Allahabad High Court
M/S Somendra Medical Store Baghauli ... vs U.O.I. Thru. Ministry Of Drugs ... on 15 October, 2025
HIGH COURT OF JUDICATURE AT ALLAHABAD, LUCKNOW BENCH
Neutral Citation No. - 2025:AHC-LKO:64230-DB
HIGH COURT OF JUDICATURE AT ALLAHABAD
LUCKNOW
WRIT - C No. - 10078 of 2025
M/S Somendra Medical Store Baghauli Hardoi Thru. Proprietor Somendra Gupta
.....Petitioner(s)
Versus
U.O.I. Thru. Ministry Of Drugs Controller General Of India/D.G. Health/Family Welfare And 5 Others
.....Respondent(s)
Counsel for Petitioner(s)
:
Santosh Kumar Gupta
Counsel for Respondent(s)
:
A.S.G.I., C.S.C.
Court No. - 3
HON'BLE SHEKHAR B. SARAF, J.
HON'BLE PRASHANT KUMAR, J.
1. Heard Shri Santosh Kumar Gupta, learned counsel for the petitioner, Shri Ambrish Rai, learned standing counsel for respondent No.1 and Shri Ajay Kumar Singh Tomar, learned counsel for respondent Nos.2 to 5.
2. This is an application under Article 226 of the Constitution of India wherein the writ petitioner is aggrieved by an order dated September 26, 2025 passed by the Drugs Inspector, District Hardoi being the respondent No.6 in the writ petition. By virtue of this order, medical shop of the petitioner has been sealed and he has been prohibited from carrying on his business.
3. Learned counsel appearing on behalf of the petitioner has submitted that the entire action of the authorities is in violation of Articles 14 and 19 (i)(g) of the Constitution of India. He has further relied on the Supreme Court judgment passed in M/S Bhagwati Medical Hall & Anr. vs. Central Drugs Standard Control Organization & ors. (Civil Appeal Nos.14735-14736 of 2024) to buttress his arguments that the action of respondents are in complete derogation of the orders passed by the Supreme Court.
4. Learned counsel appearing on behalf of the respondent has submitted that bottles that have been seized of Orange Tincture has been sent on September 26, 2025 to the Forensic Lab for testing and the report is awaited. It is to be noted that in M/S Bhagwati Medical Hall (supra), the matter had come up before the Supreme Court against the order passed by High Court of Judicature at Allahabad wherein the High Court had upheld the order passed by the Drug Controller. The Supreme Court after examining the relevant sections including Section 22(i)(d) of the Drugs and Control Act, 1940 and Section 26(a) of the said Act came to the following findings:-
"7. The aromatic tincture of cardamom at issue is governed by the D&C Act, 1940 and the rules framed thereunder. Under this statutory framework, the manufacture, sale, and distribution of drugs are subject to a carefully calibrated regulatory regime. The D&C Act, 1940 classifies drugs, prescribes licensing requirements, mandates compliance with quality standards, and delineates the respective powers of Central and State authorities. Crucially, the power to impose a prohibition or to declare a drug as banned or restricted for reasons of public interest lies exclusively with the Central Government, as provided in Section 26A of the D&C Act, 1940, which has been reproduced hereunder:
?Section 26A: Powers of Central Government to regulate, restrict or prohibit manufacture, etc., of drug and cosmetic in public interest: Without prejudice to any other provision contained in this Chapter, if the Central Government is satisfied, that the use of any drug or cosmetic is likely to involve any risk to human
beings or animals or that any drug does not have the therapeutic value claimed or purported to be claimed for it or contains ingredients and in such quantity for which there is no therapeutic justification and that in the public interest it is necessary or expedient so to do, then, that Government may, by notification in the Official Gazette, [regulate, restrict or prohibit] the manufacture, sale or distribution of such drug or cosmetic.?
8. Section 26A of the D&C Act, 1940 empowers the Central Government, if satisfied that the use of any drug involves risk to human beings or animals, or that it lacks the therapeutic value claimed, or that it contains ingredients in a quantity for which there is no therapeutic justification, to regulate, restrict, or prohibit its manufacture, sale, or distribution by a notification in the Official Gazette. This is the sole statutory mechanism through which a drug, previously permissible, can be effectively taken off the market or subjected to special conditions. The provision ensures that any decision to restrict a drug stem from a central, uniform, and scientifically informed process, guided by expert advice, safety evaluations, and considered policy determinations. This centralized approach is deliberate, aimed at preventing arbitrary or inconsistent local measures that would fragment the national drug regulatory regime.
9. In the present case, there is no notification issued under Section 26A of the D&C Act, 1940 prohibiting or restricting the aromatic tincture of cardamom. The absence of such a notification is decisive. Without it, the tincture remains a licensed medicinal preparation that can be manufactured and sold in accordance with the general rules and the conditions of the license held by the Appellants. The Respondent authorities cannot, on their own accord, treat this lawful product as a ?prohibited article.? Any such classification by subordinate authorities would undermine the statutory scheme, which deliberately centralizes the ultimate decision-making power over prohibition with the Central Government. To hold otherwise would effectively allow local officials to unilaterally bypass the checks and balances embedded in the Act, and to create, in practice, an ad hoc ban outside the statutory process.
