Union Health Ministry's proposal to classify ENDS devices as 'drugs' sent to Attorney General

The Union Health ministry's proposal to classify ENDS devices including e-cigarettes as "drugs" in order to ban their manufacture, sale, distribution and import, has been sent to the Attorney General for his opinion, officials said Thursday.

Banning such alternative smoking devices like e-cigarettes, heat-not-burn devices, vape and e-nicotine flavoured hookah among others, is one of the priorities of the Health ministry in the first 100 days agenda of the second term of the Modi government, an official source said.

"The proposal which has been approved by the Drug Technical Advisory Board (DTAB), the government's top advisory body on technical matters related to medicines in the country is now awaiting opinion from the Attorney General," the source said.

The Union Health Ministry's proposal pertains to classifying ENDS devices including e-cigarettes as "drugs" under the Drugs and Cosmetics Act.

A high-decibal debate is on globally over the harm-reduction aspects of ENDS with some organisations claiming that these devices help in smoking cessation and are less harmful alternatives to traditional cigarettes, while the government is seeking to ban them contending that they pose health risks to users, similar to those of conventional cigarettes.

ENDS are devices that heat a solution to create an aerosol, which also frequently contains flavours, usually dissolved into propylene glycol and glycerin.

The Central Drugs Standard Control Organisation (CDSCO), under the health ministry has proposed that manufacture, sale and distribution of ENDS, including e-cigarettes and similar products, should be prohibited under Section 26A of the Drugs and Cosmetics Act, 1940, while their import should be outlawed under Section 10A of the legislation.

The proposal stated that under the provisions of 'drugs' in the Act, any item intended to be used as an aid to help quit smoking is covered under the definition of drugs.

Apex research body - the Indian Council of Medical Research (ICMR) has recommended a "complete ban" on Electronic Nicotine Delivery Systems (ENDS), saying their use can initiate nicotine addiction among non-smokers also.

In a white paper released recently, the ICMR said e-cigarettes adversely affects the cardiovascular system, impairs respiratory immune cell function and airways in a way similar to cigarette smoking and is responsible for severe respiratory diseases.

However, a consumer body, the Association of Vapers India (AVI), has questioned the veracity of ICMR white paper on ENDS, saying empirical evidence from countries that have allowed e-cigarettes show "smoking rates have declined at a historic pace".

More than 3,000 users of these devices, recently, also wrote to the prime minister,
The voluntary association of Trade Representatives of ENDS in India (TRENDS) comprising importers, distributors, and marketers of such "alternative" smoking devices