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Health ministry plans to regulate nicotine delivery devices as drugs towards public health safety

Shardul Nautiyal, Mumbai
Friday, August 23, 2019, 08:00 Hrs  [IST]

Union health ministry is all set to regulate nicotine delivery device or Electronic Nicotine Delivery System (ENDS) as drug in the interest of public health safety.

According to the ministry, devices that enable nicotine delivery have neither been tested and assessed for safety and efficacy in Indian population. They have also not been approved under the provision of the D&C Act 1940 and Rules thereunder.

Availability of ENDS products is widespread pan-India posing serious health risks to the users and non-users, the Drug Technical Advisory Board (DTAB) under the Union Health Ministry in its recent recommendation has cautioned.

These products which fall under ENDS include e-cigarette, heat-not burn devices, vape, e-sheesha, e-nicotine flavoured hookah and such devices which enable nicotine delivery.

The state governments of Punjab, Haryana and Union Territory of Chandigarh have declared ENDS or e-cigarette as an unapproved drug under the D&C Act 1940 and Rules 1945 and have commenced prosecutions of sellers of ENDS under the D&C Act 1940.

DTAB has after detailed deliberations recommended that manufacture, sale (including online sale) and distribution of ENDS including e-cigarette, heat-not burn devices, vape, e-sheesha, e-nicotine, flavoured hookah and the like products shall be prohibited under Section 26A of the D&C Act, 1940. It will also prohibit their import (including personal purpose) under Section 10 A of the said Act.

ENDS including e-cigarettes are promoted by the industry body as a smoking cessation aid but their efficacy and safety as a quitting aid has not yet been firmly established. A considerable number of ex-smokers who have reported stopping cigarette use with the aid of ENDS continue using the latter product, thus, sustaining nicotine dependence.

The Food and Drugs Administration (FDA), Haryana has taken action after conducting raids and collected samples of above mentioned products considering these products as unapproved drugs manufactured without licence and launched 37 prosecutions in the competent courts of Chief Judicial Magistrates (CJMs) of various districts.

The Government of India had issued an advisory dated August 28, 2018 on Electronic Nicotine Delivery System (ENDS) stating that ENDS is not sold (including on line sale), manufactured, distributed, traded, imported and advertised in their jurisdiction, except for the purpose and in the manner and to the extent, as may be approved under the D&C Act 1940 and Rules made thereunder.

Subsequent to this advisory, CDSCO on February 22, 2019 had issued letters to all state/UT Drugs Controllers that ENDS including e-cigarette, Heat-Not burn devices, Vape, e-Sheesha, e-Nicotine, Flavoured Hookah and the like products has not yet been approved under the Drugs and Cosmetics Act 1940 and Rules made thereunder and requested them to ensure that any of aforementioned products are not sold (including on line sale), manufactured, distributed, traded, imported and advertised in their jurisdictions.

Also, the State Governments of Karnataka, Kerala, Mizoram, Maharashtra, Jammu & Kashmir, Uttar Pradesh and Bihar have issued necessary orders banning the manufacture, distribution and sale of e-cigarettes as unapproved drug under the D&C Act, 1940.

The ICMR has recommended a complete ban on e-cigarettes and other ENDS based on currently available scientific evidence.

Drug Consultative Committee in its 56th meeting deliberated the issue considering above facts and revisited the previous recommendation of 48th DCC to finally recommend that ENDS including e-cigarette, heat-not burn devices, vape, e-sheesha, e-nicotine, flavoured hookah and the like products are used as a tobacco cessation product and functions for nicotine delivery for reasons including nicotine de-addiction.

Hence these devices and products fall under the definition of “drug” as defined under Section 3(b) of the D&C Act 1940. Nicotine is a drug and has official monographs in various international pharmacopoeias BP, USP, EP dictating the standards and specifications and also comes under the definition of Drug as defined under section 3(b) of D&C Act 1940.

Manufacturing licenses for nicotine drug products, COPPs for export purpose have been issued to various firms after satisfactory joint inspections by state and central licensing authority.


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