Ban on e-Cigarettes indicts tobacco industry for promoting cancer

[dropcap]I[/dropcap]N a history-making decision, the government of India has prohibited electronic cigarettes by the promulgation of the Prohibition of Electronic Cigarettes (Production, Manufacture, Import, Export, Transport, Sale, Distribution, Storage and Advertisement) Ordinance, 2019 on September 18.

The effect of the ordinance is to ban production, manufacture, import, export, transport, sale, distribution, storage and advertisement of electronic cigarettes.

The decision was preceded by extensive scientific research conducted by eminent researcher Dr Pankaj Chaturvedi of Tata Memorial Hospital, Mumbai and many others.

There are several steps which were taken before the Ordinance came into effect.

The Ministry of Health & Family Welfare, conducted a National Consultation on July 4, 2014, wherein it was recommended, the available scientific evidence indicate that Electronic Nicotine Delivery Systems (ENDS) are hazardous for an active as well as passive user and therefore constructive efforts should be made to curb its manufacture and sale. Pursuant to the said recommendations of the national consultations, Ministry of Health & Family Welfare constituted sub-groups to consider the issue of banning/regulating ENDS in India. Thereafter, these sub-groups submitted its report in August 2017, and inter -alia recommended imposing a complete ban on the manufacture, import and sale of ENDS.

After examining the sub-group reports and orders issued by various State Governments to ban ENDS, it was realised that before issuing appropriate guidelines/advisory, to all State Governments/UT`s for regulating including banning the manufacture, import, sale and any kind trade-in nicotine (other than for therapeutic use approved and prescribed under Drugs & Cosmetic Act) or any device such as ENDS or E-Cigarettes, a wider consultation/deliberation was organised in June, 2018, wherein one of the key recommendations of the Consultation was that in view of the threat from new and emerging tobacco products like ENDS, Heat- Not-Burn products, the Ministry of Health & Family Welfare to develop its policy to prohibit such products based on the existing scientific evidence and global best practices and accordingly send advisories to the States.

In the background of the available scientific evidence, reports/recommendations of sub-groups, orders of various State governments, statutory provisions, judicial orders and global best practice on ENDS or e-Cigarettes and the like devices, the MoHFW on 28.08.18, issued an advisory to the State Governments/Union Territories in larger public health interest and in order to prevent the initiation of ENDS by non-smokers and youth with special attention to vulnerable groups, to ensure that any ENDS including e-Cigarettes, Heat-Not-Burn devices, Vape, e-Sheesha, e-Nicotine Flavoured Hookah, and the like devices that enable nicotine delivery are not sold (including online sale), manufactured, distributed, traded, imported and advertised in their jurisdictions, except for the purpose & in the manner and to the extent, as may be approved under the Drugs and Cosmetics Act, 1940 and Rules made thereunder.

The  Central Board of Excise and Customs (Anti-Smuggling Unit), Department of Revenue had issued a Circular dated 27th November, 2018 to Customs Field Formations to ensure implementation of MoHFW's Advisory by referring import consignments of ENDS including e-cigarettes , Heat-Not-Burn devices, Vape, e-Sheesha, e-Nicotine Flavoured Hookah, and the like devices/products to the Assistant/Deputy Drugs Controller in their jurisdiction, who may thereafter check the compliance of such goods in terms of Drugs and Cosmetics Act, 1940 and the rules made thereunder. Based on the reports of the Assistant/Deputy Drugs Controller, non-compliant consignments should not be allowed clearance and appropriate action should be initiated for violation of provisions of the allied Act.

The Central Drugs Standard Control Organisation (CDSCO) vide letter dated 22nd February, 2019 informed State/UT Drug Controllers that 'since no ENDS including e-cigarettes, Heat- Not Burn devices, Vape, e-Sheesha, e-Nicotine Flavoured Hookah and the like products has not yet been approved under Drugs and Cosmetics Act, 1940 and the Rules made thereunder and directed to ensure that any ENDS including e-cigarettes, Heat-Not Burn devices, Vape, e-Sheesha, e-Nicotine Flavoured Hookah and the like devices that enable nicotine delivery, are not sold (including on-line sale), manufactured, distributed, traded, imported and advertised in respective jurisdictions.

