1. Central Government
At the sixth session of the Conference of the Parties to the WHO Framework Convention on Tobacco Control held in October 2014, parties were urged to consider regulating or prohibiting Electronic Nicotine Delivery System (“ENDS”) and restricting or banning advertisement and promotion of ENDS.[1] A national level Roundtable Discussion was held in 2014 to discuss and explore the impact of ENDS on public health. As a result of this, three sub-groups were formed i.e. Sub-Group for (i) Legal Implication on ENDS; (ii) Health Effects of ENDS; and (iii) Advocacy and Public Opinion to consider the issue of banning/regulating ENDS in India.[2] The sub-groups recommended that the manufacture, distribution, import and sale of ENDS be prohibited.
Unlike cigarettes, ENDS are not regulated under Cigarettes and other Tobacco Products Act, 2003 (“COTPA”) as they do not fall within the definition of either “cigarette” or “tobacco product” as under the COTPA.[3]
Circular F. No- P -16012 / 19 /2017 -TC dated 28 August 2018 issued by the Ministry of Health & Family Welfare (“MoHFW Advisory”) advised the States/Union Territories to prohibit the (i) sale (including online sale); (ii) manufacture; (iii) distribution; (iv) trade; (v) import and (vi) advertisement of ENDS including electronic cigarettes (“e-cigarettes”) in their jurisdictions.[4] It is unclear as to what enabling provision/ statute the MoHFW Advisory was issued under. The Delhi High Court held that the MoHFW Advisory is not binding on the States/ Union Territories.[5]
In 2015, the Calcutta High Court had allowed a petition wherein the petitioner had claimed that their consignment of e-cigarettes had been wrongfully seized by the customs authorities for want of any provision of law restraining or prohibiting the import of e-cigarettes into the country.[6] However, on 27 November 2018, with a view to implement the MoHFW Advisory, the Central Board of Indirect Taxes and Customs issued Circular F. No- P -394/121/2018 – Cus(AS) (“Customs Circular”) that requires all import consignments of ENDS to be cleared by the Drugs Controller as being compliant with the Drugs and Cosmetics Act 1940 (the “DCA”) and the rules made thereunder.[7] This will, to a great extent ensure that the MoHFW Advisory is given effect even in States/ Union Territories that have not prohibited the manufacture, distribution, import and sale of ENDS notwithstanding the MoHFW Advisory being non-binding upon the States.
The Ministry of Electronics and Information Technology (“MEITY”) has proposed an amendment to the Information Technology (Intermediary Guidelines) Rules 2018 (“Intermediary Guidelines Amendment”) to inter alia ban the advertisement of ENDS (including e-cigarettes) except for the purpose & in the manner and to the extent, as may be approved under the DCA and rules made thereunder.[8] MEITY has since received comments[9] and counter-comments[10] on its proposal, and is yet to take any further action.
The Customs Circular as well as the proposed Intermediary Guidelines Amendment (to the extent that it deals with advertisement of ENDS) furthers the understanding that ENDS are regulated under the DCA. However, e-cigarettes are not covered under the definition of the term “drug” under section 3(b), Drugs and Cosmetics Act, 1940 and therefore cannot be regulated under the provisions of the said Act.[11] Further, in response to RTI queries, the Central Drugs Standard Control Organization (“CDSCO”) and the Director General of Health Services (“DGHS”) have stated that e-cigarettes are not regulated under the DCA.[12]
2. State Governments
The State Governments of Punjab [vide Circular dated 05 September 2013], Karnataka [vide Circular dated 15 June 2016], Mizoram [vide Circular dated 08 June 2016], Kerala [vide Circular dated 01 August 2016], Jammu & Kashmir [vide Circular dated 24 July 2017], Uttar Pradesh [vide order dated 14th November, 2017], Bihar [vide order dated 28 November 2017] and Tamil Nadu [vide order dated 03 September 2018] have prohibited the manufacture, distribution, import and sale of ENDS. In certain cases, the possession, purchase and use of e-cigarettes have also been prohibited [in Kashmir Division vide order of Divisional Commissioner Kashmir dated 10 May 2018; in Tamil Nadu vide order dated 03 September 2018].