10. It must be noted that the ?aromatic tincture of cardamom? is not ?prohibited? as can be seen from the list of prohibited drugs as issued by the Ministry of Health and Family Welfare through their gazette notifications which has been attached as Annexure P17 before us. The said tincture is prepared by licensed manufactures who are duly approved by the Indian Government and the appellant procures the same from one such supplied, i.e. British Pharmacopoeia which is approved by the Indian Government. The Tincture list in British Pharmacopoeia 2022 has the following approved tinctures and serial number 11 contains Cardamom Tincture Compound:
1. Capsicum Tincture
2. Camphorated Opium Tincture
3. Concentrated Camphorated Opium Tincture
4. Bitter Orange Epicarp and Mesocarp Tincture
5. Orange Tincture
6. Arnica Tincture
7. Aromatic Cardamom Tincture
8. Belladonna Tincture
9. Belladonna Tincture Compound
10. Capsicum Tincture Standardized
11. Cardamom Tincture Compound
12. Compound Benzoin Tincture
13. Compound Cardamom Tincture
14. Compound Rhubarb Tincture
15. Concentrated Camphorated Opium Tincture
16. Gentian Tincture
17. Ginger Tincture
18. Ipecacuanha Tincture Standardized
19. Myrrh Tincture
20. Opium Tincture
21. Opium Tincture Camphorated
22. Opium Tincture Concentrated Camphorated
23. Opium Tincture Standardized
24. Quillaia Tincture
25. Rhatany Tincture
26. Sage Tincture
27. Siam Benzoin Tincture
28. Standardized Belladonna Leaf Tincture
29. Standardized Ipecacuanha Tincture
30. Strong Ginger Tincture
31. Sumatra Benzoin Tincture
32. Tormentil Tincture
33. Valerian Tincture
11. The Respondent authorities have attempted to justify their actions by relying on Section 22(1)(d) of the D&C Act, 1940. This provision empowers Inspectors, within the local limits of their jurisdiction, to exercise such powers as may be necessary for carrying out the purposes of the Chapter or any rules made thereunder. The scope of this provision is essentially procedural, intended to facilitate inspection, sampling, seizure of non-compliant drugs, and enforcement of existing statutory and regulatory requirements. It does not, however, confer authority to impose new prohibitions or to classify a duly licensed drug as contraband. Section 22(1)(d) is not a substitute for Section 26A of the D&C Act, 1940. While an Inspector may inspect premises, verify licenses, ensure proper record-keeping, and take action against specific offenses under the Act, the Inspector cannot supplant the Central Government?s prerogative by effectively banning a drug simply because of alleged misuse in certain quarters.
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13. By endorsing the characterization of the aromatic tincture of cardamom as a ?prohibited article? without any notification from the Central Government, the impugned orders of the High Court have effectively circumvented the legislative design. The High Court?s reasoning overlooks the clear distinction drawn by the D&C Act, 1940 between general regulatory authority and the special, centralized power to prohibit drugs. This approach also disregards the rights of a duly licensed trader who is entitled to carry on business in a product that remains lawful unless and until lawfully prohibited. Fundamental principles of administrative law, as well as the very structure of the D&C Act, 1940, demand that any restriction on a licensed medicinal preparation must rest on a firm statutory footing.
14. It follows that the impugned orders dated 12.07.2022 and 22.09.2022 must be set aside. The Appellants, holding a valid license and acting within the boundaries of existing regulations, are entitled to resume their business of selling the aromatic tincture of cardamom and any other duly permitted medicines. The Respondent authorities, if genuinely concerned about misuse, may intensify lawful regulatory oversight, ensuring strict compliance with licensing conditions and quality standards. However, they cannot assume the power to declare the product banned or treat it as such in the absence of a notification under Section 26A of the D&C Act, 1940. The statutory scheme envisions uniformity, predictability, and legal certainty? values that would be undermined if local authorities could unilaterally impose prohibitions contrary to the nationally determined regime.
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17. Consequently, the orders dated 28.02.2022 and 11.04.2022 issued by the Respondent No.5 and Respondent No.8 are also quashed. It is further directed that the Respondent authorities shall not, in the absence of any valid prohibition or restriction notified by the Central Government under the D&C Act, 1940 or the rules made thereunder, impose any limitations, conditions, or curbs on the Appellants? lawful business activities relating to the sale, distribution, and wholesaling of the aromatic tincture of cardamom or any other duly licensed medicine. The Appellants shall be entitled to carry on their trade in accordance with their valid license and all applicable statutory provisions, free from unwarranted interference."
5. The ratio that emerges from the judgment of Supreme Court is that Orange Tincture is not a prohibited item in the list of prohibited drugs as issued by the Ministry of Health and Family Welfare. Such being the case, the characterization of the Orange Tincture as a prohibited article by the authorities is in contravention of the laws and accordingly we are duty-bound to strike down any action in absence of a gazette notification prohibiting the particular item. The statutory scheme envisions uniformity, predictability, and legal certainty? values that would be undermined if local authorities could unilaterally impose prohibitions contrary to the nationally determined regime.
6. The Supreme Court has further specifically directed that the respondent authorities in absence of any valid prohibition or restriction notified by the Central Government under the D&C Act, 1940 or the rules made thereunder, impose any limitations, conditions, or curbs on the appellants? lawful business activities relating to the sale, distribution, and wholesaling of the aromatic tincture of cardamom or any other duly licensed medicine.
7. The Supreme Court has further clarified that the petitioner's should be entitled to carry on his trade in accordance with his valid license and all applicable statutory provisions, free from unwarranted interference.
8. In view of above discussion, it is clear that action of the authorities is de hors the legislative intent and is not backed by any statutory authority. Accordingly, the impugned order dated September 26, 2025 is quashed and set aside and the authorities are directed to immediately de-seal the medical shop of the petitioner within a period of two days from date.
9. With the above directions, the writ petition is allowed.
10. We make it clear that if the report of forensic lab indicates that the petitioner is selling any prohibited items, the authority shall be at liberty to take action in accordance with law.
(Prashant Kumar,J.) (Shekhar B. Saraf,J.)
October 15, 2025
Saurabh Yadav/-
