The Maharashtra Health Department is in the process of asking the state Food and Drug Administration to ban e-cigarettes, an electronic smoking device that is often marketed as a “harmless alternative” to tobacco cigarettes. Even as several studies have underscored the dangers of e-cigarettes, their import, distribution and sale has been growing in India’s unregulated markets for a decade. Last month, the Union Health Ministry formed a working group to assess the effect of e-cigarettes on the Indian population, and whether it presents a need for prohibition.
So, what exactly is an e-cigarette?
An e-cigarette or Electronic Nicotine Delivery System (ENDS) is a battery-operated smoking device that creates an aerosol by heating a mix of liquid nicotine, propylene glycol, water, glycerine and flavour, which, when inhaled, gives the feel of smoking a real cigarette. Manufacturers claim the aerosol is just water vapour, but tests have detected the presence of toxic chemicals in it.
Smoking an e-cigarette is sometimes referred to as “vaping”. The device first appeared in Chinese markets in 2004, and was sold as a “healthy alternative to tobacco”. According to the World Health Organisation, since 2005, the e-cigarette industry has grown from just one Chinese manufacturer to a global business worth an estimated $ 3 billion, with 500 brands and 8,000 flavours. The cost of an e-cigarette ranges between Rs 500 to Rs 5,000.
What are some of the specific concerns around e-cigarettes?
Several studies indicate that e-cigarette vapour, although less toxic than smoke from normal cigarettes, is harmful for children, adolescents, and for foetuses in pregnant women. A 2016 Elsevier study on 27 individuals surveyed globally for e-cigarettes found three deaths associated with nicotine poisoning. The report also recorded harmful effects such as respiratory ailments and gastrointestinal problems. “It was claimed the device would help people quit smoking. But studies show it has, in fact, encouraged more people to start smoking because it’s marketed as a product with no harmful effects,” Dr Pankaj Chaturvedi, head and neck oncosurgeon at Tata Memorial Hospital, Mumbai, said. Dr P C Gupta, director of Healis Sekhsaria Institute of Public Health in Navi Mumbai, described e-cigarettes as the gateway for adolescents to start smoking. OD’ing on e-cigarettes can even be fatal. The minimum lethal dose of nicotine is 30-60 mg; an e-cigarette vial contains about 10 mg of nicotine.
Where are e-cigarettes sold in India?
Between 30% and 50% of the Indian e-cigarette market is online, and China is the biggest supplier. ITC makes EON vaping devices in India. India does not regulate e-cigarette sales, making it easy for children and adolescents to buy vapes online. In July 2014, Health Secretary C K Mishra (who was then Additional Secretary in the Ministry) chaired a roundtable under the National Tobacco Control Programme to discuss the potential impact of e-cigarettes. Those present agreed there should be “strong means to stop illegal import of ENDS”, record the minutes of the meeting. Nothing much happened, however. In 2015, the Maharashtra FDA approached the Drug Controller General of India to take steps to regulate the business of e-cigarettes, and sent notices to 23 importers of liquid nicotine in Mumbai, threatening action. Last month, the Union Health Ministry finally formed a working group to study the effects of e-cigarettes, and submit a report on the situation of the Indian market.
So, has no state acted so far?
Punjab has. Through a circular in September 2013, the Punjab State Drug Controller declared e-cigarettes illegal, saying they contained liquid nicotine, which is currently an unregistered drug in India. Nicotine gum (2 mg and 4 mg) and lozenges are regulated under Chapter IV of the Drugs and Cosmetics Act. Rule 122 (E) of the Act states that any change in the form of the same substance will establish it as a new drug. That makes liquid nicotine, which is used in e-cigarettes, technically a new drug, requiring DCGI approval before it can be launched in Indian markets — even though the product continues to be imported, distributed, marketed and sold without licence or registration.
After the Punjab government registered cases against e-cigarette sellers, a sessions court in April 2016 sentenced a Mohali seller to three years in jail, making it the first such conviction and sentencing in India. “We issued public notices to advertise the harmful effects of e-cigarettes. Selling them can attract a fine of Rs 1 lakh or three years’ imprisonment. Conviction in this case has helped spread awareness,” Rakesh Gupta, Deputy Director, Non-Communicable Diseases, Punjab, said.
What is the way forward for authorities in India now?
The way shown by Punjab notwithstanding, until a law or policy is laid down, drug inspectors will find themselves working in a legal grey zone. Sales of e-cigarettes are on the rise, with mint and bubblegum flavours being most favoured by adolescent users. E-commerce outlets retail the device in their Health section with keywords such as “No tobacco, No tar”. E-retail sales make it very difficult to track the age of buyers. In Europe, sales to children under the age of 18 is banned; in the US, e-cigarettes are regulated by the USFDA. American health groups have been demanding that e-cigarettes be treated under the category of tobacco, and be subject to tougher restrictions.