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]
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]
As published in the Supreme Court Reports, Supreme Court of India. Headnotes prepared by: Niti Richhariya, Hony. Associate Editor (Verified by: Abhinav Mukerji, Sr. Adv.). Text from the Indian Supreme Court Judgments open data set (Dattam Labs), CC BY 4.0.
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