CHENNAI: Will Electronic Cigarettes, said to be free of the harmful ingredient of tobacco, come under the purview of the Drugs and Cosmetics Act, 1940?
Madras High Court is witness to this interesting debate!
While Steamz Agro India Private Limited in Ponniammanmedu claimed that the innovative product was not a drug and would not come under the regime of the 1940 Act, Director of Drugs Control and his subordinate Inspectors contended that one of its ingredients contained nicotine, bringing it naturally under the ambit of the legislation.
According to petitioner company, started in 2011, it was engaged in the manufacture of electronic cigarettes and had distributors throughout the country
. It had obtained ATC certificate of compliance of EC Council Directive with regard to electromagnetic compatibility in June, 2009. The Sargam Laboratory too reported in October 2012 that the product had no integral part to constitute the same as a drug.
However, the Drug Inspectors in Teynampet, Madhavaram, Tiruvotriyur and Meenambakkam ranges raided the company premises and its branches in the City on August 29 last year and seized all the goods stored holding that the products were drugs stored in contravention of Sec. 18(c) of the Drugs and Cosmetics Act.
Under Sec. 3(b)(ii) of the Act, only substances which affect the structure or function of the human body alone could be classified as a drug.
The product is an electronic cigarette, which is 90 per cent safer than the traditional cigarettes containing tobacco.
It is not highly risky for users and does not have any adverse effect on health like that of a regular cigarette,the petitioner said and sought to quash the seizure proceedings and to return the seized products.
On the other hand, the counter filed by Additional Government Pleader P Sanjay Gandhi on behalf of the Director of Drugs Control and his subordinates pointed out that as per the label on the cartridges, the ingredients specified are water, propylene, glycol, glycerin, flavoring agent containing nicotine).
A suitable mouth piece is provided for inhalation of nicotine.Particulars such as manufacturing licence and batch numbers, content of nicotine and expiry date are not printed.
Therefore, it amounts to violation of Rule 96 of the Drugs and Cosmetics Rules, 1945 and deemed to be mis-branded as defined under Sec. 17(b) of the Act.
The nicotine inhalation cartridges is defined in the British Pharmacopoeia as nicotine-impregnated plugs for use with a suitable mouth piece. The product acts as a central nervous system stimulant and used for nicotine replacement therapy.