Most of the circulars/ orders issued by the State governments appear to cite the following reasons as the basis for banning ENDS: (i) that ENDS are not approved as nicotine replacement therapies under the DCA and the rules made thereunder; (ii) that ENDS are being sold without obtaining appropriate license as required under the DCA and (iii) that the use of nicotine in food products and the consumption by public is banned under the Food Safety and Standard Act 2006 (“FSSA”) read with Notification No. F.No.2-15015/13/2010 dated 01 August 2011 and under para 2, 3, 4 of Food Safety and Standards (Prohibition and Restriction on Sales) Regulation, 2011. This would imply that ENDS are regulated under the DCA and/ or the FSSA and rules made thereunder. However, the CDSCO and the DGHS have stated that e-cigarettes are not regulated under the DCA.[13] Further, the prohibition on the use of nicotine in food products does not seem applicable in the present case as ENDS do not squarely fall within the definition of ‘food’ under the FSSA.[14]
Further, the fact that nicotine is present in traditional tobacco products such as paper rolled cigarettes and the same are not prohibited begs the question as to why a distinction is being made in the treatment of regular tobacco products and ENDS. The validity of some of these circulars prohibiting the manufacture, distribution, import, sale, possession, purchase and use have been challenged in Courts. The table below summarises the available details of such litigation.
| Name of Case | Court | Relevant Development | Documents Reviewed |
| Seema Sehgal v. Union of India and Others | Delhi High Court | Seema Sehgal filed a PIL claiming that the impact of ENDS on health are not known and therefore they should be regulated. The Court asked all respondents, including the Central Government to respond. The response and affidavit filed by the Government made it clear that it intended to ban ENDS.[15]
|
(i) Government’s Response
(ii) Affidavit filed by Government (iii) Counter Affidavit filed by Government (iv) Affidavit filed by DGHS |
| Council for Harm Reduced Alternatives v. State of Karnataka and Others
[W.P. No. 36696/2017]
|
Karnataka High Court | The petition prays for (i) the issuance of a writ of certiorari quashing the impugned Karnataka Government circular dated 15 June 2016 and (ii) the issuance of a writ of mandamus directing the Respondents to permit the use, sale and manufacture of ENDS by framing necessary regulations for this purpose, if necessary.[16]
|
(i) Memorandum of Writ Petition
(ii) Objections filed by Karnataka Government |
| Council for Harm Reduced Alternatives v. State of J&K and Others[17] | Jammu & Kashmir High Court (Srinagar Bench) | The petition prays for (i) the issuance of a writ of certiorari quashing the impugned Jammu& Kashmir Government circular dated 24 July 2017 and (ii) the issuance of a writ of mandamus directing the Respondents to permit the use, sale and manufacture of ENDS by framing necessary regulations for this purpose, if necessary.[18]
|
(i) Petition |
| Ms. Carry Edwards v. State of Tamil Nadu and Others[19] | Madras High Court | The petition prays for the issuance of a writ of certiorari quashing the impugned Tamil Nadu Government order dated 03 September 2018. The petitioner claims that the impugned order infringes her right to life with dignity and makes an unreasonable distinction between ENDS and other tobacco products. Further, the petitioner contends that there is no nexus between the impugned order and the object sought to be achieved.
|
(ii) Affidavit filed by Petitioner |
3. Collated Right to Information (RTI) Responses
| S. No. | Organisation | RTI Response | Date of Response |
| 1. | CDSCO | E-cigarettes are not regulated under the provisions of DCA and Rules 1945 there under.
|
16 April 2018 |
| 2. | DGHS | E-cigarettes for smoking are not regulated under the provisions of DCA and Rules 1945 there under.
|
29 August 2017 |
| 3. | Principal Commissioner of Customs, ACC-Import, New Customs House Delhi | Import of non-tobacco and non-nicotine electronic vaping devices and e-cigarettes alone are not banned or restricted.
Liquids containing propylene glycol, vegetable glycerine or flavouring are not banned.
Nicotine liquids of strengths 0.3mg/ml, 0.6 mg/ml, 1.2 mg/ml, 1.8 mg/ml, 3 mg/ml, 6 mg/ml are not banned and not on the restricted import list.
Import of e-cigarette & e-liquids is governed by the existing EXIM policy, DGFT Circular and rules, notifications and instructions issued by Ministry of Health.
At present no notification banning the import of accessories for non-tobacco and non-nicotine e-cigarettes has been issued by the Central Board of Excise and Customs.
|
10 May 2018 |
| 4. | Principal Commissioner of Customs (Airport & Admin), Kolkata | The import of items falling under any category that are not included in the restricted list is allowed subject to compliance with the Customs Act and rules.
The Central Customs Department has not issued any circular banning or regulating the import of non-tobacco and non-nicotine vaping devices and accessories used for smoking cessation. They are not banned and do not feature on the restricted import list with Indian Central Customs Department.
