Sale of electronic cigarettes (e-cigarettes) containing nicotine has been officially labeled 'illegal' in Maharashtra.
To rein in the rampant use of the battery operated device which is currently available everywhere from departmental stores to paan shops, the state Food and Drug Administration (FDA) has issued show-cause notices to its importers, distributors and dealers for selling the product without mandatory permission from Drug Controller General of India (DCGI) which is in direct contravention of Drugs and Cosmetics Act and makes the trade illegal.
"As per Rule 122 (E) of Drugs and Cosmetics Act 1940 and Rule 1945, every new drug product should be sold in the country with the prior approval of the DCGI. However, import, distribution and sale of e-cigarettes containing nicotine are not approved. Since e-cigarettes are being sold in market without permission, this is contravention of section 18 (b) and 18 (C) of Drugs and Cosmetics Act. Hence, its sale is illegal," state FDA commissioner Harshadeep Kamble told TOI.
He added that importing, manufacturing, selling and distributing e-cigarettes without permission from DCGI and licence from state FDA is illegal and may result in imprisonment of three to five years. Mumbai alone has 23 importers and sellers of e-cigarettes who were issued notices by the FDA on Saturday.
Nicotine is approved for use in de-addiction based chewing gums and lozenges containing less than 2 milligrams of the ingredient. In e-cigarettes, the nicotine levels are very high.
"Permission to sale lozenges, gums containing nicotine less than 2mg are already given by the DCGI. Nicotine products above 2mg are sold only with prescriptions from registered medical practitioners," Kamble said.
The sale of e-cigarettes containing nicotine is on the rise and it is being sold as an alternative to the original cigarettes and mostly marketed to college students.
"Considering that e-cigarettes are addictive and their ill effects on the health of the younger generation especially college students, FDA Maharashtra has decided to curb the illegal trade," Kamble said
As per the Drugs and Cosmetics Act there are certain set of rules and regulations for manufacturing of various drugs and such quality control does not exist for e-cigarettes. Therefore, the quality of e-cigarettes cannot to be ascertained. Smoking of e-cigarettes also leads to addiction and it affects the health badly. There have been demands from various social quarters, NGOs and doctors that e-cigarettes should be banned.
FDA has appealed to the public that smoking of cigarettes, e-cigarettes and products containing tobacco lead to addiction and is very harmful to the health therefore they should refrain from use of such substances to lead a healthy life.
To rein in the rampant use of the battery operated device which is currently available everywhere from departmental stores to paan shops, the state Food and Drug Administration (FDA) has issued show-cause notices to its importers, distributors and dealers for selling the product without mandatory permission from Drug Controller General of India (DCGI) which is in direct contravention of Drugs and Cosmetics Act and makes the trade illegal.
"As per Rule 122 (E) of Drugs and Cosmetics Act 1940 and Rule 1945, every new drug product should be sold in the country with the prior approval of the DCGI. However, import, distribution and sale of e-cigarettes containing nicotine are not approved. Since e-cigarettes are being sold in market without permission, this is contravention of section 18 (b) and 18 (C) of Drugs and Cosmetics Act. Hence, its sale is illegal," state FDA commissioner Harshadeep Kamble told TOI.
He added that importing, manufacturing, selling and distributing e-cigarettes without permission from DCGI and licence from state FDA is illegal and may result in imprisonment of three to five years. Mumbai alone has 23 importers and sellers of e-cigarettes who were issued notices by the FDA on Saturday.
Nicotine is approved for use in de-addiction based chewing gums and lozenges containing less than 2 milligrams of the ingredient. In e-cigarettes, the nicotine levels are very high.
"Permission to sale lozenges, gums containing nicotine less than 2mg are already given by the DCGI. Nicotine products above 2mg are sold only with prescriptions from registered medical practitioners," Kamble said.
The sale of e-cigarettes containing nicotine is on the rise and it is being sold as an alternative to the original cigarettes and mostly marketed to college students.
"Considering that e-cigarettes are addictive and their ill effects on the health of the younger generation especially college students, FDA Maharashtra has decided to curb the illegal trade," Kamble said
As per the Drugs and Cosmetics Act there are certain set of rules and regulations for manufacturing of various drugs and such quality control does not exist for e-cigarettes. Therefore, the quality of e-cigarettes cannot to be ascertained. Smoking of e-cigarettes also leads to addiction and it affects the health badly. There have been demands from various social quarters, NGOs and doctors that e-cigarettes should be banned.
FDA has appealed to the public that smoking of cigarettes, e-cigarettes and products containing tobacco lead to addiction and is very harmful to the health therefore they should refrain from use of such substances to lead a healthy life.
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