Drugs & Cosmetics Act, 1940; Constitution of India. List of Keywords Prohibited article; Aromatic Tincture of cardamom; Alcohol mixed tincture; Restriction; Sale; Ban; prohibition; Public interest; Medicine; Section 26A and Section 22 of Drugs & Cosmetics Act; Central government; Local authorities. Case Arising From CIVIL APPELLATE JURISDICTION: Civil Appeal No(s). 14735- 14736 of 2024 From the Judgment and Order dated 12.07.2022 and 22.09.2022 of the High Court of Judicature at Allahabad in WRITC No. 13134 of 2022 and CMRA No. 355 of 2022 respectively Appearances for Parties Nikhil Goel, Sr. Adv., Ms. Parul Shukla, Ms. Shubhangi Pandey, Saday Mondol, Advs. for the Appellants. K M Nataraj, A.S.G., Samar Vijay Singh, Ms. Sabarni Som, Fateh Singh, Keshav Mittal, Dr. Sukhdev Sharma, Venkatesh Rajput, Santosh Kumar, Sharath Nambiar, Vinayak Sharma, B K Satija, Annirudha Sharma- II, Amrish Kumar Sharma, Gurmeet Singh Makker, Advs. for the Respondents. 2104 [2024] 12 S.C.R. Supreme Court Reports Judgment / Order of the Supreme Court Order 1. Leave granted. 2. These appeals, by the Appellants, challenge the correctness of the orders dated 12.07.2022 and 22.09.2022 passed by the High Court of Judicature at Allahabad in Writ C No.13134 of 2022 and Civil Misc. Review Application No.355 of 2022, respectively. By the impugned orders, the High Court dismissed the writ petition as well as the review petition preferred by the Appellants, thereby upholding the actions taken by the Respondent authorities restricting the sale of a medicinal preparation known as “aromatic tincture of cardamom” at the Appellants’ medical shops. 3. The factual background giving rise to the present appeals are as follo
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