Wednesday, August 21, 2019

Can a poison be available over the counter?

Dr KK Aggarwal

The Karnataka state has classified nicotine as a poisonous substance under the Karnataka Poisons Rules, 2019 under the Poisons Act, 1919.

Applicable laws

1. Section 02: Power of the state government to regulate possession for sale and sale of any poison: (1) The [State Government] may by rule regulate within the whole or any part of the territories under its administration the possession for sale and the sale, whether wholesale or retail, of any specified poison.

2. Section 03: Power to prohibit importation into the states of any poison except under licence: The [Central Government] may, by notification in the [Official Gazette], prohibit except under and in accordance with the conditions of a licence, the importation into [India] [across any customs frontier defined by the Central Government] of any specified poison, and may by rule regulate the grant of licences.

State government has amended the Karnataka Poisons (Possession and Sale) Rules, 2015 to notify nicotine as a Class A poison. As per the new rule, sale and consumption of nicotine tablets of only 2 mg and 4 mg dosages will be allowed for deaddiction.

Question: Can a poison be allowed to be sold as an over the counter (OTC) drug (nicotine gums and patches) under schedule K of the Drugs and Cosmetics Act?

Even if they classify it as carcinogen, is it comparable to tobacco?

Let us see what WHO has to say (

“9. Processed meat was classified as carcinogenic to humans (Group 1). Tobacco smoking and asbestos are also both classified as carcinogenic to humans (Group 1). Does this mean that consumption of processed meat is as carcinogenic as tobacco smoking and asbestos?

No, processed meat has been classified in the same category as causes of cancer such as tobacco smoking and asbestos (IARC Group 1, carcinogenic to humans), but this does NOT mean that they are all equally dangerous. The IARC classifications describe the strength of the scientific evidence about an agent being a cause of cancer, rather than assessing the level of risk.”

If not, bringing it as a poison does not make a case of banning it under the new rules. Remember tobacco is an over-the-counter product.

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