The State Governments of Punjab [Vide Circular dated 5.9.13]; Maharashtra [vide circular dated 17.01.2014]; Karnataka [Vide Circular dated 15.06.2016]; Mizoram [Vide Circular dated 08.06.2016]; Kerala [Vide Order dated 01.08.2016]; Jammu & Kashmir [Vide Circular dated 24.07.2017]; Uttar Pradesh [Vide Order dated 14.11.2017]; Bihar [Vide Order dated 28.11.2017] have prohibited the manufacture, distribution, import and sale of Electronic Nicotine Delivery Systems (ENDS). States of Tamil Nadu (03.09.2018), Punjab (03.10.2018), Himachal Pradesh (11.09.2018), Jharkhand (07.03.2019) and Union Territory of Puducherry (23.01.2019) have issued circulars/orders for the prohibition of ENDS and ENDS like products in the interest of public health.

Prosecutions 

Apart from administrative orders, prosecutions have been launched in the state of Punjab in relation to the sale of electronic cigarettes. (para 18) Complaint Case No. 09 dated February 5, 2015, at S.A.S Nagar, Mohali. As per the Order of sentence, the convict failed to produce any valid drug sale license. An E-cigarette contains nicotine in the chemical form which is addictive and lethal. In today's society, the youth take up to such kind of addictive and potentially lethal products and the offenders involved in promoting and selling such products should be dealt with sternly by law for the welfare of society.

No regulatory framework in place 

The truth is there was no regulatory regime to govern electronic cigarettes and as consequences manufacturers were manufacturing or smuggling electronic cigarettes into the country.

It is rumoured that manufacturers of these electronic cigarettes are none other  but cigarette manufactures themselves. In other words, what have become difficult to do because of the effective ban on tobacco advertising under the Cigarettes and other Tobacco Products (Prohibition of Advertisement and Regulation of Trade and Commerce, Production, Supply and Distribution) Act, 2003 (COTPA, 2003) was now being done by delivering nicotine through electronic cigarettes.

As the ordinance indicates, India is a signatory to the World Health Organisation Framework Convention on Tobacco Control adopted in Geneva, Switzerland on May 21, 2003, and brought into force on February 27, 2005.

India has also committed itself to regulate electronic cigarettes at the Conference of Parties established under article 23 of the said Convention which took a decision on October 18, 2014, to consider prohibiting or regulating the electronic cigarettes.

Legislative Recognition of Harmful effects of smoking 

For the first time in Indian legal history, we have acknowledged the fact that these devices are injurious to public health and proliferation of these products has a negative impact on public health and  it is expedient to prohibit the production, manufacture, import, export, transport, sale, distribution, storage and advertisement of electronic cigarettes as enjoined by Article 47 of the Constitution of India.

Tobacco is a carcinogen

The ban is historic because the tobacco industry has been in denial mode that tobacco causes cancer and poses a threat to public health.

It has been three decades now since there has been litigation in the United States holding the tobacco industry responsible for deteriorating public health on account of of being a carcinogen. The courts in the United States impose large monitory fines on the tobacco companies to compensate state government for public expenditure on improving the public health system.

The ordinance by one stroke of pen acknowledges this impact, something we have been struggling to do in the courts.

The Health Minister Harsh Vardhan has been focusing his undivided attention on the matters related to public health. That apart Dr Anubumani Ramdoss, who was also the health minister under the UPA government between 2004 to 2009, had implemented the COTPA, 2003 with great vigour.

Threatened litigation by industry 

As we all know the tobacco industry is endowed with unlimited funds and resources throughout the world. They have consistently hired senior most lawyers to challenge the COTPA Act 2003. Some of the challenges are still pending.

I distinctly remember arguing the petition against Indian Tabaco Company (ITC) in the Supreme Court challenging the order of Delhi High Court banning smoking in all public spaces. In Court No 2, before the bench presided by Justice B N Agarwal, I heard the late Mr Arun Jaitely and Mr Harish Salve asking for the overturning of order on behalf of ICT. I laughed and told the judges: "My Lord Mr Jaitely is not a smoker for good reasons and Mr Salve calls himself a reformed smoker". The judge also laughed and passed order upholding the ban on smoking in public places which holds till today.

Not a Drug 

The truth is that although electronic cigarettes are claimed to be a therapeutic form to help people get off smoking, it is not classified as a drug under the Drugs and Cosmetics Act, 1940. This is what made   the Ordinance necessary and the government must be congratulated on focusing on public health.

The first of the tobacco control cases to go to court was the case of the late Murli Deora who had a total commitment to eliminate tobacco consumption in India for health reasons. It was in his petition that Justice M B Shah held that there must be no smoking in public places. This latter became a law. It is to Murli Deora who was a class mate of mine to whom much of the credit for awareness of the need for tobacco control should go and it was he who introduced me to the public health hazards of tobacco world-wide.

(With inputs from Dr Pankaj Chaturvedi)