The Delhi High Court, in a hearing scheduled on 17 May, extended its stay on the ban on Electronic Nicotine Delivery Systems (ENDS), until the next hearing scheduled on 22 August 2019.A two-member bench under the Chief Justice of the Delhi High Court had earlier, on May 16,denied the Centre’s appeal against the interim stay that had been imposed on the ban. So far,contrary to the Government’s position, judges presiding over multiple matters pertaining to ENDS have held that these products cannot be banned under the Drugs and Cosmetics Act.
Background of case
- In August 2018, the Ministry of Health and Family Welfare issued an advisory to states asking them to ban sales, trade, import, manufacturing and promotion of ENDS.
- In November 2018, the Central Board of Indirect Taxes and Customs (CBIC) directed customs officials to refer all import shipments of ENDS to regional Drug Controllers to check for Compliance under Drugs and Cosmetics Act.
- In February 2019, the Directorate General of Health Services (DGHS) wrote to State Drug Controllers asking them to ensure that ENDS are not sold in their jurisdiction.
- OnMarch 18, 2019, while hearing a writ petition filed by importers, Hon’ble Justice Vibhu Bakhru of Delhi High Court ordered a stay on both these documents until the May 17, 2019 hearing. He stated that since these products cannot be defined as drugs, they would not come under the jurisdiction of the DGHS.
Instead of submitting a counter-affidavit, the Government had filed an appeal against the interim stay granted on the ENDS ban. The hearing was listed before a two-member divisional bench under the Chief Justice of Delhi High Court on May 16, 2019. The Government’s Counsel argued that ENDS were akin to nicotine replacement therapy (NRT) products such as nicotine patches, gums, and would therefore, fall under the definition of ‘drug’ as per the Drugs and Cosmetics Act, 1940. However, the Chief Justice agreed with Hon’bleJustice VibhuBakhru’s stance that ENDScannot be defined as ‘drugs’ and therefore, cannot be regulated or banned under the Drugs and Cosmetics Act and dismissed the appeal.
The writ petitions were scheduled for the next hearing on May 17, 2019, however, counsel for the Government of India sought further time to file their counter-affidavit. The Court allowed the Government time till July 1 to file their response, post which the petitioners will have 4 weeks to file a rejoinder. The single judge also extended interim stay order until the next hearing on August 22, 2019.
So far, 10 states and union territories have banned ENDS, and most of these done so under the Drugs and Cosmetics Act, 1940. In the absence of existing relevant legislation, the Centre and State Governments attempts to ban ENDS are essentially bad in law.
Need for regulation
ENDS, or vapes, as they are commonly called, are a popular reduced harm alternative to cigarette smoking. Global scientific evidence suggests that ENDS are at least 95 per cent less harmful than tobacco smoking, and has the potential to drastically reduce the world’s tobacco burden. In India, over 1.35 million people die due to tobacco related illnesses annually.
ENDS are a sui generis product and instead of uninformed and irrational banning or prohibiting use, steps must be taken by the concerned authorities to enact regulations that will ensure its safety and quality in the market.Public health experts argue that adult smokers should be given access to quality-controlled ENDS, with the objective of reducing harm caused by cigarettes. At present, 34 out of 36 OECD countries have regulated ENDS, covering aspects of marketing, labelling, manufacturing quality, standards for contaminants and also restricting access of these products to youth. Countries like UK and US have seen significant reduction in smoking rates since ENDS have become commonly available as less harmful alternatives.