Drugs Inspector can’t ban product in absence of Central govt notification: SC

New Delhi, Jan 9 (IANS) The Supreme Court has ruled that in the absence of notification issued by the Central government prohibiting “aromatic tincture of cardamom”, a Drugs Inspector lacks authority to impose new prohibitions or to classify a duly licensed drug as contraband.

A bench of Justices Vikram Nath and P.B. Varale was hearing special leave petitions filed against the decision of the Allahabad High Court upholding the restrictions imposed on sale of a medicinal preparation known as “aromatic tincture of cardamom” at the appellants’ medical shops.

The appellants, engaged in the wholesale and retail sale of drugs and medicines at Uttar Pradesh’s Agra, hold valid and subsisting licenses under the Drugs & Cosmetics Act, 1940 and the rules framed thereunder, permitting them to sell, stock, and distribute various drugs, including a herbal medicinal preparation commonly referred to as “aromatic tincture of cardamom”.

Before the Supreme Court, they complained that despite the lawful nature of their business, the authorities, including officers from the Drug Control and Excise Departments, subjected their shops to repeated inspections, abrupt closures, and harassment. Further grievances arose when the District Magistrate (DM) of Agra constituted a joint team to curb the sale of “alcohol mixed tinctures”, and the Drug Inspector thereafter, in April 2022, directed the appellants not to sell “aromatic tincture of cardamom”.

The appellants sought restoration of their right to carry on their business in accordance with their valid license and the statutory provisions. As per the appellants, the said tincture is a non-prescription, licensed medicine recognised under the 1940 Act and is used for treating mild ailments such as indigestion, flatulence, stomach pain, nausea, and vomiting.

The tincture is manufactured by licensed manufacturers who are approved by the Union government, and they procured their supplies from such recognised sources, including the British Pharmacopoeia-approved suppliers, contended the appellants.

They added that the Allahabad High Court erred in categorising aromatic tincture of cardamom as a “prohibited article” and no such prohibition exists under the Drugs & Cosmetics Act, 1940, or any notification issued thereunder.

Under Section 26A, only the Central government can regulate, restrict, or prohibit the sale and distribution of any drug in the public interest, and there being no notification prohibiting this particular tincture, the authorities had no jurisdiction to treat it as a banned substance, said the appellants.

Referring to multiple RTI responses received from different governmental departments, the appellants said that aromatic tincture of cardamom is a licensed medicine and does not require a doctor’s prescription and therefore, the restriction placed by the authorities was wholly unjustified and arbitrary.

On the other hand, the authorities argued that the manner of sale and the demographics of the customers indicate that the tincture is effectively being used as an intoxicant rather than a medicinal preparation and the substance is being misused as a cheap substitute for country liquor by vulnerable sections of society, including daily-wage earners and rickshaw pullers.

Further, the authorities claimed that the misuse is causing substantial revenue losses, as the tincture is replacing taxed country liquor.

After considering the arguments advanced by both sides, the Supreme Court said that it is clear that the action taken by the authorities “lacks a sustainable reasoning”.

“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,” ruled the apex court.

In the present case, there is no notification issued prohibiting or restricting the aromatic tincture of cardamom and 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, it added.

The Supreme Court said that the authorities cannot, on their own accord, treat this lawful product as a “prohibited article”.

It further said: “Any such classification by subordinate authorities would undermine the statutory scheme, which deliberately centralises 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.”

Setting aside the impugned orders of the Allahabad HC, the Supreme Court held that the appellants are entitled to resume their business of selling the aromatic tincture of cardamom and any other duly permitted medicines.

The authorities, if genuinely concerned about misuse, may intensify lawful regulatory oversight, ensuring strict compliance with licensing conditions and quality standards but 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 Drugs & Cosmetics Act, 1940, said the apex court.

–IANS

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