Three Ministries Advance Regulations to Control E-Cigarettes

A proposed amendment to the IT Act will ban the advertisement of e-cigarettes in India.

New Delhi: Various forms of e-cigarettes face growing resistance from the government in their efforts to break into the Indian market. At least three ministries have advanced new regulations on the marketing or import of Electronic Nicotine Delivery Systems – widely known as vapes – while the medical community debates their actual effects on health.

The Ministry of Electronics and Information Technology (MEITY) has proposed an amendment to the Information Technology (Intermediary Guidelines) Rules 2018 to ban the advertisement of e-cigarettes.

Also Read: Why the E-Cigarette Industry Needs Global Regulations

Meanwhile, the Central Board of Indirect Taxes and Customs has issued a circular – referring to an advisory from the Union health ministry – that all import consignments of e-cigarettes must be cleared by the drug controller first.

Electronic Nicotine Delivery Systems (ENDS) include various types of e-cigarettes, which deliver nicotine without some of the known harmful substances from cigarettes containing tobacco. Some work on the principal of ‘heat not burn’, where tobacco or nicotine solutions are heated to temperatures lower than cigarettes.

According to the Global Adult Tobacco Survey (2016- 2017), awareness of e-cigarettes is already the highest among adolescents (4%). A World Health Organisation report in 2014 said nicotine may function as a “tumour promoter” and recommends that countries prohibit the advertisement of ENDS and any “implicit or explicit claims” about its effectiveness.

Curbing advertisements

The most striking curb on e-cigarettes comes from the proposed amendments to the IT Act. The legislation was enacted in 2000 to boost and regulate e-commerce transactions, to prevent digital crime and – more recently – to curb fake news on social media.

Section three of the proposed rules states that “intermediaries” should ensure they do not publish information on anything that threatens public health or safety. It goes on to specifically mention tobacco products, intoxicants including alcohol and also specifically mentions ENDS.

The inclusion of ENDS is surprising because Section 3 is brief, but with some grave prohibitions listed.

For example, it directs intermediaries to not publish anything that threatens the “unity, integrity, defence, security or sovereignty of India”, or that is obscene, pornographic, paedophilic, invasive of privacy or racist.

Public health professionals working on tobacco control say the proposed amendment is a good idea. “E-cigarettes are not yet approved for manufacture or sale under the Drugs and Cosmetics Act,” said Dr Rakesh Gupta, deputy director of the health department, Punjab. “Nicotine is a highly addictive chemical which can lead to neurological, cardio-vascular and lung disease and can be lethal if ingested accidentally.”

Also Read: Taking Steps To Completely Ban E-Cigarettes, Delhi Government Tells Court

Advocates for e-cigarettes in India, however, say that the government is curbing the spread of useful information. “This proposed amendment to the IT Act is another instance of the government clamping down on safer alternatives to tobacco, which kills a million Indians every year,” said Samrat Chowdhery of the Association of Vapers India.

A screenshot of the guidelines. Credit: meity.gov.in

Health implications

A health ministry advisory issued in August 2018 contradicts the lobbyists’ claims. It says ENDS is a “great health risk to public at large, especially to children, adolescents, pregnant women and women of reproductive age.” It says that young people may get addicted to nicotine (the addictive component of tobacco products) and then are “likely to switch to cigarette smoking.”

It also advises all states to ensure that nicotine devices are “not sold (including online), manufactured, distributed, traded, imported and advertised.”

In November, a Delhi high court order said this advisory is not binding on states.

Even so, nicotine is already regulated and even banned by at least four Indian laws. It is already listed as a hazardous chemical and as an insecticide. It is also prohibited as an ingredient in food products.

The Drugs and Cosmetics Act will also need to approve ENDS as a valid nicotine replacement therapy, before ENDS products can obtain drug manufacturing or sale licenses. India’s drug controller has not yet approved these products.

Electronic cigarette vaporisers. Credit: Wikipedia

Regulating imports

A recent customs department circular which The Wire has a copy of, has also cramped access to Indian markets.

The circular refers to the health ministry’s advisory and says that it should be implemented. It says all ENDS import consignments should be referred to the respective drug controllers of the state, who can then check the compliance of the products against the Drugs and Cosmetics Act. Based on those reports, non-compliant consignments can be denied clearance and punitive action can be taken against those in violation.

Also Read: High-Nicotine E-Cigarettes Flood US Market Despite FDA Rule

A finance ministry official explained to The Wire that this regulation would apply to consignments that arrive at maritime ports as well as inland posts. “While the Delhi high court has said that the advisory is not binding and the circular asks drug controllers to decide, ENDS still will need to be approved by the central drug controller first, before it is let into the market,” he said. “State drug controllers are likely to also adhere to this.”

The Central Drugs Standard Control Organisation (CDSCO) is a body under the Union health ministry, which issued the advisory in the first place.