Non-tobacco and non-nicotine liquids, liquids that do not contain nicotine and contain propylene glycol, vegetable glycerine and flavours are not banned or included in the restricted import list with Indian Central Customs Department.
Nicotine liquids of strengths 0.3mg/ml, 0.6 mg/ml, 1.2 mg/ml, 1.8 mg/ml, 3 mg/ml, 6 mg/ml, 12 mg/ml, 18 mg/ml are not banned and not on the restricted import list.
|
12 March 2018 |
| 5. | Ministry of Health and Family Welfare (Tobacco Control Division) | The Division has not conducted any studies or survey in relation with e-cigarettes or to assess the harm caused by e-cigarettes vis-à-vis the harm caused by traditional cigarettes.
|
12 April 2018 |
This post was authored by Srishti Ghoshal during her internship with Ikigai Law, with inputs from Nehaa Chaudhari, Public Policy Lead, and Anirudh Rastogi, Managing Partner.
[1] Available at http://apps.who.int/gb/fctc/PDF/cop6/FCTC_COP6(9)-en.pdf (last visited on 07 February 2019).
[2]Available at http://vapeindia.org/india/govt/ (last visited on 07 February 2019).
[3] § 3(b) and 3(p), the Cigarettes and other Tobacco Products Act, 2003.
[4] Available at https://mohfw.gov.in/sites/default/files/ADVISORY%20ON%20ELECTRONIC%20NICOTINE%20DELIVERY%20SYSTEMS%20ENDS.pdf (last visited on 07 February 2019).
[5] Piyush Ahluwalia v. Union of India [W.P. (C) 12163/2018]; available at https://www.hindustantimes.com/delhi-news/government-advisory-on-e-cigarette-ban-not-binding-on-states-delhi-hc/story-itEykdxL0hTAjovpASdTPI.html (last visited on 07 February 2019); available at http://www.indialegallive.com/constitutional-law-news/courts-news/delhi-hc-tells-states-to-take-dim-view-of-centres-advisory-on-e-cigarettes-57254 (last visited on 07 February 2019); available at https://barandbench.com/wp-content/uploads/2018/11/Delhi-HC-e-Cigarette.pdf (last visited on 07 February 2019).
[6] M/s. Joybuddy Fun Products Pvt. Ltd. v. Union of India and Ors. [W.P. 26950 (W) of 2014].
[7] Available at https://thewire.in/health/three-ministries-advance-regulations-to-control-e-cigarettes (last visited on 07 February 2019).
[8] Available at https://meity.gov.in/writereaddata/files/Draft_Intermediary_Amendment_24122018.pdf (last visited on 08 February 2019); https://thewire.in/health/three-ministries-advance-regulations-to-control-e-cigarettes (last visited on 07 February 2019).
[9] Available at https://meity.gov.in/content/counter-comments-invited-comments-received-publicstakeholders-draft-%E2%80%9C-information-technology (last visited on 16 March 2019).
[10] Available at https://meity.gov.in/content/counter-comments-comments-received-draft-intermediary-guidelines-2018 (last visited on 16 March 2019).
[11] Pg. 57, Report of the 48th Meeting of the Drugs Consultative Committee available at http://www.cdsco.nic.in/writereaddata/Report-of-48th-DCC-Meeting.pdf (last visited on 01 February 2019).
[12] Available at http://vapeindia.org/india/rti-replies/(last visited on 07 February 2019).
[13] Available at http://vapeindia.org/india/rti-replies/(last visited on 07 February 2019).
[14] § 3(1)(j), the Food Safety and Standard Act 2006.
[15]Available at https://indianexpress.com/article/cities/delhi/govt-to-ban-e-cigarettes-health-ministry-tells-delhi-hc-5135393/ (last visited on 07 February 2019); available at http://vapeindia.org/india/legal/ (last visited on 07 February 2019).
[16] Available at https://scroll.in/pulse/851118/proposed-e-cigarette-ban-users-are-up-in-arms-fear-they-will-return-to-smoking-tobacco (last visited on 07 February 2019); available at https://timesofindia.indiatimes.com/city/bengaluru/Vapers-claim-e-cigarette-ban-not-based-on-any-study-cite-RTI-reply/articleshow/53609261.cms (last visited on 07 February 2019); available at http://vapeindia.org/india/legal/(last visited on 07 February 2019).
[17] Citation awaited
[18] Available at http://vapeindia.org/india/legal/ (last visited on 07 February 2019).
[19] Citation awaited.
