There has been a spate of recent reports that among the actionable items under the 100-day agenda of the re-elected Narendra Modi government, the Ministry of Health and Family Welfare (MOH) wants to ban Electronic Nicotine Delivery Systems (ENDS). Backed by scientific research, ENDS products have emerged as a possible alternative to smokers who are not able to quit smoking. These products, while providing the smokers an opportunity to satiate the craving for nicotine — an addictive substance — do not force the smokers to inhale “smoke” from the combustion of tobacco leaves as in traditional combustible cigarettes.
MOH, however, perceives the issue differently, and in fact in an obtuse manner. Whereas the MOH allows traditional cigarettes, with a proven track record of health hazards, to be readily available in the market, it has decided to stub out ENDS without even attempting a fair trial of their risks and benefits as compared to traditional combustible cigarettes.
Sequence Of Events
The intention of MOH is not quite recent. There was apparently some sort of consultation in 2013 following which six states had already notified bans on various grounds including under the Drugs and Cosmetics Act 1945 (DCA). The ban under DCA was issued as nicotine gums/lozenges of the strength of 2 mg/4mg and nicotine transdermal therapeutic patches are the only nicotine containing drugs approved by Drugs Controller General of India (DCGI). These bans are also under challenge in various High Courts.
In August 2018, the MOH had sent out an advisory to all states to prohibit the sale of ENDS. In November 2018, MOH wrote to the Ministry of Finance asking for prohibition of import of ENDS at all ports by customs authorities and customs department issued a circular directing all port offices to stop import of ENDS. Six more states issued ban orders after the advisory.
In February 2019, the Directorate General of Health Services (DGHS) shot off directions to all states and Union Territories requiring them to prohibit sales of ENDS as they are “unapproved drugs”. The stated rationale for advising the ban is that nicotine in ENDS have not been approved by DCGI and that ENDS were being sold in the market without relevant approval from the DCGI and hence such sale was in contravention of Section 18 (b) and (c) of DCA.
The move was, quite predictably challenged before the Delhi High Court which as an interim measure stayed the operation of the directions from the DGHS. The preliminary case before the High Court was that MOH’s own advisory body, the Drug Consultative Committee (DCC) had, in July 2015, in explicit and unequivocal terms opined that ENDS are not drugs and therefore not within the purview of regulations under DCA. The averment was simple, something, which is not a drug, cannot be an “unapproved drug” and powers under DCA cannot be exercised upon substances that are not drugs.
A Strange U-Turn!
MOH, therefore went on to a seemingly bizarre expedition in order to justify its otherwise legally untenable stand. In June 2019, it got the same DCC to opine that ENDS are tobacco cessation devices and therefore are drugs. A complete U-turn from DCC’s earlier stand, which not only puts an apparent question mark on the credibility of DCC’s comprehension of regulatory and legal issues but also questions its independent locus for providing consultation to the Government. DCC, after all, is more of a congregation of the State Drug Control Departments, not quite at arm’s length from the MOH.
The flip-flop of the DCC on the issue of whether ENDS are drugs or not needs examination under the purview of the definition of “Drugs” in the DCA itself. Section 3(b) of the DCA defines “drugs as any substance intended to be used for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings or any substance intended for use as components of a drug”.
It is true that a plain reading of the definition is comprehensive enough to cover smoking-cessation products containing nicotine that help people to stop smoking cigarettes or using other forms of tobacco. However, the underlying requirement for a substance to be designated as a ‘drug’ is that it should have an “intended therapeutic claim” and must be claimed as one.
The fact with ENDS is that these products do not have any therapeutic claim. No known manufacturer of ENDS has ever claimed that the products are meant for tobacco cessation or are otherwise intended for any therapeutic use. ENDS are not intended to be used for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings and therefore ENDS would fall out of the ambit of the definition of drugs. The products are simply alternative forms of nicotine delivery that do not use combustion of tobacco as means to deliver nicotine giving a choice to the smoker to choose an alternative.
The government, however, seems to have assumed upon itself the onus of making an unsubstantiated therapeutic claim in respect of ENDS just to somehow brand these products as drugs as defined under Section 3(b) of DCA, with the ultimate intent to ban them under Section 26 A of the same statute. How much more bizarre can it get!
Before taking a hasty action against ENDS on the basis of such questionably prejudiced methodology, the government needs to do some fact-checks: Has any maker of ENDS hitherto made an application for approval of any ENDS products under DCA? Are there any established therapeutic claims that have been made by ENDS manufacturers?
Presently, it seems that in the case of ENDS, MOH is just trying to justify its prejudice, without resorting to prudence. The need of the day is to bring a
sui generis regulation to regulate ENDS so that they are not misused as gateway products as is done in the United Kingdom, New Zealand et el.
Krishna Sarma is managing partner and Bhaskar Bhattacharya partner at Corporate Law Group.