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 flavored 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-decibel debate is on globally over the harm-reduction aspects of ENDS with some organizations 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 flavors, 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, requesting him to legalize ENDS claiming their health has improved significantly after they switched to vaping from smoking conventional cigarettes.

The voluntary association of Trade Representatives of ENDS in India (TRENDS) comprising importers, distributors, and marketers of such “alternative” smoking devices also has urged the government to refrain from rushing into any proposals to ban such devices without examining the facts. It has suggested that the government should initiate a consultative process so that the opinion of all stakeholders can be heard and facts placed in the correct perspective.

Asserting that availability of ENDS devices is widespread in the country and is posing serious health risks, the health ministry proposal mentioned that the safety aspect of these products has not been established and their efficacy on Indian population too has not been approved under the provisions of the drug law. In August last year, the Union Health Ministry issued an advisory to all states and Union Territories to stop the manufacture, sale, and import of ENDS. The advisory was subsequently challenged in the Delhi High Court which ruled it to be non-binding on states and government bodies.

The Delhi High Court has stayed the Centre’s circular banning sale and manufacture of ENDS like e-cigarettes and e-hookah with nicotine flavor, saying as the products were not a “drug”, the authorities did not have the jurisdiction to issue such a direction. However, some states, including Punjab, Karnataka, Kerala, Bihar, Uttar Pradesh, Himachal Pradesh, Tamil Nadu, Maharashtra, Jharkhand, Rajasthan, and Mizoram have already banned use and sale of e-cigarettes, vape and e-hookah.

Over 1,000 doctors from 24 states and three UTs in April this year urged Prime Minister Narendra Modi to enforce a ban on ENDS before it becomes an “epidemic in India”, especially among the youth.