The Bombay High Court has disposed of petitions concerning the sale of nicotine pouches at duty-free shops at Mumbai airport, leaving open the question of whether such products fall within the definition of ‘drug’ under Section 3(b) of the Drugs and Cosmetics Act, 1940.
A Division Bench of Justice Suman Shyam and Justice Advait M. Sethna held that determining whether nicotine pouches qualify as ‘drugs’ would require a factual examination of their composition and specifications. The Court noted that the petitioners had not furnished the product specifications and that it was therefore unable to determine whether the products fell within Section 3(b), or whether any exemption under Schedule D or Schedule K applied.
The Court further observed that the Drug Controller could insist upon a licence or impose a ban only if the product was established to be a ‘drug’ within the meaning of Section 3(b). It found that the requisite jurisdictional facts had not been clearly established in the present case.
While the Court did not set aside the impugned communication banning the sale, it permitted the petitioners to make fresh representations before the appropriate authority, including the CDSCO, along with supporting material to establish that the products were either not ‘drugs’ or were covered by the applicable exemptions. The authorities have been directed to consider such representations on merits and pass a reasoned order, if filed within four weeks, within 30 days of receiving the representations.
The petitions were accordingly disposed of with no order as to costs.
