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Don't allow sale, manufacture & ad of e-cigarettes, ENDS: Central Drug Regulator to states, UTs

PTI Mar 13, 2019

The Central Drug Regulator has directed all drug controllers in states and Union territories to not allow the manufacture, sale, import and advertisement of Electronic Nicotine Delivery Systems, including e-cigarettes and flavoured hookah, in their jurisdictions.




"Since no Electronic Nicotine Delivery Systems (ENDS), including e-cigarettes, heat-not-burn devices, vape, e-sheesha, e-nicotine flavoured hookah, and the like products have not yet been approved under the Drugs and Cosmetics Act 1940 and rules made thereunder, you are requested to ensure devices that enable nicotine delivery are not sold (including online sale), manufactured, distributed, traded, imported and advertised in your jurisdictions," the regulator's order stated.

In August last year, the Health Ministry issued an advisory to all states and UTs to stop the manufacture, sale and import of ENDS after the Delhi HC took a strong exception to the Centre for delay in coming up with appropriate measures to tackle the new emerging threat of e-cigarettes in the country.

ENDS are devices that heat a solution to create an aerosol, which also frequently contains flavours, usually dissolved into propylene glycol and glycerin. Electronic cigarettes or e-cigarettes, the most common prototype, are devices that do not burn or use tobacco leaves but instead vaporise a solution, which a user then inhales.

The main constituents of the solution, in addition to nicotine, are propylene glycol (with or without glycerol and flavouring agents). After the MoHFW advisory, the Ministry of Electronics and Information Technology, too, proposed an amendment to the Information Technology (Intermediary Guidelines) Rules 2018 to ban the advertisement of e-cigarettes.

Even the Central Board of Indirect Taxes and Customs issued a circular recently, saying that all import consignments of e-cigarettes must be cleared by the drug controller first. Steadfast in its commitment to protect the health of children, adolescents and women of reproductive age, 36 countries around the world and 12 states in India have banned the sale of e-cigarettes due to its health harms. 

In India, Punjab, Maharashtra, Karnataka, Kerala, Bihar, Uttar Pradesh, Jammu & Kashmir, Himachal Pradesh, Tamil Nadu, Puducherry and Jharkhand have taken steps to ban the use of ENDS. "Nicotine is highly toxic chemical and potentially carcinogenic. Infact, it will not be an exaggeration if it is considered as a poison. Therefore, any nicotine product should be taken under strict medical supervision for controlling withdrawal symptoms during cessation therapy. I laud government of India for taking us a tough stand against these newer nicotine delivery devices," Pankaj Chaturvedi, oncologist, Tata Memorial Hospital, said.

The increasing popularity of Electronic Nicotine Delivery Systems (ENDS), more commonly known as e-cigarettes or vapes , threatens to undermine recent progress on tobacco control in India. E-cigarettes do not fall within the scope of existing national legislation on tobacco production, distribution, and use, yet pose significant health risks to users that are frighteningly similar to those of conventional cigarettes.

As per a report prepared by the World Health Organisation, ENDS emits nicotine, the addictive component of tobacco products. In addition to dependence, nicotine can have adverse effects on the development of the foetus during pregnancy and may contribute to cardiovascular disease.

There is no substantial evidence to prove that ENDS work for cessation and are less harmful than the tobacco products, Prakash C Gupta, director of Healis Sekhsaria Institute of Public Health, said. "Naming 'e-cigarette' is a tactic used by the industry to fool media and public by giving it a tubular shape and putting a red LED at the tip which lights up when the tube is sucked to mimic cigarette smoking. "It is as incorrect to call it a tobacco product as calling penicillin, a fungal product. It is a nicotine delivery device and ought to be regulated as such," Gupta said.

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