ENDS cannot be defined as drugs as under section 3(b) of the Drugs and Cosmetics Act

India

healtysoch.com

New Delhi, September 08, 2019 :

There have been various newspaper reports that the Health Ministry is considering classifying electronic nicotine delivery systems (ENDS) as “drug” to justify its order to ban their manufacture, sale and import in India.

If the Government is proposing to do so, it would be taking a stand opposite to its earlier position that ENDS are not a drug.

In 2015, the Drug Consultative Committee (DCC) had conclusively held that “e-cigarettes are not covered under the definition of the term ‘drug’ and therefore do not come under the purview of the Drugs and Cosmetics Act, 1940. E-Cigarettes therefore cannot be regulated under the provisions of the said Act”. But strangely, the DCC changed its opinion and now (in 2019) holds that ENDS are ‘Drug’ items as per the definition of ‘Drugs’ provided in the Drugs and Cosmetic Act, 1940 and, therefore, can be regulated by the authorities under this Act.

The DCC is a statutory committee formed under Section 7 of the D&C Act. It advises the Central Government, the State Governments and the Drugs Technical Advisory Board on any matter tending to secure uniformity throughout India in the administration of the D&C Act. Hence, such a turnabout is surprising to say the least. And, there has been no clarification as to why the government reversed its viewpoint or even re-examined its decision.

If we examine whether ENDS can be categorized as a drug, this merits a relook at the definition of drug as included in Section 3(b) of the D&C Act.

ENDS are not used for any diagnosis, treatment or prevention of any disease. They are used as a substitute for or alternative to combustible cigarettes; clearly, ENDS cannot be classified as “drug” or “medicine”.

The High Court of Delhi also took a similar view and prima facie held that ENDS cannot be defined as drugs as under section 3(b) of the Drugs and Cosmetics Act 1940 and issued a stay on the government’s advisory to states, the Central Board of Indirect Taxes and Customs (CBIC) and state drug controllers asking them to ban sales, trade, import, manufacturing and promotion of ENDS. There is no final verdict on this.

Since ENDS do not fit the bill as per Section 3(b) of the D&C Act, Sections 10A (to ban the import of ENDS) or 26A (to ban the manufacture of ENDS) will not be applicable to ENDS.

It is ironic that while the government is seeking to enforce a ban on ENDS by categorizing them as a “drug”, it continues to allow the sale of combustible cigarettes.

If the government is convinced that ENDS are harmful to health, by the same yardstick, combustible cigarettes must also be banned. Combustible cigarettes mandatorily carry statutory graphical and textual health warnings. There already exists a large body of evidence documenting their harmful effects on human health.

A danger that the government must anticipate, if ENDS are banned, is the availability of counterfeit devices, which may even pose a threat to life. And, the government may have no control over them.

ENDS are a less-harmful alternative to combustible cigarettes. According to an evidence review by the Public Health England, ENDS are 95% less harmful than tobacco smoking.

Instead of completely prohibiting their sale and manufacture, ENDS can be regulated under COTPA or the Cigarettes and Other Tobacco Products Act, 2003. This would effectively stop sale of ENDS to the youth, a major concern of the government. COTPA will also take care of public advertising and marketing strategies adopted for ENDS. If combustible cigarettes can be regulated under COTPA, there is scope for ENDS to be also included under the purview of the same law.

Author : Personal Opinion of  KK Aggarwal , Padma Shri Awardee