A month after India’s top drug advisory body recommended moves to help the government ban products like e-cigarettes and vapes, the Health Ministry has sought the Law Ministry’s opinion on whether it can go ahead with them, The Indian Express has learnt. This is because the Health Ministry is locked in litigation opposing the ban, according to senior officials aware of the development.
In June, the Drugs Technical Advisory Board (DTAB) approved a proposal to regulate Electronic Nicotine Delivery Systems (ENDS) as ‘drugs’ and prohibit their sale in the country — a move that may hit India’s nascent vapour products market, reportedly expected to grow nearly 60 per cent annually up to 2022. This includes products like e-cigarettes, vapes, e-sheeshas, e-nicotine flavoured hookas and heat-not burn devices, all not approved under India’s drug regulations.
A senior official confirmed banning ENDS is part of the Health Ministry’s 100-day agenda, but another said it is holding off on implementing DTAB’s recommendations to clear legal hurdles.
“The Ministry wants to know, at this juncture, when the matter is already in court, whether the government can (move ahead with a ban),” the official said on condition of anonymity, adding that views have been sought from the Law Ministry.
Litigation on the proposed ban include petitions at the Delhi High Court by UK-based e-cigarette firm Litejoy and Focus Brands Trading (India) against government letters in February asking states and union territories to ensure ENDS products were prohibited in their jurisdictions.
Court orders show Litejoy argued the direction was “without the authority of law” as ENDS is not classified as a drug under India’s drug regulations. Focus Brands Trading claimed ENDS like e-cigarettes are substitutes to smoking combustible cigarettes and are “healthier” because no tar is inhaled in the process.
The court in March stayed the government’s directions, stating the products do not fall within the definition of a ‘drug’ under the Drugs and Cosmetics Act, 1940.
As a result, the government “would not have the jurisdiction” to issue such directions to states or prevent imports, according to the court, which also stayed a November 2018 circular on prohibiting ENDS to all customs authorities.
The Mumbai High Court last week also stopped state authorities from acting against Godfrey Philips India while it heard the tobacco maker’s case on seizure of its e-cigarettes. “The ministry’s view is clear—it wants to ban (ENDS),” said the Health Ministry official cited earlier.
Various bodies have made representations to the Ministry against banning ENDS products. For instance, the Voluntary Association of Trade Representatives of ENDS in India (TRENDS) on July 24 wrote to Union Health Minister Harsh Vardhan stating 69 nations allow and regulate ENDS. It said it was willing to enforce “self-regulatory measures” to prohibit sale of these products to minors.
Another senior official had earlier said that the government would act on recommendations and evidence produced by its own research bodies, including the Indian Council of Medical Research (ICMR).
“We will go by the risk associated with the products based on recommendations (from our experts).”
ENDS have not been assessed for safety and efficacy in India’s population, according to government sources.
E-cigarettes are the most common type of ENDS — more than 460 different brands with over 7,700 flavours are marketed here currently, according to government data. Commerce Ministry data shows that imports of e-cigarettes, its accessories and ENDS grew around 119 per cent to $83,483.54 in 2018-19 from $38,126.34 in 2016-17.
ICMR’s white paper in May stated that ENDS contain “highly addictive” nicotine solution and ingredients that are “harmful” for health.
Adverse effects include DNA damage, potential cancer formation and respiratory and cardiovascular disorders, according to it.