Summary
The Supreme Court held that local drug and excise authorities could not treat aromatic tincture of cardamom, a licensed medicinal preparation, as a prohibited article because of its alcohol content and alleged misuse. Only the Central Government may prohibit or restrict a drug, by Gazette notification under Section 26A of the Drugs and Cosmetics Act, 1940, and no such notification existed; Section 22(1)(d) gives Inspectors no power to ban a drug.
Issues
- Whether State authorities could restrict or stop the sale of aromatic tincture of cardamom by licensed chemists, treating it as a prohibited article, in the absence of a Central Government notification under Section 26A of the Drugs and Cosmetics Act, 1940.
- Whether the Inspector's powers under Section 22(1)(d) of the Act authorise such a restriction on account of alleged misuse of the tincture as an intoxicant.
Provisions considered
- Section 26A, Drugs and Cosmetics Act, 1940Read as the sole statutory mechanism by which a lawful drug can be regulated, restricted or prohibited in the public interest, exercisable only by the Central Government on the stated satisfaction and by notification in the Official Gazette. As no notification covered aromatic tincture of cardamom, it remained a lawful licensed preparation. (¶¶ 7, 8, 9, 12, 14)
- Section 22(1)(d), Drugs and Cosmetics Act, 1940Held to be essentially procedural, enabling Inspectors to exercise powers needed to carry out the Chapter, such as inspection, sampling, seizure of non-compliant drugs and enforcement of existing requirements; it does not authorise new prohibitions or treating a licensed drug as contraband and is no substitute for Section 26A. (¶ 11)
- Article 19(1)(g), Constitution of IndiaThe appellants' right to carry on lawful trade was invoked; the Court held that a duly licensed trader is entitled to deal in a product that remains lawful until lawfully prohibited, and any restriction must rest on a firm statutory footing. (¶¶ 4.2, 13)
Held
- The power to prohibit, ban or restrict a drug in the public interest lies exclusively with the Central Government under Section 26A, exercised by Gazette notification after a central, uniform and expert-informed process; this centralisation is deliberate, to prevent arbitrary or inconsistent local bans. (¶¶ 7, 8)
- In the absence of a Section 26A notification covering aromatic tincture of cardamom (which did not appear in the Ministry's list of prohibited drugs), it remained a licensed medicinal preparation, and subordinate authorities could not of their own accord classify it as a prohibited article or create an ad hoc ban. (¶¶ 9, 10)
- Section 22(1)(d) does not empower a Drug Inspector to impose new prohibitions or effectively ban a licensed drug because of alleged misuse in some quarters; the Inspector may inspect premises, verify licences, ensure record-keeping and act against specific offences under the Act. (¶ 11)
- Concerns about high alcohol content or misuse must be addressed through mechanisms within the Act and Rules, such as insisting on proper records, the presence of a qualified pharmacist at the time of sale, regular inspections and penal action for breach of licence conditions; if the authorities consider prohibition necessary, their recourse is to move the Central Government under Section 26A. (¶¶ 12, 14)
- The High Court erred in endorsing the characterisation of the tincture as a prohibited article without any Central notification, overlooking the Act's distinction between general regulatory authority and the special, centralised power to prohibit, and the rights of a licensed trader. (¶ 13)
Result
Appeals allowed; High Court orders dated 12.07.2022 and 22.09.2022 set aside; the District Magistrate's order dated 28.02.2022 and the Drug Inspector's direction dated 11.04.2022 quashed; authorities directed not to curb the appellants' licensed trade in aromatic tincture of cardamom or other licensed medicines absent a valid Central Government prohibition or restriction, while remaining free to enforce licence conditions lawfully.